FDA.reportPublic FDA data

Clopidogrel bisulfate

Product NDC
68071-5277
11-digit product format
680715277
Labeler code
68071
Product ID
68071-5277_1d7904db-ccb2-b88e-e063-6294a90ac568
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Clopidogrel bisulfate
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
NuCare Pharmaceuticals,Inc.
Application
ANDA204165
Marketing category
ANDA
Marketing start
2015-09-15
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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Clopidogrel bisulfate
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CLOPIDOGREL BISULFATE75 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii08I79HTP27
Rxcui309362

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
39fa80eb-1490-ce82-3d3a-820ae7c37b85Product name520250618

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
68071-5277-92022-05-26C16284748780-1d6a99b39-c28e-a426-e053-dadaa90af4c2These highlights do not include all the information needed to use CLOPIDOGREL TABLETS safely and effectively. See full prescribing information for CLOPIDOGREL TABLETS. CLOPIDOGREL tablets, for oral use Initial U.S. Approval: 1997
68071-5277-92022-01-28C16284748780-1d6a99b39-c28e-a426-e053-dadaa90af4c2These highlights do not include all the information needed to use CLOPIDOGREL TABLETS safely and effectively. See full prescribing information for CLOPIDOGREL TABLETS. CLOPIDOGREL tablets, for oral use Initial U.S. Approval: 1997

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68071-5277-9Clopidogrel bisulfate90 in 1 BOTTLETABLET, FILM COATED9021

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68071-5277CLOPIDOGREL BISULFATE TABLET, FILM COATED [NUCARE PHARMACEUTICALS,INC.]21Current NDC, Legacy NDC, 1 package rows20240719_a7bf847d-43e9-166e-e053-2995a90a239e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
309362clopidogrel 75 MG Oral TabletPSNa7bf847d-43e9-166e-e053-2995a90a239e21
309362clopidogrel 75 MG Oral TabletSCDa7bf847d-43e9-166e-e053-2995a90a239e21
309362clopidogrel 75 MG (as clopidogrel bisulfate 97.875 MG) Oral TabletSYa7bf847d-43e9-166e-e053-2995a90a239e21

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
68071-5277-96807152770990 TABLET, FILM COATED in 1 BOTTLE (68071-5277-9) 2020-06-100000-00-00NoNoCurrent