FDA.reportPublic FDA data

PRASUGREL

Product NDC
43817-239
11-digit product format
438170239
Labeler code
43817
Product ID
43817-239_2de10117-c50f-95af-e063-6294a90ab07d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
PRASUGREL
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Panacea Biotec Limited
Application
ANDA205897
Marketing category
ANDA
Marketing start
2017-10-16
Marketing end
2027-02-28
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
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
PRASUGREL

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PRASUGREL HYDROCHLORIDE5 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiG89JQ59I13
Rxcui855812, 855818

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
43817-239-012025-02-11C16284748780-12cef2736-95b8-d83d-e063-dadaa90ab31fThese 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
43817-239-012025-01-30C16284748780-12cef2736-95b8-d83d-e063-dadaa90ab31fThese 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
43817-239-01PRASUGREL30 in 1 BOTTLETABLET, FILM COATED303

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43817-239PRASUGREL TABLET, FILM COATED [PANACEA BIOTEC LIMITED]3Current NDC, Legacy NDC, 1 package rows20250213_944c195a-de24-a44c-8baa-84b624b5ddcb.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
855812prasugrel 10 MG Oral TabletPSN944c195a-de24-a44c-8baa-84b624b5ddcb3
855818prasugrel 5 MG Oral TabletPSN944c195a-de24-a44c-8baa-84b624b5ddcb3
855812prasugrel 10 MG Oral TabletSCD944c195a-de24-a44c-8baa-84b624b5ddcb3
855818prasugrel 5 MG Oral TabletSCD944c195a-de24-a44c-8baa-84b624b5ddcb3
855812prasugrel (as prasugrel HCl 10.98 MG) 10 MG Oral TabletSY944c195a-de24-a44c-8baa-84b624b5ddcb3
855818prasugrel (as prasugrel HCl 5.49 MG ) 5 MG Oral TabletSY944c195a-de24-a44c-8baa-84b624b5ddcb3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
43817-239-014381702390130 TABLET, FILM COATED in 1 BOTTLE (43817-239-01) 2017-10-162027-02-28NoNoCurrent