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
- Aurobindo Pharma Limited
- Product type
- HUMAN PRESCRIPTION DRUG
- SPL set ID
- 9f002ad9-58e7-44f2-a980-3cc3f36bbd9b
- SPL ID
- 58bf1607-c076-466c-a0ff-a0ecf74f84b8
- Version
- 8
- Effective date
- 2026-04-10
- Source export date
- 2026-09-28
- 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/2026-09-28/4bbc9760f647649b787710953d978bd6419e899ba8b90f32c3d972aae43947f8/drug-label-0010-of-0014.json.zip
- Source manifest SHA-256
- cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
- Import run
- 20260929T050834Z
- Imported at
- 2026-09-29 06:06:24
| 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 | 205661 | derived:openfda.application_number |
| application number | ANDA205661 | openfda.application_number | |
| brand name | Methenamine Hippurate | openfda.brand_name | |
| generic name | METHENAMINE HIPPURATE | openfda.generic_name | |
| manufacturer name | Aurobindo Pharma Limited | openfda.manufacturer_name | |
| ndc | package | 65862-782-01 | openfda.package_ndc |
| ndc | product | 65862-782 | openfda.product_ndc |
| ndc11 | package | 65862078201 | derived:openfda.package_ndc |
| rxcui | 992150 | openfda.rxcui | |
| spl id | 58bf1607-c076-466c-a0ff-a0ecf74f84b8 | id | |
| spl set id | 9f002ad9-58e7-44f2-a980-3cc3f36bbd9b | 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 Aurobindo Pharma USA, Inc. at 1-866-850-2876 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.