Clopidogrel

Product NDC
53808-0616
11-digit product format
538080616
Labeler code
53808
Product ID
53808-0616_34db910e-8a16-4cee-a04e-27a363f0c269
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Clopidogrel Bisulfate
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
State of Florida DOH Central Pharmacy
Application
ANDA090540
Marketing category
ANDA
Marketing start
2013-01-01
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
2019-12-31
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
53808-0616-2Clopidogrel60 in 1 BLISTER PACKTABLET, FILM COATED601

DailyMed Socrata Ingredients#

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

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53808-0616CLOPIDOGREL (CLOPIDOGREL BISULFATE ) TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]1Legacy NDC, 1 package rows20140404_e3136829-54e8-40bc-80e5-73038f478c3b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
309362clopidogrel 75 MG Oral TabletPSNe3136829-54e8-40bc-80e5-73038f478c3b1
309362clopidogrel 75 MG Oral TabletSCDe3136829-54e8-40bc-80e5-73038f478c3b1
309362clopidogrel 75 MG (as clopidogrel bisulfate 97.875 MG) Oral TabletSYe3136829-54e8-40bc-80e5-73038f478c3b1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
53808-0616-25380806160260 in 1 BLISTER PACKHistorical