Prescription drug · ANDA
Fosfomycin tromethamine NDC 59651-651
Fosfomycin tromethamine 3 g/1 · Granule, For solution · Oral · Aurobindo Pharma Limited
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 59651-651-03 | 59651065103 | 1 PACKET in 1 CARTON (59651-651-03) / 1 GRANULE, FOR SOLUTION in 1 PACKETMarketed from Nov 14, 2025 |
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
- Aurobindo Pharma Limited
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 217608
- Marketing start
- Listing expires
- Identifiers
- Product ID 59651-651_f8ec4771-3f8d-473a-a1d0-e42038f61a42SPL ID f8ec4771-3f8d-473a-a1d0-e42038f61a42SPL set ID f8ec4771-3f8d-473a-a1d0-e42038f61a42RxCUI 808917UNII 7FXW6U30GY
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
N459651065103followed by a unit qualifier and the quantityPackage 59651-0651-03. 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 AND 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.