Austedo: Package Insert and Label Information (Page 5 of 5)

Package/Label Display Panel

NDC 68546-170 -60
Austedo ® (deutetrabenazine) tablets
6 mg
60 tabletsMedication Guide Required: Each time AUSTEDO is dispensed, give the patient a Medication Guide.

image
(click image for full-size original)

Package/Label Display Panel

NDC 68546-171 -60
Austedo ® (deutetrabenazine) tablets
9 mg
60 tabletsMedication Guide Required: Each time AUSTEDO is dispensed, give the patient a Medication Guide.

image
(click image for full-size original)

Package/Label Display Panel

NDC 68546-172 -60
Austedo ® (deutetrabenazine) tablets
12 mg
60 tabletsMedication Guide Required: Each time AUSTEDO is dispensed, give the patient a Medication Guide.

image
(click image for full-size original)

Package/Label Display Panel

NDC 68546-182-70
AUSTEDO®
(deutetrabenazine) tablets
6 mg, 9 mg, 12 mg
4 Week
Patient Titration Kit
12 mg Starting Dose
SAMPLE – NOT FOR SALE
Rx Only
Medication Guide Required: Each time AUSTEDO is dispensed, give the patient the accompanying Medication Guide.
Dispense in this sealed carton.
Monthly carton contains 70 tablets in 3 child-resistant packs including, 28 purple tablets, each containing 6 mg of deutetrabenazine, 28 blue tablets, each containing 9 mg of deutetrabenazine, and 14 beige tablets, each containing 12 mg of deutetrabenazine.teva

image
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Package/Label Display Panel

NDC 68546-181-49
Rx Only
Chorea associated with Huntington’s disease
4 Week Patient Titration Kit
6 mg Starting Dose
AUSTEDO® (deutetrabenazine) tablets
6 mg, 9 mg, 12 mg

Week Tablets per day
1 Take 1 (6 mg) tablet every morning
2 Take 1 (6 mg) tablet every morning and 1 (6 mg) tablet every evening
3 Take 1 (9 mg) tablet every morning and 1 (9 mg) tablet every evening
4 Take 1 (12 mg) tablet every morning and 1 (12 mg) tablet every evening

SAMPLE – NOT FOR SALE Medication Guide Required: Each time AUSTEDO is dispensed, give the patient the accompanying Medication Guide.
Dispense in this sealed carton.
Monthly carton contains 49 tablets in 2 child-resistant packs including, 21 purple tablets, each containing 6 mg of deutetrabenazine, 14 blue tablets, each containing 9 mg of deutetrabenazine, and 14 beige tablets, each containing 12 mg of deutetrabenazine.teva

HD 4-week kit
(click image for full-size original)

HD 4-week kit

Package/Label Display Panel

NDC 68546-176-28 Rx Only
1 PRESS AND HOLD HERE
Tardive Dyskinesia Titration Pack 12 mg Starting Dose
AUSTEDO® (deutetrabenazine) tablets
6 mg and 9 mg
SAMPLE – NOT FOR SALE
1 Press & hold button 2 Pull out card
Medication Guide Required: Each time AUSTEDO is dispensed, give the patient the accompanying Medication Guide.
1 tablet dispenser containing 28 tablets in the following order:

  • Week 1: 14 purple tablets containing 6 mg deutetrabenazine
  • Week 2: 14 blue tablets containing 9 mg deutetrabenazine

2 PULL OUT HEREteva

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(click image for full-size original)

Package/Label Display Panel

NDC 68546-177-21 Rx Only
1 PRESS AND HOLD HERE
Chorea associated with Huntington’s disease Titration Pack 6 mg Starting Dose
AUSTEDO® (deutetrabenazine) tablets
6 mg
SAMPLE – NOT FOR SALE
1 Press & hold button 2 Pull out card
Medication Guide Required: Each time AUSTEDO is dispensed, give the patient the accompanying Medication Guide.
1 tablet dispenser containing 21 tablets in the following order:

