Fosfomycin Tromethamine
- Product NDC
- 60219-3955
- 11-digit product format
- 602193955
- Labeler code
- 60219
- Product ID
- 60219-3955_5fd9aeff-694c-48be-93de-a2ba381ea436
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Fosfomycin Tromethamine
- Dosage form
- GRANULE, FOR SOLUTION
- Route
- ORAL
- Labeler
- Amneal Pharmaceuticals NY LLC
- Application
- ANDA216600
- Marketing category
- ANDA
- Marketing start
- 2024-04-02
- 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 |
|---|
| 60219-3955-1 | Fosfomycin Tromethamine | 1 in 1 CARTON | GRANULE, FOR SOLUTION | 1 | | 4 |
| 60219-3955-3 | Fosfomycin Tromethamine | 1 in 1 PACKET | GRANULE, FOR SOLUTION | 1 | | 4 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 60219-3955 | FOSFOMYCIN TROMETHAMINE GRANULE, FOR SOLUTION [AMNEAL PHARMACEUTICALS NY LLC] | 4 | Current NDC, 2 package rows | 20240403_aacd04a4-f2d5-45a2-b9e7-0e92244a5880.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 60219-3955-1 | 60219395501 | 1 PACKET in 1 CARTON (60219-3955-1) / 1 GRANULE, FOR SOLUTION in 1 PACKET (60219-3955-3) | 1 packet | 2024-04-02 | No | No | Historical |
| 60219-3955-3 | 60219395503 | 1 in 1 PACKET | | | | | Historical |