Prasugrel (Page 7 of 7)

PACKAGE LABEL-PRASUGREL TABLET 5 mg 30 Tablets

NDC 43817-239-01

30 Tablets

Prasugrel Tablets

5 mg

Rx only

Dispense and keep only in original container.

Keep container closed and do not remove desiccant from bottle.

Dispense accompanying Medication Guide to each patient.

image description
(click image for full-size original)

PACKAGE LABEL-PRASUGREL TABLET 10 mg 30 Tablets

NDC 43817-240-01

30 Tablets

Prasugrel Tablets 10 mg

Rx only

Dispense and keep only in original container.

Keep container closed and do not remove desiccant from bottle.

Dispense accompanying Medication Guide to each patient.

image description
(click image for full-size original)

PRASUGREL prasugrel tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:43817-239
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Prasugrel Hydrochloride (Prasugrel) Prasugrel 5 mg
Inactive Ingredients
Ingredient Name Strength
MANNITOL
HYPROMELLOSE 2208 (100 MPA.S)
HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTED
MICROCRYSTALLINE CELLULOSE
STEARIC ACID
GLYCERYL BEHENATE/EICOSADIOATE
LACTOSE MONOHYDRATE
TITANIUM DIOXIDE
TRIACETIN
FERRIC OXIDE YELLOW
Product Characteristics
Color YELLOW (yellow) Score no score
Shape ROUND (round) Size 6mm
Flavor Imprint Code P;5
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:43817-239-01 30 TABLET, FILM COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA205897 10/16/2017
PRASUGREL prasugrel tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:43817-240
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Prasugrel Hydrochloride (Prasugrel) Prasugrel 10 mg
Inactive Ingredients
Ingredient Name Strength
MANNITOL
HYPROMELLOSE 2208 (100 MPA.S)
HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTED
MICROCRYSTALLINE CELLULOSE
STEARIC ACID
GLYCERYL BEHENATE/EICOSADIOATE
LACTOSE MONOHYDRATE
TITANIUM DIOXIDE
TRIACETIN
FERRIC OXIDE YELLOW
FERRIC OXIDE RED
Product Characteristics
Color WHITE (beige) Score no score
Shape ROUND (round) Size 8mm
Flavor Imprint Code P;10
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:43817-240-01 30 TABLET, FILM COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA205897 10/16/2017
Labeler — Panacea Biotec Limited (650090566)
Registrant — Panacea Biotec Pharma Limited (878533279)
Establishment
Name Address ID/FEI Operations
Panacea Biotec Pharma Limited 857979552 manufacture (43817-239), manufacture (43817-240)

Revised: 12/2020 Panacea Biotec Limited

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