PRASUGREL

Product NDC
60505-4643
11-digit product format
605054643
Labeler code
60505
Product ID
60505-4643_4eed584a-92dd-f219-e063-6394a90a0dd0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
PRASUGREL
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Apotex Corp.
Application
ANDA205897
Marketing category
ANDA
Marketing start
2017-10-16
Marketing end
2027-09-30
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
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
PRASUGREL

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
60505-4643-3PRASUGREL30 in 1 BOTTLETABLET, FILM COATED309

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
60505-4643-3EA - Each60505-4643beca959c-5bcd-4898-b8cb-10ec9c37b29912017-11-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60505-4643PRASUGREL TABLET, FILM COATED [APOTEX CORP.]8Current NDC, Legacy NDC, 1 package rows20250305_f51e64e0-f556-65d0-a876-fb709aaeefea.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
855812prasugrel 10 MG Oral TabletPSNf51e64e0-f556-65d0-a876-fb709aaeefea9
855818prasugrel 5 MG Oral TabletPSNf51e64e0-f556-65d0-a876-fb709aaeefea9
855812prasugrel 10 MG Oral TabletSCDf51e64e0-f556-65d0-a876-fb709aaeefea9
855818prasugrel 5 MG Oral TabletSCDf51e64e0-f556-65d0-a876-fb709aaeefea9
855812prasugrel (as prasugrel HCl 10.98 MG) 10 MG Oral TabletSYf51e64e0-f556-65d0-a876-fb709aaeefea9
855818prasugrel (as prasugrel HCl 5.49 MG ) 5 MG Oral TabletSYf51e64e0-f556-65d0-a876-fb709aaeefea9

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
60505-4643-36050546430330 TABLET, FILM COATED in 1 BOTTLE (60505-4643-3) 2017-10-162027-09-30NoNoCurrent