FDA.reportPublic FDA data

Clopidogrel

Product NDC
50090-5781
11-digit product format
500905781
Labeler code
50090
Product ID
50090-5781_4a4c0017-ff4f-4475-8257-c0994ad0e332
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Clopidogrel
Dosage form
TABLET
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA202928
Marketing category
ANDA
Marketing start
2012-10-16
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
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
50090-5781-02023-02-07C16284748780-1f386c649-b17d-0266-e053-dadaa90a7c1aThese 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
50090-5781-12023-02-07C16284748780-1f386c649-b17d-0266-e053-dadaa90a7c1aThese 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
50090-5781-02023-01-30C16284748780-1f386c649-b17d-0266-e053-dadaa90a7c1aThese 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
50090-5781-12023-01-30C16284748780-1f386c649-b17d-0266-e053-dadaa90a7c1aThese 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
50090-5781-0Clopidogrel30 in 1 BOTTLETABLET309
50090-5781-1Clopidogrel90 in 1 BOTTLETABLET909

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-5781CLOPIDOGREL TABLET [A-S MEDICATION SOLUTIONS]9Current NDC, Legacy NDC, 2 package rows20241102_02f0eaf8-0fc2-425d-8259-cef00156e25d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
309362clopidogrel 75 MG Oral TabletPSN02f0eaf8-0fc2-425d-8259-cef00156e25d9
309362clopidogrel 75 MG Oral TabletSCD02f0eaf8-0fc2-425d-8259-cef00156e25d9
309362clopidogrel 75 MG (as clopidogrel bisulfate 97.875 MG) Oral TabletSY02f0eaf8-0fc2-425d-8259-cef00156e25d9

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-5781-05009057810030 TABLET in 1 BOTTLE (50090-5781-0) 30 tablet2021-10-080000-00-00NoNoCurrent
50090-5781-15009057810190 TABLET in 1 BOTTLE (50090-5781-1) 90 tablet2021-10-080000-00-00NoNoCurrent