Clopidogrel

Product NDC
50436-9986
11-digit product format
504369986
Labeler code
50436
Product ID
50436-9986_d2f13046-b901-4b53-a3d0-76fb752a2768
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Clopidogrel Bisulfate
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Unit Dose Services
Application
ANDA090540
Marketing category
ANDA
Marketing start
2012-05-17
Marketing end
0000-00-00
Substance
CLOPIDOGREL BISULFATE
Active strength
75 mg/1
Pharmacologic classes
Decreased Platelet Aggregation [PE],P2Y12 Platelet Inhibitor [EPC],P2Y12 Receptor Antagonists [MoA],Cytochrome P450 2C8 Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2020-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
39fa80eb-1490-ce82-3d3a-820ae7c37b85Product name520250618
a62a50ac-1535-4461-9768-8ae703e2e9fbProduct name120210525
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
bc07ef78-e82d-0c19-31f4-31f263780582Product name120140508

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50436-9986-1Clopidogrel30 in 1 BOTTLETABLET, FILM COATED3011
50436-9986-3Clopidogrel90 in 1 BOTTLETABLET, FILM COATED9011

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CLOPIDOGREL BISULFATEACTIVE INGREDIENT08I79HTP27CLOPIDOGREL (CLOPIDOGREL BISULFATE) TABLET, FILM COATED [UNIT DOSE SERVICES]2
CLOPIDOGRELACTIVE MOIETYA74586SNO7CLOPIDOGREL (CLOPIDOGREL BISULFATE) TABLET, FILM COATED [UNIT DOSE SERVICES]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UCLOPIDOGREL (CLOPIDOGREL BISULFATE) TABLET, FILM COATED [UNIT DOSE SERVICES]2
CROSPOVIDONEINACTIVE INGREDIENT68401960MKCLOPIDOGREL (CLOPIDOGREL BISULFATE) TABLET, FILM COATED [UNIT DOSE SERVICES]2
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675CLOPIDOGREL (CLOPIDOGREL BISULFATE) TABLET, FILM COATED [UNIT DOSE SERVICES]2
HYDROGENATED CASTOR OILINACTIVE INGREDIENTZF94AP8MEYCLOPIDOGREL (CLOPIDOGREL BISULFATE) TABLET, FILM COATED [UNIT DOSE SERVICES]2
HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTEDINACTIVE INGREDIENT2165RE0K14CLOPIDOGREL (CLOPIDOGREL BISULFATE) TABLET, FILM COATED [UNIT DOSE SERVICES]2
HYPROMELLOSE 2910 (15 MPA.S)INACTIVE INGREDIENT36SFW2JZ0WCLOPIDOGREL (CLOPIDOGREL BISULFATE) TABLET, FILM COATED [UNIT DOSE SERVICES]2
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XCLOPIDOGREL (CLOPIDOGREL BISULFATE) TABLET, FILM COATED [UNIT DOSE SERVICES]2
MANNITOLINACTIVE INGREDIENT3OWL53L36ACLOPIDOGREL (CLOPIDOGREL BISULFATE) TABLET, FILM COATED [UNIT DOSE SERVICES]2
POLYETHYLENE GLYCOL 6000INACTIVE INGREDIENT30IQX730WECLOPIDOGREL (CLOPIDOGREL BISULFATE) TABLET, FILM COATED [UNIT DOSE SERVICES]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPCLOPIDOGREL (CLOPIDOGREL BISULFATE) TABLET, FILM COATED [UNIT DOSE SERVICES]2
TRIACETININACTIVE INGREDIENTXHX3C3X673CLOPIDOGREL (CLOPIDOGREL BISULFATE) TABLET, FILM COATED [UNIT DOSE SERVICES]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50436-9986CLOPIDOGREL (CLOPIDOGREL BISULFATE) TABLET, FILM COATED [UNIT DOSE SERVICES]11Legacy NDC, 2 package rows20171109_2ed86bc8-8ea5-4ffa-a762-4fc266c1e620.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
309362clopidogrel 75 MG Oral TabletPSN2ed86bc8-8ea5-4ffa-a762-4fc266c1e62011
309362clopidogrel 75 MG Oral TabletSCD2ed86bc8-8ea5-4ffa-a762-4fc266c1e62011
309362clopidogrel 75 MG (as clopidogrel bisulfate 97.875 MG) Oral TabletSY2ed86bc8-8ea5-4ffa-a762-4fc266c1e62011

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
50436-9986-15043699860130 in 1 BOTTLEHistorical
50436-9986-35043699860390 in 1 BOTTLEHistorical