FDA.reportPublic FDA data

PRASUGREL

Product NDC
0440-0604
11-digit product format
004400604
Labeler code
0440
Product ID
0440-0604_60853d14-ac2a-4e48-9c0c-afd8069b83c6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Prasugrel
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Liberty Pharmaceuticals, Inc.
Application
ANDA205790
Marketing category
ANDA
Marketing start
2017-10-17
Marketing end
0000-00-00
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
2020-12-31
Current FDA listing
Historical FDA.report record

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
0440-0604-302021-01-29C16284748780-1ba0f9c33-3c84-a910-e053-dadaa90a0b85These highlights do not include all the information needed to use PRASUGREL TABLETS safely and effectively. See full prescribing information for PRASUGREL TABLETS. PRASUGREL tablets, for oral use Initial U.S. Approval: 2009

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0440-0604-30EA - Each0440-0604ff66a789-9d39-4422-b913-caa40f53066112019-09-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0440-0604PRASUGREL TABLET, FILM COATED [LIBERTY PHARMACEUTICALS, INC.]1Legacy NDC20190823_60853d14-ac2a-4e48-9c0c-afd8069b83c6.zip