Application 212172

Type: ANDA
Sponsor: MICRO LABS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	METHENAMINE HIPPURATE	METHENAMINE HIPPURATE	TABLET;ORAL	1GM	No	No

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
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.

Product history page 1 of 2 · 41 observed 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
2026-08-18 06:07:40	2026-07	A212172-001	METHENAMINE HIPPURATE	1GM	TABLET / ORAL	AB	2019-08-01	`caaa826d4ba7…`
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…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A212172-001	AB	1	`caaa826d4ba7…`
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…`

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 (product): 42571-332
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 ndc (product): 60687-694
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 ndc (product): 50268-549

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 5 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
42571-332	Methenamine Hippurate	Methenamine Hippurate	Micro Labs Limited	ANDA	Current
42571-332	Methenamine Hippurate	Methenamine Hippurate	Micro Labs Limited	ANDA	Current
50268-549	Methenamine Hippurate	Methenamine Hippurate	AvPAK	ANDA	Current
50268-549	Methenamine Hippurate	Methenamine Hippurate	AvPAK	ANDA	Current
60687-694	Methenamine Hippurate	Methenamine Hippurate	American Health Packaging	ANDA	Current