FDA.reportPublic FDA data

Clopidogrel

Product NDC
71335-0581
11-digit product format
713350581
Labeler code
71335
Product ID
71335-0581_71bf33e7-049d-4d2d-a83c-ed205142f17d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Clopidogrel
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA202928
Marketing category
ANDA
Marketing start
2012-10-16
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
71335-0581-1Clopidogrel90 in 1 BOTTLETABLET908
71335-0581-2Clopidogrel30 in 1 BOTTLETABLET308
71335-0581-3Clopidogrel60 in 1 BOTTLETABLET608
71335-0581-4Clopidogrel20 in 1 BOTTLETABLET208
71335-0581-5Clopidogrel10 in 1 BOTTLETABLET108

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71335-0581-1EA - Each71335-05818d18b155-76a9-4ed3-8068-23b80a9e8b9912018-03-08
71335-0581-2EA - Each71335-0581076c35c3-5910-4ad7-8ed0-ee7f0f3a98e412018-03-08
71335-0581-3EA - Each71335-058187717bd3-4517-408d-ba9e-8746f88702a312018-03-08
71335-0581-4EA - Each71335-05818141136d-1d6e-4297-ba48-d047e868972012018-03-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-0581CLOPIDOGREL TABLET [BRYANT RANCH PREPACK]8Current NDC, Legacy NDC, 5 package rows20240413_85df051d-0fa9-41b3-8862-9d6ca851a9cc.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
309362clopidogrel 75 MG Oral TabletPSN85df051d-0fa9-41b3-8862-9d6ca851a9cc8
309362clopidogrel 75 MG Oral TabletSCD85df051d-0fa9-41b3-8862-9d6ca851a9cc8
309362clopidogrel 75 MG (as clopidogrel bisulfate 97.875 MG) Oral TabletSY85df051d-0fa9-41b3-8862-9d6ca851a9cc8

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71335-0581-17133505810190 TABLET in 1 BOTTLE (71335-0581-1) 90 tablet2020-01-170000-00-00NoNoCurrent
71335-0581-27133505810230 TABLET in 1 BOTTLE (71335-0581-2) 30 tablet2020-03-100000-00-00NoNoCurrent
71335-0581-37133505810360 TABLET in 1 BOTTLE (71335-0581-3) 60 tablet2024-04-030000-00-00NoNoCurrent
71335-0581-47133505810420 TABLET in 1 BOTTLE (71335-0581-4) 20 tablet2024-04-030000-00-00NoNoCurrent
71335-0581-57133505810510 TABLET in 1 BOTTLE (71335-0581-5) 10 tablet2024-04-030000-00-00NoNoCurrent