FDA.reportPublic FDA data

Clopidogrel bisulfate

Product NDC
62034-017
11-digit product format
620340017
Labeler code
62034
Product ID
62034-017_74b235fb-7b6d-4d07-ba6e-3bca30e847c5
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Clopidogrel bisulfate
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Blenheim Pharmacal, Inc.
Application
ANDA204165
Marketing category
ANDA
Marketing start
2016-03-01
Marketing end
0000-00-00
Substance
CLOPIDOGREL BISULFATE
Active strength
300 mg/1
Pharmacologic classes
Decreased Platelet Aggregation [PE],P2Y12 Platelet Inhibitor [EPC],P2Y12 Receptor Antagonists [MoA],Cytochrome P450 2C8 Inhibitors [MoA]
NDC exclude flag
E
Listing certified through
2017-12-31
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
62034-017-732020-01-31C16284748780-19d75b9d1-0e3d-f424-e053-dadaa90a57ceThese 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
62034-017-11Clopidogrel bisulfate1 in 1 BLISTER PACKTABLET, FILM COATED11
62034-017-73Clopidogrel bisulfate30 in 1 BOX, UNIT-DOSETABLET, FILM COATED301

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62034-017CLOPIDOGREL BISULFATE TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.]1Legacy NDC, 2 package rows20160301_994dc0b4-0158-45db-965f-db827296f619.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
749196clopidogrel 300 MG Oral TabletPSN994dc0b4-0158-45db-965f-db827296f6191
749196clopidogrel 300 MG Oral TabletSCD994dc0b4-0158-45db-965f-db827296f6191
749196clopidogrel 300 MG (as clopidogrel bisulfate 391.5 MG) Oral TabletSY994dc0b4-0158-45db-965f-db827296f6191

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
62034-017-11620340017111 in 1 BLISTER PACKHistorical
62034-017-736203400177330 in 1 BOX, UNIT-DOSEHistorical