Application 078596

Type: ANDA
Sponsor: AMNEAL PHARMS NY

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	TABLET, EXTENDED RELEASE;ORAL	500MG	No	No
002	METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	TABLET, EXTENDED RELEASE;ORAL	750MG	No	Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A078596-001	METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL			2008-01-03
A078596-002	METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	750MG	TABLET, EXTENDED RELEASE / ORAL			2008-01-03

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 3 · 84 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	A078596-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL			2008-01-03	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078596-002	METFORMIN HYDROCHLORIDE	750MG	TABLET, EXTENDED RELEASE / ORAL			2008-01-03	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A078596-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB1		2008-01-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078596-002	METFORMIN HYDROCHLORIDE	750MG	TABLET, EXTENDED RELEASE / ORAL	AB		2008-01-03	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078596-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB1		2008-01-03	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078596-002	METFORMIN HYDROCHLORIDE	750MG	TABLET, EXTENDED RELEASE / ORAL	AB		2008-01-03	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078596-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB1		2008-01-03	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078596-002	METFORMIN HYDROCHLORIDE	750MG	TABLET, EXTENDED RELEASE / ORAL	AB		2008-01-03	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078596-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB1		2008-01-03	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078596-002	METFORMIN HYDROCHLORIDE	750MG	TABLET, EXTENDED RELEASE / ORAL	AB		2008-01-03	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078596-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB1		2008-01-03	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078596-002	METFORMIN HYDROCHLORIDE	750MG	TABLET, EXTENDED RELEASE / ORAL	AB		2008-01-03	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078596-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB1		2008-01-03	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078596-002	METFORMIN HYDROCHLORIDE	750MG	TABLET, EXTENDED RELEASE / ORAL	AB		2008-01-03	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078596-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB1		2008-01-03	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078596-002	METFORMIN HYDROCHLORIDE	750MG	TABLET, EXTENDED RELEASE / ORAL	AB		2008-01-03	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078596-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB1		2008-01-03	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078596-002	METFORMIN HYDROCHLORIDE	750MG	TABLET, EXTENDED RELEASE / ORAL	AB		2008-01-03	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078596-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB1		2008-01-03	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078596-002	METFORMIN HYDROCHLORIDE	750MG	TABLET, EXTENDED RELEASE / ORAL	AB		2008-01-03	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078596-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB1		2008-01-03	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078596-002	METFORMIN HYDROCHLORIDE	750MG	TABLET, EXTENDED RELEASE / ORAL	AB		2008-01-03	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078596-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB1		2008-01-03	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078596-002	METFORMIN HYDROCHLORIDE	750MG	TABLET, EXTENDED RELEASE / ORAL	AB		2008-01-03	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078596-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB1		2008-01-03	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078596-002	METFORMIN HYDROCHLORIDE	750MG	TABLET, EXTENDED RELEASE / ORAL	AB		2008-01-03	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078596-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB1		2008-01-03	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078596-002	METFORMIN HYDROCHLORIDE	750MG	TABLET, EXTENDED RELEASE / ORAL	AB		2008-01-03	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A078596-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB1		2008-01-03	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A078596-002	METFORMIN HYDROCHLORIDE	750MG	TABLET, EXTENDED RELEASE / ORAL	AB		2008-01-03	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078596-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB1		2008-01-03	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078596-002	METFORMIN HYDROCHLORIDE	750MG	TABLET, EXTENDED RELEASE / ORAL	AB		2008-01-03	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A078596-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB1		2008-01-03	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A078596-002	METFORMIN HYDROCHLORIDE	750MG	TABLET, EXTENDED RELEASE / ORAL	AB		2008-01-03	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A078596-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB1		2008-01-03	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A078596-002	METFORMIN HYDROCHLORIDE	750MG	TABLET, EXTENDED RELEASE / ORAL	AB		2008-01-03	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A078596-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB1		2008-01-03	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A078596-002	METFORMIN HYDROCHLORIDE	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2008-01-03	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A078596-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL	BX		2008-01-03	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A078596-002	METFORMIN HYDROCHLORIDE	750MG	TABLET, EXTENDED RELEASE / ORAL	BX		2008-01-03	`bb7c543d1eb4…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 80 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A078596-001	AB1	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078596-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078596-001	AB1	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078596-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078596-001	AB1	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078596-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078596-001	AB1	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078596-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078596-001	AB1	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078596-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078596-001	AB1	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078596-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078596-001	AB1	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078596-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078596-001	AB1	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078596-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078596-001	AB1	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078596-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078596-001	AB1	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078596-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078596-001	AB1	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078596-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078596-001	AB1	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078596-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078596-001	AB1	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078596-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A078596-001	AB1	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A078596-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078596-001	AB1	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078596-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A078596-001	AB1	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A078596-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A078596-001	AB1	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A078596-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A078596-001	AB1	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A078596-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A078596-001	BX	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A078596-002	BX	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A078596-001	BX	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A078596-002	BX	1	`782e0a99824c…`

