FDA.reportPublic FDA data

Clopidogrel bisulfate

Product NDC
71335-1646
11-digit product format
713351646
Labeler code
71335
Product ID
71335-1646_c87019f9-85a2-4438-8b1c-950b2676e2d5
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Clopidogrel bisulfate
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA204165
Marketing category
ANDA
Marketing start
2015-09-15
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 bisulfate
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
71335-1646-1Clopidogrel bisulfate90 in 1 BOTTLETABLET, FILM COATED904
71335-1646-2Clopidogrel bisulfate30 in 1 BOTTLETABLET, FILM COATED304
71335-1646-3Clopidogrel bisulfate60 in 1 BOTTLETABLET, FILM COATED604
71335-1646-4Clopidogrel bisulfate20 in 1 BOTTLETABLET, FILM COATED204
71335-1646-5Clopidogrel bisulfate10 in 1 BOTTLETABLET, FILM COATED104

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-1646CLOPIDOGREL BISULFATE TABLET, FILM COATED [BRYANT RANCH PREPACK]4Current NDC, Legacy NDC, 5 package rows20231108_7c4b3bc3-8f3b-4232-835d-e37d93b92c3e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
309362clopidogrel 75 MG Oral TabletPSN7c4b3bc3-8f3b-4232-835d-e37d93b92c3e4
309362clopidogrel 75 MG Oral TabletSCD7c4b3bc3-8f3b-4232-835d-e37d93b92c3e4
309362clopidogrel 75 MG (as clopidogrel bisulfate 97.875 MG) Oral TabletSY7c4b3bc3-8f3b-4232-835d-e37d93b92c3e4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71335-1646-17133516460190 TABLET, FILM COATED in 1 BOTTLE (71335-1646-1) 2020-06-160000-00-00NoNoCurrent
71335-1646-27133516460230 TABLET, FILM COATED in 1 BOTTLE (71335-1646-2) 2020-07-060000-00-00NoNoCurrent
71335-1646-37133516460360 TABLET, FILM COATED in 1 BOTTLE (71335-1646-3) 2020-06-170000-00-00NoNoCurrent
71335-1646-47133516460420 TABLET, FILM COATED in 1 BOTTLE (71335-1646-4) 2021-12-280000-00-00NoNoCurrent
71335-1646-57133516460510 TABLET, FILM COATED in 1 BOTTLE (71335-1646-5) 2021-12-280000-00-00NoNoCurrent