ibuprofen

Product NDC
50090-7653
11-digit product format
500907653
Labeler code
50090
Product ID
50090-7653_65d7cba1-ee25-42e5-908f-a0e1e3416914
Type
HUMAN OTC DRUG
Nonproprietary name
ibuprofen
Dosage form
SUSPENSION
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA211666
Marketing category
ANDA
Marketing start
2024-08-15
Substance
IBUPROFEN
Active strength
100 mg/5mL
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
50090-7653-0500907653001 BOTTLE, PLASTIC in 1 CARTON (50090-7653-0) / 120 mL in 1 BOTTLE, PLASTIC2025-09-09NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Children's Ibuprofen Oral Suspension, USP Drug FactsA-S Medication Solutions2025-09-11HUMAN OTC DRUG LABEL2