Ibuprofen and famotidine
- Product NDC
- 59651-908
- 11-digit product format
- 596510908
- Labeler code
- 59651
- Product ID
- 59651-908_21688404-41fb-487e-8ba0-aea4431a42fa
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Ibuprofen and famotidine
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Aurobindo Pharma Limited
- Application
- ANDA219538
- Marketing category
- ANDA
- Marketing start
- 2025-06-30
- 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 UNII Ingredients
| UNII | Preferred term | Registry number | Matched term |
|---|
| 5QZO15J2Z8 | FAMOTIDINE | 76824-35-6 | FAMOTIDINE |
| WK2XYI10QM | IBUPROFEN | 15687-27-1 | IBUPROFEN |
Packages
| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 59651-908-90 | 59651090890 | 90 TABLET, FILM COATED in 1 BOTTLE (59651-908-90) | 2025-06-30 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| Ibuprofen and famotidine | Aurobindo Pharma Limited | 2025-07-03 | Human Prescription Drug Label | 1 |