What is NDC 60219-3955?

60219-3955 is the product NDC for Fosfomycin Tromethamine, Fosfomycin tromethamine 3 g/1 granule, for solution, listed with the FDA by Amneal Pharmaceuticals NY LLC. It has 1 package NDC, shown above in 10- and 11-digit form.

Amneal Pharmaceuticals NY LLC, NDC labeler code 60219. 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.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Fosfomycin Tromethamine NDC 60219-3955

NDC codes

FDA NDC Directory

Product NDC (as listed)60219-3955Labeler and product segments. Claims need a package NDC.

Product NDC at billing width60219-3955Add 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 NDC	11-digit (billing)	Package	Copy
60219-3955-1	60219395501	1 PACKET in 1 CARTON (60219-3955-1) / 1 GRANULE, FOR SOLUTION in 1 PACKET (60219-3955-3)Marketed from Apr 2, 2024

How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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: Amneal Pharmaceuticals NY LLCNDC labeler code 60219
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 216600
Marketing start: Apr 2, 2024
Listing expires: Dec 31, 2026
Identifiers: Product ID 60219-3955_5fd9aeff-694c-48be-93de-a2ba381ea436SPL ID 5fd9aeff-694c-48be-93de-a2ba381ea436SPL set ID aacd04a4-f2d5-45a2-b9e7-0e92244a5880RxCUI 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

N460219395501 followed by a unit qualifier and the quantity

Package 60219-3955-01. 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 Apr 2, 2024.

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.

Full label on DailyMed (opens in a new tab)

About NDC 60219-3955

What is NDC 60219-3955?: 60219-3955 is the product NDC for Fosfomycin Tromethamine, Fosfomycin tromethamine 3 g/1 granule, for solution, listed with the FDA by Amneal Pharmaceuticals NY LLC. 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?: Amneal Pharmaceuticals NY LLC, NDC labeler code 60219. 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
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	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