Home NDC 72578-175 Methenamine hippurate
Product NDC 72578-175
11-digit product format 725780175
Labeler code 72578
Product ID 72578-175_d3ad1ad7-1d50-420e-9e4e-ba9283325925
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Methenamine hippurate
Dosage form TABLET
Route ORAL
Labeler Viona Pharmaceuticals Inc
Application ANDA219661
Marketing category ANDA
Marketing start 2025-03-12
Substance METHENAMINE HIPPURATE
Active strength 1 g/1
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A219661-001 METHENAMINE HIPPURATE METHENAMINE HIPPURATE 1GM TABLET / ORAL AB 2025-03-10
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A219661-001 AB
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 Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-08-18 06:07:40 2026-07 A219661-001 METHENAMINE HIPPURATE 1GM TABLET / ORAL AB 2025-03-10 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A219661-001 METHENAMINE HIPPURATE 1GM TABLET / ORAL AB 2025-03-10 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A219661-001 METHENAMINE HIPPURATE 1GM TABLET / ORAL AB 2025-03-10 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A219661-001 METHENAMINE HIPPURATE 1GM TABLET / ORAL AB 2025-03-10 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A219661-001 METHENAMINE HIPPURATE 1GM TABLET / ORAL AB 2025-03-10 fd3edfee7708…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A219661-001 METHENAMINE HIPPURATE 1GM TABLET / ORAL AB 2025-03-10 a50c72e98297…
Observed Orange Book normalized TE history# Additional Listing Data#
Finished product Yes
Brand name base Methenamine hippurate
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength METHENAMINE HIPPURATE 1 g/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination M329791L57 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 992150 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 72578-175-01 Methenamine hippurate 100 in 1 BOTTLE TABLET 100 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 72578-175 METHENAMINE HIPPURATE TABLET [VIONA PHARMACEUTICALS INC] 1 Current NDC, 1 package rows 20250315_759b3725-0934-4974-a3ac-59a20aee81c6.zip
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 · 2 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 72578-175-01 72578017501 100 TABLET in 1 BOTTLE (72578-175-01) 100 tablet 2025-03-12 No No Current