Clopidogrel Bisulfate

Product NDC
0904-6294
11-digit product format
009046294
Labeler code
0904
Product ID
0904-6294_c55b83a2-a7e7-407b-ae9d-fdfc2f86e384
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Clopidogrel Bisulfate
Dosage form
TABLET
Route
ORAL
Labeler
Major Pharmaceuticals
Application
ANDA090844
Marketing category
ANDA
Marketing start
2012-05-17
Marketing end
0000-00-00
Substance
CLOPIDOGREL BISULFATE
Active strength
75 mg/1
Pharmacologic classes
Decreased Platelet Aggregation [PE],P2Y12 Platelet Inhibitor [EPC],P2Y12 Receptor Antagonists [MoA],Cytochrome P450 2C8 Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2022-12-31
Current FDA listing
Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0904-6294-61EA - Each0904-629483499f4d-816c-4aef-a686-301bdc11a0ad12013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CLOPIDOGREL BISULFATEACTIVE INGREDIENT08I79HTP27CLOPIDOGREL BISULFATE TABLET [MAJOR PHARMACEUTICALS]5
CLOPIDOGRELACTIVE MOIETYA74586SNO7CLOPIDOGREL BISULFATE TABLET [MAJOR PHARMACEUTICALS]5
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UCLOPIDOGREL BISULFATE TABLET [MAJOR PHARMACEUTICALS]5
HYDROGENATED CASTOR OILINACTIVE INGREDIENTZF94AP8MEYCLOPIDOGREL BISULFATE TABLET [MAJOR PHARMACEUTICALS]5
HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTEDINACTIVE INGREDIENT2165RE0K14CLOPIDOGREL BISULFATE TABLET [MAJOR PHARMACEUTICALS]5
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XCLOPIDOGREL BISULFATE TABLET [MAJOR PHARMACEUTICALS]5
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30CLOPIDOGREL BISULFATE TABLET [MAJOR PHARMACEUTICALS]5
MANNITOLINACTIVE INGREDIENT3OWL53L36ACLOPIDOGREL BISULFATE TABLET [MAJOR PHARMACEUTICALS]5
POLYETHYLENE GLYCOL 6000INACTIVE INGREDIENT30IQX730WECLOPIDOGREL BISULFATE TABLET [MAJOR PHARMACEUTICALS]5
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4CLOPIDOGREL BISULFATE TABLET [MAJOR PHARMACEUTICALS]5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0904-6294CLOPIDOGREL TABLET, FILM COATED [MAJOR PHARMACEUTICALS]13Legacy NDC20250418_c3248d43-3dd6-4ca9-afca-528c7abe0fce.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0904-6294-6100904629461100 BLISTER PACK in 1 CARTON (0904-6294-61) > 1 TABLET in 1 BLISTER PACK100 blister pack2012-05-170000-00-00NoNoCurrent