Clopidogrel Bisulfate

Product NDC
55154-3376
11-digit product format
551543376
Labeler code
55154
Product ID
55154-3376_3c73aa6a-372d-4475-8e24-ee4dfb061f2e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Clopidogrel Bisulfate
Dosage form
TABLET
Route
ORAL
Labeler
Cardinal Health
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
Cytochrome P450 2C8 Inhibitors [MoA], Decreased Platelet Aggregation [PE], P2Y12 Platelet Inhibitor [EPC], P2Y12 Receptor Antagonists [MoA]
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CLOPIDOGREL BISULFATEACTIVE INGREDIENT08I79HTP27CLOPIDOGREL BISULFATE TABLET [CARDINAL HEALTH]4
CLOPIDOGRELACTIVE MOIETYA74586SNO7CLOPIDOGREL BISULFATE TABLET [CARDINAL HEALTH]4
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UCLOPIDOGREL BISULFATE TABLET [CARDINAL HEALTH]4
HYDROGENATED CASTOR OILINACTIVE INGREDIENTZF94AP8MEYCLOPIDOGREL BISULFATE TABLET [CARDINAL HEALTH]4
HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTEDINACTIVE INGREDIENT2165RE0K14CLOPIDOGREL BISULFATE TABLET [CARDINAL HEALTH]4
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XCLOPIDOGREL BISULFATE TABLET [CARDINAL HEALTH]4
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30CLOPIDOGREL BISULFATE TABLET [CARDINAL HEALTH]4
MANNITOLINACTIVE INGREDIENT3OWL53L36ACLOPIDOGREL BISULFATE TABLET [CARDINAL HEALTH]4
POLYETHYLENE GLYCOL 6000INACTIVE INGREDIENT30IQX730WECLOPIDOGREL BISULFATE TABLET [CARDINAL HEALTH]4
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4CLOPIDOGREL BISULFATE TABLET [CARDINAL HEALTH]4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55154-3376CLOPIDOGREL TABLET, FILM COATED [CARDINAL HEALTH 107, LLC]14Legacy NDC20250514_c7ff7600-3c75-4b60-ae2e-a7ccdc33cf90.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55154-3376-05515433760010 BLISTER PACK in 1 BAG (55154-3376-0) > 1 TABLET in 1 BLISTER PACK10 blister pack2012-05-170000-00-00NoNoCurrent