Clopidogrel

Product NDC
68645-430
11-digit product format
686450430
Labeler code
68645
Product ID
68645-430_1191b0c2-049d-4401-8a63-e92d8ef3908c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Clopidogrel
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Legacy Pharmaceutical Packaging
Application
ANDA076999
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
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#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68645-430-54Clopidogrel30 in 1 BOTTLETABLET, FILM COATED304

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CLOPIDOGREL BISULFATEACTIVE INGREDIENT08I79HTP27CLOPIDOGREL TABLET, FILM COATED [LEGACY PHARMACEUTICAL PACKAGING]4
CLOPIDOGRELACTIVE MOIETYA74586SNO7CLOPIDOGREL TABLET, FILM COATED [LEGACY PHARMACEUTICAL PACKAGING]4
ALUMINUM OXIDEINACTIVE INGREDIENTLMI26O6933CLOPIDOGREL TABLET, FILM COATED [LEGACY PHARMACEUTICAL PACKAGING]4
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UCLOPIDOGREL TABLET, FILM COATED [LEGACY PHARMACEUTICAL PACKAGING]4
COCHINEALINACTIVE INGREDIENTTZ8Z31B35MCLOPIDOGREL TABLET, FILM COATED [LEGACY PHARMACEUTICAL PACKAGING]4
CROSPOVIDONEINACTIVE INGREDIENT68401960MKCLOPIDOGREL TABLET, FILM COATED [LEGACY PHARMACEUTICAL PACKAGING]4
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKCLOPIDOGREL TABLET, FILM COATED [LEGACY PHARMACEUTICAL PACKAGING]4
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675CLOPIDOGREL TABLET, FILM COATED [LEGACY PHARMACEUTICAL PACKAGING]4
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTCLOPIDOGREL TABLET, FILM COATED [LEGACY PHARMACEUTICAL PACKAGING]4
HYDROGENATED COTTONSEED OILINACTIVE INGREDIENTZ82Y2C65EACLOPIDOGREL TABLET, FILM COATED [LEGACY PHARMACEUTICAL PACKAGING]4
HYDROXYPROPYL CELLULOSE (TYPE H)INACTIVE INGREDIENTRFW2ET671PCLOPIDOGREL TABLET, FILM COATED [LEGACY PHARMACEUTICAL PACKAGING]4
HYPROMELLOSE 2910 (15 MPA.S)INACTIVE INGREDIENT36SFW2JZ0WCLOPIDOGREL TABLET, FILM COATED [LEGACY PHARMACEUTICAL PACKAGING]4
LACTOSEINACTIVE INGREDIENTJ2B2A4N98GCLOPIDOGREL TABLET, FILM COATED [LEGACY PHARMACEUTICAL PACKAGING]4
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XCLOPIDOGREL TABLET, FILM COATED [LEGACY PHARMACEUTICAL PACKAGING]4
POLYETHYLENE GLYCOL 4000INACTIVE INGREDIENT4R4HFI6D95CLOPIDOGREL TABLET, FILM COATED [LEGACY PHARMACEUTICAL PACKAGING]4
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JCLOPIDOGREL TABLET, FILM COATED [LEGACY PHARMACEUTICAL PACKAGING]4
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPCLOPIDOGREL TABLET, FILM COATED [LEGACY PHARMACEUTICAL PACKAGING]4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68645-430CLOPIDOGREL TABLET, FILM COATED [LEGACY PHARMACEUTICAL PACKAGING]4Legacy NDC, 1 package rows20121005_2e8d1503-a431-40ca-95bc-285557795bf7.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
309362clopidogrel 75 MG Oral TabletPSN2e8d1503-a431-40ca-95bc-285557795bf74
309362clopidogrel 75 MG Oral TabletSCD2e8d1503-a431-40ca-95bc-285557795bf74
309362clopidogrel 75 MG (as clopidogrel bisulfate 97.875 MG) Oral TabletSY2e8d1503-a431-40ca-95bc-285557795bf74

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
68645-430-546864504305430 in 1 BOTTLEHistorical