warnings
WARNING Large doses of methenamine (8 grams daily for 3 weeks to 4 weeks) have caused bladder irritation, painful and frequent micturition, albuminuria, and gross hematuria.
Methenamine hippurate
openFDA label record#
This page contains supplementary openFDA label data. For the canonical label presentation, use the corresponding DailyMed Structured Product Label.
Verified complete openFDA source JSON
- Brand name
- Methenamine hippurate
- Generic name
- METHENAMINE HIPPURATE
- Manufacturer
- Viona Pharmaceuticals Inc
- Product type
- HUMAN PRESCRIPTION DRUG
- SPL set ID
- 759b3725-0934-4974-a3ac-59a20aee81c6
- SPL ID
- d3ad1ad7-1d50-420e-9e4e-ba9283325925
- Version
- 1
- Effective date
- 2024-06-13
- Source export date
- 2026-10-12
- Source partition
- 11
- Source file
- https://download.open.fda.gov/drug/label/drug-label-0011-of-0014.json.zip
- Source object key
- raw/openfda/drug-label/2026-10-12/a497e765d824a2e2aa9e88d5f0eea2aae9dcba363989e5f163395cda5c3c9dd8/drug-label-0011-of-0014.json.zip
- Source manifest SHA-256
- 7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
- Import run
- 20261013T011858Z
- Imported at
- 2026-10-13 02:46:17
| Harmonized routes |
|---|
| ORAL |
Harmonized identifier links#
Every typed identifier imported from the complete openFDA harmonization object is paginated here; values are not reduced to a first match.
| Type | Scope | Identifier | Source field |
|---|---|---|---|
| application applno | ANDA | 219661 | derived:openfda.application_number |
| application number | ANDA219661 | openfda.application_number | |
| brand name | Methenamine hippurate | openfda.brand_name | |
| generic name | METHENAMINE HIPPURATE | openfda.generic_name | |
| manufacturer name | Viona Pharmaceuticals Inc | openfda.manufacturer_name | |
| ndc | package | 72578-175-01 | openfda.package_ndc |
| ndc | product | 72578-175 | openfda.product_ndc |
| ndc11 | package | 72578017501 | derived:openfda.package_ndc |
| rxcui | 992150 | openfda.rxcui | |
| spl id | d3ad1ad7-1d50-420e-9e4e-ba9283325925 | id | |
| spl set id | 759b3725-0934-4974-a3ac-59a20aee81c6 | set_id | |
| unii | M329791L57 | openfda.unii |
Warnings cross-check#
openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
Adverse reactions cross-check#
openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
adverse reactions
ADVERSE REACTIONS Minor adverse reactions have been reported in less than 3.5% of patients treated. These reactions have included nausea, upset stomach, dysuria, and rash. To report SUSPECTED ADVERSE REACTIONS, contact Viona Pharmaceuticals Inc. at 1-888-304-5011 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.