Tyvaso DPI: Package Insert and Label Information (Page 4 of 4)

PRINCIPAL DISPLAY PANEL — 16 mcg Maintenance Kit

NDC 66302-616-03
Rx ONLY

Maintenance Kit

FOR ORAL INHALATION ONLY
KIT CONTAINS:

112 cartridges, each containing
16 mcg per cartridge
+ 5
Inhalers

This MAINTENANCE KIT is NOT intended
for initial titration.

TYVASO DPI™
(treprostinil)
INHALATION
POWDER

16
mcg per
cartridge

BLISTER STORAGE
Unopened Blister Cards/Strips:
Store refrigerated at 2°C to 8°C (36°F to 46°F). Discard
unopened blister strips stored at room temperature after 5 weeks.

Opened Blister Strips:
Store at 20°C to 25°C (68°F to 77°F) with excursions permitted
to 15°C to 30°C (59°F to 86°F) [See USP Controlled Room
Temperature]. Discard opened blister strips holding unused
cartridges 3 days after opening.

INHALER STORAGE
Store at 2°C to 25°C (36°F to 77°F) excursions permitted.
May be stored refrigerated, but must be at room temperature
before use.

The inhaler can be used for up to 7 days from the date of
first use. After 7 days of use, discard the used inhaler and replace with a new inhaler.

PRINCIPAL DISPLAY PANEL -- 16 mcg Maintenance Kit
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 16 mcg Institutional Kit

NDC 66302-716-04
Rx ONLY

Institutional Kit

FOR ORAL INHALATION ONLY
KIT CONTAINS:

16 cartridges, each containing
16 mcg per cartridge
+ 2
Inhalers

This INSTITUTIONAL KIT is NOT intended
for initial titration.

TYVASO DPI™
(treprostinil)
INHALATION
POWDER

16
mcg per
cartridge

BLISTER STORAGE
Unopened Blister Cards/Strips:
Store refrigerated at 2°C to 8°C (36°F to 46°F). Discard
unopened blister strips stored at room temperature after 5 weeks.

Opened Blister Strips:
Store at 20°C to 25°C (68°F to 77°F) with excursions permitted
to 15°C to 30°C (59°F to 86°F) [See USP Controlled Room
Temperature]. Discard opened blister strips holding unused
cartridges 3 days after opening.

INHALER STORAGE
Store at 2°C to 25°C (36°F to 77°F) excursions permitted.
May be stored refrigerated, but must be at room temperature
before use.

The inhaler can be used for up to 7 days from the date of
first use. After 7 days of use, discard the used inhaler and replace with a new inhaler.

PRINCIPAL DISPLAY PANEL -- 16 mcg Institutional Kit
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 32 mcg Maintenance Kit

NDC 66302-632-03
Rx ONLY

Maintenance Kit

FOR ORAL INHALATION ONLY
KIT CONTAINS:

112 cartridges, each containing
32 mcg per cartridge
+ 5
Inhalers

This MAINTENANCE KIT is NOT intended
for initial titration.

TYVASO DPI™
(treprostinil)
INHALATION
POWDER

32
mcg per
cartridge

BLISTER STORAGE
Unopened Blister Cards/Strips:
Store refrigerated at 2°C to 8°C (36°F to 46°F). Discard
unopened blister strips stored at room temperature after 5 weeks.

Opened Blister Strips:
Store at 20°C to 25°C (68°F to 77°F) with excursions permitted
to 15°C to 30°C (59°F to 86°F) [See USP Controlled Room
Temperature]. Discard opened blister strips holding unused
cartridges 3 days after opening.

INHALER STORAGE
Store at 2°C to 25°C (36°F to 77°F) excursions permitted.
May be stored refrigerated, but must be at room temperature
before use.

The inhaler can be used for up to 7 days from the date of
first use. After 7 days of use, discard the used inhaler and replace with a new inhaler.

