Fosfomycin tromethamine
- Product NDC
- 59651-651
- 11-digit product format
- 596510651
- Labeler code
- 59651
- Product ID
- 59651-651_f8ec4771-3f8d-473a-a1d0-e42038f61a42
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Fosfomycin tromethamine
- Dosage form
- GRANULE, FOR SOLUTION
- Route
- ORAL
- Labeler
- Aurobindo Pharma Limited
- Application
- ANDA217608
- Marketing category
- ANDA
- Marketing start
- 2025-11-14
- Substance
- FOSFOMYCIN TROMETHAMINE
- Active strength
- 3 g/1
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Related UNII Ingredients
| UNII | Preferred term | Registry number | Matched term |
|---|
| 7FXW6U30GY | FOSFOMYCIN TROMETHAMINE | 78964-85-9 | FOSFOMYCIN TROMETHAMINE |
Packages
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 59651-651-03 | 59651065103 | 1 PACKET in 1 CARTON (59651-651-03) / 1 GRANULE, FOR SOLUTION in 1 PACKET | 1 packet | 2025-11-14 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| Fosfomycin Tromethamine | Aurobindo Pharma Limited | APL HEALTHCARE LIMITED | 2025-11-17 | Human Prescription Drug Label | 1 |