CLOPIDOGREL

Product NDC
61919-007
11-digit product format
619190007
Labeler code
61919
Product ID
61919-007_e9d22011-7a77-3c03-e053-2995a90a673e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
CLOPIDOGREL
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
DIRECT RX
Application
ANDA090540
Marketing category
ANDA
Marketing start
2014-01-01
Marketing end
0000-00-00
Substance
CLOPIDOGREL BISULFATE
Active strength
75 mg/1
Pharmacologic classes
Cytochrome P450 2C8 Inhibitors [MoA], Decreased Platelet Aggregation [PE], P2Y12 Platelet Inhibitor [EPC], P2Y12 Receptor Antagonists [MoA]
NDC exclude flag
No
Listing certified through
2023-12-31
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#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
61919-007-302025-01-30C16284748780-19d75b9d0-9f9d-f424-e053-dadaa90a57ceCLOPIDOGREL
61919-007-902025-01-30C16284748780-19d75b9d0-9f9d-f424-e053-dadaa90a57ceCLOPIDOGREL
61919-007-302020-06-18C16284748780-19d75b9d0-9f9d-f424-e053-dadaa90a57ceCLOPIDOGREL
61919-007-302020-01-31C16284748780-19d75b9d0-9f9d-f424-e053-dadaa90a57ceCLOPIDOGREL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61919-007-30CLOPIDOGREL30 in 1 BOTTLETABLET, FILM COATED307
61919-007-90CLOPIDOGREL90 in 1 BOTTLETABLET, FILM COATED907

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
61919-007-30EA - Each61919-0073d051338-9869-486c-9a36-2c5dc59520b912015-10-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CLOPIDOGREL BISULFATEACTIVE INGREDIENT08I79HTP27CLOPIDOGREL TABLET, FILM COATED [DIRECT RX]2
CLOPIDOGRELACTIVE MOIETYA74586SNO7CLOPIDOGREL TABLET, FILM COATED [DIRECT RX]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UCLOPIDOGREL TABLET, FILM COATED [DIRECT RX]2
CROSPOVIDONEINACTIVE INGREDIENT68401960MKCLOPIDOGREL TABLET, FILM COATED [DIRECT RX]2
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675CLOPIDOGREL TABLET, FILM COATED [DIRECT RX]2
HYDROGENATED CASTOR OILINACTIVE INGREDIENTZF94AP8MEYCLOPIDOGREL TABLET, FILM COATED [DIRECT RX]2
HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTEDINACTIVE INGREDIENT2165RE0K14CLOPIDOGREL TABLET, FILM COATED [DIRECT RX]2
HYPROMELLOSE 2910 (15 MPA.S)INACTIVE INGREDIENT36SFW2JZ0WCLOPIDOGREL TABLET, FILM COATED [DIRECT RX]2
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XCLOPIDOGREL TABLET, FILM COATED [DIRECT RX]2
MANNITOLINACTIVE INGREDIENT3OWL53L36ACLOPIDOGREL TABLET, FILM COATED [DIRECT RX]2
POLYETHYLENE GLYCOL 6000INACTIVE INGREDIENT30IQX730WECLOPIDOGREL TABLET, FILM COATED [DIRECT RX]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPCLOPIDOGREL TABLET, FILM COATED [DIRECT RX]2
TRIACETININACTIVE INGREDIENTXHX3C3X673CLOPIDOGREL TABLET, FILM COATED [DIRECT RX]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61919-007CLOPIDOGREL TABLET, FILM COATED [DIRECT RX]7Legacy NDC, 2 package rows20230331_98a83879-4e53-41f5-83bc-681b342884dd.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
309362clopidogrel 75 MG Oral TabletPSN98a83879-4e53-41f5-83bc-681b342884dd7
309362clopidogrel 75 MG Oral TabletSCD98a83879-4e53-41f5-83bc-681b342884dd7
309362clopidogrel 75 MG (as clopidogrel bisulfate 97.875 MG) Oral TabletSY98a83879-4e53-41f5-83bc-681b342884dd7

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
61919-007-306191900073030 TABLET, FILM COATED in 1 BOTTLE (61919-007-30) 2020-06-180000-00-00NoNoCurrent
61919-007-906191900079090 TABLET, FILM COATED in 1 BOTTLE (61919-007-90) 2014-01-010000-00-00NoNoCurrent