Application 077880

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;ORAL	500MG	No	No
002	METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	TABLET;ORAL	850MG	No	No
003	METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	TABLET;ORAL	1GM	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	Approval date
A077880-001	METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	500MG	TABLET / ORAL	2006-06-05
A077880-002	METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	850MG	TABLET / ORAL	2006-06-05
A077880-003	METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	1GM	TABLET / ORAL	2006-06-05

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 4 · 123 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
2026-02-19 14:30 UTC	2026-02	A077880-001	METFORMIN HYDROCHLORIDE	500MG	TABLET / ORAL		2006-06-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077880-002	METFORMIN HYDROCHLORIDE	850MG	TABLET / ORAL		2006-06-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077880-003	METFORMIN HYDROCHLORIDE	1GM	TABLET / ORAL		2006-06-05	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077880-001	METFORMIN HYDROCHLORIDE	500MG	TABLET / ORAL		2006-06-05	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077880-002	METFORMIN HYDROCHLORIDE	850MG	TABLET / ORAL		2006-06-05	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077880-003	METFORMIN HYDROCHLORIDE	1GM	TABLET / ORAL		2006-06-05	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077880-001	METFORMIN HYDROCHLORIDE	500MG	TABLET / ORAL		2006-06-05	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077880-002	METFORMIN HYDROCHLORIDE	850MG	TABLET / ORAL		2006-06-05	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077880-003	METFORMIN HYDROCHLORIDE	1GM	TABLET / ORAL		2006-06-05	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077880-001	METFORMIN HYDROCHLORIDE	500MG	TABLET / ORAL		2006-06-05	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077880-002	METFORMIN HYDROCHLORIDE	850MG	TABLET / ORAL		2006-06-05	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077880-003	METFORMIN HYDROCHLORIDE	1GM	TABLET / ORAL		2006-06-05	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077880-001	METFORMIN HYDROCHLORIDE	500MG	TABLET / ORAL		2006-06-05	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077880-002	METFORMIN HYDROCHLORIDE	850MG	TABLET / ORAL		2006-06-05	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077880-003	METFORMIN HYDROCHLORIDE	1GM	TABLET / ORAL		2006-06-05	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077880-001	METFORMIN HYDROCHLORIDE	500MG	TABLET / ORAL		2006-06-05	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077880-002	METFORMIN HYDROCHLORIDE	850MG	TABLET / ORAL		2006-06-05	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077880-003	METFORMIN HYDROCHLORIDE	1GM	TABLET / ORAL		2006-06-05	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077880-001	METFORMIN HYDROCHLORIDE	500MG	TABLET / ORAL		2006-06-05	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077880-002	METFORMIN HYDROCHLORIDE	850MG	TABLET / ORAL		2006-06-05	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077880-003	METFORMIN HYDROCHLORIDE	1GM	TABLET / ORAL		2006-06-05	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077880-001	METFORMIN HYDROCHLORIDE	500MG	TABLET / ORAL		2006-06-05	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077880-002	METFORMIN HYDROCHLORIDE	850MG	TABLET / ORAL		2006-06-05	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077880-003	METFORMIN HYDROCHLORIDE	1GM	TABLET / ORAL		2006-06-05	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077880-001	METFORMIN HYDROCHLORIDE	500MG	TABLET / ORAL		2006-06-05	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077880-002	METFORMIN HYDROCHLORIDE	850MG	TABLET / ORAL		2006-06-05	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077880-003	METFORMIN HYDROCHLORIDE	1GM	TABLET / ORAL		2006-06-05	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077880-001	METFORMIN HYDROCHLORIDE	500MG	TABLET / ORAL		2006-06-05	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077880-002	METFORMIN HYDROCHLORIDE	850MG	TABLET / ORAL		2006-06-05	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077880-003	METFORMIN HYDROCHLORIDE	1GM	TABLET / ORAL		2006-06-05	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077880-001	METFORMIN HYDROCHLORIDE	500MG	TABLET / ORAL		2006-06-05	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077880-002	METFORMIN HYDROCHLORIDE	850MG	TABLET / ORAL		2006-06-05	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077880-003	METFORMIN HYDROCHLORIDE	1GM	TABLET / ORAL		2006-06-05	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077880-001	METFORMIN HYDROCHLORIDE	500MG	TABLET / ORAL	AB	2006-06-05	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077880-002	METFORMIN HYDROCHLORIDE	850MG	TABLET / ORAL	AB	2006-06-05	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077880-003	METFORMIN HYDROCHLORIDE	1GM	TABLET / ORAL	AB	2006-06-05	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077880-001	METFORMIN HYDROCHLORIDE	500MG	TABLET / ORAL	AB	2006-06-05	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077880-002	METFORMIN HYDROCHLORIDE	850MG	TABLET / ORAL	AB	2006-06-05	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077880-003	METFORMIN HYDROCHLORIDE	1GM	TABLET / ORAL	AB	2006-06-05	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A077880-001	METFORMIN HYDROCHLORIDE	500MG	TABLET / ORAL	AB	2006-06-05	`8072bd15b7f6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 87 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077880-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077880-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077880-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077880-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077880-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077880-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A077880-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A077880-002	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A077880-003	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077880-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077880-002	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077880-003	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A077880-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A077880-002	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A077880-003	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A077880-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A077880-002	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A077880-003	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A077880-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A077880-002	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A077880-003	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A077880-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A077880-002	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A077880-003	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A077880-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A077880-002	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A077880-003	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A077880-001	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A077880-002	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A077880-003	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A077880-001	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A077880-002	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A077880-003	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A077880-001	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A077880-002	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A077880-003	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A077880-001	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A077880-002	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A077880-003	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A077880-001	AB	1	`3f01610625f2…`

