warnings
WARNINGS 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
- Ingenus Pharmaceuticals, LLC
- Product type
- HUMAN PRESCRIPTION DRUG
- SPL set ID
- 4412d667-63f6-427e-a5c6-376a0e1e172d
- SPL ID
- 7fd02d91-96c5-46b0-a6d1-ebaef663f54c
- Version
- 8
- Effective date
- 2023-05-23
- Source export date
- 2026-10-12
- Source partition
- 5
- Source file
- https://download.open.fda.gov/drug/label/drug-label-0005-of-0014.json.zip
- Source object key
- raw/openfda/drug-label/2026-10-12/13cbfcd236c665f0ee69e2d9141331148dcdff45d1679c92f029cfba27dd74a2/drug-label-0005-of-0014.json.zip
- Source manifest SHA-256
- 7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
- Import run
- 20261013T011858Z
- Imported at
- 2026-10-13 01:43:38
| 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 | 210068 | derived:openfda.application_number |
| application number | ANDA210068 | openfda.application_number | |
| brand name | METHENAMINE HIPPURATE | openfda.brand_name | |
| generic name | METHENAMINE HIPPURATE | openfda.generic_name | |
| manufacturer name | Ingenus Pharmaceuticals, LLC | openfda.manufacturer_name | |
| ndc | package | 50742-142-01 | openfda.package_ndc |
| ndc | product | 50742-142 | openfda.product_ndc |
| ndc11 | package | 50742014201 | derived:openfda.package_ndc |
| rxcui | 992150 | openfda.rxcui | |
| spl id | 7fd02d91-96c5-46b0-a6d1-ebaef663f54c | id | |
| spl set id | 4412d667-63f6-427e-a5c6-376a0e1e172d | 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 Ingenus Pharmaceuticals, LLC at 1-877-748-1970 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.