Clopidogrel

Product NDC
71610-527
11-digit product format
716100527
Labeler code
71610
Product ID
71610-527_5364ce21-e700-4cce-bd59-aadec2a56428
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
clopidogrel bisulfate
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Aphena Pharma Solutions - Tennessee, LLC
Application
ANDA076274
Marketing category
ANDA
Marketing start
2012-05-17
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
2026-12-31
Current FDA listing
Yes

Related Records

Related UNII Ingredients

UNIIPreferred termRegistry numberMatched term
08I79HTP27CLOPIDOGREL BISULFATE120202-66-6CLOPIDOGREL BISULFATE

Packages

Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
71610-527-607161005276090 TABLET, FILM COATED in 1 BOTTLE (71610-527-60) 2021-02-12NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
ClopidogrelAphena Pharma Solutions - Tennessee, LLC2021-03-18HUMAN PRESCRIPTION DRUG LABEL1