Home NDC 59746-797 Methenamine Hippurate
Product NDC 59746-797
11-digit product format 597460797
Labeler code 59746
Product ID 59746-797_66ecc892-3ddf-4fc3-b58d-ce1d3581ea2c
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Methenamine Hippurate
Dosage form TABLET
Route ORAL
Labeler Jubilant Cadista Pharmaceuticals Inc.
Application ANDA217675
Marketing category ANDA
Marketing start 2023-01-24
Substance METHENAMINE HIPPURATE
Active strength 1 g/1
NDC exclude flag No
Listing certified through 2027-12-31
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 A217675-001 METHENAMINE HIPPURATE METHENAMINE HIPPURATE 1GM TABLET / ORAL AB 2023-12-01
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A217675-001 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 A217675-001 METHENAMINE HIPPURATE 1GM TABLET / ORAL AB 2023-12-01 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A217675-001 METHENAMINE HIPPURATE 1GM TABLET / ORAL AB 2023-12-01 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A217675-001 METHENAMINE HIPPURATE 1GM TABLET / ORAL AB 2023-12-01 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A217675-001 METHENAMINE HIPPURATE 1GM TABLET / ORAL AB 2023-12-01 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A217675-001 METHENAMINE HIPPURATE 1GM TABLET / ORAL AB 2023-12-01 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A217675-001 METHENAMINE HIPPURATE 1GM TABLET / ORAL AB 2023-12-01 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A217675-001 METHENAMINE HIPPURATE 1GM TABLET / ORAL AB 2023-12-01 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A217675-001 METHENAMINE HIPPURATE 1GM TABLET / ORAL AB 2023-12-01 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A217675-001 METHENAMINE HIPPURATE 1GM TABLET / ORAL AB 2023-12-01 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A217675-001 METHENAMINE HIPPURATE 1GM TABLET / ORAL AB 2023-12-01 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A217675-001 METHENAMINE HIPPURATE 1GM TABLET / ORAL AB 2023-12-01 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A217675-001 METHENAMINE HIPPURATE 1GM TABLET / ORAL AB 2023-12-01 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A217675-001 METHENAMINE HIPPURATE 1GM TABLET / ORAL AB 2023-12-01 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A217675-001 METHENAMINE HIPPURATE 1GM TABLET / ORAL AB 2023-12-01 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A217675-001 METHENAMINE HIPPURATE 1GM TABLET / ORAL AB 2023-12-01 8072bd15b7f6…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A217675-001 METHENAMINE HIPPURATE 1GM TABLET / ORAL AB 2023-12-01 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A217675-001 METHENAMINE HIPPURATE 1GM TABLET / ORAL AB 2023-12-01 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A217675-001 METHENAMINE HIPPURATE 1GM TABLET / ORAL AB 2023-12-01 ea1830bbd6c7…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A217675-001 METHENAMINE HIPPURATE 1GM TABLET / ORAL AB 2023-12-01 a50c72e98297…
Observed Orange Book normalized TE history# Additional Listing Data#
Finished product Yes
Brand name base Methenamine Hippurate
Listing expiration 2027-12-31 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 59746-797-01 Methenamine Hippurate 100 in 1 BOTTLE TABLET 100 2 59746-797-65 Methenamine Hippurate 20 in 1 BOTTLE TABLET 20 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 59746-797 METHENAMINE HIPPURATE TABLET [JUBILANT CADISTA PHARMACEUTICALS INC.] 1 Current NDC, 2 package rows 20240515_4263d826-7de2-4011-b8ec-ba1f5222f0e6.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 · 1 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 59746-797-01 59746079701 100 TABLET in 1 BOTTLE (59746-797-01) 100 tablet 2023-01-24 No No Current 59746-797-65 59746079765 20 TABLET in 1 BOTTLE (59746-797-65) 20 tablet 2023-01-24 No No Current