Prescription drug · ANDA
Fosfomycin Tromethamine NDC 68094-064
Fosfomycin tromethamine 3 g/1 · Granule · Oral · Precision Dose, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 68094-064-20 | 6809400642068094006420 | 1 PACKET in 1 CARTON (68094-064-20) / 1 GRANULE in 1 PACKET (68094-064-01)Marketed from Feb 15, 2026 |
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
- Route
- Oral
- Labeler
- Precision Dose, Inc.NDC labeler code 68094
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 217187
- Marketing start
- Listing expires
- Identifiers
- Product ID 68094-064_f59f5f6f-5038-436d-8ed4-fb1dfce51c1eSPL ID f59f5f6f-5038-436d-8ed4-fb1dfce51c1eSPL set ID f44b79d0-a789-46cb-ab70-7eb33a7debafRxCUI 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
N468094006420followed by a unit qualifier and the quantityPackage 68094-0064-20. 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 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, other therapeutic agents should be selected. (See PRECAUTIONS and CLINICAL STUDIES sections.)
Excerpt only. Read the full label for complete information.
About NDC 68094-064
- What is NDC 68094-064?
- 68094-064 is the product NDC for Fosfomycin Tromethamine, Fosfomycin tromethamine 3 g/1 granule, listed with the FDA by Precision Dose, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Fosfomycin Tromethamine.
- What is the active ingredient?
- Fosfomycin tromethamine.
- Who is the labeler?
- Precision Dose, Inc., NDC labeler code 68094. 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 | 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 |
| Fosfomycin Tromethaminegranules for oral solution | Fosfomycin tromethamine 3 g/1 | PowderOral | XIROMED LLC | 70700-268 | 70700-0268-9470700-0268-99 |