Ibuprofen

Product NDC
68071-3589
11-digit product format
680713589
Labeler code
68071
Product ID
68071-3589_141b6717-62ab-4bfb-e063-6394a90a884d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ibuprofen
Dosage form
SUSPENSION
Route
ORAL
Labeler
NuCare Pharmaceuticals,Inc.
Application
ANDA209178
Marketing category
ANDA
Marketing start
2018-02-16
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 formatDescriptionUnitsMarketing startSampleExclude flagStatus
68071-3589-4680713589041 BOTTLE in 1 CARTON (68071-3589-4) / 120 mL in 1 BOTTLE1 bottle2024-03-20NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Ibuprofen Oral Suspension USP Rx OnlyNuCare Pharmaceuticals,Inc.2024-03-20HUMAN PRESCRIPTION DRUG LABEL1