PRINCIPAL DISPLAY PANEL -- 32 mcg Maintenance Kit
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 32 mcg Institutional Kit

NDC 66302-732-04
Rx ONLY

Institutional Kit

FOR ORAL INHALATION ONLY
KIT CONTAINS:

16 cartridges, each containing
32 mcg per cartridge
+ 2
Inhalers

This INSTITUTIONAL KIT is NOT intended
for initial titration.

TYVASO DPI™
(treprostinil)
INHALATION
POWDER

32
mcg per
cartridge

BLISTER STORAGE
Unopened Blister Cards/Strips:
Store refrigerated at 2°C to 8°C (36°F to 46°F). Discard
unopened blister strips stored at room temperature after 5 weeks.

Opened Blister Strips:
Store at 20°C to 25°C (68°F to 77°F) with excursions permitted
to 15°C to 30°C (59°F to 86°F) [See USP Controlled Room
Temperature]. Discard opened blister strips holding unused
cartridges 3 days after opening.

INHALER STORAGE
Store at 2°C to 25°C (36°F to 77°F) excursions permitted.
May be stored refrigerated, but must be at room temperature
before use.

The inhaler can be used for up to 7 days from the date of
first use. After 7 days of use, discard the used inhaler and replace with a new inhaler.

PRINCIPAL DISPLAY PANEL -- 32 mcg Institutional Kit
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 48 mcg Maintenance Kit

NDC 66302-648-03
Rx ONLY

Maintenance Kit

FOR ORAL INHALATION ONLY
KIT CONTAINS:

112 cartridges, each containing
48 mcg per cartridge
+ 5
Inhalers

This MAINTENANCE KIT is NOT intended
for initial titration.

TYVASO DPI™
(treprostinil)
INHALATION
POWDER

48
mcg per
cartridge

BLISTER STORAGE
Unopened Blister Cards/Strips:
Store refrigerated at 2°C to 8°C (36°F to 46°F). Discard
unopened blister strips stored at room temperature after 5 weeks.

Opened Blister Strips:
Store at 20°C to 25°C (68°F to 77°F) with excursions permitted
to 15°C to 30°C (59°F to 86°F) [See USP Controlled Room
Temperature]. Discard opened blister strips holding unused
cartridges 3 days after opening.

INHALER STORAGE
Store at 2°C to 25°C (36°F to 77°F) excursions permitted.
May be stored refrigerated, but must be at room temperature
before use.

The inhaler can be used for up to 7 days from the date of
first use. After 7 days of use, discard the used inhaler and replace with a new inhaler.

PRINCIPAL DISPLAY PANEL -- 48 mcg Maintenance Kit
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 48 mcg Institutional Kit

NDC 66302-748-04
Rx ONLY

Institutional Kit

FOR ORAL INHALATION ONLY
KIT CONTAINS:

16 cartridges, each containing
48 mcg per cartridge
+ 2
Inhalers

This INSTITUTIONAL KIT is NOT intended
for initial titration.

TYVASO DPI™
(treprostinil)
INHALATION
POWDER

48
mcg per
cartridge

BLISTER STORAGE
Unopened Blister Cards/Strips:
Store refrigerated at 2°C to 8°C (36°F to 46°F). Discard
unopened blister strips stored at room temperature after 5 weeks.

Opened Blister Strips:
Store at 20°C to 25°C (68°F to 77°F) with excursions permitted
to 15°C to 30°C (59°F to 86°F) [See USP Controlled Room
Temperature]. Discard opened blister strips holding unused
cartridges 3 days after opening.

INHALER STORAGE
Store at 2°C to 25°C (36°F to 77°F) excursions permitted.
May be stored refrigerated, but must be at room temperature
before use.

The inhaler can be used for up to 7 days from the date of
first use. After 7 days of use, discard the used inhaler and replace with a new inhaler.

