FDA.reportPublic FDA data

Prasugrel

Product NDC
65862-829
11-digit product format
658620829
Labeler code
65862
Product ID
65862-829_ad62076d-f75e-4cfa-b68f-3e873f244bcb
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Prasugrel
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Aurobindo Pharma Limited
Application
ANDA205888
Marketing category
ANDA
Marketing start
2017-10-16
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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Prasugrel
Listing expiration
2026-12-31

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
65862-829-03Prasugrel3 in 1 CARTONTABLET, FILM COATED311
65862-829-10Prasugrel10 in 1 BLISTER PACKTABLET, FILM COATED1011
65862-829-30Prasugrel30 in 1 BOTTLETABLET, FILM COATED3011

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
65862-829-30EA - Each65862-829c53e1d06-fab7-4b36-b637-f74668a1a41a12017-12-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65862-829PRASUGREL TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]11Current NDC, Legacy NDC, 3 package rows20240202_596c923d-db8d-4b96-bf31-52186a38c30d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
855812prasugrel 10 MG Oral TabletPSN596c923d-db8d-4b96-bf31-52186a38c30d11
855818prasugrel 5 MG Oral TabletPSN596c923d-db8d-4b96-bf31-52186a38c30d11
855812prasugrel 10 MG Oral TabletSCD596c923d-db8d-4b96-bf31-52186a38c30d11
855818prasugrel 5 MG Oral TabletSCD596c923d-db8d-4b96-bf31-52186a38c30d11
855812prasugrel (as prasugrel HCl 10.98 MG) 10 MG Oral TabletSY596c923d-db8d-4b96-bf31-52186a38c30d11
855818prasugrel (as prasugrel HCl 5.49 MG ) 5 MG Oral TabletSY596c923d-db8d-4b96-bf31-52186a38c30d11

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
65862-829-03658620829033 BLISTER PACK in 1 CARTON (65862-829-03) / 10 TABLET, FILM COATED in 1 BLISTER PACK (65862-829-10) 3 blister pack2017-10-160000-00-00NoNoCurrent
65862-829-106586208291010 in 1 BLISTER PACKHistorical
65862-829-306586208293030 TABLET, FILM COATED in 1 BOTTLE (65862-829-30) 2017-10-160000-00-00NoNoCurrent