FDA.reportPublic FDA data

Methenamine Hippurate Tablets, USP

Manufacturer
Zydus Lifesciences Limited | Zydus Pharmaceuticals Limited
Effective date
2025-03-12
Label type
HUMAN PRESCRIPTION DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 21:27:27

Label at a glance#

ProductMethenamine hippurate
Active ingredientMETHENAMINE HIPPURATE
Label structure1 sections

Label contents#

Full prescribing information#

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 70771-1919-1

Methenamine Hippurate Tablets, USP 1gram

100 tablets

Rx only

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
992150methenamine hippurate 1 GM Oral TabletPSN1
992150methenamine hippurate 1000 MG Oral TabletSCD1
992150methenamine hippurate 1 GM Oral TabletSY1

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
260b0da6-d3d7-262f-a60f-d4b36d5f1b4dProduct name620251210

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70771-1919-1Methenamine hippurate100 in 1 BOTTLETABLET1001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70771-1919METHENAMINE HIPPURATE TABLET [ZYDUS LIFESCIENCES LIMITED]1Current NDC, 1 package rows20250315_7e0d13d1-e564-4f3e-9054-65161eddfc57.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 7 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
70771-191970771-1919-1

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 6 matching rows.

Name, UNII, Kind table
NameUNIIKind
METHENAMINE HIPPURATEM329791L57ACTIB
CROSPOVIDONE, UNSPECIFIED2S7830E561IACT
MAGNESIUM STEARATE70097M6I30IACT
POVIDONE, UNSPECIFIEDFZ989GH94EIACT
SACCHARIN SODIUMSB8ZUX40TYIACT
SILICON DIOXIDEETJ7Z6XBU4IACT

Source Document#

Source XML

Orange Book application contexts#

All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.

Orange Book application contexts page 1 of 1 · 1 matching rows.

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A219661-001METHENAMINE HIPPURATEMETHENAMINE HIPPURATE1GMTABLET / ORALAB2025-03-10

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-productTE code
A219661-001AB

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A219661-001METHENAMINE HIPPURATE1GMTABLET / ORALAB2025-03-1084e616aacf4f…
2026-08-18 06:07:402026-07A219661-001METHENAMINE HIPPURATE1GMTABLET / ORALAB2025-03-10caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A219661-001METHENAMINE HIPPURATE1GMTABLET / ORALAB2025-03-10011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A219661-001METHENAMINE HIPPURATE1GMTABLET / ORALAB2025-03-1031067a03dcf5…
2025-08-23 18:47 UTC2025-08A219661-001METHENAMINE HIPPURATE1GMTABLET / ORALAB2025-03-106a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A219661-001METHENAMINE HIPPURATE1GMTABLET / ORALAB2025-03-10fd3edfee7708…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A219661-001METHENAMINE HIPPURATE1GMTABLET / ORALAB2025-03-10a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-09-14 22:38:342026-08A219661-001AB184e616aacf4f…
2026-08-18 06:07:402026-07A219661-001AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A219661-001AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A219661-001AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A219661-001AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A219661-001AB1fd3edfee7708…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A219661-001AB1a50c72e98297…

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Methenamine hippurateMETHENAMINE HIPPURATEZydus Lifesciences Limited7e0d13d1-e564-4f3e-9054-65161eddfc572025-03-12Exact identifier
ndc (package): 70771-1919-1
ndc (product): 70771-1919
ndc11 (package): 70771191901
spl id: c3524692-fabc-438a-9d6e-2cca27172693
spl set id: 7e0d13d1-e564-4f3e-9054-65161eddfc57

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.