Ibuprofen

Product NDC
67296-2196
11-digit product format
672962196
Labeler code
67296
Product ID
67296-2196_44f2c5dd-aa7d-92b6-e063-6294a90ab9a4
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ibuprofen
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Redpharm Drug
Application
ANDA202413
Marketing category
ANDA
Marketing start
2024-05-23
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
67296-2196-16729621960110 TABLET, FILM COATED in 1 BOTTLE (67296-2196-1) 2024-05-23NoNoHistorical
67296-2196-36729621960330 TABLET, FILM COATED in 1 BOTTLE (67296-2196-3) 2024-05-23NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Ibuprofen Tablets, USP 300 mg, 400 mg, 600 mg and 800 mgRedpharm Drug2025-12-02HUMAN PRESCRIPTION DRUG LABEL2