FDA.reportPublic FDA data

Effient

Product NDC
0713-0882
11-digit product format
007130882
Labeler code
0713
Product ID
0713-0882_e8172297-af81-4c37-e053-2995a90ad4e5
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Prasugrel Hydrochloride
Dosage form
TABLET, COATED
Route
ORAL
Labeler
Cosette Pharmaceuticals, Inc.
Application
NDA022307
Marketing category
NDA
Marketing start
2022-09-01
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
Effient
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PRASUGREL HYDROCHLORIDE10 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiG89JQ59I13
Rxcui855812, 855816, 855818, 855820

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
0713-0882-302024-01-30C16284748780-11030e365-1bae-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use EFFIENT safely and effectively. See full prescribing information for EFFIENT. EFFIENT ® (prasugrel) tablets, for oral use Initial U.S. Approval: 2009

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0713-0882-30Effient30 in 1 BOTTLETABLET, COATED302

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0713-0882-30EA - Each0713-088284724cfa-2a05-4f03-adf7-09e7055e883512022-07-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0713-0882EFFIENT (PRASUGREL HYDROCHLORIDE) TABLET, COATED [COSETTE PHARMACEUTICALS, INC.]2Current NDC, Legacy NDC, 1 package rows20220909_69ea2d58-5353-4222-b61f-cab976fa7e5e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
855816Effient 10 MG Oral TabletPSN69ea2d58-5353-4222-b61f-cab976fa7e5e2
855820Effient 5 MG Oral TabletPSN69ea2d58-5353-4222-b61f-cab976fa7e5e2
855812prasugrel 10 MG Oral TabletPSN69ea2d58-5353-4222-b61f-cab976fa7e5e2
855818prasugrel 5 MG Oral TabletPSN69ea2d58-5353-4222-b61f-cab976fa7e5e2
855816prasugrel 10 MG Oral Tablet [Effient]SBD69ea2d58-5353-4222-b61f-cab976fa7e5e2
855820prasugrel 5 MG Oral Tablet [Effient]SBD69ea2d58-5353-4222-b61f-cab976fa7e5e2
855812prasugrel 10 MG Oral TabletSCD69ea2d58-5353-4222-b61f-cab976fa7e5e2
855818prasugrel 5 MG Oral TabletSCD69ea2d58-5353-4222-b61f-cab976fa7e5e2
855816Effient 10 MG (as prasugrel hydrochloride 10.98 MG) Oral TabletSY69ea2d58-5353-4222-b61f-cab976fa7e5e2
855816Effient 10 MG Oral TabletSY69ea2d58-5353-4222-b61f-cab976fa7e5e2
855820Effient 5 MG (prasugrel hydrochloride 5.49 MG) Oral TabletSY69ea2d58-5353-4222-b61f-cab976fa7e5e2
855820Effient 5 MG Oral TabletSY69ea2d58-5353-4222-b61f-cab976fa7e5e2
855812prasugrel (as prasugrel HCl 10.98 MG) 10 MG Oral TabletSY69ea2d58-5353-4222-b61f-cab976fa7e5e2
855818prasugrel (as prasugrel HCl 5.49 MG ) 5 MG Oral TabletSY69ea2d58-5353-4222-b61f-cab976fa7e5e2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0713-0882-300071308823030 TABLET, COATED in 1 BOTTLE (0713-0882-30) 2022-09-010000-00-00NoNoCurrent