  • Week 1: 7 purple tablets containing 6 mg deutetrabenazine
  • Week 2: 14 purple tablets containing 6 mg deutetrabenazine

2 PULL OUT HEREteva

image
(click image for full-size original)
AUSTEDO deutetrabenazine tablet, coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68546-170
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DEUTETRABENAZINE (DEUTETRABENAZINE) DEUTETRABENAZINE 6 mg
Inactive Ingredients
Ingredient Name Strength
AMMONIA
FERROSOFERRIC OXIDE
BUTYL ALCOHOL
BUTYLATED HYDROXYANISOLE
BUTYLATED HYDROXYTOLUENE
MAGNESIUM STEARATE
MANNITOL
MICROCRYSTALLINE CELLULOSE
POLYETHYLENE GLYCOL, UNSPECIFIED
POLYSORBATE 80
POLYVINYL ALCOHOL, UNSPECIFIED
POVIDONE, UNSPECIFIED
PROPYLENE GLYCOL
SHELLAC
TALC
TITANIUM DIOXIDE
FD&C BLUE NO. 2
FD&C RED NO. 40
POLYETHYLENE GLYCOL 2000000
Product Characteristics
Color purple Score no score
Shape ROUND Size 10mm
Flavor Imprint Code SD;6
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:68546-170-60 60 TABLET, COATED in 1 BOTTLE None
2 NDC:68546-170-66 60 TABLET, COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA208082 04/12/2017
AUSTEDO deutetrabenazine tablet, coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68546-171
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DEUTETRABENAZINE (DEUTETRABENAZINE) DEUTETRABENAZINE 9 mg
Inactive Ingredients
Ingredient Name Strength
AMMONIA
FERROSOFERRIC OXIDE
BUTYL ALCOHOL
BUTYLATED HYDROXYANISOLE
BUTYLATED HYDROXYTOLUENE
MAGNESIUM STEARATE
MANNITOL
MICROCRYSTALLINE CELLULOSE
POLYETHYLENE GLYCOL, UNSPECIFIED
POLYSORBATE 80
POLYVINYL ALCOHOL, UNSPECIFIED
POVIDONE, UNSPECIFIED
PROPYLENE GLYCOL
SHELLAC
TALC
TITANIUM DIOXIDE
FD&C BLUE NO. 2
POLYETHYLENE GLYCOL 2000000
Product Characteristics
Color blue Score no score
Shape ROUND Size 10mm
Flavor Imprint Code SD;9
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:68546-171-60 60 TABLET, COATED in 1 BOTTLE None
2 NDC:68546-171-66 60 TABLET, COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA208082 04/12/2017
AUSTEDO deutetrabenazine tablet, coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68546-172
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DEUTETRABENAZINE (DEUTETRABENAZINE) DEUTETRABENAZINE 12 mg
Inactive Ingredients
Ingredient Name Strength
AMMONIA
FERROSOFERRIC OXIDE
BUTYL ALCOHOL
BUTYLATED HYDROXYANISOLE
BUTYLATED HYDROXYTOLUENE
MAGNESIUM STEARATE
MANNITOL
MICROCRYSTALLINE CELLULOSE
POLYETHYLENE GLYCOL, UNSPECIFIED
POLYSORBATE 80
POLYVINYL ALCOHOL, UNSPECIFIED
POVIDONE, UNSPECIFIED
PROPYLENE GLYCOL
SHELLAC
TALC
TITANIUM DIOXIDE
FD&C BLUE NO. 2
FD&C YELLOW NO. 6
POLYETHYLENE GLYCOL 2000000
Product Characteristics
Color brown (beige) Score no score
Shape ROUND Size 10mm
Flavor Imprint Code SD;12
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:68546-172-60 60 TABLET, COATED in 1 BOTTLE None
2 NDC:68546-172-66 60 TABLET, COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA208082 04/12/2017
AUSTEDO deutetrabenazine kit
