Ibuprofen

Product NDC
68071-3442
11-digit product format
680713442
Labeler code
68071
Product ID
68071-3442_29a54361-e109-20d7-e063-6294a90a117a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ibuprofen
Dosage form
TABLET
Route
ORAL
Labeler
NuCare Pharmaceuticals,Inc.
Application
ANDA213794
Marketing category
ANDA
Marketing start
2020-05-08
Substance
IBUPROFEN
Active strength
400 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
68071-3442-26807134420220 TABLET in 1 BOTTLE (68071-3442-2) 20 tablet2024-12-19NoNoHistorical
68071-3442-36807134420330 TABLET in 1 BOTTLE (68071-3442-3) 30 tablet2023-06-20NoNoHistorical
68071-3442-96807134420990 TABLET in 1 BOTTLE (68071-3442-9) 90 tablet2023-06-20NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Ibuprofen Tablets, USP Rx onlyNuCare Pharmaceuticals,Inc.2024-12-19HUMAN PRESCRIPTION DRUG LABEL3