PRINCIPAL DISPLAY PANEL -- 48 mcg Institutional Kit
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 64 mcg Maintenance Kit

NDC 66302-664-03
Rx ONLY

Maintenance Kit

FOR ORAL INHALATION ONLY
KIT CONTAINS:

112 cartridges, each containing
64 mcg per cartridge
+ 5
Inhalers

This MAINTENANCE KIT is NOT intended
for initial titration.

TYVASO DPI™
(treprostinil)
INHALATION
POWDER

64
mcg per
cartridge

BLISTER STORAGE
Unopened Blister Cards/Strips:
Store refrigerated at 2°C to 8°C (36°F to 46°F). Discard
unopened blister strips stored at room temperature after 5 weeks.

Opened Blister Strips:
Store at 20°C to 25°C (68°F to 77°F) with excursions permitted
to 15°C to 30°C (59°F to 86°F) [See USP Controlled Room
Temperature]. Discard opened blister strips holding unused
cartridges 3 days after opening.

INHALER STORAGE
Store at 2°C to 25°C (36°F to 77°F) excursions permitted.
May be stored refrigerated, but must be at room temperature
before use.

The inhaler can be used for up to 7 days from the date of
first use. After 7 days of use, discard the used inhaler and replace with a new inhaler.

PRINCIPAL DISPLAY PANEL -- 64 mcg Maintenance Kit
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 64 mcg Institutional Kit

NDC 66302-764-04
Rx ONLY

Institutional Kit

FOR ORAL INHALATION ONLY
KIT CONTAINS:

16 cartridges, each containing
64 mcg per cartridge
+ 2
Inhalers

This INSTITUTIONAL KIT is NOT intended
for initial titration.

TYVASO DPI™
(treprostinil)
INHALATION
POWDER

64
mcg per
cartridge

BLISTER STORAGE
Unopened Blister Cards/Strips:
Store refrigerated at 2°C to 8°C (36°F to 46°F). Discard
unopened blister strips stored at room temperature after 5 weeks.

Opened Blister Strips:
Store at 20°C to 25°C (68°F to 77°F) with excursions permitted
to 15°C to 30°C (59°F to 86°F) [See USP Controlled Room
Temperature]. Discard opened blister strips holding unused
cartridges 3 days after opening.

INHALER STORAGE
Store at 2°C to 25°C (36°F to 77°F) excursions permitted.
May be stored refrigerated, but must be at room temperature before use.

The inhaler can be used for up to 7 days from the date of
first use. After 7 days of use, discard the used inhaler and replace with a new inhaler.

PRINCIPAL DISPLAY PANEL -- 64 mcg Institutional Kit
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 16 mcg 32 mcg Titration Kit

NDC 66302-600-02
Rx ONLY

Titration Kit

FOR ORAL INHALATION ONLY
KIT CONTAINS:

112 cartridges, each containing
16 mcg per cartridge
84 cartridges, each containing
32 mcg per cartridge
+ 5
Inhalers

TYVASO DPI™
(treprostinil)
INHALATION
POWDER

16
mcg per
cartridge
32
mcg per
cartridge

BLISTER STORAGE
Unopened Blister Cards/Strips:
Store refrigerated at 2°C to 8°C (36°F to 46°F). Discard
unopened blister strips stored at room temperature after 5 weeks.

Opened Blister Strips:
Store at 20°C to 25°C (68°F to 77°F) with excursions permitted
to 15°C to 30°C (59°F to 86°F) [See USP Controlled Room
Temperature]. Discard opened blister strips holding unused
cartridges 3 days after opening.

INHALER STORAGE
Store at 2°C to 25°C (36°F to 77°F) excursions permitted.
May be stored refrigerated, but must be at room temperature
before use.

The inhaler can be used for up to 7 days from the date of
first use. After 7 days of use, discard the used inhaler and replace with a new inhaler.

