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 -- 75 mg Tablet Bottle Label
(click image for full-size original)

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

PRINCIPAL DISPLAY PANEL -- 300 mg Tablet Blister Pack Carton
(click image for full-size original)
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

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