FDA.reportPublic FDA data

Clopidogrel

Product NDC
71335-0080
11-digit product format
713350080
Labeler code
71335
Product ID
71335-0080_1de06f75-f138-4f1d-b71e-ad82b549d41b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Clopidogrel Bisulfate
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA090540
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

Additional Listing Data#

Finished product
Yes
Brand name base
Clopidogrel
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CLOPIDOGREL BISULFATE75 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii08I79HTP27
Rxcui309362

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
39fa80eb-1490-ce82-3d3a-820ae7c37b85Product name520250618

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71335-0080-1Clopidogrel90 in 1 BOTTLETABLET, FILM COATED908
71335-0080-2Clopidogrel30 in 1 BOTTLETABLET, FILM COATED308
71335-0080-3Clopidogrel60 in 1 BOTTLETABLET, FILM COATED608
71335-0080-4Clopidogrel20 in 1 BOTTLETABLET, FILM COATED208
71335-0080-5Clopidogrel10 in 1 BOTTLETABLET, FILM COATED108

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71335-0080-1EA - Each71335-008049fc14f7-f642-47a8-b2d1-b5287679760512018-03-08
71335-0080-2EA - Each71335-00809d481f76-ae0a-4432-970a-3881f0d53a8e12018-03-08
71335-0080-3EA - Each71335-00801a27a737-d912-47c8-b2e1-048f413d216612018-03-08
71335-0080-4EA - Each71335-008006baafdc-5132-4926-908b-1d90f664c99512018-03-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-0080CLOPIDOGREL (CLOPIDOGREL BISULFATE) TABLET, FILM COATED [BRYANT RANCH PREPACK]8Current NDC, Legacy NDC, 5 package rows20240601_e8f98886-4771-4be3-8b57-edfbbc1b4661.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
309362clopidogrel 75 MG Oral TabletPSNe8f98886-4771-4be3-8b57-edfbbc1b46618
309362clopidogrel 75 MG Oral TabletSCDe8f98886-4771-4be3-8b57-edfbbc1b46618
309362clopidogrel 75 MG (as clopidogrel bisulfate 97.875 MG) Oral TabletSYe8f98886-4771-4be3-8b57-edfbbc1b46618

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71335-0080-17133500800190 TABLET, FILM COATED in 1 BOTTLE (71335-0080-1) 2023-04-210000-00-00NoNoCurrent
71335-0080-27133500800230 TABLET, FILM COATED in 1 BOTTLE (71335-0080-2) 2023-05-020000-00-00NoNoCurrent
71335-0080-37133500800360 TABLET, FILM COATED in 1 BOTTLE (71335-0080-3) 2024-05-290000-00-00NoNoCurrent
71335-0080-47133500800420 TABLET, FILM COATED in 1 BOTTLE (71335-0080-4) 2024-05-290000-00-00NoNoCurrent
71335-0080-57133500800510 TABLET, FILM COATED in 1 BOTTLE (71335-0080-5) 2024-05-290000-00-00NoNoCurrent