PRINCIPAL DISPLAY PANEL -- 16 mcg 32 mcg Titration Kit
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 32 mcg 48 mcg Maintenance Kit

NDC 66302-620-03
Rx ONLY

Maintenance Kit

FOR ORAL INHALATION ONLY
KIT CONTAINS:

112 cartridges, each containing
32 mcg per cartridge
112 cartridges, each containing
48 mcg per cartridge
+ 5
Inhalers

This MAINTENANCE KIT is NOT intended
for initial titration.

TYVASO DPI™
(treprostinil)
INHALATION
POWDER

32
mcg per
cartridge
48
mcg per
cartridge

BLISTER STORAGE
Unopened Blister Cards/Strips:
Store refrigerated at 2°C to 8°C (36°F to 46°F). Discard
unopened blister strips stored at room temperature after 5 weeks.

Opened Blister Strips:
Store at 20°C to 25°C (68°F to 77°F) with excursions permitted
to 15°C to 30°C (59°F to 86°F) [See USP Controlled Room
Temperature]. Discard opened blister strips holding unused
cartridges 3 days after opening.

INHALER STORAGE
Store at 2°C to 25°C (36°F to 77°F) excursions permitted.
May be stored refrigerated, but must be at room temperature
before use.

The inhaler can be used for up to 7 days from the date of
first use. After 7 days of use, discard the used inhaler and replace with a new inhaler.

PRINCIPAL DISPLAY PANEL -- 32 mcg 48 mcg Maintenance Kit
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 32 mcg 48 mcg Institutional Kit

NDC 66302-720-04
Rx ONLY

Institutional Kit

FOR ORAL INHALATION ONLY
KIT CONTAINS:

16 cartridges, each containing
32 mcg per cartridge
16 cartridges, each containing
48 mcg per cartridge
+ 2
Inhalers

This INSTITUTIONAL KIT is NOT intended
for initial titration.

TYVASO DPI™
(treprostinil)
INHALATION
POWDER

32
mcg per
cartridge
48
mcg per
cartridge

BLISTER STORAGE
Unopened Blister Cards/Strips:
Store refrigerated at 2°C to 8°C (36°F to 46°F). Discard
unopened blister strips stored at room temperature after 5 weeks.

Opened Blister Strips:
Store at 20°C to 25°C (68°F to 77°F) with excursions permitted
to 15°C to 30°C (59°F to 86°F) [See USP Controlled Room
Temperature]. Discard opened blister strips holding unused
cartridges 3 days after opening.

INHALER STORAGE
Store at 2°C to 25°C (36°F to 77°F) excursions permitted.
May be stored refrigerated, but must be at room temperature
before use.

The inhaler can be used for up to 7 days from the date of
first use. After 7 days of use, discard the used inhaler and replace with a new inhaler.

PRINCIPAL DISPLAY PANEL -- 32 mcg 48 mcg Institutional Kit
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 16 mcg 32 mcg 48 mcg Titration Kit

NDC 66302-610-02
Rx ONLY

Titration Kit

FOR ORAL INHALATION ONLY
KIT CONTAINS:

112 cartridges, each containing
16 mcg per cartridge
112 cartridges, each containing
32 mcg per cartridge
28 cartridges, each containing
48 mcg per cartridge
+ 5
Inhalers

TYVASO DPI™
(treprostinil)
INHALATION
POWDER

16
mcg per
cartridge
32
mcg per
cartridge
48
mcg per
cartridge

BLISTER STORAGE
Unopened Blister Cards/Strips:
Store refrigerated at 2°C to 8°C (36°F to 46°F). Discard
unopened blister strips stored at room temperature after 5 weeks.

Opened Blister Strips:
Store at 20°C to 25°C (68°F to 77°F) with excursions permitted
to 15°C to 30°C (59°F to 86°F) [See USP Controlled Room
Temperature]. Discard opened blister strips holding unused
cartridges 3 days after opening.

INHALER STORAGE
Store at 2°C to 25°C (36°F to 77°F) excursions permitted.
May be stored refrigerated, but must be at room temperature
before use.

