infants ibuprofen

Product NDC
0363-8139
11-digit product format
003638139
Labeler code
0363
Product ID
0363-8139_94c22b51-c5b9-4970-b78a-bbe915434293
Type
HUMAN OTC DRUG
Nonproprietary name
Ibuprofen
Dosage form
SUSPENSION/ DROPS
Route
ORAL
Labeler
Walgreen Company
Application
ANDA075217
Marketing category
ANDA
Marketing start
2024-01-09
Substance
IBUPROFEN
Active strength
50 mg/1.25mL
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
0363-8139-10003638139101 BOTTLE in 1 CARTON (0363-8139-10) / 30 mL in 1 BOTTLE1 bottle2024-01-09NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Walgreen Co. Infants’ Ibuprofen Drug FactsWalgreen Company2024-01-09HUMAN OTC DRUG LABEL2