Plavix

Product NDC
21695-665
11-digit product format
216950665
Labeler code
21695
Product ID
21695-665_1086a7b4-b89b-4bee-8120-5f752626c046
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
clopidogrel bisulfate
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Rebel Distributors Corp
Application
NDA020839
Marketing category
NDA
Marketing start
1900-01-01
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
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
21695-665-30Plavix30 in 1 BOTTLETABLET, FILM COATED301
21695-665-90Plavix90 in 1 BOTTLETABLET, FILM COATED901

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
21695-665-30EA - Each21695-6651268266a-1568-4ad7-b016-dd5325167c8e12012-07-24
21695-665-90EA - Each21695-66569f693a1-b380-462d-9ed5-0e30c2ccb7b012012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
clopidogrel bisulfateACTIVE INGREDIENT08I79HTP27PLAVIX (CLOPIDOGREL BISULFATE) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]1
clopidogrelACTIVE MOIETYA74586SNO7PLAVIX (CLOPIDOGREL BISULFATE) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]1
carnauba waxINACTIVE INGREDIENTR12CBM0EIZPLAVIX (CLOPIDOGREL BISULFATE) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]1
castor oilINACTIVE INGREDIENTD5340Y2I9GPLAVIX (CLOPIDOGREL BISULFATE) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]1
cellulose, microcrystallineINACTIVE INGREDIENTOP1R32D61UPLAVIX (CLOPIDOGREL BISULFATE) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]1
ferric oxide redINACTIVE INGREDIENT1K09F3G675PLAVIX (CLOPIDOGREL BISULFATE) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]1
hydroxypropyl celluloseINACTIVE INGREDIENTRFW2ET671PPLAVIX (CLOPIDOGREL BISULFATE) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]1
lactose monohydrateINACTIVE INGREDIENTEWQ57Q8I5XPLAVIX (CLOPIDOGREL BISULFATE) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]1
mannitolINACTIVE INGREDIENT3OWL53L36APLAVIX (CLOPIDOGREL BISULFATE) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]1
polyethylene glycol 6000INACTIVE INGREDIENT30IQX730WEPLAVIX (CLOPIDOGREL BISULFATE) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]1
titanium dioxideINACTIVE INGREDIENT15FIX9V2JPPLAVIX (CLOPIDOGREL BISULFATE) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]1
triacetinINACTIVE INGREDIENTXHX3C3X673PLAVIX (CLOPIDOGREL BISULFATE) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
21695-665PLAVIX (CLOPIDOGREL BISULFATE) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]1Legacy NDC, 2 package rows20110104_1086a7b4-b89b-4bee-8120-5f752626c046.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
309362clopidogrel 75 MG Oral TabletPSN1086a7b4-b89b-4bee-8120-5f752626c0461
213169Plavix 75 MG Oral TabletPSN1086a7b4-b89b-4bee-8120-5f752626c0461
213169clopidogrel 75 MG Oral Tablet [Plavix]SBD1086a7b4-b89b-4bee-8120-5f752626c0461
309362clopidogrel 75 MG Oral TabletSCD1086a7b4-b89b-4bee-8120-5f752626c0461
309362clopidogrel 75 MG (as clopidogrel bisulfate 97.875 MG) Oral TabletSY1086a7b4-b89b-4bee-8120-5f752626c0461
213169Plavix 75 MG (clopidogrel bisulfate 97.875 MG) Oral TabletSY1086a7b4-b89b-4bee-8120-5f752626c0461
213169Plavix 75 MG Oral TabletSY1086a7b4-b89b-4bee-8120-5f752626c0461

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
21695-665-302169506653030 in 1 BOTTLEHistorical
21695-665-902169506659090 in 1 BOTTLEHistorical