Prescription drug · UNAPPROVED DRUG OTHER
Methenamine Mandelate NDC 69367-436
Methenamine mandelate 500 mg/1 · Tablet, Film coated · Oral · Westminster Pharmaceuticals, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 69367-436-01 | 6936704360169367043601 | 100 TABLET, FILM COATED in 1 BOTTLE (69367-436-01)Marketed from Mar 19, 2026 | |
| 69367-436-60 | 6936704366069367043660 | 60 TABLET, FILM COATED in 1 BOTTLE (69367-436-60)Marketed from Mar 19, 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/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- Westminster Pharmaceuticals, LLCNDC labeler code 69367
- Product type
- Prescription drug
- Marketing category
- Unapproved drug (other)
- Marketing start
- Listing expires
- Identifiers
- Product ID 69367-436_6e6f983d-9926-4c26-afc1-0946184911d1SPL ID 6e6f983d-9926-4c26-afc1-0946184911d1SPL set ID 1d76d132-6fd8-4139-989b-0bc38257ea3bRxCUI 992153, 992184UNII 695N30CINRUPC 0369367437011, 0369367436014
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
N469367043601followed by a unit qualifier and the quantityPackage 69367-0436-01. 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 .
Indications (excerpt from the label)
INDICATIONS AND USAGE Methenamine mandelate is indicated for the suppression or elimination of bacteriuria associated with pyelonephritis, cystitis, and other chronic urinary tract infections; also those neurologic diseases leading to an infected residual urine. When used as recommended, methenamine mandelate 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 because of the nonspecific effect of formaldehyde formed in an acid urine. Prophylactic Use Rationale Urine is a good culture medium for …
Excerpt only. Read the full label for complete information.
About NDC 69367-436
- What is NDC 69367-436?
- 69367-436 is the product NDC for Methenamine Mandelate, Methenamine mandelate 500 mg/1 tablet, film coated, listed with the FDA by Westminster Pharmaceuticals, LLC. It has 2 package NDCs, 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?
- Westminster Pharmaceuticals, LLC, NDC labeler code 69367. 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.
Related NDCs: other Methenamine Mandelate products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Methenamine Mandelate | Methenamine mandelate 500 mg/5mL | SolutionOral | Oncora Pharma, LLC | 85477-115 | 85477-0115-16 |
| 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 |