Prescription drug · ANDA
Fosfomycin Tromethamine NDC 67877-749
Fosfomycin tromethamine 3 g/1 · Granule, For solution · Oral · Ascend Laboratories, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 67877-749-57 | 67877074957 | 1 PACKET in 1 CARTON (67877-749-57) / 1 GRANULE, FOR SOLUTION in 1 PACKETMarketed from Oct 22, 2021 |
How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules
Product information
- Brand name (proprietary)
- Fosfomycin Tromethamine
- Generic name (nonproprietary)
- fosfomycin tromethamine
- Active ingredients
- Fosfomycin tromethamine — 3 g/1
- Dosage form
- Granule, For solution
- Route
- Oral
- Labeler
- Ascend Laboratories, LLC
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 214554
- Marketing start
- Listing expires
- Identifiers
- Product ID 67877-749_0ebb79a9-df22-4fec-b872-b020b5129b14SPL ID 0ebb79a9-df22-4fec-b872-b020b5129b14SPL set ID 48e352bc-52ea-4778-905a-60ef38a5c18aRxCUI 808917UNII 7FXW6U30GYUPC 0367877749570
Billing references
What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.
- HCPCS codeNo match
No HCPCS code in Med-Code's directory. Oral products like this are usually dispensed by a pharmacy and billed by NDC.
- NDC on a medical claim
N467877074957followed by a unit qualifier and the quantityPackage 67877-0749-57. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier
Product label
Current FDA label (SPL), effective .
Indications (excerpt from the label)
INDICATIONS & USAGE Fosfomycin tromethamine granules for oral solution is indicated only for the treatment of uncomplicated urinary tract infections (acute cystitis) in women due to susceptible strains of Escherichia coli and Enterococcus faecalis . Fosfomycin tromethamine granules for oral solution is not indicated for the treatment of pyelonephritis or perinephric abscess. If persistence or reappearance of bacteriuria occurs after treatment with fosfomycin tromethamine granules for oral solution, other therapeutic agents should be selected. (See PRECAUTIONS and CLINICAL STUDIES sections.)
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 214554
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Fosfomycin Tromethamine | Fosfomycin tromethamine 3 g/1 | Granule, For solutionOral | A-S Medication Solutions | 50090-6130 |
| Fosfomycin Tromethamine | Fosfomycin tromethamine 3 g/1 | Granule, For solutionOral | Kesin Pharma Corporation | 81033-024 |