The inhaler can be used for up to 7 days from the date of
first use. After 7 days of use, discard the used inhaler and replace with a new inhaler.

PRINCIPAL DISPLAY PANEL -- 16 mcg 32 mcg 48 mcg Titration Kit
(click image for full-size original)
TYVASO DPI treprostinil inhalant
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:66302-616
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
treprostinil (treprostinil) treprostinil 16 ug
Inactive Ingredients
Ingredient Name Strength
fumaryl diketopiperazine
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:66302-616-03 4 BLISTER PACK in 1 KIT contains a BLISTER PACK
1 7 BLISTER PACK in 1 BLISTER PACK This package is contained within the KIT (66302-616-03) and contains a BLISTER PACK
1 4 INHALANT in 1 BLISTER PACK This package is contained within a BLISTER PACK and a KIT (66302-616-03)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA214324 05/23/2022
TYVASO DPI treprostinil inhalant
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:66302-716
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
treprostinil (treprostinil) treprostinil 16 ug
Inactive Ingredients
Ingredient Name Strength
fumaryl diketopiperazine
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:66302-716-04 1 BLISTER PACK in 1 KIT contains a BLISTER PACK
1 4 BLISTER PACK in 1 BLISTER PACK This package is contained within the KIT (66302-716-04) and contains a BLISTER PACK
1 4 INHALANT in 1 BLISTER PACK This package is contained within a BLISTER PACK and a KIT (66302-716-04)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA214324 05/23/2022
TYVASO DPI treprostinil inhalant
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:66302-632
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
treprostinil (treprostinil) treprostinil 32 ug
Inactive Ingredients
Ingredient Name Strength
fumaryl diketopiperazine
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:66302-632-03 4 BLISTER PACK in 1 KIT contains a BLISTER PACK
1 7 BLISTER PACK in 1 BLISTER PACK This package is contained within the KIT (66302-632-03) and contains a BLISTER PACK
1 4 INHALANT in 1 BLISTER PACK This package is contained within a BLISTER PACK and a KIT (66302-632-03)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA214324 05/23/2022
TYVASO DPI treprostinil inhalant
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:66302-732
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
treprostinil (treprostinil) treprostinil 32 ug
Inactive Ingredients
Ingredient Name Strength
fumaryl diketopiperazine
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:66302-732-04 1 BLISTER PACK in 1 KIT contains a BLISTER PACK
1 4 BLISTER PACK in 1 BLISTER PACK This package is contained within the KIT (66302-732-04) and contains a BLISTER PACK
1 4 INHALANT in 1 BLISTER PACK This package is contained within a BLISTER PACK and a KIT (66302-732-04)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA214324 05/23/2022
TYVASO DPI treprostinil inhalant
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:66302-648
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
treprostinil (treprostinil) treprostinil 48 ug
Inactive Ingredients
Ingredient Name Strength
fumaryl diketopiperazine
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:66302-648-03 4 BLISTER PACK in 1 KIT contains a BLISTER PACK
1 7 BLISTER PACK in 1 BLISTER PACK This package is contained within the KIT (66302-648-03) and contains a BLISTER PACK
1 4 INHALANT in 1 BLISTER PACK This package is contained within a BLISTER PACK and a KIT (66302-648-03)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA214324 05/23/2022
TYVASO DPI treprostinil inhalant
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:66302-748
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
treprostinil (treprostinil) treprostinil 48 ug
Inactive Ingredients
Ingredient Name Strength
fumaryl diketopiperazine
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:66302-748-04 1 BLISTER PACK in 1 KIT contains a BLISTER PACK
1 4 BLISTER PACK in 1 BLISTER PACK This package is contained within the KIT (66302-748-04) and contains a BLISTER PACK
1 4 INHALANT in 1 BLISTER PACK This package is contained within a BLISTER PACK and a KIT (66302-748-04)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA214324 05/23/2022
