FDA.reportPublic FDA data

Prasugrel

Product NDC
60687-883
11-digit product format
606870883
Labeler code
60687
Product ID
60687-883_2ddfdce2-a7ba-b612-e063-6294a90a0ce3
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Prasugrel
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
American Health Packaging
Application
ANDA205888
Marketing category
ANDA
Marketing start
2025-03-02
Substance
PRASUGREL HYDROCHLORIDE
Active strength
10 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 HYDROCHLORIDE10 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiG89JQ59I13
Rxcui855812

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
b7c49f42-bd3a-58c0-797d-351eed22235aProduct name820250616
a62a50ac-1535-4461-9768-8ae703e2e9fbProduct name120210525
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
bc07ef78-e82d-0c19-31f4-31f263780582Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
60687-883-11Prasugrel1 in 1 BLISTER PACKTABLET, FILM COATED11
60687-883-21Prasugrel30 in 1 CARTONTABLET, FILM COATED301

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
60687-883-11EA - Each60687-88352c216f3-862a-4c79-b855-acfc80b5dc6a12025-03-04
60687-883-21EA - Each60687-88366a6043d-3fd3-4673-8929-4396f76b225712025-03-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60687-883PRASUGREL TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]1Current NDC, 2 package rows20250303_35aa7f3e-bbd8-4eae-b61f-29d1abca2224.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
855812prasugrel 10 MG Oral TabletPSN35aa7f3e-bbd8-4eae-b61f-29d1abca22241
855812prasugrel 10 MG Oral TabletSCD35aa7f3e-bbd8-4eae-b61f-29d1abca22241
855812prasugrel (as prasugrel HCl 10.98 MG) 10 MG Oral TabletSY35aa7f3e-bbd8-4eae-b61f-29d1abca22241

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
60687-883-11606870883111 in 1 BLISTER PACKHistorical
60687-883-216068708832130 BLISTER PACK in 1 CARTON (60687-883-21) / 1 TABLET, FILM COATED in 1 BLISTER PACK (60687-883-11) 30 blister pack2025-03-02NoNoHistorical