FOSFOMYCIN TROMETHAMINE
- Product NDC
- 69097-579
- 11-digit product format
- 690970579
- Labeler code
- 69097
- Product ID
- 69097-579_80c866f4-c984-469e-b2a5-5c23f29b9750
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- FOSFOMYCIN TROMETHAMINE
- Dosage form
- GRANULE, FOR SOLUTION
- Route
- ORAL
- Labeler
- Cipla USA Inc.
- Application
- ANDA211881
- Marketing category
- ANDA
- Marketing start
- 2022-01-26
- 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 |
|---|
| 69097-579-67 | FOSFOMYCIN TROMETHAMINE | 1 in 1 DOSE PACK | GRANULE, FOR SOLUTION | 1 | | 4 |
| 69097-579-67 | FOSFOMYCIN TROMETHAMINE | 1 in 1 CARTON | GRANULE, FOR SOLUTION | 1 | | 4 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 69097-579 | FOSFOMYCIN TROMETHAMINE GRANULE, FOR SOLUTION [CIPLA USA INC.] | 3 | Current NDC, Legacy NDC, 2 package rows | 20241024_d101b5d8-bffc-4ee6-b93b-4589fcb8750d.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 69097-579-67 | 69097057967 | 1 DOSE PACK in 1 CARTON (69097-579-67) / 1 GRANULE, FOR SOLUTION in 1 DOSE PACK | 1 dose pack | 2022-01-26 | 0000-00-00 | No | No | Current |