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68546-177
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:68546-177-21 1 BLISTER PACK in 1 CARTON contains a BLISTER PACK
1 1 KIT in 1 BLISTER PACK This package is contained within the CARTON (68546-177-21)
Quantity of Parts
Part # Package Quantity Total Product Quantity
Part 1 21
Part 1 of 1
AUSTEDO deutetrabenazine tablet
Product Information
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DEUTETRABENAZINE (DEUTETRABENAZINE) DEUTETRABENAZINE 6 mg
Inactive Ingredients
Ingredient Name Strength
AMMONIA
FERROSOFERRIC OXIDE
BUTYL ALCOHOL
BUTYLATED HYDROXYANISOLE
BUTYLATED HYDROXYTOLUENE
MAGNESIUM STEARATE
MANNITOL
MICROCRYSTALLINE CELLULOSE
POLYETHYLENE GLYCOL, UNSPECIFIED
POLYSORBATE 80
POLYVINYL ALCOHOL, UNSPECIFIED
POVIDONE
PROPYLENE GLYCOL
SHELLAC
TALC
TITANIUM DIOXIDE
FD&C BLUE NO. 2
FD&C RED NO. 40
POLYETHYLENE GLYCOL 2000000
Product Characteristics
Color purple Score no score
Shape ROUND Size 10mm
Flavor Imprint Code SD;6
Contains
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA208082 02/01/2020
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA208082 02/01/2020 02/28/2023
AUSTEDO deutetrabenazine kit
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68546-176
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:68546-176-28 1 BLISTER PACK in 1 CARTON contains a BLISTER PACK
1 1 KIT in 1 BLISTER PACK This package is contained within the CARTON (68546-176-28)
Quantity of Parts
Part # Package Quantity Total Product Quantity
Part 1 14
Part 2 14
Part 1 of 2
AUSTEDO deutetrabenazine tablet
Product Information
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DEUTETRABENAZINE (DEUTETRABENAZINE) DEUTETRABENAZINE 6 mg
Inactive Ingredients
Ingredient Name Strength
AMMONIA
FERROSOFERRIC OXIDE
BUTYL ALCOHOL
BUTYLATED HYDROXYANISOLE
BUTYLATED HYDROXYTOLUENE
MAGNESIUM STEARATE
MANNITOL
MICROCRYSTALLINE CELLULOSE
POLYETHYLENE GLYCOL, UNSPECIFIED
POLYSORBATE 80
POLYVINYL ALCOHOL, UNSPECIFIED
POVIDONE
PROPYLENE GLYCOL
SHELLAC
TALC
TITANIUM DIOXIDE
FD&C BLUE NO. 2
FD&C RED NO. 40
POLYETHYLENE GLYCOL 2000000
Product Characteristics
Color purple Score no score
Shape ROUND Size 10mm
Flavor Imprint Code SD;6
Contains
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA208082 02/01/2020
Part 2 of 2
AUSTEDO deutetrabenazine tablet
Product Information
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DEUTETRABENAZINE (DEUTETRABENAZINE) DEUTETRABENAZINE 9 mg
Inactive Ingredients
Ingredient Name Strength
AMMONIA
FERROSOFERRIC OXIDE
BUTYL ALCOHOL
BUTYLATED HYDROXYANISOLE
BUTYLATED HYDROXYTOLUENE
MAGNESIUM STEARATE
MANNITOL
MICROCRYSTALLINE CELLULOSE
POLYETHYLENE GLYCOL, UNSPECIFIED
POLYSORBATE 80
POLYVINYL ALCOHOL, UNSPECIFIED
POVIDONE, UNSPECIFIED
PROPYLENE GLYCOL
SHELLAC
TALC
TITANIUM DIOXIDE
FD&C BLUE NO. 2
POLYETHYLENE GLYCOL 2000000
Product Characteristics
Color blue Score no score
Shape ROUND Size 10mm
Flavor Imprint Code SD;9
Contains
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA208082 02/01/2020
