Plavix

Product NDC
53808-0763
11-digit product format
538080763
Labeler code
53808
Product ID
53808-0763_510501a7-61be-4fa1-8120-4bd218a01d8d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
clopidogrel bisulfate
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
State of Florida DOH Central Pharmacy
Application
NDA020839
Marketing category
NDA
Marketing start
2009-07-01
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
E
Listing certified through
2017-12-31
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
53808-0763-1Plavix30 in 1 BLISTER PACKTABLET, FILM COATED301

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CLOPIDOGREL BISULFATEACTIVE INGREDIENT08I79HTP27PLAVIX (CLOPIDOGREL BISULFATE) TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
clopidogrelACTIVE MOIETYA74586SNO7PLAVIX (CLOPIDOGREL BISULFATE) TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
CARNAUBA WAXINACTIVE INGREDIENTR12CBM0EIZPLAVIX (CLOPIDOGREL BISULFATE) TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
CASTOR OILINACTIVE INGREDIENTD5340Y2I9GPLAVIX (CLOPIDOGREL BISULFATE) TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UPLAVIX (CLOPIDOGREL BISULFATE) TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675PLAVIX (CLOPIDOGREL BISULFATE) TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
HYDROXYPROPYL CELLULOSEINACTIVE INGREDIENTRFW2ET671PPLAVIX (CLOPIDOGREL BISULFATE) TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XPLAVIX (CLOPIDOGREL BISULFATE) TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
MANNITOLINACTIVE INGREDIENT3OWL53L36APLAVIX (CLOPIDOGREL BISULFATE) TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
POLYETHYLENE GLYCOL 6000INACTIVE INGREDIENT30IQX730WEPLAVIX (CLOPIDOGREL BISULFATE) TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPPLAVIX (CLOPIDOGREL BISULFATE) TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
TRIACETININACTIVE INGREDIENTXHX3C3X673PLAVIX (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
53808-0763PLAVIX (CLOPIDOGREL BISULFATE) TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]1Legacy NDC, 1 package rows20100611_079ed521-3ff0-47fa-86d5-a336732056cc.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
309362clopidogrel 75 MG Oral TabletPSN079ed521-3ff0-47fa-86d5-a336732056cc1
213169Plavix 75 MG Oral TabletPSN079ed521-3ff0-47fa-86d5-a336732056cc1
213169clopidogrel 75 MG Oral Tablet [Plavix]SBD079ed521-3ff0-47fa-86d5-a336732056cc1
309362clopidogrel 75 MG Oral TabletSCD079ed521-3ff0-47fa-86d5-a336732056cc1
309362clopidogrel 75 MG (as clopidogrel bisulfate 97.875 MG) Oral TabletSY079ed521-3ff0-47fa-86d5-a336732056cc1
213169Plavix 75 MG (clopidogrel bisulfate 97.875 MG) Oral TabletSY079ed521-3ff0-47fa-86d5-a336732056cc1
213169Plavix 75 MG Oral TabletSY079ed521-3ff0-47fa-86d5-a336732056cc1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
53808-0763-15380807630130 in 1 BLISTER PACKHistorical