Clopidogrel

Product NDC
58118-0357
11-digit product format
581180357
Labeler code
58118
Product ID
58118-0357_b0252b2f-7583-4829-e053-2a95a90a6328
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Clopidogrel Bisulfate
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Clinical Solutions Wholesale
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
2021-12-31
Current FDA listing
Historical FDA.report record

FDA-Initiated Inactive NDC Indexing#

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CLOPIDOGREL BISULFATEACTIVE INGREDIENT08I79HTP27CLOPIDOGREL (CLOPIDOGREL BISULFATE) TABLET, FILM COATED [CLINICAL SOLUTIONS WHOLESALE]1
CLOPIDOGRELACTIVE MOIETYA74586SNO7CLOPIDOGREL (CLOPIDOGREL BISULFATE) TABLET, FILM COATED [CLINICAL SOLUTIONS WHOLESALE]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UCLOPIDOGREL (CLOPIDOGREL BISULFATE) TABLET, FILM COATED [CLINICAL SOLUTIONS WHOLESALE]1
CROSPOVIDONEINACTIVE INGREDIENT68401960MKCLOPIDOGREL (CLOPIDOGREL BISULFATE) TABLET, FILM COATED [CLINICAL SOLUTIONS WHOLESALE]1
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675CLOPIDOGREL (CLOPIDOGREL BISULFATE) TABLET, FILM COATED [CLINICAL SOLUTIONS WHOLESALE]1
HYDROGENATED CASTOR OILINACTIVE INGREDIENTZF94AP8MEYCLOPIDOGREL (CLOPIDOGREL BISULFATE) TABLET, FILM COATED [CLINICAL SOLUTIONS WHOLESALE]1
HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTEDINACTIVE INGREDIENT2165RE0K14CLOPIDOGREL (CLOPIDOGREL BISULFATE) TABLET, FILM COATED [CLINICAL SOLUTIONS WHOLESALE]1
HYPROMELLOSE 2910 (15 MPA.S)INACTIVE INGREDIENT36SFW2JZ0WCLOPIDOGREL (CLOPIDOGREL BISULFATE) TABLET, FILM COATED [CLINICAL SOLUTIONS WHOLESALE]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XCLOPIDOGREL (CLOPIDOGREL BISULFATE) TABLET, FILM COATED [CLINICAL SOLUTIONS WHOLESALE]1
MANNITOLINACTIVE INGREDIENT3OWL53L36ACLOPIDOGREL (CLOPIDOGREL BISULFATE) TABLET, FILM COATED [CLINICAL SOLUTIONS WHOLESALE]1
POLYETHYLENE GLYCOL 6000INACTIVE INGREDIENT30IQX730WECLOPIDOGREL (CLOPIDOGREL BISULFATE) TABLET, FILM COATED [CLINICAL SOLUTIONS WHOLESALE]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPCLOPIDOGREL (CLOPIDOGREL BISULFATE) TABLET, FILM COATED [CLINICAL SOLUTIONS WHOLESALE]1
TRIACETININACTIVE INGREDIENTXHX3C3X673CLOPIDOGREL (CLOPIDOGREL BISULFATE) TABLET, FILM COATED [CLINICAL SOLUTIONS WHOLESALE]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58118-0357CLOPIDOGREL (CLOPIDOGREL BISULFATE) TABLET, FILM COATED [CLINICAL SOLUTIONS WHOLESALE]8Legacy NDC20200926_7c96b52e-99c9-4b70-b467-3d00bbc58acf.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
58118-0357-85811803570830 TABLET, FILM COATED in 1 BLISTER PACK (58118-0357-8) 2012-05-170000-00-00NoNoCurrent