Prasugrel

Product NDC
51407-444
11-digit product format
514070444
Labeler code
51407
Product ID
51407-444_20262c39-020c-b649-e063-6294a90a2d9f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Prasugrel
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Golden State Medical Supply, Inc.
Application
ANDA205927
Marketing category
ANDA
Marketing start
2017-07-12
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
51407-444-30Prasugrel30 in 1 BOTTLE, PLASTICTABLET, FILM COATED304

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
51407-444-30EA - Each51407-4449935c815-664a-4b68-ab8e-ceea242dd08212021-03-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51407-444PRASUGREL TABLET, FILM COATED [GOLDEN STATE MEDICAL SUPPLY, INC.]4Current NDC, Legacy NDC, 1 package rows20240822_bb78f952-69a5-1620-e053-2a95a90afe97.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
855812prasugrel 10 MG Oral TabletPSNbb78f952-69a5-1620-e053-2a95a90afe974
855818prasugrel 5 MG Oral TabletPSNbb78f952-69a5-1620-e053-2a95a90afe974
855812prasugrel 10 MG Oral TabletSCDbb78f952-69a5-1620-e053-2a95a90afe974
855818prasugrel 5 MG Oral TabletSCDbb78f952-69a5-1620-e053-2a95a90afe974
855812prasugrel (as prasugrel HCl 10.98 MG) 10 MG Oral TabletSYbb78f952-69a5-1620-e053-2a95a90afe974
855818prasugrel (as prasugrel HCl 5.49 MG ) 5 MG Oral TabletSYbb78f952-69a5-1620-e053-2a95a90afe974

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
51407-444-305140704443030 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (51407-444-30) 2021-01-200000-00-00NoNoCurrent