FDA.reportPublic FDA data

PRASUGREL

Product NDC
67877-604
11-digit product format
678770604
Labeler code
67877
Product ID
67877-604_d09e39d8-259f-e46d-e053-2a95a90ad97f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Prasugrel
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Ascend Laboratories, LLC
Application
ANDA205790
Marketing category
ANDA
Marketing start
2017-10-17
Marketing end
0000-00-00
Substance
PRASUGREL HYDROCHLORIDE
Active strength
5 mg/1
Pharmacologic classes
Decreased Platelet Aggregation [PE],P2Y12 Platelet Inhibitor [EPC],P2Y12 Receptor Antagonists [MoA]
NDC exclude flag
No
Listing certified through
2022-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
b7c49f42-bd3a-58c0-797d-351eed22235aProduct name820250616

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
67877-604-302023-01-30C16284748780-1c7ccaba7-12a2-fd44-e053-dadaa90aa01bThese highlights do not include all the information needed to use PRASUGREL TABLETS safely and effectively. See full prescribing information for PRASUGREL TABLETS. PRASUGREL tablets, for oral use Initial U.S. Approval: 2009
67877-604-302021-11-12C16284748780-1c7ccaba7-12a2-fd44-e053-dadaa90aa01bThese highlights do not include all the information needed to use PRASUGREL TABLETS safely and effectively. See full prescribing information for PRASUGREL TABLETS. PRASUGREL tablets, for oral use Initial U.S. Approval: 2009
67877-604-302021-07-23C16284748780-1c7ccaba7-12a2-fd44-e053-dadaa90aa01bThese highlights do not include all the information needed to use PRASUGREL TABLETS safely and effectively. See full prescribing information for PRASUGREL TABLETS. PRASUGREL tablets, for oral use Initial U.S. Approval: 2009

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67877-604-30PRASUGREL30 in 1 BOTTLETABLET, FILM COATED306

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
67877-604-30EA - Each67877-6043e22cfea-b621-49d4-a461-cf32fd973f5112017-11-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67877-604PRASUGREL TABLET, FILM COATED [ASCEND LABORATORIES, LLC]6Legacy NDC, 1 package rows20211113_85c41426-e3a4-4133-8328-e0367693a9c9.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
855812prasugrel 10 MG Oral TabletPSN85c41426-e3a4-4133-8328-e0367693a9c96
855818prasugrel 5 MG Oral TabletPSN85c41426-e3a4-4133-8328-e0367693a9c96
855812prasugrel 10 MG Oral TabletSCD85c41426-e3a4-4133-8328-e0367693a9c96
855818prasugrel 5 MG Oral TabletSCD85c41426-e3a4-4133-8328-e0367693a9c96
855812prasugrel (as prasugrel HCl 10.98 MG) 10 MG Oral TabletSY85c41426-e3a4-4133-8328-e0367693a9c96
855818prasugrel (as prasugrel HCl 5.49 MG ) 5 MG Oral TabletSY85c41426-e3a4-4133-8328-e0367693a9c96

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
67877-604-306787706043030 TABLET, FILM COATED in 1 BOTTLE (67877-604-30) 2017-10-170000-00-00NoNoCurrent