FDA.reportPublic FDA data

Clopidogrel

Product NDC
67046-100
11-digit product format
670460100
Labeler code
67046
Product ID
67046-100_598e28ee-0a2b-3ccc-e053-2991aa0a0a56
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Clopidogrel bisulphate
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Contract Pharmacy Services-PA
Application
ANDA202925
Marketing category
ANDA
Marketing start
2017-09-19
Marketing end
0000-00-00
Substance
CLOPIDOGREL BISULFATE
Active strength
75 mg/1
Pharmacologic classes
Decreased Platelet Aggregation [PE],P2Y12 Platelet Inhibitor [EPC],P2Y12 Receptor Antagonists [MoA],Cytochrome P450 2C8 Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2020-12-31
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
67046-100-072022-01-28C16284748780-1d6a99b39-4e87-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 100 Initial U.S. Approval: 1997
67046-100-142022-01-28C16284748780-1d6a99b39-4e87-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 100 Initial U.S. Approval: 1997
67046-100-152022-01-28C16284748780-1d6a99b39-4e87-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 100 Initial U.S. Approval: 1997
67046-100-212022-01-28C16284748780-1d6a99b39-4e87-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 100 Initial U.S. Approval: 1997
67046-100-282022-01-28C16284748780-1d6a99b39-4e87-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 100 Initial U.S. Approval: 1997
67046-100-302022-01-28C16284748780-1d6a99b39-4e87-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 100 Initial U.S. Approval: 1997
67046-100-602022-01-28C16284748780-1d6a99b39-4e87-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 100 Initial U.S. Approval: 1997

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67046-100-07Clopidogrel7 in 1 BLISTER PACKTABLET, FILM COATED71
67046-100-14Clopidogrel14 in 1 BLISTER PACKTABLET, FILM COATED141
67046-100-15Clopidogrel15 in 1 BLISTER PACKTABLET, FILM COATED151
67046-100-21Clopidogrel21 in 1 BLISTER PACKTABLET, FILM COATED211
67046-100-28Clopidogrel28 in 1 BLISTER PACKTABLET, FILM COATED281
67046-100-30Clopidogrel30 in 1 BLISTER PACKTABLET, FILM COATED301
67046-100-60Clopidogrel60 in 1 BLISTER PACKTABLET, FILM COATED601

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67046-100CLOPIDOGREL (CLOPIDOGREL BISULPHATE) TABLET, FILM COATED [CONTRACT PHARMACY SERVICES-PA]1Legacy NDC, 7 package rows20170919_598e28ee-0a2a-3ccc-e053-2991aa0a0a56.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
309362clopidogrel 75 MG Oral TabletPSN598e28ee-0a2a-3ccc-e053-2991aa0a0a561
309362clopidogrel 75 MG Oral TabletSCD598e28ee-0a2a-3ccc-e053-2991aa0a0a561
309362clopidogrel 75 MG (as clopidogrel bisulfate 97.875 MG) Oral TabletSY598e28ee-0a2a-3ccc-e053-2991aa0a0a561

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
67046-100-07670460100077 TABLET, FILM COATED in 1 BLISTER PACK (67046-100-07) 2017-09-190000-00-00NoNoCurrent
67046-100-146704601001414 TABLET, FILM COATED in 1 BLISTER PACK (67046-100-14) 2017-09-190000-00-00NoNoCurrent
67046-100-156704601001515 TABLET, FILM COATED in 1 BLISTER PACK (67046-100-15) 2017-09-190000-00-00NoNoCurrent
67046-100-216704601002121 TABLET, FILM COATED in 1 BLISTER PACK (67046-100-21) 2017-09-190000-00-00NoNoCurrent
67046-100-286704601002828 TABLET, FILM COATED in 1 BLISTER PACK (67046-100-28) 2017-09-190000-00-00NoNoCurrent
67046-100-306704601003030 TABLET, FILM COATED in 1 BLISTER PACK (67046-100-30) 2017-09-190000-00-00NoNoCurrent
67046-100-606704601006060 TABLET, FILM COATED in 1 BLISTER PACK (67046-100-60) 2017-09-190000-00-00NoNoCurrent