FDA.reportPublic FDA data

Clopidogrel

Product NDC
69367-194
11-digit product format
693670194
Labeler code
69367
Product ID
69367-194_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
2018-07-27
Substance
CLOPIDOGREL BISULFATE
Active strength
300 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 BISULFATE300 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
a62a50ac-1535-4461-9768-8ae703e2e9fbProduct name120210525
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
bc07ef78-e82d-0c19-31f4-31f263780582Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69367-194-05Clopidogrel500 in 1 BOTTLE, PLASTICTABLET, FILM COATED5007
69367-194-30Clopidogrel30 in 1 BOTTLE, PLASTICTABLET, FILM COATED307

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69367-194-05EA - Each69367-19419243824-8910-4915-85c6-1b02e5bf12af12018-09-05
69367-194-30EA - Each69367-194360e99a5-3bd9-4dee-ba27-f7aed80fe75e12018-09-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69367-194CLOPIDOGREL (CLOPIDOGREL BISULFATE) TABLET, FILM COATED [WESTMINSTER PHARMACEUTICALS, LLC]7Current NDC, Legacy NDC, 2 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
749196clopidogrel 300 MG Oral TabletPSN94a5cdc4-e063-1d46-e053-2995a90a7e155
749196clopidogrel 300 MG Oral TabletSCD94a5cdc4-e063-1d46-e053-2995a90a7e155
749196clopidogrel 300 MG (as clopidogrel bisulfate 391.5 MG) Oral TabletSY94a5cdc4-e063-1d46-e053-2995a90a7e155
749196clopidogrel 300 MG Oral TabletPSN330702d9-842c-416d-9b11-b4a9b707e9b21
749196clopidogrel 300 MG Oral TabletSCD330702d9-842c-416d-9b11-b4a9b707e9b21
749196clopidogrel 300 MG (as clopidogrel bisulfate 391.5 MG) Oral TabletSY330702d9-842c-416d-9b11-b4a9b707e9b21

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
69367-194-0569367019405500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (69367-194-05) 2018-07-270000-00-00NoNoCurrent
69367-194-306936701943030 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (69367-194-30) 2018-07-270000-00-00NoNoCurrent