Clopidogrel

Product NDC
63187-362
11-digit product format
631870362
Labeler code
63187
Product ID
63187-362_34f7e985-f275-4c4b-ab35-ffa37e49052b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Clopidogrel
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA076999
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
351abe41-466c-4dd8-840a-0fdb68318bd5Product name120230316

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63187-362-30Clopidogrel30 in 1 BOTTLETABLET, FILM COATED303
63187-362-60Clopidogrel60 in 1 BOTTLETABLET, FILM COATED603
63187-362-90Clopidogrel90 in 1 BOTTLETABLET, FILM COATED903

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63187-362CLOPIDOGREL TABLET, FILM COATED [PROFICIENT RX LP]3Current NDC, Legacy NDC, 3 package rows20210115_25ed3120-7960-4e87-8422-de5c2026062c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
309362clopidogrel 75 MG Oral TabletPSN25ed3120-7960-4e87-8422-de5c2026062c3
309362clopidogrel 75 MG Oral TabletSCD25ed3120-7960-4e87-8422-de5c2026062c3
309362clopidogrel 75 MG (as clopidogrel bisulfate 97.875 MG) Oral TabletSY25ed3120-7960-4e87-8422-de5c2026062c3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
63187-362-306318703623030 TABLET, FILM COATED in 1 BOTTLE (63187-362-30) 2016-08-010000-00-00NoNoCurrent
63187-362-606318703626060 TABLET, FILM COATED in 1 BOTTLE (63187-362-60) 2016-08-010000-00-00NoNoCurrent
63187-362-906318703629090 TABLET, FILM COATED in 1 BOTTLE (63187-362-90) 2016-08-010000-00-00NoNoCurrent