FDA.reportPublic FDA data

Clopidogrel Bisulfate

Product NDC
43063-371
11-digit product format
430630371
Labeler code
43063
Product ID
43063-371_2f2711fd-44b7-517f-e063-6294a90a0982
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Clopidogrel Bisulfate
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
PD-Rx Pharmaceuticals, Inc.
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 Bisulfate
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
43063-371-30Clopidogrel Bisulfate30 in 1 BOTTLE, PLASTICTABLET, FILM COATED3022
43063-371-60Clopidogrel Bisulfate60 in 1 BOTTLE, PLASTICTABLET, FILM COATED6022
43063-371-90Clopidogrel Bisulfate90 in 1 BOTTLE, PLASTICTABLET, FILM COATED9022

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
43063-371-30EA - Each43063-371a661ca67-ad6f-40f9-b158-bcbebec1ebd112013-02-13
43063-371-60EA - Each43063-371a57d69f1-b680-4ef5-beba-dc274c53b7d312013-02-13
43063-371-90EA - Each43063-3710659c5c3-659e-442c-9f08-56985a1d9b9f12013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
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
43063-371CLOPIDOGREL BISULFATE TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]22Current NDC, Legacy NDC, 3 package rows20250305_03bec9ad-cd22-44d3-9b82-2796157de1d1.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

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
43063-371-304306303713030 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-371-30) 2012-07-230000-00-00NoNoCurrent
43063-371-604306303716060 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-371-60) 2012-07-230000-00-00NoNoCurrent
43063-371-904306303719090 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-371-90) 2012-07-230000-00-00NoNoCurrent