Ibuprofen Famotidine

Product NDC
72189-641
11-digit product format
721890641
Labeler code
72189
Product ID
72189-641_3f16596d-dd5b-7985-e063-6294a90a6f9d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ibuprofen Famotidine
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Direct_Rx
Application
ANDA211890
Marketing category
ANDA
Marketing start
2025-09-18
Substance
FAMOTIDINE; IBUPROFEN
Active strength
26.6; 800 mg/1; mg/1
Pharmacologic classes
Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Histamine H2 Receptor Antagonists [MoA], Histamine-2 Receptor Antagonist [EPC], 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
5QZO15J2Z8FAMOTIDINE76824-35-6FAMOTIDINE
WK2XYI10QMIBUPROFEN15687-27-1IBUPROFEN

Packages

Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
72189-641-907218906419090 TABLET, FILM COATED in 1 BOTTLE (72189-641-90) 2025-09-18NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Ibuprofen FamotidineDirect_Rx2025-09-18HUMAN PRESCRIPTION DRUG LABEL1