Ibuprofen

Product NDC
72189-564
11-digit product format
721890564
Labeler code
72189
Product ID
72189-564_410c415a-9f59-049c-e063-6294a90a0012
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ibuprofen
Dosage form
TABLET
Route
ORAL
Labeler
Direct_rx
Application
ANDA213794
Marketing category
ANDA
Marketing start
2024-06-27
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
72189-564-307218905643030 TABLET in 1 BOTTLE (72189-564-30) 30 tablet2024-06-27NoNoHistorical
72189-564-607218905646060 TABLET in 1 BOTTLE (72189-564-60) 60 tablet2024-06-27NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
IbuprofenDirect_rx2025-10-13HUMAN PRESCRIPTION DRUG LABEL2
IbuprofenDirect_rx2024-06-27HUMAN PRESCRIPTION DRUG LABEL1