Prasugrel

Product NDC
50090-5169
11-digit product format
500905169
Labeler code
50090
Product ID
50090-5169_97da99c2-06b3-4d0f-85fc-da6c35f940e7
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Prasugrel
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA205987
Marketing category
ANDA
Marketing start
2019-01-16
Marketing end
0000-00-00
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
2023-12-31
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#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-5169-0Prasugrel30 in 1 BOTTLETABLET, FILM COATED308

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-5169PRASUGREL TABLET, FILM COATED [A-S MEDICATION SOLUTIONS]8Legacy NDC, 1 package rows20220804_04e7e0e8-2199-438f-83db-6b8f0f219b99.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
855812prasugrel 10 MG Oral TabletPSN04e7e0e8-2199-438f-83db-6b8f0f219b998
855812prasugrel 10 MG Oral TabletSCD04e7e0e8-2199-438f-83db-6b8f0f219b998
855812prasugrel (as prasugrel HCl 10.98 MG) 10 MG Oral TabletSY04e7e0e8-2199-438f-83db-6b8f0f219b998

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
50090-5169-05009051690030 TABLET, FILM COATED in 1 BOTTLE (50090-5169-0) 2020-09-240000-00-00NoNoCurrent