Clopidogrel Bisulfate (Page 6 of 6)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL SECTION

Carton Label

Unvarnished Area consists of: 2D Barcode, Lot Number, Expiry Date and Serial Number.

carton1
(click image for full-size original)
CLOPIDOGREL BISULFATE clopidogrel bisulfate tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:63739-178
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Clopidogrel bisulfate (Clopidogrel) Clopidogrel 300 mg
Inactive Ingredients
Ingredient Name Strength
croscarmellose sodium
HYDROGENATED CASTOR OIL
Hydroxypropyl Cellulose, Unspecified
mannitol
CELLULOSE, MICROCRYSTALLINE
Hypromellose 2910 (5 Mpa.S)
FERRIC OXIDE RED
polyethylene glycol 400
titanium dioxide
Product Characteristics
Color PINK Score no score
Shape CAPSULE Size 19mm
Flavor Imprint Code R;671
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:63739-178-30 5 BLISTER PACK in 1 CARTON contains a BLISTER PACK
1 6 TABLET, FILM COATED in 1 BLISTER PACK This package is contained within the CARTON (63739-178-30)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA091023 08/18/2022
Labeler — McKesson Corporation dba SKY Packaging (140529962)
Establishment
Name Address ID/FEI Operations
DR. REDDY’S LABORATORIES LIMITED (FTO-Sez-Process Unit-01) 860037244 analysis (63739-178), manufacture (63739-178)

Revised: 09/2022 McKesson Corporation dba SKY Packaging

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