Prescription drug · ANDA
Methenamine Hippurate NDC 65862-782
Methenamine hippurate 1 g/1 · Tablet · Oral · Aurobindo Pharma Limited
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 65862-782-01 | 65862078201 | 100 TABLET in 1 BOTTLE (65862-782-01)Marketed from Jul 5, 2016 |
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
- Aurobindo Pharma Limited
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 205661
- Marketing start
- Listing expires
- Identifiers
- Product ID 65862-782_58bf1607-c076-466c-a0ff-a0ecf74f84b8SPL ID 58bf1607-c076-466c-a0ff-a0ecf74f84b8SPL set ID 9f002ad9-58e7-44f2-a980-3cc3f36bbd9bRxCUI 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
N465862078201followed by a unit qualifier and the quantityPackage 65862-0782-01. 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 | NorthStar Rx LLC | 72603-816 |