Ibuprofen

Product NDC
68071-3849
11-digit product format
680713849
Labeler code
68071
Product ID
68071-3849_3520dfb1-22ac-c3e8-e063-6294a90af543
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ibuprofen
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
NuCare Pharmaceuticals, Inc.
Application
ANDA202413
Marketing category
ANDA
Marketing start
2024-05-23
Substance
IBUPROFEN
Active strength
600 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
68071-3849-4680713849044 TABLET, FILM COATED in 1 BOTTLE (68071-3849-4) 2025-05-14NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Ibuprofen Tablets, USP 300 mg, 400 mg, 600 mg and 800 mgNuCare Pharmaceuticals, Inc.2025-05-14HUMAN PRESCRIPTION DRUG LABEL1