TYVASO DPI treprostinil inhalant
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:66302-664
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
treprostinil (treprostinil) treprostinil 64 ug
Inactive Ingredients
Ingredient Name Strength
fumaryl diketopiperazine
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:66302-664-03 4 BLISTER PACK in 1 KIT contains a BLISTER PACK
1 7 BLISTER PACK in 1 BLISTER PACK This package is contained within the KIT (66302-664-03) and contains a BLISTER PACK
1 4 INHALANT in 1 BLISTER PACK This package is contained within a BLISTER PACK and a KIT (66302-664-03)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA214324 05/23/2022
TYVASO DPI treprostinil inhalant
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:66302-764
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
treprostinil (treprostinil) treprostinil 64 ug
Inactive Ingredients
Ingredient Name Strength
fumaryl diketopiperazine
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:66302-764-04 1 BLISTER PACK in 1 KIT contains a BLISTER PACK
1 4 BLISTER PACK in 1 BLISTER PACK This package is contained within the KIT (66302-764-04) and contains a BLISTER PACK
1 4 INHALANT in 1 BLISTER PACK This package is contained within a BLISTER PACK and a KIT (66302-764-04)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA214324 05/23/2022
TYVASO DPI treprostinil kit
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:66302-600
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:66302-600-02 1 KIT in 1 PACKAGE None
Quantity of Parts
Part # Package Quantity Total Product Quantity
Part 1 28 BLISTER PACK 112
Part 2 21 BLISTER PACK 84
Part 1 of 2
TYVASO DPI treprostinil inhalant
Product Information
Item Code (Source) NDC:66302-616
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
treprostinil (treprostinil) treprostinil 16 ug
Inactive Ingredients
Ingredient Name Strength
fumaryl diketopiperazine
Packaging
# Item Code Package Description Multilevel Packaging
1 4 INHALANT in 1 BLISTER PACK None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA214324 05/23/2022
Part 2 of 2
TYVASO DPI treprostinil inhalant
Product Information
Item Code (Source) NDC:66302-632
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
treprostinil (treprostinil) treprostinil 32 ug
Inactive Ingredients
Ingredient Name Strength
fumaryl diketopiperazine
Packaging
# Item Code Package Description Multilevel Packaging
1 4 INHALANT in 1 BLISTER PACK None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA214324 05/23/2022
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA214324 05/23/2022
TYVASO DPI treprostinil kit
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:66302-620
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:66302-620-03 1 KIT in 1 PACKAGE None
Quantity of Parts
Part # Package Quantity Total Product Quantity
Part 1 28 BLISTER PACK 112
Part 2 28 BLISTER PACK 112
Part 1 of 2
TYVASO DPI treprostinil inhalant
Product Information
Item Code (Source) NDC:66302-632
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
treprostinil (treprostinil) treprostinil 32 ug
Inactive Ingredients
Ingredient Name Strength
fumaryl diketopiperazine
Packaging
# Item Code Package Description Multilevel Packaging
1 4 INHALANT in 1 BLISTER PACK None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA214324 05/23/2022
Part 2 of 2
TYVASO DPI treprostinil inhalant
Product Information
Item Code (Source) NDC:66302-648
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
treprostinil (treprostinil) treprostinil 48 ug
Inactive Ingredients
Ingredient Name Strength
fumaryl diketopiperazine
Packaging
# Item Code Package Description Multilevel Packaging
1 4 INHALANT in 1 BLISTER PACK None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA214324 05/23/2022
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA214324 05/23/2022
TYVASO DPI treprostinil kit
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:66302-720
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:66302-720-04 1 KIT in 1 PACKAGE None
Quantity of Parts
Part # Package Quantity Total Product Quantity
Part 1 4 BLISTER PACK 16
Part 2 4 BLISTER PACK 16