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 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Metformin Hydrochloride	METFORMIN HYDROCHLORIDE	Amneal Pharmaceuticals NY LLC	dc65065b-cba0-46d7-8fb5-3368f3210b4d	2026-02-20	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078596 application number: ANDA078596 ndc (product): 69238-2126 ndc (product): 69238-2125
Metformin Hydrochloride	METFORMIN HYDROCHLORIDE	Aphena Pharma Solutions - Tennessee, LLC	38687872-ca68-4965-b317-637c25ba041e	2023-11-09	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078596 application number: ANDA078596
Metformin Hydrochloride	METFORMIN HYDROCHLORIDE	Aphena Pharma Solutions - Tennessee, LLC	6b8824c0-ece0-4b15-ba71-e893d6d2bfdf	2022-07-15	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078596 application number: ANDA078596 ndc (product): 71610-652
Metformin Hydrochloride	METFORMIN HYDROCHLORIDE	Amneal Pharmaceuticals LLC	c01a79e0-f2b7-4d99-857e-bda7f24fe319	2018-08-30	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078596 application number: ANDA078596 ndc (product): 65162-179 ndc (product): 65162-178

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 47 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
10544-535	Metformin Hydrochloride	Metformin Hydrochloride	Blenheim Pharmacal, Inc.	ANDA	Current
33261-372	Metformin Hydrochloride	Metformin Hydrochloride	Aidarex Pharmaceuticals LLC	ANDA	Current
42291-497	Metformin Hydrochloride	Metformin Hydrochloride	AvKARE	ANDA	Current
42291-497	Metformin Hydrochloride	Metformin Hydrochloride	AvKARE	ANDA	Current
42291-498	Metformin Hydrochloride	Metformin Hydrochloride	AvKARE	ANDA	Current
42291-610	Metformin Hydrochloride	Metformin Hydrochloride	AvKARE, Inc.	ANDA	Current
42291-610	Metformin Hydrochloride	Metformin Hydrochloride	AvKARE, Inc.	ANDA	Current
42291-610	Metformin Hydrochloride	Metformin Hydrochloride	AvKARE, Inc.	ANDA	Current
42291-610	Metformin Hydrochloride	Metformin Hydrochloride	AvKARE, Inc.	ANDA	Current
42291-610	Metformin Hydrochloride	Metformin Hydrochloride	AvKARE	ANDA	Current
42291-610	Metformin Hydrochloride	Metformin Hydrochloride	AvKARE	ANDA	Current
42291-611	Metformin Hydrochloride	Metformin Hydrochloride	AvKARE, Inc.	ANDA	Current
42291-611	Metformin Hydrochloride	Metformin Hydrochloride	AvKARE, Inc.	ANDA	Current
42291-611	Metformin Hydrochloride	Metformin Hydrochloride	AvKARE, Inc.	ANDA	Current
42291-611	Metformin Hydrochloride	Metformin Hydrochloride	AvKARE, Inc.	ANDA	Current
42291-611	Metformin Hydrochloride	Metformin Hydrochloride	AvKARE	ANDA	Current
43063-428	Metformin Hydrochloride	Metformin Hydrochloride	PD-Rx Pharmaceuticals, In	ANDA	Current
43063-428	Metformin Hydrochloride	Metformin Hydrochloride	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-428	Metformin Hydrochloride	Metformin Hydrochloride	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
