Home NDC 50742-142 METHENAMINE HIPPURATE
Product NDC 50742-142
11-digit product format 507420142
Labeler code 50742
Product ID 50742-142_7fd02d91-96c5-46b0-a6d1-ebaef663f54c
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name methenamine hippurate
Dosage form TABLET
Route ORAL
Labeler Ingenus Pharmaceuticals, LLC
Application ANDA210068
Marketing category ANDA
Marketing start 2020-12-18
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 A210068-001 METHENAMINE HIPPURATE METHENAMINE HIPPURATE 1GM TABLET / ORAL AB 2020-11-27
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A210068-001 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 A210068-001 METHENAMINE HIPPURATE 1GM TABLET / ORAL AB 2020-11-27 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A210068-001 METHENAMINE HIPPURATE 1GM TABLET / ORAL AB 2020-11-27 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A210068-001 METHENAMINE HIPPURATE 1GM TABLET / ORAL AB 2020-11-27 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A210068-001 METHENAMINE HIPPURATE 1GM TABLET / ORAL AB 2020-11-27 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A210068-001 METHENAMINE HIPPURATE 1GM TABLET / ORAL AB 2020-11-27 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A210068-001 METHENAMINE HIPPURATE 1GM TABLET / ORAL AB 2020-11-27 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A210068-001 METHENAMINE HIPPURATE 1GM TABLET / ORAL AB 2020-11-27 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A210068-001 METHENAMINE HIPPURATE 1GM TABLET / ORAL AB 2020-11-27 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A210068-001 METHENAMINE HIPPURATE 1GM TABLET / ORAL AB 2020-11-27 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A210068-001 METHENAMINE HIPPURATE 1GM TABLET / ORAL AB 2020-11-27 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A210068-001 METHENAMINE HIPPURATE 1GM TABLET / ORAL AB 2020-11-27 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A210068-001 METHENAMINE HIPPURATE 1GM TABLET / ORAL AB 2020-11-27 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A210068-001 METHENAMINE HIPPURATE 1GM TABLET / ORAL AB 2020-11-27 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A210068-001 METHENAMINE HIPPURATE 1GM TABLET / ORAL AB 2020-11-27 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A210068-001 METHENAMINE HIPPURATE 1GM TABLET / ORAL AB 2020-11-27 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A210068-001 METHENAMINE HIPPURATE 1GM TABLET / ORAL AB 2020-11-27 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A210068-001 METHENAMINE HIPPURATE 1GM TABLET / ORAL AB 2020-11-27 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A210068-001 METHENAMINE HIPPURATE 1GM TABLET / ORAL AB 2020-11-27 4b0b4de00fa7…2022-03-09 01:35 UTC 2022-03 A210068-001 METHENAMINE HIPPURATE 1GM TABLET / ORAL AB 2020-11-27 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A210068-001 METHENAMINE HIPPURATE 1GM TABLET / ORAL AB 2020-11-27 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A210068-001 METHENAMINE HIPPURATE 1GM TABLET / ORAL AB 2020-11-27 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A210068-001 METHENAMINE HIPPURATE 1GM TABLET / ORAL AB 2020-11-27 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A210068-001 METHENAMINE HIPPURATE 1GM TABLET / ORAL AB 2020-11-27 8869cabd3fbd…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A210068-001 METHENAMINE HIPPURATE 1GM TABLET / ORAL AB 2020-11-27 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A210068-001 METHENAMINE HIPPURATE 1GM TABLET / ORAL AB 2020-11-27 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A210068-001 METHENAMINE HIPPURATE 1GM TABLET / ORAL AB 2020-11-27 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A210068-001 METHENAMINE HIPPURATE 1GM TABLET / ORAL AB 2020-11-27 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A210068-001 METHENAMINE HIPPURATE 1GM TABLET / ORAL AB 2020-11-27 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A210068-001 METHENAMINE HIPPURATE 1GM TABLET / ORAL AB 2020-11-27 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A210068-001 METHENAMINE HIPPURATE 1GM TABLET / ORAL AB 2020-11-27 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A210068-001 METHENAMINE HIPPURATE 1GM TABLET / ORAL AB 2020-11-27 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A210068-001 METHENAMINE HIPPURATE 1GM TABLET / ORAL AB 2020-11-27 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A210068-001 METHENAMINE HIPPURATE 1GM TABLET / ORAL AB 2020-11-27 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A210068-001 METHENAMINE HIPPURATE 1GM TABLET / ORAL AB 2020-11-27 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A210068-001 METHENAMINE HIPPURATE 1GM TABLET / ORAL AB 2020-11-27 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A210068-001 METHENAMINE HIPPURATE 1GM TABLET / ORAL AB 2020-11-27 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A210068-001 METHENAMINE HIPPURATE 1GM TABLET / ORAL AB 2020-11-27 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 50742-142-01 METHENAMINE HIPPURATE 100 in 1 BOTTLE TABLET 100 8
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 50742-142 METHENAMINE HIPPURATE TABLET [INGENUS PHARMACEUTICALS, LLC] 8 Current NDC, Legacy NDC, 1 package rows 20230616_4412d667-63f6-427e-a5c6-376a0e1e172d.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 Marketing end Sample Exclude flag Status 50742-142-01 50742014201 100 TABLET in 1 BOTTLE (50742-142-01) 100 tablet 2020-12-18 0000-00-00 No No Current