FDA.reportPublic FDA data

Prasugrel

Product NDC
0378-5186
11-digit product format
003785186
Labeler code
0378
Product ID
0378-5186_9e234352-49b7-46e3-bc59-acf63e0a7a14
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Prasugrel
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Mylan Pharmaceuticals Inc.
Application
ANDA205927
Marketing category
ANDA
Marketing start
2017-08-15
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, 855818

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
0378-5186-93Prasugrel30 in 1 BOTTLE, PLASTICTABLET, FILM COATED309

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0378-5186-93EA - Each0378-5186a6abe663-2dcb-4418-bc83-e2ed77a2116812017-09-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0378-5186PRASUGREL TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]9Current NDC, Legacy NDC, 1 package rows20240131_41a4e332-6725-4cb7-940a-8291cf56cfe4.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
855812prasugrel 10 MG Oral TabletPSN41a4e332-6725-4cb7-940a-8291cf56cfe49
855818prasugrel 5 MG Oral TabletPSN41a4e332-6725-4cb7-940a-8291cf56cfe49
855812prasugrel 10 MG Oral TabletSCD41a4e332-6725-4cb7-940a-8291cf56cfe49
855818prasugrel 5 MG Oral TabletSCD41a4e332-6725-4cb7-940a-8291cf56cfe49
855812prasugrel (as prasugrel HCl 10.98 MG) 10 MG Oral TabletSY41a4e332-6725-4cb7-940a-8291cf56cfe49
855818prasugrel (as prasugrel HCl 5.49 MG ) 5 MG Oral TabletSY41a4e332-6725-4cb7-940a-8291cf56cfe49
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
0378-5186-930037851869330 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-5186-93) 2017-08-150000-00-00NoNoCurrent