Ibuprofen

Product NDC
68071-2939
11-digit product format
680712939
Labeler code
68071
Product ID
68071-2939_29299135-c2e9-f499-e063-6294a90aff99
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ibuprofen
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
NuCare Pharmaceuticals,Inc.
Application
ANDA071268
Marketing category
ANDA
Marketing start
2021-10-21
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 formatDescriptionMarketing startSampleExclude flagStatus
68071-2939-4680712939044 TABLET, FILM COATED in 1 BOTTLE (68071-2939-4) 2023-02-16NoNoHistorical
68071-2939-6680712939066 TABLET, FILM COATED in 1 BOTTLE (68071-2939-6) 2023-02-16NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Ibuprofen Tablet, USPNuCare Pharmaceuticals,Inc.2024-12-13HUMAN PRESCRIPTION DRUG LABEL3