Methenamine Hippurate

Product NDC: 42571-332
Requested package NDC: 42571-332-01
11-digit product format: 425710332
Labeler code: 42571
Product ID: 42571-332_350168e0-c68a-6cfa-e063-6294a90ab7fe
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Methenamine Hippurate
Dosage form: TABLET
Route: ORAL
Labeler: Micro Labs Limited
Application: ANDA212172
Marketing category: ANDA
Marketing start: 2019-08-15
Substance: METHENAMINE HIPPURATE
Active strength: 1000 mg/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 1.

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
A212172-001	METHENAMINE HIPPURATE	METHENAMINE HIPPURATE	1GM	TABLET / ORAL	AB		2019-08-01

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A212172-001	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	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A212172-001	METHENAMINE HIPPURATE	1GM	TABLET / ORAL	AB	2019-08-01	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212172-001	METHENAMINE HIPPURATE	1GM	TABLET / ORAL	AB	2019-08-01	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A212172-001	METHENAMINE HIPPURATE	1GM	TABLET / ORAL	AB	2019-08-01	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212172-001	METHENAMINE HIPPURATE	1GM	TABLET / ORAL	AB	2019-08-01	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212172-001	METHENAMINE HIPPURATE	1GM	TABLET / ORAL	AB	2019-08-01	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212172-001	METHENAMINE HIPPURATE	1GM	TABLET / ORAL	AB	2019-08-01	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212172-001	METHENAMINE HIPPURATE	1GM	TABLET / ORAL	AB	2019-08-01	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212172-001	METHENAMINE HIPPURATE	1GM	TABLET / ORAL	AB	2019-08-01	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212172-001	METHENAMINE HIPPURATE	1GM	TABLET / ORAL	AB	2019-08-01	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A212172-001	METHENAMINE HIPPURATE	1GM	TABLET / ORAL	AB	2019-08-01	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A212172-001	METHENAMINE HIPPURATE	1GM	TABLET / ORAL	AB	2019-08-01	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A212172-001	METHENAMINE HIPPURATE	1GM	TABLET / ORAL	AB	2019-08-01	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A212172-001	METHENAMINE HIPPURATE	1GM	TABLET / ORAL	AB	2019-08-01	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A212172-001	METHENAMINE HIPPURATE	1GM	TABLET / ORAL	AB	2019-08-01	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A212172-001	METHENAMINE HIPPURATE	1GM	TABLET / ORAL	AB	2019-08-01	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A212172-001	METHENAMINE HIPPURATE	1GM	TABLET / ORAL	AB	2019-08-01	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A212172-001	METHENAMINE HIPPURATE	1GM	TABLET / ORAL	AB	2019-08-01	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A212172-001	METHENAMINE HIPPURATE	1GM	TABLET / ORAL	AB	2019-08-01	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A212172-001	METHENAMINE HIPPURATE	1GM	TABLET / ORAL	AB	2019-08-01	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A212172-001	METHENAMINE HIPPURATE	1GM	TABLET / ORAL	AB	2019-08-01	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A212172-001	METHENAMINE HIPPURATE	1GM	TABLET / ORAL	AB	2019-08-01	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A212172-001	METHENAMINE HIPPURATE	1GM	TABLET / ORAL	AB	2019-08-01	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A212172-001	METHENAMINE HIPPURATE	1GM	TABLET / ORAL	AB	2019-08-01	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A212172-001	METHENAMINE HIPPURATE	1GM	TABLET / ORAL	AB	2019-08-01	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A212172-001	METHENAMINE HIPPURATE	1GM	TABLET / ORAL	AB	2019-08-01	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A212172-001	METHENAMINE HIPPURATE	1GM	TABLET / ORAL	AB	2019-08-01	`b00525d2431f…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A212172-001	METHENAMINE HIPPURATE	1GM	TABLET / ORAL	AB	2019-08-01	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A212172-001	METHENAMINE HIPPURATE	1GM	TABLET / ORAL	AB	2019-08-01	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A212172-001	METHENAMINE HIPPURATE	1GM	TABLET / ORAL	AB	2019-08-01	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A212172-001	METHENAMINE HIPPURATE	1GM	TABLET / ORAL	AB	2019-08-01	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A212172-001	METHENAMINE HIPPURATE	1GM	TABLET / ORAL	AB	2019-08-01	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A212172-001	METHENAMINE HIPPURATE	1GM	TABLET / ORAL	AB	2019-08-01	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A212172-001	METHENAMINE HIPPURATE	1GM	TABLET / ORAL	AB	2019-08-01	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A212172-001	METHENAMINE HIPPURATE	1GM	TABLET / ORAL	AB	2019-08-01	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A212172-001	METHENAMINE HIPPURATE	1GM	TABLET / ORAL	AB	2019-08-01	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A212172-001	METHENAMINE HIPPURATE	1GM	TABLET / ORAL	AB	2019-08-01	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A212172-001	METHENAMINE HIPPURATE	1GM	TABLET / ORAL	AB	2019-08-01	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A212172-001	METHENAMINE HIPPURATE	1GM	TABLET / ORAL	AB	2019-08-01	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A212172-001	METHENAMINE HIPPURATE	1GM	TABLET / ORAL	AB	2019-08-01	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A212172-001	METHENAMINE HIPPURATE	1GM	TABLET / ORAL	AB	2019-08-01	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A212172-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212172-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A212172-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212172-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212172-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212172-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212172-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212172-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212172-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A212172-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A212172-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A212172-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A212172-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A212172-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A212172-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A212172-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A212172-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A212172-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A212172-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A212172-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A212172-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A212172-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A212172-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A212172-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A212172-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A212172-001	AB	1	`b00525d2431f…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A212172-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A212172-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A212172-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A212172-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A212172-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A212172-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A212172-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A212172-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A212172-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A212172-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A212172-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A212172-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A212172-001	AB	1	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A212172-001	AB	1	`a50c72e98297…`

