FDA.reportPublic FDA data

Clopidogrel

Product NDC
55648-315
11-digit product format
556480315
Labeler code
55648
Product ID
55648-315_79a0b285-80de-4b38-9d3f-37fb165ef36b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Clopidogrel
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Wockhardt Limited
Application
ANDA202266
Marketing category
ANDA
Marketing start
2012-11-13
Marketing end
0000-00-00
Substance
CLOPIDOGREL BISULFATE
Active strength
300 mg/1
Pharmacologic classes
Decreased Platelet Aggregation [PE],P2Y12 Platelet Inhibitor [EPC],P2Y12 Receptor Antagonists [MoA],Cytochrome P450 2C8 Inhibitors [MoA]
NDC exclude flag
E
Listing certified through
2018-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
39fa80eb-1490-ce82-3d3a-820ae7c37b85Product name520250618

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
55648-315-002020-01-31C16284748780-19d75b9d0-3b3e-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use clopidogrel safely and effectively. See full prescribing information for clopidogrel. Clopidogrel Tablets, USP Initial U.S. Approval: 1997
55648-315-012020-01-31C16284748780-19d75b9d0-3b3e-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use clopidogrel safely and effectively. See full prescribing information for clopidogrel. Clopidogrel Tablets, USP Initial U.S. Approval: 1997
55648-315-022020-01-31C16284748780-19d75b9d0-3b3e-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use clopidogrel safely and effectively. See full prescribing information for clopidogrel. Clopidogrel Tablets, USP Initial U.S. Approval: 1997
55648-315-042020-01-31C16284748780-19d75b9d0-3b3e-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use clopidogrel safely and effectively. See full prescribing information for clopidogrel. Clopidogrel Tablets, USP Initial U.S. Approval: 1997

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55648-315-00Clopidogrel1500 in 1 POUCHTABLET, FILM COATED15002
55648-315-01Clopidogrel30 in 1 BOTTLETABLET, FILM COATED302
55648-315-02Clopidogrel90 in 1 BOTTLETABLET, FILM COATED902
55648-315-04Clopidogrel10 in 1 CARTONTABLET, FILM COATED102
55648-315-04Clopidogrel10 in 1 BLISTER PACKTABLET, FILM COATED102

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CLOPIDOGREL BISULFATEACTIVE INGREDIENT08I79HTP27CLOPIDOGREL TABLET, FILM COATED [WOCKHARDT LIMITED]2
CLOPIDOGRELACTIVE MOIETYA74586SNO7CLOPIDOGREL TABLET, FILM COATED [WOCKHARDT LIMITED]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UCLOPIDOGREL TABLET, FILM COATED [WOCKHARDT LIMITED]2
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675CLOPIDOGREL TABLET, FILM COATED [WOCKHARDT LIMITED]2
GLYCERYL DIBEHENATEINACTIVE INGREDIENTR8WTH25YS2CLOPIDOGREL TABLET, FILM COATED [WOCKHARDT LIMITED]2
HYDROGENATED CASTOR OILINACTIVE INGREDIENTZF94AP8MEYCLOPIDOGREL TABLET, FILM COATED [WOCKHARDT LIMITED]2
HYDROXYPROPYL CELLULOSEINACTIVE INGREDIENTRFW2ET671PCLOPIDOGREL TABLET, FILM COATED [WOCKHARDT LIMITED]2
HYPROMELLOSE 2910 (15 MPA.S)INACTIVE INGREDIENT36SFW2JZ0WCLOPIDOGREL TABLET, FILM COATED [WOCKHARDT LIMITED]2
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XCLOPIDOGREL TABLET, FILM COATED [WOCKHARDT LIMITED]2
MANNITOLINACTIVE INGREDIENT3OWL53L36ACLOPIDOGREL TABLET, FILM COATED [WOCKHARDT LIMITED]2
POLYETHYLENE GLYCOL 6000INACTIVE INGREDIENT30IQX730WECLOPIDOGREL TABLET, FILM COATED [WOCKHARDT LIMITED]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPCLOPIDOGREL TABLET, FILM COATED [WOCKHARDT LIMITED]2
TRIACETININACTIVE INGREDIENTXHX3C3X673CLOPIDOGREL TABLET, FILM COATED [WOCKHARDT LIMITED]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55648-315CLOPIDOGREL TABLET, FILM COATED [WOCKHARDT LIMITED]2Legacy NDC, 5 package rows20121113_de099108-7445-4632-b85f-93a1bc05adf0.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
749196clopidogrel 300 MG Oral TabletPSNde099108-7445-4632-b85f-93a1bc05adf02
309362clopidogrel 75 MG Oral TabletPSNde099108-7445-4632-b85f-93a1bc05adf02
749196clopidogrel 300 MG Oral TabletSCDde099108-7445-4632-b85f-93a1bc05adf02
309362clopidogrel 75 MG Oral TabletSCDde099108-7445-4632-b85f-93a1bc05adf02
749196clopidogrel 300 MG (as clopidogrel bisulfate 391.5 MG) Oral TabletSYde099108-7445-4632-b85f-93a1bc05adf02
309362clopidogrel 75 MG (as clopidogrel bisulfate 97.875 MG) Oral TabletSYde099108-7445-4632-b85f-93a1bc05adf02

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
55648-315-00556480315001500 in 1 POUCHHistorical
55648-315-015564803150130 in 1 BOTTLEHistorical
55648-315-025564803150290 in 1 BOTTLEHistorical
55648-315-045564803150410 in 1 CARTONHistorical