Prescription drug · UNAPPROVED DRUG OTHER
Methenamine Mandelate NDC 85477-115
Methenamine mandelate 500 mg/5mL · Solution · Oral · Oncora Pharma, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 85477-115-16 | 85477011516 | 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, LLC
- Product type
- Prescription drug
- Marketing category
- Unapproved drug (other)
- Marketing start
- Listing expires
- 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
N485477011516followed by a unit qualifier and the quantityPackage 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 .
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.