Ibuprofen

Product NDC
50090-7286
11-digit product format
500907286
Labeler code
50090
Product ID
50090-7286_bfec5b3c-90ec-4be9-bf01-1a7ebc26e1c6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ibuprofen
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA202413
Marketing category
ANDA
Marketing start
2024-05-23
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
50090-7286-05009072860015 TABLET, FILM COATED in 1 BOTTLE (50090-7286-0) 2024-10-10NoNoHistorical
50090-7286-15009072860121 TABLET, FILM COATED in 1 BOTTLE (50090-7286-1) 2024-10-08NoNoHistorical
50090-7286-45009072860428 TABLET, FILM COATED in 1 BOTTLE (50090-7286-4) 2024-10-08NoNoHistorical
50090-7286-55009072860590 TABLET, FILM COATED in 1 BOTTLE (50090-7286-5) 2024-10-08NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Ibuprofen Tablets, USP 400 mg, 600 mg and 800 mgA-S Medication Solutions2024-10-11HUMAN PRESCRIPTION DRUG LABEL2