Ibuprofen and famotidine

Product NDC
68788-8897
11-digit product format
687888897
Labeler code
68788
Product ID
68788-8897_e2f29ca9-9ec8-4b82-8c80-8628d9e3ab2f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ibuprofen and famotidine
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Preferred Pharmaceuticals Inc.
Application
ANDA211890
Marketing category
ANDA
Marketing start
2025-08-01
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
68788-8897-96878888970990 TABLET, FILM COATED in 1 BOTTLE (68788-8897-9) 2025-08-01NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Ibuprofen and famotidinePreferred Pharmaceuticals Inc.2025-08-01HUMAN PRESCRIPTION DRUG LABEL1