CLOPIDOGREL BISULFATE

Product NDC
71093-142
11-digit product format
710930142
Labeler code
71093
Product ID
71093-142_f176d230-bef1-4056-891c-6b67b6230a99
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
clopidogrel bisulfate
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
ACI Healthcare USA, Inc
Application
ANDA078004
Marketing category
ANDA
Marketing start
2022-07-01
Marketing end
0000-00-00
Substance
CLOPIDOGREL BISULFATE
Active strength
75 mg/1
Pharmacologic classes
Cytochrome P450 2C8 Inhibitors [MoA], Decreased Platelet Aggregation [PE], P2Y12 Platelet Inhibitor [EPC], P2Y12 Receptor Antagonists [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#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71093-142-04CLOPIDOGREL BISULFATE90 in 1 BOTTLETABLET, FILM COATED906
71093-142-05CLOPIDOGREL BISULFATE500 in 1 BOTTLETABLET, FILM COATED5006

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71093-142CLOPIDOGREL BISULFATE TABLET, FILM COATED [ACI HEALTHCARE USA, INC]6Legacy NDC, 2 package rows20230116_52902cfe-2863-490a-b700-3f47dfe3cf50.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
309362clopidogrel 75 MG Oral TabletPSN52902cfe-2863-490a-b700-3f47dfe3cf506
309362clopidogrel 75 MG Oral TabletSCD52902cfe-2863-490a-b700-3f47dfe3cf506
309362clopidogrel 75 MG (as clopidogrel bisulfate 97.875 MG) Oral TabletSY52902cfe-2863-490a-b700-3f47dfe3cf506

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71093-142-047109301420490 TABLET, FILM COATED in 1 BOTTLE (71093-142-04) 2020-12-010000-00-00NoNoCurrent
71093-142-0571093014205500 TABLET, FILM COATED in 1 BOTTLE (71093-142-05) 2020-12-010000-00-00NoNoCurrent