METHENAMINE HIPPURATE

Product NDC
51407-880
11-digit product format
514070880
Labeler code
51407
Product ID
51407-880_1319ee69-8b45-5815-e063-6294a90a5ad5
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
methenamine hippurate
Dosage form
TABLET
Route
ORAL
Labeler
Golden State Medical Supply, Inc.
Application
ANDA210068
Marketing category
ANDA
Marketing start
2020-11-27
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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A210068-001METHENAMINE HIPPURATEMETHENAMINE HIPPURATE1GMTABLET / ORALAB2020-11-27

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-productTE code
A210068-001AB

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A210068-001METHENAMINE HIPPURATE1GMTABLET / ORALAB2020-11-27caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A210068-001METHENAMINE HIPPURATE1GMTABLET / ORALAB2020-11-27011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A210068-001METHENAMINE HIPPURATE1GMTABLET / ORALAB2020-11-2731067a03dcf5…
2025-08-23 18:47 UTC2025-08A210068-001METHENAMINE HIPPURATE1GMTABLET / ORALAB2020-11-276a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A210068-001METHENAMINE HIPPURATE1GMTABLET / ORALAB2020-11-27fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A210068-001METHENAMINE HIPPURATE1GMTABLET / ORALAB2020-11-27b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A210068-001METHENAMINE HIPPURATE1GMTABLET / ORALAB2020-11-2703ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A210068-001METHENAMINE HIPPURATE1GMTABLET / ORALAB2020-11-272680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A210068-001METHENAMINE HIPPURATE1GMTABLET / ORALAB2020-11-275bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A210068-001METHENAMINE HIPPURATE1GMTABLET / ORALAB2020-11-27d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A210068-001METHENAMINE HIPPURATE1GMTABLET / ORALAB2020-11-27d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A210068-001METHENAMINE HIPPURATE1GMTABLET / ORALAB2020-11-2779d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A210068-001METHENAMINE HIPPURATE1GMTABLET / ORALAB2020-11-27301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A210068-001METHENAMINE HIPPURATE1GMTABLET / ORALAB2020-11-271e350fbaab3a…
2024-05-31 18:47 UTC2024-05A210068-001METHENAMINE HIPPURATE1GMTABLET / ORALAB2020-11-278072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A210068-001METHENAMINE HIPPURATE1GMTABLET / ORALAB2020-11-275c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A210068-001METHENAMINE HIPPURATE1GMTABLET / ORALAB2020-11-275d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A210068-001METHENAMINE HIPPURATE1GMTABLET / ORALAB2020-11-274b0b4de00fa7…
2022-03-09 01:35 UTC2022-03A210068-001METHENAMINE HIPPURATE1GMTABLET / ORALAB2020-11-27bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A210068-001METHENAMINE HIPPURATE1GMTABLET / ORALAB2020-11-27782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A210068-001METHENAMINE HIPPURATE1GMTABLET / ORALAB2020-11-2787673890dc5c…
2021-03-12 10:30 UTC2021-03A210068-001METHENAMINE HIPPURATE1GMTABLET / ORALAB2020-11-275aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A210068-001METHENAMINE HIPPURATE1GMTABLET / ORALAB2020-11-278869cabd3fbd…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A210068-001METHENAMINE HIPPURATE1GMTABLET / ORALAB2020-11-276a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A210068-001METHENAMINE HIPPURATE1GMTABLET / ORALAB2020-11-271c564ffb4f44…
2023-12-20 04:57 UTC2023-12A210068-001METHENAMINE HIPPURATE1GMTABLET / ORALAB2020-11-27ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A210068-001METHENAMINE HIPPURATE1GMTABLET / ORALAB2020-11-27a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A210068-001METHENAMINE HIPPURATE1GMTABLET / ORALAB2020-11-279b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A210068-001METHENAMINE HIPPURATE1GMTABLET / ORALAB2020-11-27a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A210068-001METHENAMINE HIPPURATE1GMTABLET / ORALAB2020-11-273f0d92c62455…
2023-05-13 08:27 UTC2023-05A210068-001METHENAMINE HIPPURATE1GMTABLET / ORALAB2020-11-27053a50430f4f…
2023-01-26 05:58 UTC2023-01A210068-001METHENAMINE HIPPURATE1GMTABLET / ORALAB2020-11-273bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A210068-001METHENAMINE HIPPURATE1GMTABLET / ORALAB2020-11-273a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A210068-001METHENAMINE HIPPURATE1GMTABLET / ORALAB2020-11-27f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A210068-001METHENAMINE HIPPURATE1GMTABLET / ORALAB2020-11-27e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A210068-001METHENAMINE HIPPURATE1GMTABLET / ORALAB2020-11-27cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A210068-001METHENAMINE HIPPURATE1GMTABLET / ORALAB2020-11-27a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A210068-001AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A210068-001AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A210068-001AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A210068-001AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A210068-001AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A210068-001AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A210068-001AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A210068-001AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A210068-001AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A210068-001AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A210068-001AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A210068-001AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A210068-001AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A210068-001AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A210068-001AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A210068-001AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A210068-001AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A210068-001AB14b0b4de00fa7…
2022-03-09 01:35 UTC2022-03A210068-001AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A210068-001AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A210068-001AB187673890dc5c…
2021-03-12 10:30 UTC2021-03A210068-001AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A210068-001AB18869cabd3fbd…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A210068-001AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A210068-001AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A210068-001AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A210068-001AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A210068-001AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A210068-001AB1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A210068-001AB13f0d92c62455…
2023-05-13 08:27 UTC2023-05A210068-001AB1053a50430f4f…
2023-01-26 05:58 UTC2023-01A210068-001AB13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A210068-001AB13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A210068-001AB1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A210068-001AB1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A210068-001AB1cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A210068-001AB1a50c72e98297…

Additional Listing Data#

Finished product
Yes
Brand name base
METHENAMINE HIPPURATE
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
METHENAMINE HIPPURATE1 g/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
M329791L57Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
992150Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
131a1322-0182-7a4e-e063-6394a90accbfAvailable on FDA.report

DailyMed Product Concepts#

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51407-880-01METHENAMINE HIPPURATE100 in 1 BOTTLETABLET1001

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
51407-880-01EA - Each51407-880a33d38f0-36e2-44ad-a475-351d4fa52a2012024-04-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51407-880METHENAMINE HIPPURATE TABLET [GOLDEN STATE MEDICAL SUPPLY, INC.]1Current NDC, 1 package rows20240308_131a1322-0182-7a4e-e063-6394a90accbf.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.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
METHENAMINE HIPPURATEMETHENAMINE HIPPURATEGolden State Medical Supply, Inc.131a1322-0182-7a4e-e063-6394a90accbf2024-03-07Warnings, Adverse reactionsExact identifier
application applno (ANDA): 210068
application number: ANDA210068
ndc (product): 51407-880
METHENAMINE HIPPURATEMETHENAMINE HIPPURATEIngenus Pharmaceuticals, LLC4412d667-63f6-427e-a5c6-376a0e1e172d2023-05-23Warnings, Adverse reactionsExact identifier
application applno (ANDA): 210068
application number: ANDA210068

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
992150methenamine hippurate 1 GM Oral TabletPSN131a1322-0182-7a4e-e063-6394a90accbf1
992150methenamine hippurate 1000 MG Oral TabletSCD131a1322-0182-7a4e-e063-6394a90accbf1
992150methenamine hippurate 1 GM Oral TabletSY131a1322-0182-7a4e-e063-6394a90accbf1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
51407-880-0151407088001100 TABLET in 1 BOTTLE (51407-880-01) 100 tablet2024-01-30NoNoCurrent