Ibuprofen

Product NDC
83615-0001
11-digit product format
836150001
Labeler code
83615
Product ID
83615-0001_b03fb995-0ee7-4043-b6cb-8e5a444d3d62
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ibuprofen
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA091625
Marketing category
ANDA
Marketing start
2015-12-21
Substance
IBUPROFEN
Active strength
600 mg/1
Pharmacologic classes
Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Related Records

Related UNII Ingredients

UNIIPreferred termRegistry numberMatched term
WK2XYI10QMIBUPROFEN15687-27-1IBUPROFEN

Packages

Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
83615-0001-38361500010330 TABLET, FILM COATED in 1 BOTTLE (83615-0001-3) 2023-08-23NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
IBUPROFEN Tablets, USPBryant Ranch Prepack2025-09-11HUMAN PRESCRIPTION DRUG LABEL2