Methenamine Hippurate

Product NDC
0115-1754
11-digit product format
001151754
Labeler code
0115
Product ID
0115-1754_033c1926-f6c4-4259-aa36-7a7b8e88f6da
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Methenamine Hippurate
Dosage form
TABLET
Route
ORAL
Labeler
Amneal Pharmaceuticals of New York LLC
Application
ANDA076411
Marketing category
ANDA
Marketing start
2003-07-01
Marketing end
0000-00-00
Substance
METHENAMINE HIPPURATE
Active strength
1 g/1
NDC exclude flag
No
Listing certified through
2021-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct0115-1754IInactivated by FDA2026-08-17
excluded packagepackage0115-17540115-1754-01IInactivated by FDA2026-08-17

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 30 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage0115-1754-01d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage0115-1754-01f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage0115-1754-012ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage0115-1754-01a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage0115-1754-01cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage0115-1754-01cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage0115-1754-01302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage0115-1754-01ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage0115-1754-010efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage0115-1754-01ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage0115-1754-01367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage0115-1754-01557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproduct8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage0115-1754-018af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage0115-1754-01834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage0115-1754-011332a3947898…d4bfe170f9cd…

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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A076411-001METHENAMINE HIPPURATEMETHENAMINE HIPPURATE1GMTABLET / ORAL2003-06-20

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A076411-001METHENAMINE HIPPURATE1GMTABLET / ORAL2003-06-20caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A076411-001METHENAMINE HIPPURATE1GMTABLET / ORAL2003-06-20011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076411-001METHENAMINE HIPPURATE1GMTABLET / ORAL2003-06-2031067a03dcf5…
2025-08-23 18:47 UTC2025-08A076411-001METHENAMINE HIPPURATE1GMTABLET / ORAL2003-06-206a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076411-001METHENAMINE HIPPURATE1GMTABLET / ORAL2003-06-20fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076411-001METHENAMINE HIPPURATE1GMTABLET / ORAL2003-06-20b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076411-001METHENAMINE HIPPURATE1GMTABLET / ORAL2003-06-2003ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076411-001METHENAMINE HIPPURATE1GMTABLET / ORAL2003-06-202680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076411-001METHENAMINE HIPPURATE1GMTABLET / ORAL2003-06-205bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076411-001METHENAMINE HIPPURATE1GMTABLET / ORAL2003-06-20d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A076411-001METHENAMINE HIPPURATE1GMTABLET / ORAL2003-06-20d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A076411-001METHENAMINE HIPPURATE1GMTABLET / ORAL2003-06-2079d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A076411-001METHENAMINE HIPPURATE1GMTABLET / ORAL2003-06-20301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A076411-001METHENAMINE HIPPURATE1GMTABLET / ORAL2003-06-201e350fbaab3a…
2024-05-31 18:47 UTC2024-05A076411-001METHENAMINE HIPPURATE1GMTABLET / ORAL2003-06-208072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A076411-001METHENAMINE HIPPURATE1GMTABLET / ORAL2003-06-205c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A076411-001METHENAMINE HIPPURATE1GMTABLET / ORAL2003-06-205d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A076411-001METHENAMINE HIPPURATE1GMTABLET / ORAL2003-06-204b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A076411-001METHENAMINE HIPPURATE1GMTABLET / ORALAB2003-06-2074a2ff9319b5…
2022-03-09 01:35 UTC2022-03A076411-001METHENAMINE HIPPURATE1GMTABLET / ORAL2003-06-20bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A076411-001METHENAMINE HIPPURATE1GMTABLET / ORAL2003-06-20782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A076411-001METHENAMINE HIPPURATE1GMTABLET / ORAL2003-06-2087673890dc5c…
2021-03-12 10:30 UTC2021-03A076411-001METHENAMINE HIPPURATE1GMTABLET / ORAL2003-06-205aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A076411-001METHENAMINE HIPPURATE1GMTABLET / ORAL2003-06-208869cabd3fbd…
2020-11-12 02:37 UTC2020-11A076411-001METHENAMINE HIPPURATE1GMTABLET / ORAL2003-06-20c0c555d07b60…
2019-12-14 00:12 UTC2019-12A076411-001METHENAMINE HIPPURATE1GMTABLET / ORALAB2003-06-203f01610625f2…
2019-09-15 20:21 UTC2019-09A076411-001METHENAMINE HIPPURATE1GMTABLET / ORALAB2003-06-20b00525d2431f…
2019-07-19 19:46 UTC2019-07A076411-001METHENAMINE HIPPURATE1GMTABLET / ORALAB2003-06-20ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A076411-001METHENAMINE HIPPURATE1GMTABLET / ORAL2003-06-206a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A076411-001METHENAMINE HIPPURATE1GMTABLET / ORAL2003-06-201c564ffb4f44…
2023-12-20 04:57 UTC2023-12A076411-001METHENAMINE HIPPURATE1GMTABLET / ORAL2003-06-20ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A076411-001METHENAMINE HIPPURATE1GMTABLET / ORAL2003-06-20a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A076411-001METHENAMINE HIPPURATE1GMTABLET / ORAL2003-06-209b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A076411-001METHENAMINE HIPPURATE1GMTABLET / ORAL2003-06-20a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A076411-001METHENAMINE HIPPURATE1GMTABLET / ORAL2003-06-203f0d92c62455…
2023-05-13 08:27 UTC2023-05A076411-001METHENAMINE HIPPURATE1GMTABLET / ORAL2003-06-20053a50430f4f…
2023-01-26 05:58 UTC2023-01A076411-001METHENAMINE HIPPURATE1GMTABLET / ORAL2003-06-203bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A076411-001METHENAMINE HIPPURATE1GMTABLET / ORAL2003-06-203a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A076411-001METHENAMINE HIPPURATE1GMTABLET / ORAL2003-06-20f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A076411-001METHENAMINE HIPPURATE1GMTABLET / ORAL2003-06-20e64feba35796…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2019-12-13 00:20 UTC2019-12A076411-001AB174a2ff9319b5…
2019-12-14 00:12 UTC2019-12A076411-001AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A076411-001AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A076411-001AB1ea99ee380514…

DailyMed Product Concepts#

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
0115-1754-012023-01-30C16284748780-1f386c649-cddd-0266-e053-dadaa90a7c1aMETHENAMINE HIPPURATE TABLETS, USP 1 g Rx only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0115-1754-01Methenamine Hippurate100 in 1 BOTTLE, PLASTICTABLET1003

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0115-1754METHENAMINE HIPPURATE TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK LLC]3Legacy NDC, 1 package rows20201231_0da9c9c7-c101-41c2-9265-8618e65de762.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
992150methenamine hippurate 1 GM Oral TabletPSN0da9c9c7-c101-41c2-9265-8618e65de7623
992150methenamine hippurate 1000 MG Oral TabletSCD0da9c9c7-c101-41c2-9265-8618e65de7623
992150methenamine hippurate 1 GM Oral TabletSY0da9c9c7-c101-41c2-9265-8618e65de7623

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0115-1754-0100115175401100 TABLET in 1 BOTTLE, PLASTIC (0115-1754-01) 100 tablet2003-07-010000-00-00NoNoCurrent