ibuprofen

Product NDC
0363-0604
11-digit product format
003630604
Labeler code
0363
Product ID
0363-0604_8c0ff9e7-6d01-4bab-b0ca-7779c10d9b77
Type
HUMAN OTC DRUG
Nonproprietary name
Ibuprofen
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Walgreen Company
Application
ANDA072096
Marketing category
ANDA
Marketing start
2009-01-21
Substance
IBUPROFEN
Active strength
200 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
0363-0604-62003630604621 BOTTLE in 1 CARTON (0363-0604-62) / 24 TABLET, FILM COATED in 1 BOTTLE1 bottle2021-09-09NoNoHistorical
0363-0604-71003630604711 BOTTLE in 1 CARTON (0363-0604-71) / 50 TABLET, FILM COATED in 1 BOTTLE1 bottle2021-09-09NoNoHistorical
0363-0604-76003630604761 BOTTLE in 1 CARTON (0363-0604-76) / 120 TABLET, FILM COATED in 1 BOTTLE1 bottle2024-12-13NoNoHistorical
0363-0604-78003630604781 BOTTLE in 1 CARTON (0363-0604-78) / 100 TABLET, FILM COATED in 1 BOTTLE1 bottle2021-09-29NoNoHistorical
0363-0604-82003630604822 BOTTLE in 1 CARTON (0363-0604-82) / 100 TABLET, FILM COATED in 1 BOTTLE2 bottle2024-01-19NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Walgreen Co. Ibuprofen Drug FactsWalgreen Company2025-09-03HUMAN OTC DRUG LABEL8