Quick answers
- What is Methenamine hippurate used for?
- The FDA-approved label (Methenamine Hippurate, ANI Pharmaceuticals, Inc., August 7, 2026) says: “Methenamine hippurate tablets 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. …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Methenamine hippurate have a boxed warning?
- No. None of the 12 FDA labels we found for this medicine has a boxed warning.
- Is there a shortage of Methenamine hippurate?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Methenamine hippurate been recalled?
- No recall linked to the products of this medicine appears in the FDA enforcement reports we use.
- Who makes Methenamine hippurate?
- 12 companies list prescription products of Methenamine hippurate in the FDA NDC Directory, including Micro Labs Limited, AvPAK and Golden State Medical Supply, Inc..
What Methenamine hippurate is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
Methenamine hippurate tablets 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. …
— FDA label: Methenamine Hippurate, ANI Pharmaceuticals, Inc., effective August 7, 2026. Read the full label on DailyMed →
The FDA has 12 labels for products of this medicine (different makers and forms); uses can differ between them. Check the label that comes with your own medicine.
This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
Boxed warning
A boxed warning (“black box”) is the FDA’s strongest warning on a drug label, for serious or life-threatening risks.
The label quoted above has no boxed warning.
0 of 12 FDA labels for this medicine have a boxed warning.
Forms and how it is given
| Dosage forms | Tablet |
|---|---|
| Route | Oral |
| Prescription products | 12 in the FDA NDC Directory |
What pharmacies pay (NADAC)
The National Average Drug Acquisition Cost (NADAC) is the average price U.S. retail pharmacies paid to buy one unit of a medicine (one tablet, one mL or one gram), from a monthly survey of pharmacy invoices by the Centers for Medicare & Medicaid Services (CMS). State Medicaid programs use it to pay pharmacies.
This is not the price you pay. What you pay depends on your insurance (copay or coinsurance), your pharmacy and any discounts, and pharmacies also charge for filling a prescription. Ask your pharmacist or your health plan what your price will be.
| Strength and form | Generic or brand | Pharmacies pay |
|---|---|---|
| methenamine hippurate 1 g tablet | Generic | $0.3109 per tablet |
| methenamine hippurate 1000 mg tablet | Generic | $0.3109 per tablet |
NADAC list of November 4, 2026; these prices took effect on October 21, 2026. Shown only where a package’s NDC code matches the NADAC list exactly, and only for that exact strength and form: nothing is averaged across strengths. Strengths and forms not listed here have no NADAC price.
Source: NADAC (National Average Drug Acquisition Cost) 2026, data.medicaid.gov (CMS) →
Companies that list this medicine
Labelers in the FDA NDC Directory: the company named on the package (maker or distributor), with the number of prescription products.
- Micro Labs Limited1 product
- AvPAK1 product
- Golden State Medical Supply, Inc.1 product
- Jubilant Cadista Pharmaceuticals Inc.1 product
- Ingenus Pharmaceuticals, LLC1 product
- ANI Pharmaceuticals, Inc.1 product
- NorthStar Rx LLC1 product
- Aurobindo Pharma Limited1 product
- Zydus Lifesciences Limited1 product
- American Health Packaging1 product
- Alvogen Inc.1 product
- Viona Pharmaceuticals Inc1 product
FDA approval history
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
- ANDA: Abbreviated New Drug Application: how a generic version is approved.
| Application | Sponsor | Approved | Later changes approved |
|---|---|---|---|
| NDA016151 UREX | Quagen | July 5, 1967 | 8, latest March 30, 2015 2015: Manufacturing (CMC) · 2008: Labeling · 1993: Manufacturing (CMC) |
| NDA017681 HIPREX | Esjay Pharma | September 9, 1976 | 16, latest December 28, 2021 2021: Manufacturing (CMC) · 2017: Labeling · 2016: Manufacturing (CMC) |
Generic approvals (5)
- ANDA205661Aurobindo Pharma Ltd · July 5, 2016
- ANDA212172Micro Labs · August 1, 2019
- ANDA210068Ingenus Pharms LLC · November 27, 2020
- ANDA217675Jubilant Cadista · December 1, 2023
- ANDA219661Zydus Lifesciences · March 10, 2025
Shortage status
The FDA drug shortage list does not show these products.
Recalls
No recall linked to these products (by their NDC code) appears in the FDA enforcement reports.
Official identifiers
| RxCUI (RxNorm) | 992150 |
|---|---|
| SPL set ID of the quoted label | a3eeacd4-1983-49ec-a60d-3abaf505ce57 |
| FDA labels (SPL) | 12 |
| FDA applications | NDA016151, NDA017681, 5 ANDA |
| Active ingredients (FDA) | METHENAMINE HIPPURATE |
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Methenamine Hippurate, ANI Pharmaceuticals, Inc., effective August 7, 2026; via openFDA, FDA data exported October 30, 2026, retrieved October 31, 2026
- NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
- Drug shortages (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
openFDA data is provided by the FDA as is; it may be incomplete. Always rely on the label that comes with your medicine. FDA Enforcement Report search →