FDA.reportPublic FDA data

Clopidogrel bisulfate

Product NDC
70934-797
11-digit product format
709340797
Labeler code
70934
Product ID
70934-797_d44c110b-890e-67a2-e053-2a95a90a6a03
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Clopidogrel bisulfate
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Denton Pharma, Inc. DBA Northwind Pharmaceuticals
Application
ANDA204165
Marketing category
ANDA
Marketing start
2020-11-09
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
2022-12-31
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
70934-797-302023-01-30C16284748780-1f386c64a-14fa-0266-e053-dadaa90a7c1aThese 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
70934-797-902023-01-30C16284748780-1f386c64a-14fa-0266-e053-dadaa90a7c1aThese 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
70934-797-30Clopidogrel bisulfate30 in 1 BOTTLE, PLASTICTABLET, FILM COATED303
70934-797-90Clopidogrel bisulfate90 in 1 BOTTLE, PLASTICTABLET, FILM COATED903

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70934-797CLOPIDOGREL BISULFATE TABLET, FILM COATED [DENTON PHARMA, INC. DBA NORTHWIND PHARMACEUTICALS]3Legacy NDC, 2 package rows20211230_b6ff2c45-6583-7d0a-e053-2995a90a976f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
309362clopidogrel 75 MG Oral TabletPSNb6ff2c45-6583-7d0a-e053-2995a90a976f3
309362clopidogrel 75 MG Oral TabletSCDb6ff2c45-6583-7d0a-e053-2995a90a976f3
309362clopidogrel 75 MG (as clopidogrel bisulfate 97.875 MG) Oral TabletSYb6ff2c45-6583-7d0a-e053-2995a90a976f3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
70934-797-307093407973030 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70934-797-30) 2021-03-160000-00-00NoNoCurrent
70934-797-907093407979090 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70934-797-90) 2020-11-090000-00-00NoNoCurrent