Part 1 of 2
TYVASO DPI treprostinil inhalant
Product Information
Item Code (Source) NDC:66302-632
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
treprostinil (treprostinil) treprostinil 32 ug
Inactive Ingredients
Ingredient Name Strength
fumaryl diketopiperazine
Packaging
# Item Code Package Description Multilevel Packaging
1 4 INHALANT in 1 BLISTER PACK None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA214324 05/23/2022
Part 2 of 2
TYVASO DPI treprostinil inhalant
Product Information
Item Code (Source) NDC:66302-648
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
treprostinil (treprostinil) treprostinil 48 ug
Inactive Ingredients
Ingredient Name Strength
fumaryl diketopiperazine
Packaging
# Item Code Package Description Multilevel Packaging
1 4 INHALANT in 1 BLISTER PACK None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA214324 05/23/2022
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA214324 05/23/2022
TYVASO DPI treprostinil kit
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:66302-610
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:66302-610-02 1 KIT in 1 PACKAGE None
Quantity of Parts
Part # Package Quantity Total Product Quantity
Part 1 28 BLISTER PACK 112
Part 2 28 BLISTER PACK 112
Part 3 7 BLISTER PACK 28
Part 1 of 3
TYVASO DPI treprostinil inhalant
Product Information
Item Code (Source) NDC:66302-616
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
treprostinil (treprostinil) treprostinil 16 ug
Inactive Ingredients
Ingredient Name Strength
fumaryl diketopiperazine
Packaging
# Item Code Package Description Multilevel Packaging
1 4 INHALANT in 1 BLISTER PACK None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA214324 05/23/2022
Part 2 of 3
TYVASO DPI treprostinil inhalant
Product Information
Item Code (Source) NDC:66302-632
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
treprostinil (treprostinil) treprostinil 32 ug
Inactive Ingredients
Ingredient Name Strength
fumaryl diketopiperazine
Packaging
# Item Code Package Description Multilevel Packaging
1 4 INHALANT in 1 BLISTER PACK None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA214324 05/23/2022
Part 3 of 3
TYVASO DPI treprostinil inhalant
Product Information
Item Code (Source) NDC:66302-648
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
treprostinil (treprostinil) treprostinil 48 ug
Inactive Ingredients
Ingredient Name Strength
fumaryl diketopiperazine
Packaging
# Item Code Package Description Multilevel Packaging
1 4 INHALANT in 1 BLISTER PACK None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA214324 05/23/2022
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA214324 05/23/2022
Labeler — United Therapeutics Corporation (965460025)
Establishment
Name Address ID/FEI Operations
United Therapeutics Corporation 965460025 API MANUFACTURE (66302-616), API MANUFACTURE (66302-632), API MANUFACTURE (66302-648), API MANUFACTURE (66302-664), API MANUFACTURE (66302-600), API MANUFACTURE (66302-610), API MANUFACTURE (66302-620), API MANUFACTURE (66302-716), API MANUFACTURE (66302-732), API MANUFACTURE (66302-748), API MANUFACTURE (66302-764), API MANUFACTURE (66302-720), ANALYSIS (66302-616), ANALYSIS (66302-632), ANALYSIS (66302-648), ANALYSIS (66302-664), ANALYSIS (66302-600), ANALYSIS (66302-610), ANALYSIS (66302-620), ANALYSIS (66302-716), ANALYSIS (66302-732), ANALYSIS (66302-748), ANALYSIS (66302-764), ANALYSIS (66302-720)

Revised: 05/2022 United Therapeutics Corporation

Page 4 of 4 1 2 3 4

DrugInserts.com provides trustworthy package insert and label information about marketed drugs as submitted by manufacturers to the US Food and Drug Administration. Package information is not reviewed or updated separately by DrugInserts.com. Every individual package label entry contains a unique identifier which can be used to secure further details directly from the US National Institutes of Health and/or the FDA.

As the leading independent provider of trustworthy medication information, we source our database directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. Our material is not intended as a substitute for direct consultation with a qualified health professional.

Terms of Use | Copyright © 2022. All Rights Reserved.