CLOPIDOGREL (Page 6 of 6)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Clopidogrel-tablets-75mg-30s-container

Clopidogrel-tablets-75mg-30s-container
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Clopidogrel-tablets-300mg-30s-container

Clopidogrel-tablets-300mg-30s-container
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CLOPIDOGREL clopidogrel tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:31722-758
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CLOPIDOGREL (CLOPIDOGREL) CLOPIDOGREL 75 mg
Inactive Ingredients
Ingredient Name Strength
SILICON DIOXIDE
CROSPOVIDONE (120 .MU.M)
HYDROGENATED CASTOR OIL
LACTOSE MONOHYDRATE
LOW-SUBSTITUTED HYDROXYPROPYL CELLULOSE, UNSPECIFIED
MANNITOL
MICROCRYSTALLINE CELLULOSE 112
FERRIC OXIDE RED
TITANIUM DIOXIDE
TRIACETIN
AMMONIA
ISOPROPYL ALCOHOL
PROPYLENE GLYCOL
BUTYL ALCOHOL
POLYETHYLENE GLYCOL, UNSPECIFIED
HYPROMELLOSE 2910 (6 MPA.S)
SHELLAC
FERROSOFERRIC OXIDE
Product Characteristics
Color pink Score no score
Shape ROUND (beveledged biconvex) Size 9mm
Flavor Imprint Code I;2
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:31722-758-30 30 TABLET in 1 BOTTLE None
2 NDC:31722-758-90 90 TABLET in 1 BOTTLE None
3 NDC:31722-758-05 500 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA205345 08/04/2023
CLOPIDOGREL clopidogrel tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:31722-759
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CLOPIDOGREL (CLOPIDOGREL) CLOPIDOGREL 300 mg
Inactive Ingredients
Ingredient Name Strength
SILICON DIOXIDE
CROSPOVIDONE (120 .MU.M)
HYDROGENATED CASTOR OIL
LACTOSE MONOHYDRATE
LOW-SUBSTITUTED HYDROXYPROPYL CELLULOSE, UNSPECIFIED
MANNITOL
MICROCRYSTALLINE CELLULOSE 112
FERRIC OXIDE RED
TITANIUM DIOXIDE
TRIACETIN
AMMONIA
ISOPROPYL ALCOHOL
PROPYLENE GLYCOL
BUTYL ALCOHOL
FERROSOFERRIC OXIDE
HYPROMELLOSE 2910 (6 MPA.S)
SHELLAC
POLYETHYLENE GLYCOL, UNSPECIFIED
Product Characteristics
Color pink Score no score
Shape CAPSULE (biconvex) Size 18mm
Flavor Imprint Code I;1
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:31722-759-30 30 TABLET in 1 BOTTLE None
2 NDC:31722-759-05 500 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA205345 08/04/2023
Labeler — Camber Pharmaceuticals, Inc. (826774775)
Establishment
Name Address ID/FEI Operations
Annora Pharma Private Limited 650980746 analysis (31722-758), analysis (31722-759), manufacture (31722-758), manufacture (31722-759)

Revised: 09/2023 Camber Pharmaceuticals, Inc.

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