Prasugrel (Page 7 of 7)

PRASUGREL TABLET, FILM COATED

Label ImageLabel Image
PRASUGREL prasugrel tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:50090-5169(NDC:16729-273)
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
MICROCRYSTALLINE CELLULOSE
HYPROMELLOSE 2910 (6 MPA.S)
LOW-SUBSTITUTED HYDROXYPROPYL CELLULOSE (8% HYDROXYPROPYL: 140000 MW)
SUCROSE STEARATE
LACTOSE MONOHYDRATE
TITANIUM DIOXIDE
TRIACETIN
FERRIC OXIDE YELLOW
FERRIC OXIDE RED
HYPROMELLOSE 2910 (5 MPA.S)
Product Characteristics
Color brown ( beige ) Score no score
Shape HEXAGON (6 sided) Size 11mm
Flavor Imprint Code AA2
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:50090-5169-0 30 TABLET, FILM COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA205987 01/16/2019
Labeler — A-S Medication Solutions (830016429)
Establishment
Name Address ID/FEI Operations
A-S Medication Solutions 830016429 RELABEL (50090-5169)

Revised: 07/2022 A-S Medication Solutions

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