IBUPROFEN

Product NDC
68071-5135
11-digit product format
680715135
Labeler code
68071
Product ID
68071-5135_1b54a8f5-455f-6252-e063-6394a90ab1a5
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
IBUPROFEN
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
NuCare Pharmaceuticals,Inc.
Application
ANDA090796
Marketing category
ANDA
Marketing start
2015-12-30
Substance
IBUPROFEN
Active strength
800 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
68071-5135-068071513500100 TABLET, FILM COATED in 1 BOTTLE (68071-5135-0) 2019-12-16NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
IBUPROFEN 400 MG - 600 MG AND 800 MG TABLETSNuCare Pharmaceuticals,Inc.2024-06-20HUMAN PRESCRIPTION DRUG LABEL3