FDA.reportPublic FDA data

Prasugrel

Product NDC
65162-002
11-digit product format
651620002
Labeler code
65162
Product ID
65162-002_ae5f7419-c5fe-4462-8f0e-ffc08e891cd0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Prasugrel
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Amneal Pharmaceuticals LLC
Application
ANDA205913
Marketing category
ANDA
Marketing start
2018-06-22
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
65162-002-03Prasugrel30 in 1 BOTTLETABLET, FILM COATED3013

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
65162-002-03EA - Each65162-00251d69e38-bc0a-428e-88a1-c4bdb54b2ec512018-09-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65162-002PRASUGREL TABLET, FILM COATED [AMNEAL PHARMACEUTICALS LLC]13Current NDC, Legacy NDC, 1 package rows20240711_406cc201-89b6-43cc-9e14-a59327a5b4d8.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
855812prasugrel 10 MG Oral TabletPSN406cc201-89b6-43cc-9e14-a59327a5b4d813
855818prasugrel 5 MG Oral TabletPSN406cc201-89b6-43cc-9e14-a59327a5b4d813
855812prasugrel 10 MG Oral TabletSCD406cc201-89b6-43cc-9e14-a59327a5b4d813
855818prasugrel 5 MG Oral TabletSCD406cc201-89b6-43cc-9e14-a59327a5b4d813
855812prasugrel (as prasugrel HCl 10.98 MG) 10 MG Oral TabletSY406cc201-89b6-43cc-9e14-a59327a5b4d813
855818prasugrel (as prasugrel HCl 5.49 MG ) 5 MG Oral TabletSY406cc201-89b6-43cc-9e14-a59327a5b4d813

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
65162-002-036516200020330 TABLET, FILM COATED in 1 BOTTLE (65162-002-03) 2018-06-220000-00-00NoNoCurrent