Home NDC 65862-782 Methenamine Hippurate
Product NDC 65862-782
11-digit product format 658620782
Labeler code 65862
Product ID 65862-782_58bf1607-c076-466c-a0ff-a0ecf74f84b8
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Methenamine Hippurate
Dosage form TABLET
Route ORAL
Labeler Aurobindo Pharma Limited
Application ANDA205661
Marketing category ANDA
Marketing start 2016-07-05
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 A205661-001 METHENAMINE HIPPURATE METHENAMINE HIPPURATE 1GM TABLET / ORAL AB RS 2016-07-05
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A205661-001 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.
Product history page 1 of 2 · 42 observed 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 A205661-001 METHENAMINE HIPPURATE 1GM TABLET / ORAL AB RS 2016-07-05 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A205661-001 METHENAMINE HIPPURATE 1GM TABLET / ORAL AB RS 2016-07-05 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A205661-001 METHENAMINE HIPPURATE 1GM TABLET / ORAL AB RS 2016-07-05 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A205661-001 METHENAMINE HIPPURATE 1GM TABLET / ORAL AB RS 2016-07-05 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A205661-001 METHENAMINE HIPPURATE 1GM TABLET / ORAL AB RS 2016-07-05 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A205661-001 METHENAMINE HIPPURATE 1GM TABLET / ORAL AB RS 2016-07-05 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A205661-001 METHENAMINE HIPPURATE 1GM TABLET / ORAL AB RS 2016-07-05 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A205661-001 METHENAMINE HIPPURATE 1GM TABLET / ORAL AB RS 2016-07-05 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A205661-001 METHENAMINE HIPPURATE 1GM TABLET / ORAL AB RS 2016-07-05 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A205661-001 METHENAMINE HIPPURATE 1GM TABLET / ORAL AB RS 2016-07-05 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A205661-001 METHENAMINE HIPPURATE 1GM TABLET / ORAL AB RS 2016-07-05 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A205661-001 METHENAMINE HIPPURATE 1GM TABLET / ORAL AB RS 2016-07-05 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A205661-001 METHENAMINE HIPPURATE 1GM TABLET / ORAL AB RS 2016-07-05 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A205661-001 METHENAMINE HIPPURATE 1GM TABLET / ORAL AB RS 2016-07-05 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A205661-001 METHENAMINE HIPPURATE 1GM TABLET / ORAL AB RS 2016-07-05 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A205661-001 METHENAMINE HIPPURATE 1GM TABLET / ORAL AB RS 2016-07-05 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A205661-001 METHENAMINE HIPPURATE 1GM TABLET / ORAL AB RS 2016-07-05 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A205661-001 METHENAMINE HIPPURATE 1GM TABLET / ORAL AB RS 2016-07-05 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A205661-001 METHENAMINE HIPPURATE 1GM TABLET / ORAL AB 2016-07-05 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A205661-001 METHENAMINE HIPPURATE 1GM TABLET / ORAL AB RS 2016-07-05 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A205661-001 METHENAMINE HIPPURATE 1GM TABLET / ORAL AB RS 2016-07-05 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A205661-001 METHENAMINE HIPPURATE 1GM TABLET / ORAL AB RS 2016-07-05 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A205661-001 METHENAMINE HIPPURATE 1GM TABLET / ORAL AB 2016-07-05 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A205661-001 METHENAMINE HIPPURATE 1GM TABLET / ORAL AB 2016-07-05 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A205661-001 METHENAMINE HIPPURATE 1GM TABLET / ORAL AB 2016-07-05 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A205661-001 METHENAMINE HIPPURATE 1GM TABLET / ORAL AB 2016-07-05 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A205661-001 METHENAMINE HIPPURATE 1GM TABLET / ORAL AB 2016-07-05 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A205661-001 METHENAMINE HIPPURATE 1GM TABLET / ORAL AB 2016-07-05 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A205661-001 METHENAMINE HIPPURATE 1GM TABLET / ORAL AB RS 2016-07-05 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A205661-001 METHENAMINE HIPPURATE 1GM TABLET / ORAL AB RS 2016-07-05 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A205661-001 METHENAMINE HIPPURATE 1GM TABLET / ORAL AB RS 2016-07-05 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A205661-001 METHENAMINE HIPPURATE 1GM TABLET / ORAL AB RS 2016-07-05 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A205661-001 METHENAMINE HIPPURATE 1GM TABLET / ORAL AB RS 2016-07-05 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A205661-001 METHENAMINE HIPPURATE 1GM TABLET / ORAL AB RS 2016-07-05 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A205661-001 METHENAMINE HIPPURATE 1GM TABLET / ORAL AB RS 2016-07-05 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A205661-001 METHENAMINE HIPPURATE 1GM TABLET / ORAL AB RS 2016-07-05 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A205661-001 METHENAMINE HIPPURATE 1GM TABLET / ORAL AB RS 2016-07-05 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A205661-001 METHENAMINE HIPPURATE 1GM TABLET / ORAL AB RS 2016-07-05 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A205661-001 METHENAMINE HIPPURATE 1GM TABLET / ORAL AB RS 2016-07-05 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A205661-001 METHENAMINE HIPPURATE 1GM TABLET / ORAL AB RS 2016-07-05 e64feba35796…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 42 observed states.
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 65862-782-01 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 65862-782 METHENAMINE HIPPURATE TABLET [AUROBINDO PHARMA LIMITED] 7 Current NDC, Legacy NDC, 1 package rows 20241027_9f002ad9-58e7-44f2-a980-3cc3f36bbd9b.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 65862-782-01 65862078201 100 TABLET in 1 BOTTLE (65862-782-01) 100 tablet 2016-07-05 0000-00-00 No No Current