Prescription drug · ANDA
Methenamine Hippurate NDC 72603-816
Methenamine hippurate 1 g/1 · Tablet · Oral · NorthStar Rx LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 72603-816-01 | 72603081601 | 100 TABLET in 1 BOTTLE (72603-816-01)Marketed from Apr 1, 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
- NorthStar Rx LLC
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 205661
- Marketing start
- Listing expires
- Identifiers
- Product ID 72603-816_83850c2e-5867-4acb-bd35-1261adb5b126SPL ID 83850c2e-5867-4acb-bd35-1261adb5b126SPL set ID 3c9e5bea-f61d-48c3-8e05-640eccccf2baRxCUI 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
N472603081601followed by a unit qualifier and the quantityPackage 72603-0816-01. 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 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 tablets USP and other antibacterial drugs, methenamine hippurate tablets USP 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 consid…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 205661
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Methenamine Hippurate | Methenamine hippurate 1 g/1 | TabletOral | Aurobindo Pharma Limited | 65862-782 |