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA208082 02/01/2020
AUSTEDO deutetrabenazine kit
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68546-181
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:68546-181-49 2 BLISTER PACK in 1 CARTON contains a BLISTER PACK
1 1 KIT in 1 BLISTER PACK This package is contained within the CARTON (68546-181-49)
Quantity of Parts
Part # Package Quantity Total Product Quantity
Part 1 21
Part 2 14
Part 3 14
Part 1 of 3
AUSTEDO deutetrabenazine tablet, coated
Product Information
Item Code (Source) NDC:68546-170
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DEUTETRABENAZINE (DEUTETRABENAZINE) DEUTETRABENAZINE 6 mg
Inactive Ingredients
Ingredient Name Strength
AMMONIA
BUTYL ALCOHOL
BUTYLATED HYDROXYANISOLE
BUTYLATED HYDROXYTOLUENE
MAGNESIUM STEARATE
MANNITOL
MICROCRYSTALLINE CELLULOSE
POLYETHYLENE GLYCOL, UNSPECIFIED
POLYSORBATE 80
POLYVINYL ALCOHOL, UNSPECIFIED
POVIDONE, UNSPECIFIED
PROPYLENE GLYCOL
SHELLAC
TALC
TITANIUM DIOXIDE
FD&C BLUE NO. 2
FD&C RED NO. 40
POLYETHYLENE GLYCOL 2000000
FERROSOFERRIC OXIDE
Product Characteristics
Color purple Score no score
Shape ROUND Size 10mm
Flavor Imprint Code SD;6
Contains
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA208082 05/06/2021
Part 2 of 3
AUSTEDO deutetrabenazine tablet, coated
Product Information
Item Code (Source) NDC:68546-171
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DEUTETRABENAZINE (DEUTETRABENAZINE) DEUTETRABENAZINE 9 mg
Inactive Ingredients
Ingredient Name Strength
AMMONIA
FERROSOFERRIC OXIDE
BUTYL ALCOHOL
BUTYLATED HYDROXYANISOLE
BUTYLATED HYDROXYTOLUENE
MAGNESIUM STEARATE
MANNITOL
MICROCRYSTALLINE CELLULOSE
POLYETHYLENE GLYCOL, UNSPECIFIED
POLYSORBATE 80
POLYVINYL ALCOHOL, UNSPECIFIED
POVIDONE, UNSPECIFIED
PROPYLENE GLYCOL
SHELLAC
TALC
TITANIUM DIOXIDE
FD&C BLUE NO. 2
POLYETHYLENE GLYCOL 2000000
Product Characteristics
Color blue Score no score
Shape ROUND Size 10mm
Flavor Imprint Code SD;9
Contains
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA208082 05/06/2021
Part 3 of 3
AUSTEDO deutetrabenazine tablet, coated
Product Information
Item Code (Source) NDC:68546-172
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DEUTETRABENAZINE (DEUTETRABENAZINE) DEUTETRABENAZINE 12 mg
Inactive Ingredients
Ingredient Name Strength
AMMONIA
FERROSOFERRIC OXIDE
BUTYL ALCOHOL
BUTYLATED HYDROXYANISOLE
BUTYLATED HYDROXYTOLUENE
MAGNESIUM STEARATE
MANNITOL
MICROCRYSTALLINE CELLULOSE
POLYETHYLENE GLYCOL, UNSPECIFIED
POLYSORBATE 80
POVIDONE, UNSPECIFIED
POLYVINYL ALCOHOL, UNSPECIFIED
PROPYLENE GLYCOL
SHELLAC
TALC
TITANIUM DIOXIDE
FD&C BLUE NO. 2
FD&C YELLOW NO. 6
POLYETHYLENE GLYCOL 2000000
Product Characteristics
Color brown (beige) Score no score
Shape ROUND Size 10mm
Flavor Imprint Code SD;12
Contains
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA208082 05/06/2021
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA208082 05/06/2021 02/28/2023
