FDA.reportPublic FDA data

Clopidogrel bisulfate

Product NDC
63629-8045
11-digit product format
636298045
Labeler code
63629
Product ID
63629-8045_f0d31870-86fa-4079-ae1a-508bc2f64317
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Clopidogrel bisulfate
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA204165
Marketing category
ANDA
Marketing start
2017-05-05
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 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
63629-8045-12024-01-30C16284748780-11030e365-1e89-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use CLOPIDOGREL tablets, USP safely and effectively. See full prescribing information for CLOPIDOGREL tablets, USP. CLOPIDOGREL Tablets, USP for oral use Initial U.S. Approval: 1997

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63629-8045-1Clopidogrel bisulfate90 in 1 BOTTLETABLET, FILM COATED902

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63629-8045CLOPIDOGREL BISULFATE TABLET, FILM COATED [BRYANT RANCH PREPACK]2Legacy NDC, 1 package rows20220119_f0d31870-86fa-4079-ae1a-508bc2f64317.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
309362clopidogrel 75 MG Oral TabletPSNf0d31870-86fa-4079-ae1a-508bc2f643172
309362clopidogrel 75 MG Oral TabletSCDf0d31870-86fa-4079-ae1a-508bc2f643172
309362clopidogrel 75 MG (as clopidogrel bisulfate 97.875 MG) Oral TabletSYf0d31870-86fa-4079-ae1a-508bc2f643172

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
63629-8045-16362980450190 TABLET, FILM COATED in 1 BOTTLE (63629-8045-1) 2019-07-250000-00-00NoNoCurrent