Ibuprofen

Product NDC
71610-898
11-digit product format
716100898
Labeler code
71610
Product ID
71610-898_334e4104-833e-200c-e063-6394a90acd54
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ibuprofen
Dosage form
TABLET
Route
ORAL
Labeler
Aphena Pharma Solutions - Tennessee, LLC
Application
ANDA078558
Marketing category
ANDA
Marketing start
2009-11-23
Substance
IBUPROFEN
Active strength
800 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 formatDescriptionUnitsMarketing startSampleExclude flagStatus
71610-898-607161008986090 TABLET in 1 BOTTLE (71610-898-60) 90 tablet2025-04-15NoNoHistorical
71610-898-7071610089870120 TABLET in 1 BOTTLE (71610-898-70) 120 tablet2025-04-15NoNoHistorical
71610-898-8071610089880180 TABLET in 1 BOTTLE (71610-898-80) 180 tablet2025-04-15NoNoHistorical
71610-898-9271610089892270 TABLET in 1 BOTTLE (71610-898-92) 270 tablet2025-04-15NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Ibuprofen Tablets, USP (400 mg , 600 mg and 800 mg) Rx onlyAphena Pharma Solutions - Tennessee, LLC2025-04-21HUMAN PRESCRIPTION DRUG LABEL1