FDA.reportPublic FDA data

Clopidogrel

Product NDC
13668-141
11-digit product format
136680141
Labeler code
13668
Product ID
13668-141_3cbfb162-4652-4a90-9afa-489e743fc16a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Clopidogrel
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Torrent Pharmaceuticals Limited
Application
ANDA090844
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
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
13668-141-01Clopidogrel100 in 1 BOTTLETABLET, FILM COATED10021
13668-141-05Clopidogrel500 in 1 BOTTLETABLET, FILM COATED50021
13668-141-10Clopidogrel1000 in 1 BOTTLETABLET, FILM COATED100021
13668-141-30Clopidogrel30 in 1 BOTTLETABLET, FILM COATED3021
13668-141-44Clopidogrel3100 in 1 BOTTLETABLET, FILM COATED310021
13668-141-90Clopidogrel90 in 1 BOTTLETABLET, FILM COATED9021

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
13668-141-05EA - Each13668-141ae56d2ed-05f3-45cc-9392-1a7c52f6649412012-07-24
13668-141-30EA - Each13668-141a1893503-67dd-4c1d-b0ec-33f7d88f48bb12012-07-24
13668-141-74EA - Each13668-1413cc44720-2a23-4c16-875f-d37ccbd3733b12012-07-24
13668-141-90EA - Each13668-1417aa1957b-f91b-4704-b7b2-c8df60e6b40d12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CLOPIDOGREL BISULFATEACTIVE INGREDIENT08I79HTP27CLOPIDOGREL BISULFATE TABLET [TORRENT PHARMACEUTICALS LIMITED]5
CLOPIDOGRELACTIVE MOIETYA74586SNO7CLOPIDOGREL BISULFATE TABLET [TORRENT PHARMACEUTICALS LIMITED]5
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UCLOPIDOGREL BISULFATE TABLET [TORRENT PHARMACEUTICALS LIMITED]5
COLLOIDAL SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4CLOPIDOGREL BISULFATE TABLET [TORRENT PHARMACEUTICALS LIMITED]5
HYDROGENATED CASTOR OILINACTIVE INGREDIENTZF94AP8MEYCLOPIDOGREL BISULFATE TABLET [TORRENT PHARMACEUTICALS LIMITED]5
HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTEDINACTIVE INGREDIENT2165RE0K14CLOPIDOGREL BISULFATE TABLET [TORRENT PHARMACEUTICALS LIMITED]5
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XCLOPIDOGREL BISULFATE TABLET [TORRENT PHARMACEUTICALS LIMITED]5
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30CLOPIDOGREL BISULFATE TABLET [TORRENT PHARMACEUTICALS LIMITED]5
MANNITOLINACTIVE INGREDIENT3OWL53L36ACLOPIDOGREL BISULFATE TABLET [TORRENT PHARMACEUTICALS LIMITED]5
POLYETHYLENE GLYCOL 6000INACTIVE INGREDIENT30IQX730WECLOPIDOGREL BISULFATE TABLET [TORRENT PHARMACEUTICALS LIMITED]5
CLOPIDOGREL BISULFATEACTIVE INGREDIENT08I79HTP27CLOPIDOGREL BISULFATE (CLOPIDOGREL BISULFATE) TABLET [PD-RX PHARMACEUTICALS, INC.]2
CLOPIDOGRELACTIVE MOIETYA74586SNO7CLOPIDOGREL BISULFATE (CLOPIDOGREL BISULFATE) TABLET [PD-RX PHARMACEUTICALS, INC.]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UCLOPIDOGREL BISULFATE (CLOPIDOGREL BISULFATE) TABLET [PD-RX PHARMACEUTICALS, INC.]2
COLLOIDAL SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4CLOPIDOGREL BISULFATE (CLOPIDOGREL BISULFATE) TABLET [PD-RX PHARMACEUTICALS, INC.]2
HYDROGENATED CASTOR OILINACTIVE INGREDIENTZF94AP8MEYCLOPIDOGREL BISULFATE (CLOPIDOGREL BISULFATE) TABLET [PD-RX PHARMACEUTICALS, INC.]2
HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTEDINACTIVE INGREDIENT2165RE0K14CLOPIDOGREL BISULFATE (CLOPIDOGREL BISULFATE) TABLET [PD-RX PHARMACEUTICALS, INC.]2
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XCLOPIDOGREL BISULFATE (CLOPIDOGREL BISULFATE) TABLET [PD-RX PHARMACEUTICALS, INC.]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30CLOPIDOGREL BISULFATE (CLOPIDOGREL BISULFATE) TABLET [PD-RX PHARMACEUTICALS, INC.]2
MANNITOLINACTIVE INGREDIENT3OWL53L36ACLOPIDOGREL BISULFATE (CLOPIDOGREL BISULFATE) TABLET [PD-RX PHARMACEUTICALS, INC.]2
POLYETHYLENE GLYCOL 6000INACTIVE INGREDIENT30IQX730WECLOPIDOGREL BISULFATE (CLOPIDOGREL BISULFATE) TABLET [PD-RX PHARMACEUTICALS, INC.]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
13668-141CLOPIDOGREL TABLET, FILM COATED [TORRENT PHARMACEUTICALS LIMITED]21Current NDC, Legacy NDC, 6 package rows20250125_ae07b785-b522-41c6-b27c-24c4d5cd814d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
309362clopidogrel 75 MG Oral TabletPSN03bec9ad-cd22-44d3-9b82-2796157de1d122
309362clopidogrel 75 MG Oral TabletSCD03bec9ad-cd22-44d3-9b82-2796157de1d122
309362clopidogrel 75 MG (as clopidogrel bisulfate 97.875 MG) Oral TabletSY03bec9ad-cd22-44d3-9b82-2796157de1d122
309362clopidogrel 75 MG Oral TabletPSNae07b785-b522-41c6-b27c-24c4d5cd814d21
309362clopidogrel 75 MG Oral TabletSCDae07b785-b522-41c6-b27c-24c4d5cd814d21
309362clopidogrel 75 MG (as clopidogrel bisulfate 97.875 MG) Oral TabletSYae07b785-b522-41c6-b27c-24c4d5cd814d21
309362clopidogrel 75 MG Oral TabletPSN1d8abe99-26d4-587f-e063-6394a90a091f1
309362clopidogrel 75 MG Oral TabletSCD1d8abe99-26d4-587f-e063-6394a90a091f1
309362clopidogrel 75 MG (as clopidogrel bisulfate 97.875 MG) Oral TabletSY1d8abe99-26d4-587f-e063-6394a90a091f1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
13668-141-0113668014101100 TABLET, FILM COATED in 1 BOTTLE (13668-141-01) 2012-05-170000-00-00NoNoCurrent
13668-141-0513668014105500 TABLET, FILM COATED in 1 BOTTLE (13668-141-05) 2012-05-170000-00-00NoNoCurrent
13668-141-10136680141101000 TABLET, FILM COATED in 1 BOTTLE (13668-141-10) 2012-05-170000-00-00NoNoCurrent
13668-141-301366801413030 TABLET, FILM COATED in 1 BOTTLE (13668-141-30) 2012-05-170000-00-00NoNoCurrent
13668-141-44136680141443100 TABLET, FILM COATED in 1 BOTTLE (13668-141-44) 2012-05-170000-00-00NoNoCurrent
13668-141-7413668014174100 TABLET in 1 CARTON (13668-141-74) 100 tablet2012-05-170000-00-00NoNoCurrent
13668-141-901366801419090 TABLET, FILM COATED in 1 BOTTLE (13668-141-90) 2012-05-170000-00-00NoNoCurrent