50268-531	Metformin Hydrochloride	Metformin Hydrochloride	AvPAK	ANDA	Current
50268-531	Metformin Hydrochloride	Metformin Hydrochloride	AvPAK	ANDA	Current
50268-531	Metformin Hydrochloride	Metformin Hydrochloride	AvPAK	ANDA	Current
50268-532	Metformin Hydrochloride	Metformin Hydrochloride	AvPAK	ANDA	Current
53746-178	Metformin Hydrochloride	Metformin Hydrochloride	Amneal Pharmaceuticals of New York LLC	ANDA	Current
53746-178	Metformin Hydrochloride	Metformin Hydrochloride	Amneal Pharmaceuticals of New York LLC	ANDA	Current
53746-178	Metformin Hydrochloride	Metformin Hydrochloride	Amneal Pharmaceuticals of New York LLC	ANDA	Current
53746-179	Metformin Hydrochloride	Metformin Hydrochloride	Amneal Pharmaceuticals of New York LLC	ANDA	Current
53746-179	Metformin Hydrochloride	Metformin Hydrochloride	Amneal Pharmaceuticals of New York LLC	ANDA	Current
53746-179	Metformin Hydrochloride	Metformin Hydrochloride	Amneal Pharmaceuticals of New York LLC	ANDA	Current
65162-178	Metformin Hydrochloride	Metformin Hydrochloride	Amneal Pharmaceuticals LLC	ANDA	Current
65162-178	Metformin Hydrochloride	Metformin Hydrochloride	Amneal Pharmaceuticals LLC	ANDA	Current
65162-178	Metformin Hydrochloride	Metformin Hydrochloride	Amneal Pharmaceuticals LLC	ANDA	Current
65162-178	Metformin Hydrochloride	Metformin Hydrochloride	Amneal Pharmaceuticals LLC	ANDA	Current
65162-178	Metformin Hydrochloride	Metformin Hydrochloride	Amneal Pharmaceuticals LLC	ANDA	Current
65162-179	Metformin Hydrochloride	Metformin Hydrochloride	Amneal Pharmaceuticals LLC	ANDA	Current
65162-179	Metformin Hydrochloride	Metformin Hydrochloride	Amneal Pharmaceuticals LLC	ANDA	Current
65162-179	Metformin Hydrochloride	Metformin Hydrochloride	Amneal Pharmaceuticals LLC	ANDA	Current
65162-179	Metformin Hydrochloride	Metformin Hydrochloride	Amneal Pharmaceuticals LLC	ANDA	Current
65162-179	Metformin Hydrochloride	Metformin Hydrochloride	Amneal Pharmaceuticals LLC	ANDA	Current
68084-072	Metformin Hydrochloride	Metformin Hydrochloride	American Health Packaging	ANDA	Current
68151-4218	Metformin Hydrochloride	Metformin Hydrochloride	Carilion Materials Management	ANDA	Current
69238-2125	Metformin Hydrochloride	Metformin Hydrochloride	Amneal Pharmaceuticals NY LLC	ANDA	Current
69238-2126	Metformin Hydrochloride	Metformin Hydrochloride	Amneal Pharmaceuticals NY LLC	ANDA	Current
71610-020	Metformin Hydrochloride	Metformin Hydrochloride	Aphena Pharma Solutions - Tennessee, LLC	ANDA	Current
71610-020	Metformin Hydrochloride	Metformin Hydrochloride	Aphena Pharma Solutions - Tennessee, LLC	ANDA	Current
71610-304	Metformin Hydrochloride	Metformin Hydrochloride	Aphena Pharma Solutions - Tennessee, LLC	ANDA	Current
71610-652	Metformin Hydrochloride	Metformin Hydrochloride	Aphena Pharma Solutions - Tennessee, LLC	ANDA	Current