What is NDC 50268-549?

50268-549 is the product NDC for Methenamine Hippurate, Methenamine hippurate 1000 mg/1 tablet, listed with the FDA by AvPAK. It has 1 package NDC, shown above in 10- and 11-digit form.

AvPAK, NDC labeler code 50268. 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 50268-549

NDC codes

FDA NDC Directory

Product NDC (as listed)50268-549Labeler and product segments. Claims need a package NDC.

Product NDC at billing width50268-0549Add 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
50268-549-15	5026805491550268054915	50 BLISTER PACK in 1 CARTON (50268-549-15) / 1 TABLET in 1 BLISTER PACK (50268-549-11)Marketed from Dec 2, 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): Methenamine Hippurate
Generic name (nonproprietary): methenamine hippurate
Active ingredients: Methenamine hippurate — 1000 mg/1
Dosage form: Tablet
Route: Oral
Labeler: AvPAKNDC labeler code 50268
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 212172
Marketing start: Dec 2, 2020
Listing expires: Dec 31, 2026
Identifiers: Product ID 50268-549_0e88fdee-dba1-56cd-e063-6394a90a47c6SPL ID 0e88fdee-dba1-56cd-e063-6394a90a47c6SPL set ID b581b655-62a4-2aa9-e053-2a95a90aa823RxCUI 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

N450268054915 followed by a unit qualifier and the quantity

Package 50268-0549-15. 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 Jan 9, 2024.

Indications (excerpt from the label)

INDICATIONS Methenamine hippurate tablets USP 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 and other antibacterial drugs, methenamine hippurate 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 selecting or mod…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 50268-549

What is NDC 50268-549?: 50268-549 is the product NDC for Methenamine Hippurate, Methenamine hippurate 1000 mg/1 tablet, listed with the FDA by AvPAK. 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?: AvPAK, NDC labeler code 50268. 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	Viona Pharmaceuticals Inc	72578-175	72578-0175-01
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 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 212172

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

FDA NDC Directory listings under ANDA 212172
Product	Strength	Form · route	Labeler	Product NDC
Methenamine Hippurate	Methenamine hippurate 1000 mg/1	TabletOral	Micro Labs Limited	42571-332
Methenamine Hippurate	Methenamine hippurate 1000 mg/1	TabletOral	American Health Packaging	60687-694