warnings
WARNING Large doses of methenamine (8 grams daily for 3 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
- Jubilant Cadista Pharmaceuticals Inc.
- Product type
- HUMAN PRESCRIPTION DRUG
- SPL set ID
- 4263d826-7de2-4011-b8ec-ba1f5222f0e6
- SPL ID
- 66ecc892-3ddf-4fc3-b58d-ce1d3581ea2c
- Version
- 2
- Effective date
- 2026-02-03
- Source export date
- 2026-10-30
- 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/2026-10-30/9abf0f8b126f8aad070e21ea702bfb5e39ce670b16ae57dd52e8877705d1bf5d/drug-label-0011-of-0014.json.zip
- Source manifest SHA-256
- b11f1f6b476c7417db937215bf14307ef1a0b69465b42b411ad52f42ae36ead3
- Import run
- 20261102T182004Z
- Imported at
- 2026-11-02 19:28:33
| 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 | 217675 | derived:openfda.application_number |
| application number | ANDA217675 | openfda.application_number | |
| brand name | Methenamine Hippurate | openfda.brand_name | |
| generic name | METHENAMINE HIPPURATE | openfda.generic_name | |
| manufacturer name | Jubilant Cadista Pharmaceuticals Inc. | openfda.manufacturer_name | |
| ndc | package | 59746-797-01 | openfda.package_ndc |
| ndc | package | 59746-797-65 | openfda.package_ndc |
| ndc | product | 59746-797 | openfda.product_ndc |
| ndc11 | package | 59746079765 | derived:openfda.package_ndc |
| ndc11 | package | 59746079701 | derived:openfda.package_ndc |
| rxcui | 992150 | openfda.rxcui | |
| spl id | 66ecc892-3ddf-4fc3-b58d-ce1d3581ea2c | id | |
| spl set id | 4263d826-7de2-4011-b8ec-ba1f5222f0e6 | 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 Jubilant Cadista Pharmaceuticals Inc. at 1-800-313-4623 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.