Fosfomycin Tromethamine
- Product NDC
- 68094-064
- 11-digit product format
- 680940064
- Labeler code
- 68094
- Product ID
- 68094-064_f59f5f6f-5038-436d-8ed4-fb1dfce51c1e
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Fosfomycin Tromethamine
- Dosage form
- GRANULE
- Route
- ORAL
- Labeler
- Precision Dose, Inc.
- Application
- ANDA217187
- Marketing category
- ANDA
- Marketing start
- 2026-02-15
- Substance
- FOSFOMYCIN TROMETHAMINE
- Active strength
- 3 g/1
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Fosfomycin Tromethamine
- Listing expiration
- 2027-12-31
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 |
|---|
| 68094-064-01 | Fosfomycin Tromethamine | 1 in 1 PACKET | GRANULE | 1 | | 1 |
| 68094-064-20 | Fosfomycin Tromethamine | 1 in 1 CARTON | GRANULE | 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 |
|---|
| 68094-064-01 | 68094006401 | 1 in 1 PACKET | | | | | Historical |
| 68094-064-20 | 68094006420 | 1 PACKET in 1 CARTON (68094-064-20) / 1 GRANULE in 1 PACKET (68094-064-01) | 1 packet | 2026-02-15 | No | No | Current |