Clopidogrel

Product NDC
76519-1016
11-digit product format
765191016
Labeler code
76519
Product ID
76519-1016_5df77934-8584-0707-e053-2991aa0a52e5
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Clopidogrel
Dosage form
TABLET
Route
ORAL
Labeler
H.J. Harkins Company Inc
Application
ANDA202928
Marketing category
ANDA
Marketing start
2017-11-06
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
2019-12-31
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
76519-1016-22020-01-31C16284748780-19d75b9d0-c66d-f424-e053-dadaa90a57ce5df77934-8583-0707-e053-2991aa0a52e5
76519-1016-32020-01-31C16284748780-19d75b9d0-c66d-f424-e053-dadaa90a57ce5df77934-8583-0707-e053-2991aa0a52e5

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
76519-1016-2Clopidogrel200 in 1 CONTAINERTABLET2001
76519-1016-3Clopidogrel30 in 1 CONTAINERTABLET301

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76519-1016CLOPIDOGREL TABLET [H.J. HARKINS COMPANY INC]1Legacy NDC, 2 package rows20171122_5df77934-8583-0707-e053-2991aa0a52e5.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
309362clopidogrel 75 MG Oral TabletPSN5df77934-8583-0707-e053-2991aa0a52e51
309362clopidogrel 75 MG Oral TabletSCD5df77934-8583-0707-e053-2991aa0a52e51
309362clopidogrel 75 MG (as clopidogrel bisulfate 97.875 MG) Oral TabletSY5df77934-8583-0707-e053-2991aa0a52e51

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
76519-1016-276519101602200 in 1 CONTAINERHistorical
76519-1016-37651910160330 in 1 CONTAINERHistorical