Clopidogrel

Product NDC
69367-200
11-digit product format
693670200
Labeler code
69367
Product ID
69367-200_175ba166-6dc4-41d9-a75e-853cb6d47aeb
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Clopidogrel Bisulfate
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Westminster Pharmaceuticals, LLC
Application
ANDA204165
Marketing category
ANDA
Marketing start
2023-05-15
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
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CLOPIDOGREL BISULFATE75 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii08I79HTP27
Rxcui309362, 749196

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
69367-200-05Clopidogrel500 in 1 BOTTLE, PLASTICTABLET, FILM COATED5007

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69367-200-05EA - Each69367-2005ebef090-44c5-404a-b331-9bebd940a0e112023-06-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69367-200CLOPIDOGREL (CLOPIDOGREL BISULFATE) TABLET, FILM COATED [WESTMINSTER PHARMACEUTICALS, LLC]7Current NDC, 1 package rows20230910_bb3b5e96-e629-4db5-8ad5-40c17c6dae18.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
749196clopidogrel 300 MG Oral TabletPSNbb3b5e96-e629-4db5-8ad5-40c17c6dae187
309362clopidogrel 75 MG Oral TabletPSNbb3b5e96-e629-4db5-8ad5-40c17c6dae187
749196clopidogrel 300 MG Oral TabletSCDbb3b5e96-e629-4db5-8ad5-40c17c6dae187
309362clopidogrel 75 MG Oral TabletSCDbb3b5e96-e629-4db5-8ad5-40c17c6dae187
749196clopidogrel 300 MG (as clopidogrel bisulfate 391.5 MG) Oral TabletSYbb3b5e96-e629-4db5-8ad5-40c17c6dae187
309362clopidogrel 75 MG (as clopidogrel bisulfate 97.875 MG) Oral TabletSYbb3b5e96-e629-4db5-8ad5-40c17c6dae187

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
69367-200-0569367020005500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (69367-200-05) 2023-05-15NoNoHistorical