Tadalafil: Package Insert and Label Information

TADALAFIL — tadalafil tablet, film coated
Cadila Healthcare Limited

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 70771-1475-3 in bottle of 30 tablets

Tadalafil Tablets USP, 2.5 mg

Rx Only

30 tablets

2.5 mg label
(click image for full-size original)

NDC 70771-1476-3 in bottle of 30 tablets

Tadalafil Tablets USP, 5 mg

Rx Only

30 tablets

5 mg
(click image for full-size original)

NDC 70771-1477-3 in bottle of 30 tablets

Tadalafil Tablets USP, 10 mg

Rx Only

30 tablets

10 mg
(click image for full-size original)

NDC 70771-1478-3 in bottle of 30 tablets

Tadalafil Tablets USP, 20 mg

Rx Only

30 tablets

20 mg
(click image for full-size original)
TADALAFIL
tadalafil tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70771-1475
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
TADALAFIL (TADALAFIL) TADALAFIL 2.5 mg
Inactive Ingredients
Ingredient Name Strength
CELLULOSE, MICROCRYSTALLINE
CROSCARMELLOSE SODIUM
HYDROXYPROPYL CELLULOSE, UNSPECIFIED
HYPROMELLOSES
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
TALC
TITANIUM DIOXIDE
TRIACETIN
Product Characteristics
Color WHITE (WHITE) Score no score
Shape CAPSULE (CAPSULE) Size 6mm
Flavor Imprint Code T;1
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:70771-1475-3 30 TABLET, FILM COATED in 1 BOTTLE None
2 NDC:70771-1475-9 90 TABLET, FILM COATED in 1 BOTTLE None
3 NDC:70771-1475-1 100 TABLET, FILM COATED in 1 BOTTLE None
4 NDC:70771-1475-5 500 TABLET, FILM COATED in 1 BOTTLE None
5 NDC:70771-1475-0 1000 TABLET, FILM COATED in 1 BOTTLE None
6 NDC:70771-1475-4 2 BLISTER PACK in 1 CARTON contains a BLISTER PACK
6 15 TABLET, FILM COATED in 1 BLISTER PACK This package is contained within the CARTON (70771-1475-4)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA206693 03/27/2019
TADALAFIL
tadalafil tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70771-1477
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
TADALAFIL (TADALAFIL) TADALAFIL 10 mg
Inactive Ingredients
Ingredient Name Strength
CELLULOSE, MICROCRYSTALLINE
CROSCARMELLOSE SODIUM
FERRIC OXIDE YELLOW
HYDROXYPROPYL CELLULOSE, UNSPECIFIED
HYPROMELLOSES
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
TALC
TITANIUM DIOXIDE
TRIACETIN
Product Characteristics
Color YELLOW (YELLOW) Score no score
Shape CAPSULE (CAPSULE) Size 10mm
Flavor Imprint Code 898
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:70771-1477-3 30 TABLET, FILM COATED in 1 BOTTLE None
2 NDC:70771-1477-9 90 TABLET, FILM COATED in 1 BOTTLE None
3 NDC:70771-1477-1 100 TABLET, FILM COATED in 1 BOTTLE None
4 NDC:70771-1477-5 500 TABLET, FILM COATED in 1 BOTTLE None
5 NDC:70771-1477-0 1000 TABLET, FILM COATED in 1 BOTTLE None
6 NDC:70771-1477-4 2 BLISTER PACK in 1 CARTON contains a BLISTER PACK
6 15 TABLET, FILM COATED in 1 BLISTER PACK This package is contained within the CARTON (70771-1477-4)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA206693 03/27/2019
TADALAFIL
tadalafil tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70771-1478
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
TADALAFIL (TADALAFIL) TADALAFIL 20 mg
Inactive Ingredients
Ingredient Name Strength
CELLULOSE, MICROCRYSTALLINE
CROSCARMELLOSE SODIUM
FERRIC OXIDE YELLOW
HYDROXYPROPYL CELLULOSE, UNSPECIFIED
HYPROMELLOSES
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
TALC
TITANIUM DIOXIDE
TRIACETIN
Product Characteristics
Color YELLOW (YELLOW) Score no score
Shape OVAL (OVAL) Size 13mm
Flavor Imprint Code 899
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:70771-1478-3 30 TABLET, FILM COATED in 1 BOTTLE None
2 NDC:70771-1478-9 90 TABLET, FILM COATED in 1 BOTTLE None
3 NDC:70771-1478-1 100 TABLET, FILM COATED in 1 BOTTLE None
4 NDC:70771-1478-5 500 TABLET, FILM COATED in 1 BOTTLE None
5 NDC:70771-1478-0 1000 TABLET, FILM COATED in 1 BOTTLE None
6 NDC:70771-1478-4 2 BLISTER PACK in 1 CARTON contains a BLISTER PACK
6 15 TABLET, FILM COATED in 1 BLISTER PACK This package is contained within the CARTON (70771-1478-4)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA206693 03/27/2019
TADALAFIL
tadalafil tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70771-1476
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
TADALAFIL (TADALAFIL) TADALAFIL 5 mg
Inactive Ingredients
Ingredient Name Strength
CELLULOSE, MICROCRYSTALLINE
CROSCARMELLOSE SODIUM
FERRIC OXIDE YELLOW
HYDROXYPROPYL CELLULOSE, UNSPECIFIED
HYPROMELLOSES
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
TALC
TITANIUM DIOXIDE
TRIACETIN
Product Characteristics
Color YELLOW (YELLOW) Score no score
Shape OVAL (OVAL) Size 8mm
Flavor Imprint Code 897
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:70771-1476-7 10 TABLET, FILM COATED in 1 BOTTLE None
2 NDC:70771-1476-3 30 TABLET, FILM COATED in 1 BOTTLE None
3 NDC:70771-1476-9 90 TABLET, FILM COATED in 1 BOTTLE None
4 NDC:70771-1476-1 100 TABLET, FILM COATED in 1 BOTTLE None
5 NDC:70771-1476-5 500 TABLET, FILM COATED in 1 BOTTLE None
6 NDC:70771-1476-0 1000 TABLET, FILM COATED in 1 BOTTLE None
7 NDC:70771-1476-4 2 BLISTER PACK in 1 CARTON contains a BLISTER PACK
7 15 TABLET, FILM COATED in 1 BLISTER PACK This package is contained within the CARTON (70771-1476-4)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA206693 03/27/2019
Labeler — Cadila Healthcare Limited (918596198)
Registrant — Cadila Healthcare Limited (918596198)
Establishment
Name Address ID/FEI Operations
Cadila Healthcare Limited 918596198 ANALYSIS (70771-1475), ANALYSIS (70771-1476), ANALYSIS (70771-1477), ANALYSIS (70771-1478), MANUFACTURE (70771-1475), MANUFACTURE (70771-1476), MANUFACTURE (70771-1477), MANUFACTURE (70771-1478)

Revised: 10/2020 Cadila Healthcare Limited

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