Prescription drug · ANDA
Fosfomycin Tromethamine (Granules for oral solution) NDC 70700-268
Fosfomycin tromethamine 3 g/1 · Powder · Oral · XIROMED LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 70700-268-94 | 7070002689470700026894 | 1 DOSE PACK in 1 CARTON (70700-268-94) / 1 POWDER in 1 DOSE PACKMarketed from Oct 6, 2020 | |
| 70700-268-99 | 7070002689970700026899 | 1 POWDER in 1 PACKET (70700-268-99)Marketed from Oct 6, 2020 |
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)
- granules for oral solution
- Active ingredients
- Fosfomycin tromethamine — 3 g/1
- Dosage form
- Powder
- Route
- Oral
- Labeler
- XIROMED LLCNDC labeler code 70700
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 212548
- Marketing start
- Listing expires
- Identifiers
- Product ID 70700-268_3b3ab408-446e-20a4-a58c-46bc75451542SPL ID 3b3ab408-446e-20a4-a58c-46bc75451542SPL set ID c3ba67e7-aaca-e682-277a-94e20b0abad7RxCUI 808917UNII 7FXW6U30GYUPC 0370700268940
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
N470700026894followed by a unit qualifier and the quantityPackage 70700-0268-94. 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 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 is not indicated for the treatment of pyelonephritis or perinephric abscess. If persistence or reappearance of bacteriuria occurs after treatment with Fosfomycin Tromethamine, other therapeutic agents should be selected. (See PRECAUTIONS and CLINICAL STUDIES sections.)
Excerpt only. Read the full label for complete information.
About NDC 70700-268
- What is NDC 70700-268?
- 70700-268 is the product NDC for Fosfomycin Tromethamine (granules for oral solution), Fosfomycin tromethamine 3 g/1 powder, listed with the FDA by XIROMED LLC. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Fosfomycin Tromethamine (Granules for Oral Solution).
- What is the active ingredient?
- Fosfomycin tromethamine.
- Who is the labeler?
- XIROMED LLC, NDC labeler code 70700. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Fosfomycin Tromethamine?
- 10 other product NDCs are listed under this name. See all Fosfomycin Tromethamine NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Fosfomycin Tromethamine products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Fosfomycin Tromethamine | Fosfomycin tromethamine 3 g/1 | Granule, For solutionOral | ANI Pharmaceuticals, Inc. | 70954-040 | 70954-0040-10 |
| Fosfomycin Tromethamine | Fosfomycin tromethamine 3 g/1 | Granule, For solutionOral | Aucta Pharmaceuticals, Inc. | 73289-0067 | 73289-0067-0173289-0067-02 |
| Fosfomycin Tromethamine | Fosfomycin tromethamine 3 g/1 | GranuleOral | Precision Dose, Inc. | 68094-064 | 68094-0064-20 |
| Fosfomycin tromethamine | Fosfomycin tromethamine 3 g/1 | Granule, For solutionOral | Aurobindo Pharma Limited | 59651-651 | 59651-0651-03 |
| Fosfomycin Tromethamine | Fosfomycin tromethamine 3 g/1 | Granule, For solutionOral | Amneal Pharmaceuticals NY LLC | 60219-3955 | 60219-3955-01 |
| Fosfomycin Tromethamine | Fosfomycin tromethamine 3 g/1 | Granule, For solutionOral | Cipla USA Inc. | 69097-579 | 69097-0579-67 |
| Fosfomycin Tromethamine | Fosfomycin tromethamine 3 g/1 | Granule, For solutionOral | A-S Medication Solutions | 50090-6130 | 50090-6130-00 |
| Fosfomycin Tromethamine | Fosfomycin tromethamine 3 g/1 | Granule, For solutionOral | Ascend Laboratories, LLC | 67877-749 | 67877-0749-57 |
| Fosfomycin Tromethamine | Fosfomycin tromethamine 3 g/1 | Granule, For solutionOral | Kesin Pharma Corporation | 81033-024 | 81033-0024-11 |
| Fosfomycin Tromethaminegranules for oral | Fosfomycin tromethamine 3 g/1 | PowderOral | A-S Medication Solutions | 50090-5826 | 50090-5826-00 |
Other NDCs under ANDA 212548
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 Tromethaminegranules for oral | Fosfomycin tromethamine 3 g/1 | PowderOral | A-S Medication Solutions | 50090-5826 |