FDA.reportPublic FDA data

Clopidogrel bisulfate

Product NDC
67046-099
11-digit product format
670460099
Labeler code
67046
Product ID
67046-099_59b6c299-a9d0-22fd-e053-2a91aa0a6286
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Clopidogrel bisulfate
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Contract Pharmacy Services-PA
Application
ANDA076273
Marketing category
ANDA
Marketing start
2017-09-21
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
67046-099-072022-01-28C16284748780-1d6a99b39-6898-a426-e053-dadaa90af4c2099 Clopidogrel 75 mg These 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
67046-099-142022-01-28C16284748780-1d6a99b39-6898-a426-e053-dadaa90af4c2099 Clopidogrel 75 mg These 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
67046-099-152022-01-28C16284748780-1d6a99b39-6898-a426-e053-dadaa90af4c2099 Clopidogrel 75 mg These 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
67046-099-202022-01-28C16284748780-1d6a99b39-6898-a426-e053-dadaa90af4c2099 Clopidogrel 75 mg These 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
67046-099-212022-01-28C16284748780-1d6a99b39-6898-a426-e053-dadaa90af4c2099 Clopidogrel 75 mg These 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
67046-099-282022-01-28C16284748780-1d6a99b39-6898-a426-e053-dadaa90af4c2099 Clopidogrel 75 mg These 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
67046-099-302022-01-28C16284748780-1d6a99b39-6898-a426-e053-dadaa90af4c2099 Clopidogrel 75 mg These 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
67046-099-602022-01-28C16284748780-1d6a99b39-6898-a426-e053-dadaa90af4c2099 Clopidogrel 75 mg These 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
67046-099-07Clopidogrel bisulfate7 in 1 BLISTER PACKTABLET, FILM COATED71
67046-099-14Clopidogrel bisulfate14 in 1 BLISTER PACKTABLET, FILM COATED141
67046-099-15Clopidogrel bisulfate15 in 1 BLISTER PACKTABLET, FILM COATED151
67046-099-20Clopidogrel bisulfate20 in 1 BLISTER PACKTABLET, FILM COATED201
67046-099-21Clopidogrel bisulfate21 in 1 BLISTER PACKTABLET, FILM COATED211
67046-099-28Clopidogrel bisulfate28 in 1 BLISTER PACKTABLET, FILM COATED281
67046-099-30Clopidogrel bisulfate30 in 1 BLISTER PACKTABLET, FILM COATED301
67046-099-60Clopidogrel bisulfate60 in 1 BLISTER PACKTABLET, FILM COATED601

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67046-099CLOPIDOGREL BISULFATE TABLET, FILM COATED [CONTRACT PHARMACY SERVICES-PA]1Legacy NDC, 8 package rows20170921_59b6c299-a9cf-22fd-e053-2a91aa0a6286.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
309362clopidogrel 75 MG Oral TabletPSN59b6c299-a9cf-22fd-e053-2a91aa0a62861
309362clopidogrel 75 MG Oral TabletSCD59b6c299-a9cf-22fd-e053-2a91aa0a62861
309362clopidogrel 75 MG (as clopidogrel bisulfate 97.875 MG) Oral TabletSY59b6c299-a9cf-22fd-e053-2a91aa0a62861

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
67046-099-07670460099077 TABLET, FILM COATED in 1 BLISTER PACK (67046-099-07) 2017-09-210000-00-00NoNoCurrent
67046-099-146704600991414 TABLET, FILM COATED in 1 BLISTER PACK (67046-099-14) 2017-09-210000-00-00NoNoCurrent
67046-099-156704600991515 TABLET, FILM COATED in 1 BLISTER PACK (67046-099-15) 2017-09-210000-00-00NoNoCurrent
67046-099-206704600992020 TABLET, FILM COATED in 1 BLISTER PACK (67046-099-20) 2017-09-210000-00-00NoNoCurrent
67046-099-216704600992121 TABLET, FILM COATED in 1 BLISTER PACK (67046-099-21) 2017-09-210000-00-00NoNoCurrent
67046-099-286704600992828 TABLET, FILM COATED in 1 BLISTER PACK (67046-099-28) 2017-09-210000-00-00NoNoCurrent
67046-099-306704600993030 TABLET, FILM COATED in 1 BLISTER PACK (67046-099-30) 2017-09-210000-00-00NoNoCurrent
67046-099-606704600996060 TABLET, FILM COATED in 1 BLISTER PACK (67046-099-60) 2017-09-210000-00-00NoNoCurrent