Effient (Page 7 of 7)

PRINCIPAL DISPLAY PANEL — 5 mg Tablet Bottle Label

30 Tablets
NDC 65597-601-30

Effient®
(prasugrel) tablets

Rx only

5 mg

Keep and dispense only in original
container. Keep container closed and
do not remove desiccant from bottle.

Dispense accompanyingMedication Guide to each patient.

Daiichi-Sankyo

PRINCIPAL DISPLAY PANEL -- 5 mg Tablet Bottle Label
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 10 mg Tablet Bottle Label

30 Tablets
NDC 65597-602-30

Effient®
(prasugrel) tablets

Rx only

10 mg

Keep and dispense only in original
container. Keep container closed and
do not remove desiccant from bottle.

Dispense accompanyingMedication Guide to each patient.

Daiichi-Sankyo

PRINCIPAL DISPLAY PANEL -- 10 mg Tablet Bottle Label
(click image for full-size original)
EFFIENT prasugrel hydrochloride tablet, coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:65597-601
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, UNSPECIFIED
LOW-SUBSTITUTED HYDROXYPROPYL CELLULOSE, UNSPECIFIED
MICROCRYSTALLINE CELLULOSE
SUCROSE STEARATE
GLYCERYL DIBEHENATE
LACTOSE MONOHYDRATE
HYPROMELLOSE 2910 (15 MPA.S)
TITANIUM DIOXIDE
TRIACETIN
FERRIC OXIDE YELLOW
Product Characteristics
Color YELLOW Score no score
Shape HEXAGON (6 SIDED) Size 7mm
Flavor Imprint Code 5;5121
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:65597-601-30 30 TABLET, COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA022307 07/10/2009 12/31/2023
EFFIENT prasugrel hydrochloride tablet, coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:65597-602
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, UNSPECIFIED
LOW-SUBSTITUTED HYDROXYPROPYL CELLULOSE, UNSPECIFIED
MICROCRYSTALLINE CELLULOSE
SUCROSE STEARATE
GLYCERYL DIBEHENATE
LACTOSE MONOHYDRATE
HYPROMELLOSE 2910 (6 MPA.S)
TITANIUM DIOXIDE
TRIACETIN
FERRIC OXIDE YELLOW
FERRIC OXIDE RED
Product Characteristics
Color BROWN (beige) Score no score
Shape HEXAGON (6 SIDED) Size 11mm
Flavor Imprint Code 10;5123
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:65597-602-30 30 TABLET, COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA022307 07/10/2009 12/31/2023
Labeler — Daiichi Sankyo, Inc. (068605067)
Establishment
Name Address ID/FEI Operations
Daiichi Sankyo Europe GmBH 551338593 ANALYSIS (65597-601), ANALYSIS (65597-602), MANUFACTURE (65597-601), MANUFACTURE (65597-602)

Revised: 06/2022 Daiichi Sankyo, Inc.

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