Plavix (Page 6 of 6)

PRINCIPAL DISPLAY PANEL — 75 mg Tablet Bottle Label

List No. 1171-60
NDC 63653-1171-6

30 Tablets

Plavix_®
(clopidogrel tablets)

75 mg

Dispense with Medication Guide

Rx only

PRINCIPAL DISPLAY PANEL — 300 mg Tablet Blister Pack Carton

List No. 1332-20
NDC 63653-1332-2

Plavix_®
(clopidogrel tablets)

300 mg

Dispense with Medication Guide

Rx only
30 film-coated tablets

Bristol-Myers Squibb Companysanofi aventis

PLAVIX clopidogrel tablet, film coated

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:63653-1171 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CLOPIDOGREL BISULFATE (CLOPIDOGREL) CLOPIDOGREL 75 mg

Inactive Ingredients Ingredient Name Strength CASTOR OIL HYDROXYPROPYL CELLULOSE (1600000 WAMW) MANNITOL MICROCRYSTALLINE CELLULOSE POLYETHYLENE GLYCOL 6000 FERRIC OXIDE RED LACTOSE MONOHYDRATE TITANIUM DIOXIDE TRIACETIN CARNAUBA WAX

Product Characteristics Color PINK Score no score Shape ROUND (biconvex) Size 9mm Flavor Imprint Code 75;1171 Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:63653-1171-6 30 TABLET, FILM COATED in 1 BOTTLE None 2 NDC:63653-1171-1 90 TABLET, FILM COATED in 1 BOTTLE None 3 NDC:63653-1171-3 10 BLISTER PACK in 1 CARTON contains a BLISTER PACK 3 10 TABLET, FILM COATED in 1 BLISTER PACK This package is contained within the CARTON (63653-1171-3) 4 NDC:63653-1171-5 500 TABLET, FILM COATED in 1 BOTTLE None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA020839 11/17/1997 07/31/2022

PLAVIX clopidogrel tablet, film coated

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:63653-1332 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 CASTOR OIL HYDROXYPROPYL CELLULOSE (1600000 WAMW) MANNITOL MICROCRYSTALLINE CELLULOSE POLYETHYLENE GLYCOL 6000 FERRIC OXIDE RED LACTOSE MONOHYDRATE TITANIUM DIOXIDE TRIACETIN CARNAUBA WAX

Product Characteristics Color PINK Score no score Shape OVAL (oblong) Size 18mm Flavor Imprint Code 300;1332 Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:63653-1332-2 3 BLISTER PACK in 1 CARTON contains a BLISTER PACK 1 10 TABLET, FILM COATED in 1 BLISTER PACK This package is contained within the CARTON (63653-1332-2) 2 NDC:63653-1332-3 10 BLISTER PACK in 1 CARTON contains a BLISTER PACK 2 10 TABLET, FILM COATED in 1 BLISTER PACK This package is contained within the CARTON (63653-1332-3)

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA020839 05/09/2009 07/31/2022

Labeler — Bristol-Myers Squibb/Sanofi Pharmaceuticals Partnership (829806988)

Establishment
Name	Address	ID/FEI	Operations
Sanofi Chimie		262600765	ANALYSIS (63653-1171), ANALYSIS (63653-1332), API MANUFACTURE (63653-1171), API MANUFACTURE (63653-1332)

Establishment
Name	Address	ID/FEI	Operations
Sanofi Winthrop Industrie		763683216	ANALYSIS (63653-1171), ANALYSIS (63653-1332), LABEL (63653-1171), LABEL (63653-1332), MANUFACTURE (63653-1171), MANUFACTURE (63653-1332), PACK (63653-1171), PACK (63653-1332)

Establishment
Name	Address	ID/FEI	Operations
Sanofi Winthrop Industrie		571879985	ANALYSIS (63653-1171), ANALYSIS (63653-1332), LABEL (63653-1171), LABEL (63653-1332), PACK (63653-1171), PACK (63653-1332)

Revised: 09/2020 Bristol-Myers Squibb/Sanofi Pharmaceuticals Partnership