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
- NorthStar Rx LLC
- Product type
- HUMAN PRESCRIPTION DRUG
- SPL set ID
- 3c9e5bea-f61d-48c3-8e05-640eccccf2ba
- SPL ID
- 83850c2e-5867-4acb-bd35-1261adb5b126
- Version
- 2
- Effective date
- 2026-05-21
- Source export date
- 2026-10-12
- Source partition
- 14
- Source file
- https://download.open.fda.gov/drug/label/drug-label-0014-of-0014.json.zip
- Source object key
- raw/openfda/drug-label/2026-10-12/acb9b4700b9af1bdda1c389c7b35bfe38fd6d1a62aa48d17832812be4029b84f/drug-label-0014-of-0014.json.zip
- Source manifest SHA-256
- 7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
- Import run
- 20261013T011858Z
- Imported at
- 2026-10-13 03:12:15
| 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 | NorthStar Rx LLC | openfda.manufacturer_name | |
| ndc | package | 72603-816-01 | openfda.package_ndc |
| ndc | product | 72603-816 | openfda.product_ndc |
| ndc11 | package | 72603081601 | derived:openfda.package_ndc |
| rxcui | 992150 | openfda.rxcui | |
| spl id | 83850c2e-5867-4acb-bd35-1261adb5b126 | id | |
| spl set id | 3c9e5bea-f61d-48c3-8e05-640eccccf2ba | 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 Northstar Rx LLC at 1-800-206-7821 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.