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
- ANI Pharmaceuticals, Inc.
- Product type
- HUMAN PRESCRIPTION DRUG
- SPL set ID
- a3eeacd4-1983-49ec-a60d-3abaf505ce57
- SPL ID
- b95c6668-cf33-4623-bcf0-02f8b4a51719
- Version
- 2
- Effective date
- 2026-08-07
- Source export date
- 2026-11-06
- Source partition
- 10
- Source file
- https://download.open.fda.gov/drug/label/drug-label-0010-of-0014.json.zip
- Source object key
- raw/openfda/drug-label/2026-11-06/b0d9ca61dc485ebaf55e14a76d7d677668e40ef1e1978cdbcc4d73d58eba0b99/drug-label-0010-of-0014.json.zip
- Source manifest SHA-256
- 4a7570ba105b5a039a8e1c94a85e7f085b9047a8882a35a96bf1e4516c5ffc97
- Import run
- 20261108T063105Z
- Imported at
- 2026-11-08 07:46:52
| 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 | NDA | 017681 | derived:openfda.application_number |
| application number | NDA017681 | openfda.application_number | |
| brand name | Methenamine Hippurate | openfda.brand_name | |
| generic name | METHENAMINE HIPPURATE | openfda.generic_name | |
| manufacturer name | ANI Pharmaceuticals, Inc. | openfda.manufacturer_name | |
| ndc | package | 70954-959-10 | openfda.package_ndc |
| ndc | product | 70954-959 | openfda.product_ndc |
| ndc11 | package | 70954095910 | derived:openfda.package_ndc |
| rxcui | 992150 | openfda.rxcui | |
| spl id | b95c6668-cf33-4623-bcf0-02f8b4a51719 | id | |
| spl set id | a3eeacd4-1983-49ec-a60d-3abaf505ce57 | set_id | |
| unii | M329791L57 | openfda.unii |
Warnings cross-check#
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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 ANI Pharmaceuticals, Inc. at 1-855-204-1431 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.