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
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Fosfomycin tromethamine
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| FOSFOMYCIN TROMETHAMINE | 3 g/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 7FXW6U30GY |
| Rxcui | 808917 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 59651-651-03 | Fosfomycin tromethamine | 1 in 1 CARTON | GRANULE, FOR SOLUTION | 1 | | 1 |
| 59651-651-03 | Fosfomycin tromethamine | 1 in 1 PACKET | GRANULE, FOR SOLUTION | 1 | | 1 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| 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 | Current |