IBUPROFEN

Product NDC
71610-532
11-digit product format
716100532
Labeler code
71610
Product ID
71610-532_afa576a9-24b6-40ee-99f6-9126eb884bed
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
IBUPROFEN
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Aphena Pharma Solutions - Tennessee, LLC
Application
ANDA090796
Marketing category
ANDA
Marketing start
2015-12-30
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
71610-532-607161005326090 TABLET, FILM COATED in 1 BOTTLE (71610-532-60) 2021-03-09NoNoHistorical
71610-532-8071610053280180 TABLET, FILM COATED in 1 BOTTLE (71610-532-80) 2021-03-09NoNoHistorical
71610-532-9271610053292270 TABLET, FILM COATED in 1 BOTTLE (71610-532-92) 2021-03-09NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
IBUPROFEN 400 MG - 600 MG AND 800 MG TABLETSAphena Pharma Solutions - Tennessee, LLC2021-04-20HUMAN PRESCRIPTION DRUG LABEL1