AUSTEDO deutetrabenazine kit
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68546-182
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:68546-182-49 3 BLISTER PACK in 1 CARTON contains a BLISTER PACK
1 1 KIT in 1 BLISTER PACK This package is contained within the CARTON (68546-182-49)
Quantity of Parts
Part # Package Quantity Total Product Quantity
Part 1 28
Part 2 28
Part 3 14
Part 1 of 3
AUSTEDO deutetrabenazine tablet, coated
Product Information
Item Code (Source) NDC:68546-170
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DEUTETRABENAZINE (DEUTETRABENAZINE) DEUTETRABENAZINE 6 mg
Inactive Ingredients
Ingredient Name Strength
AMMONIA
BUTYL ALCOHOL
BUTYLATED HYDROXYANISOLE
BUTYLATED HYDROXYTOLUENE
MAGNESIUM STEARATE
MANNITOL
MICROCRYSTALLINE CELLULOSE
POLYETHYLENE GLYCOL, UNSPECIFIED
POLYSORBATE 80
POLYVINYL ALCOHOL, UNSPECIFIED
POVIDONE, UNSPECIFIED
PROPYLENE GLYCOL
SHELLAC
TALC
TITANIUM DIOXIDE
FD&C BLUE NO. 2
FD&C RED NO. 40
POLYETHYLENE GLYCOL 2000000
FERROSOFERRIC OXIDE
Product Characteristics
Color purple Score no score
Shape ROUND Size 10mm
Flavor Imprint Code SD;6
Contains
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA208082 05/06/2021
Part 2 of 3
AUSTEDO deutetrabenazine tablet, coated
Product Information
Item Code (Source) NDC:68546-171
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DEUTETRABENAZINE (DEUTETRABENAZINE) DEUTETRABENAZINE 9 mg
Inactive Ingredients
Ingredient Name Strength
AMMONIA
FERROSOFERRIC OXIDE
BUTYL ALCOHOL
BUTYLATED HYDROXYANISOLE
BUTYLATED HYDROXYTOLUENE
MAGNESIUM STEARATE
MANNITOL
MICROCRYSTALLINE CELLULOSE
POLYETHYLENE GLYCOL, UNSPECIFIED
POLYSORBATE 80
POLYVINYL ALCOHOL, UNSPECIFIED
POVIDONE, UNSPECIFIED
PROPYLENE GLYCOL
SHELLAC
TALC
TITANIUM DIOXIDE
FD&C BLUE NO. 2
POLYETHYLENE GLYCOL 2000000
Product Characteristics
Color blue Score no score
Shape ROUND Size 10mm
Flavor Imprint Code SD;9
Contains
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA208082 05/06/2021
Part 3 of 3
AUSTEDO deutetrabenazine tablet, coated
Product Information
Item Code (Source) NDC:68546-172
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DEUTETRABENAZINE (DEUTETRABENAZINE) DEUTETRABENAZINE 12 mg
Inactive Ingredients
Ingredient Name Strength
AMMONIA
FERROSOFERRIC OXIDE
BUTYL ALCOHOL
BUTYLATED HYDROXYANISOLE
BUTYLATED HYDROXYTOLUENE
MAGNESIUM STEARATE
MANNITOL
MICROCRYSTALLINE CELLULOSE
POLYETHYLENE GLYCOL, UNSPECIFIED
POLYSORBATE 80
POLYVINYL ALCOHOL, UNSPECIFIED
POVIDONE, UNSPECIFIED
PROPYLENE GLYCOL
SHELLAC
TALC
TITANIUM DIOXIDE
FD&C BLUE NO. 2
FD&C YELLOW NO. 6
POLYETHYLENE GLYCOL 2000000
Product Characteristics
Color brown (beige) Score no score
Shape ROUND Size 10mm
Flavor Imprint Code SD;12
Contains
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA208082 05/06/2021
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA208082 05/06/2021
Labeler — Teva Neuroscience, Inc. (009906397)

Revised: 05/2022 Teva Neuroscience, Inc.

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