What is NDC 85477-115?

85477-115 is the product NDC for Methenamine Mandelate, Methenamine mandelate 500 mg/5mL solution, listed with the FDA by Oncora Pharma, LLC. It has 1 package NDC, shown above in 10- and 11-digit form.

Oncora Pharma, LLC, NDC labeler code 85477. 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 Mandelate?

8 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Methenamine Mandelate NDC 85477-115

NDC codes

FDA NDC Directory

Product NDC (as listed)85477-115Labeler and product segments. Claims need a package NDC.

Product NDC at billing width85477-0115Add 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
85477-115-16	8547701151685477011516	473 mL in 1 BOTTLE (85477-115-16)Marketed from Apr 20, 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): Methenamine Mandelate
Generic name (nonproprietary): methenamine mandelate
Active ingredients: Methenamine mandelate — 500 mg/5mL
Dosage form: Solution
Route: Oral
Labeler: Oncora Pharma, LLCNDC labeler code 85477
Product type: Prescription drug
Marketing category: Unapproved drug (other)
Marketing start: Apr 20, 2026
Listing expires: Dec 31, 2027
Identifiers: Product ID 85477-115_4fa726e6-84de-0f28-e063-6294a90aafe9SPL ID 4fa726e6-84de-0f28-e063-6294a90aafe9SPL set ID d4b79e41-eb29-4d30-aa8f-e964c16bf002RxCUI 2741045UNII 695N30CINRUPC 0385477115168

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

N485477011516 followed by a unit qualifier and the quantity

Package 85477-0115-16. 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 17, 2026.

Indications (excerpt from the label)

INDICATIONS AND USAGE Methenamine mandelate, USP is indicated for the suppression or elimination of bacteriuria associated with pyelonephritis, cystitis, and other chronic urinary tract infections; also for infected residual urine sometimes accompanying neurologic diseases. When used as recommended, methenamine mandelate, USP is particularly suitable for long-term therapy because of its safety and because resistance to the nonspecific bactericidal action of formaldehyde does not develop. Pathogens resistant to other antibacterial agents may respond to methenamine mandelate, USP because of the nonspecific effect of formaldehyde formed in an acid urine. Prophylactic Use Rationale: Urine is a g…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 85477-115

What is NDC 85477-115?: 85477-115 is the product NDC for Methenamine Mandelate, Methenamine mandelate 500 mg/5mL solution, listed with the FDA by Oncora Pharma, LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Methenamine Mandelate.
What is the active ingredient?: Methenamine mandelate.
Who is the labeler?: Oncora Pharma, LLC, NDC labeler code 85477. 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 Mandelate?: 8 other product NDCs are listed under this name. See all Methenamine Mandelate 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 Mandelate NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Methenamine Mandelate	Methenamine mandelate 500 mg/1	Tablet, Film coatedOral	Westminster Pharmaceuticals, LLC	69367-436	69367-0436-0169367-0436-60
Methenamine Mandelate	Methenamine mandelate 1000 mg/1	Tablet, Film coatedOral	Westminster Pharmaceuticals, LLC	69367-437	69367-0437-0169367-0437-60
Methenamine Mandelate	Methenamine mandelate 500 mg/1	Tablet, Film coatedOral	Bryant Ranch Prepack	72162-2654	72162-2654-01
Methenamine Mandelate	Methenamine mandelate 1000 mg/1	Tablet, Film coatedOral	Bryant Ranch Prepack	72162-2655	72162-2655-01
Methenamine Mandelate	Methenamine mandelate 500 mg/1	Tablet, Film coatedOral	Chartwell RX, LLC	62135-200	62135-0200-0162135-0200-1262135-0200-60
Methenamine Mandelate	Methenamine mandelate 1000 mg/1	Tablet, Film coatedOral	Chartwell RX, LLC	62135-201	62135-0201-0162135-0201-1262135-0201-60
Methenamine Mandelate	Methenamine mandelate 500 mg/1	TabletOral	Edenbridge Pharmaceuticals LLC.	42799-105	42799-0105-01
Methenamine Mandelate	Methenamine mandelate 1000 mg/1	TabletOral	Edenbridge Pharmaceuticals LLC.	42799-106	42799-0106-01