What is NDC 72578-175?

72578-175 is the product NDC for Methenamine hippurate, Methenamine hippurate 1 g/1 tablet, listed with the FDA by Viona Pharmaceuticals Inc. It has 1 package NDC, shown above in 10- and 11-digit form.

Viona Pharmaceuticals Inc, NDC labeler code 72578. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Methenamine hippurate?

11 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Methenamine hippurate NDC 72578-175

NDC codes

FDA NDC Directory

Product NDC (as listed)72578-175Labeler and product segments. Claims need a package NDC.

Product NDC at billing width72578-0175Add 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
72578-175-01	7257801750172578017501	100 TABLET in 1 BOTTLE (72578-175-01)Marketed from Mar 12, 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): Methenamine hippurate
Generic name (nonproprietary): methenamine hippurate
Active ingredients: Methenamine hippurate — 1 g/1
Dosage form: Tablet
Route: Oral
Labeler: Viona Pharmaceuticals IncNDC labeler code 72578
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 219661
Marketing start: Mar 12, 2025
Listing expires: Dec 31, 2026
Identifiers: Product ID 72578-175_d3ad1ad7-1d50-420e-9e4e-ba9283325925SPL ID d3ad1ad7-1d50-420e-9e4e-ba9283325925SPL set ID 759b3725-0934-4974-a3ac-59a20aee81c6RxCUI 992150UNII M329791L57

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

N472578017501 followed by a unit qualifier and the quantity

Package 72578-0175-01. 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 Jun 13, 2024.

Indications (excerpt from the label)

INDICATIONS Methenamine hippurate tablets are indicated for prophylactic or suppressive treatment of frequently recurring urinary tract infections when long-term therapy is considered necessary. This drug should only be used after eradication of the infection by other appropriate antimicrobial agents. To reduce the development of drug-resistant bacteria and maintain the effectiveness of methenamine hippurate tablets and other antibacterial drugs, methenamine hippurate tablets should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in sele…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 72578-175

What is NDC 72578-175?: 72578-175 is the product NDC for Methenamine hippurate, Methenamine hippurate 1 g/1 tablet, listed with the FDA by Viona Pharmaceuticals Inc. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Methenamine hippurate.
What is the active ingredient?: Methenamine hippurate.
Who is the labeler?: Viona Pharmaceuticals Inc, NDC labeler code 72578. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Methenamine hippurate?: 11 other product NDCs are listed under this name. See all Methenamine hippurate 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 Methenamine hippurate NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Methenamine Hippurate	Methenamine hippurate 1 g/1	TabletOral	ANI Pharmaceuticals, Inc.	70954-959	70954-0959-10
Methenamine Hippurate	Methenamine hippurate 1 g/1	TabletOral	NorthStar Rx LLC	72603-816	72603-0816-01
Methenamine hippurate	Methenamine hippurate 1 g/1	TabletOral	Zydus Lifesciences Limited	70771-1919	70771-1919-01
Methenamine Hippurate	Methenamine hippurate 1 g/1	TabletOral	Jubilant Cadista Pharmaceuticals Inc.	59746-797	59746-0797-0159746-0797-65
Methenamine Hippurate	Methenamine hippurate 1000 mg/1	TabletOral	American Health Packaging	60687-694	60687-0694-21
Methenamine Hippurate	Methenamine hippurate 1 g/1	TabletOral	Ingenus Pharmaceuticals, LLC	50742-142	50742-0142-01
Methenamine Hippurate	Methenamine hippurate 1000 mg/1	TabletOral	AvPAK	50268-549	50268-0549-15
Methenamine Hippurate	Methenamine hippurate 1 g/1	TabletOral	Golden State Medical Supply, Inc.	51407-880	51407-0880-01
Methenamine Hippurate	Methenamine hippurate 1000 mg/1	TabletOral	Micro Labs Limited	42571-332	42571-0332-0142571-0332-23
Methenamine Hippurate	Methenamine hippurate 1 g/1	TabletOral	Aurobindo Pharma Limited	65862-782	65862-0782-01

All 12 Methenamine hippurate NDCs

Other NDCs under ANDA 219661

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

FDA NDC Directory listings under ANDA 219661
Product	Strength	Form · route	Labeler	Product NDC
Methenamine hippurate	Methenamine hippurate 1 g/1	TabletOral	Zydus Lifesciences Limited	70771-1919