Clopidogrel

Product NDC
50090-5868
11-digit product format
500905868
Labeler code
50090
Product ID
50090-5868_8ed73a37-390b-4cc9-a0b4-093637038100
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Clopidogrel Bisulfate
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
A-S Medication Solutions
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
50090-5868-0Clopidogrel90 in 1 BOTTLETABLET, FILM COATED901

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-5868-0EA - Each50090-5868d813e26f-3143-41de-aa03-e6dac074c80c12024-08-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-5868CLOPIDOGREL (CLOPIDOGREL BISULFATE) TABLET, FILM COATED [A-S MEDICATION SOLUTIONS]1Current NDC, 1 package rows20230912_b6e6a9b8-bf91-4e7f-b872-880afb558426.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
309362clopidogrel 75 MG Oral TabletPSNb6e6a9b8-bf91-4e7f-b872-880afb5584261
309362clopidogrel 75 MG Oral TabletSCDb6e6a9b8-bf91-4e7f-b872-880afb5584261
309362clopidogrel 75 MG (as clopidogrel bisulfate 97.875 MG) Oral TabletSYb6e6a9b8-bf91-4e7f-b872-880afb5584261

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
50090-5868-05009058680090 TABLET, FILM COATED in 1 BOTTLE (50090-5868-0) 2021-12-07NoNoHistorical