NDC codes

FDA NDC Directory
Product NDC (as listed)81033-024Labeler and product segments. Claims need a package NDC.
Product NDC at billing width81033-0024Add the package segment from the table below.
Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC11-digit (billing)PackageCopy
81033-024-11810330024111 PACKET in 1 CARTON (81033-024-11) / 1 GRANULE, FOR SOLUTION in 1 PACKET (81033-024-03)Marketed from Oct 1, 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
Kesin Pharma CorporationNDC labeler code 81033
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 214554
Marketing start
Listing expires
Identifiers
Product ID 81033-024_3fa646b7-8ad6-3da8-e063-6394a90af80bSPL ID 3fa646b7-8ad6-3da8-e063-6394a90af80bSPL set ID 3fa61bd4-fc55-0987-e063-6394a90abce2RxCUI 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

N481033002411 followed by a unit qualifier and the quantity

Package 81033-0024-11. 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.

Full label on DailyMed (opens in a new tab)

About NDC 81033-024

What is NDC 81033-024?
81033-024 is the product NDC for Fosfomycin Tromethamine, Fosfomycin tromethamine 3 g/1 granule, for solution, listed with the FDA by Kesin Pharma Corporation. 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?
Kesin Pharma Corporation, NDC labeler code 81033. 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.

Other finished products listed under the same name: strengths, forms and labelers.

Other Fosfomycin Tromethamine NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
Fosfomycin TromethamineFosfomycin tromethamine 3 g/1Granule, For solutionOralANI Pharmaceuticals, Inc.70954-04070954-0040-10
Fosfomycin TromethamineFosfomycin tromethamine 3 g/1Granule, For solutionOralAucta Pharmaceuticals, Inc.73289-006773289-0067-0173289-0067-02
Fosfomycin TromethamineFosfomycin tromethamine 3 g/1GranuleOralPrecision Dose, Inc.68094-06468094-0064-20
Fosfomycin tromethamineFosfomycin tromethamine 3 g/1Granule, For solutionOralAurobindo Pharma Limited59651-65159651-0651-03
Fosfomycin TromethamineFosfomycin tromethamine 3 g/1Granule, For solutionOralAmneal Pharmaceuticals NY LLC60219-395560219-3955-01
Fosfomycin TromethamineFosfomycin tromethamine 3 g/1Granule, For solutionOralCipla USA Inc.69097-57969097-0579-67
Fosfomycin TromethamineFosfomycin tromethamine 3 g/1Granule, For solutionOralA-S Medication Solutions50090-613050090-6130-00
Fosfomycin TromethamineFosfomycin tromethamine 3 g/1Granule, For solutionOralAscend Laboratories, LLC67877-74967877-0749-57
Fosfomycin Tromethaminegranules for oralFosfomycin tromethamine 3 g/1PowderOralA-S Medication Solutions50090-582650090-5826-00
Fosfomycin Tromethaminegranules for oral solutionFosfomycin tromethamine 3 g/1PowderOralXIROMED LLC70700-26870700-0268-9470700-0268-99

Other NDCs under ANDA 214554

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under ANDA 214554
ProductStrengthForm · routeLabelerProduct NDC
Fosfomycin TromethamineFosfomycin tromethamine 3 g/1Granule, For solutionOralA-S Medication Solutions50090-6130
Fosfomycin TromethamineFosfomycin tromethamine 3 g/1Granule, For solutionOralAscend Laboratories, LLC67877-749

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