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	1000 mg/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.

Identifier, FDA.report destination table
Identifier	FDA.report destination
e07ddd63-4725-49db-bec2-bd4f966c6e48	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
260b0da6-d3d7-262f-a60f-d4b36d5f1b4d	Product name	6	20251210

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
42571-332-01	Methenamine Hippurate	100 in 1 BOTTLE	TABLET	100		4
42571-332-23	Methenamine Hippurate	80 in 1 CARTON	TABLET	80		4

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
42571-332-01	EA - Each	42571-332	145f1cbf-f9f3-41d0-bea1-aea4a1c752bc	1	2019-09-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
42571-332	METHENAMINE HIPPURATE (METHENAMINE HIPPURATE) TABLET [MICRO LABS LIMITED]	4	Current NDC, Legacy NDC, 2 package rows	20250515_e07ddd63-4725-49db-bec2-bd4f966c6e48.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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Methenamine Hippurate	METHENAMINE HIPPURATE	Micro Labs Limited	e07ddd63-4725-49db-bec2-bd4f966c6e48	2025-05-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212172 application number: ANDA212172 ndc (package): 42571-332-01 ndc (product): 42571-332 ndc11 (package): 42571033201
Methenamine Hippurate	METHENAMINE HIPPURATE	American Health Packaging	fcb9b18a-6e6d-42c7-bc85-c61cb1c4a3be	2024-09-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212172 application number: ANDA212172
Methenamine Hippurate	METHENAMINE HIPPURATE	AvPAK	b581b655-62a4-2aa9-e053-2a95a90aa823	2024-01-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212172 application number: ANDA212172

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
M329791L57	METHENAMINE HIPPURATE	5714-73-8	METHENAMINE HIPPURATE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
992150	methenamine hippurate 1 GM Oral Tablet	PSN	e07ddd63-4725-49db-bec2-bd4f966c6e48	4
992150	methenamine hippurate 1000 MG Oral Tablet	SCD	e07ddd63-4725-49db-bec2-bd4f966c6e48	4
992150	methenamine hippurate 1 GM Oral Tablet	SY	e07ddd63-4725-49db-bec2-bd4f966c6e48	4
992150	methenamine hippurate 1 GM Oral Tablet	PSN	b581b655-62a4-2aa9-e053-2a95a90aa823	3
992150	methenamine hippurate 1000 MG Oral Tablet	SCD	b581b655-62a4-2aa9-e053-2a95a90aa823	3
992150	methenamine hippurate 1 GM Oral Tablet	SY	b581b655-62a4-2aa9-e053-2a95a90aa823	3
992150	methenamine hippurate 1 GM Oral Tablet	PSN	fcb9b18a-6e6d-42c7-bc85-c61cb1c4a3be	2
992150	methenamine hippurate 1000 MG Oral Tablet	SCD	fcb9b18a-6e6d-42c7-bc85-c61cb1c4a3be	2
992150	methenamine hippurate 1 GM Oral Tablet	SY	fcb9b18a-6e6d-42c7-bc85-c61cb1c4a3be	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
42571-332-01	42571033201	100 TABLET in 1 BOTTLE (42571-332-01)	100 tablet	2019-08-15	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Methenamine Hippurate	Micro Labs Limited	2025-05-13	HUMAN PRESCRIPTION DRUG LABEL	4
Methenamine Hippurate Tablets, USP Rx Only 8469421/0622F	American Health Packaging	2024-09-24	HUMAN PRESCRIPTION DRUG LABEL	2
Methenamine Hippurate	AvPAK	2024-01-09	HUMAN PRESCRIPTION DRUG LABEL	3