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
Metformin Hydrochloride	METFORMIN HYDROCHLORIDE	PD-Rx Pharmaceuticals, Inc.	0230a3c3-34cf-478b-88c3-4d96e5300018	2025-10-15	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077880 application number: ANDA077880 ndc (product): 43063-527
Metformin Hydrochloride	METFORMIN HYDROCHLORIDE	PD-Rx Pharmaceuticals, Inc.	c72cfd1a-dce9-43a3-88e2-3cf1d9078b52	2025-10-15	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077880 application number: ANDA077880 ndc (product): 43063-544
Metformin Hydrochloride	METFORMIN HYDROCHLORIDE	Amneal Pharmaceuticals of New York LLC	b090b18b-b53c-4c92-892f-d11551cfedc3	2023-12-14	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077880 application number: ANDA077880 ndc (product): 53746-218 ndc (product): 53746-220 ndc (product): 53746-219

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 51 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
42291-605	Metformin Hydrochloride	Metformin Hydrochloride	AvKARE, Inc.	ANDA	Current
42291-605	Metformin Hydrochloride	Metformin Hydrochloride	AvKARE, Inc.	ANDA	Current
42291-606	Metformin Hydrochloride	Metformin Hydrochloride	AvKARE, Inc.	ANDA	Current
42291-606	Metformin Hydrochloride	Metformin Hydrochloride	AvKARE, Inc.	ANDA	Current
42291-607	Metformin Hydrochloride	Metformin Hydrochloride	AvKARE, Inc.	ANDA	Current
42291-607	Metformin Hydrochloride	Metformin Hydrochloride	AvKARE, Inc.	ANDA	Current
43063-430	Metformin Hydrochloride	Metformin Hydrochloride	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-430	Metformin Hydrochloride	Metformin Hydrochloride	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-430	Metformin Hydrochloride	Metformin Hydrochloride	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-430	Metformin Hydrochloride	Metformin Hydrochloride	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-527	Metformin Hydrochloride	Metformin Hydrochloride	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-527	Metformin Hydrochloride	Metformin Hydrochloride	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-527	Metformin Hydrochloride	Metformin Hydrochloride	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-527	Metformin Hydrochloride	Metformin Hydrochloride	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-544	Metformin Hydrochloride	Metformin Hydrochloride	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-544	Metformin Hydrochloride	Metformin Hydrochloride	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-544	Metformin Hydrochloride	Metformin Hydrochloride	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-544	Metformin Hydrochloride	Metformin Hydrochloride	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43353-811	Metformin Hydrochloride	Metformin Hydrochloride	Aphena Pharma Solutions - Tennessee, LLC	ANDA	Current
43353-842	Metformin Hydrochloride	Metformin Hydrochloride	Aphena Pharma Solutions - Tennessee, LLC	ANDA	Current
43353-885	Metformin Hydrochloride	Metformin Hydrochloride	Aphena Pharma Solutions - Tennessee, LLC	ANDA	Current
53746-218	Metformin Hydrochloride	Metformin Hydrochloride	Amneal Pharmaceuticals of New York LLC	ANDA	Current
53746-218	Metformin Hydrochloride	Metformin Hydrochloride	Amneal Pharmaceuticals of New York LLC	ANDA	Current
53746-218	Metformin Hydrochloride	Metformin Hydrochloride	Amneal Pharmaceuticals of New York LLC	ANDA	Current
53746-219	Metformin Hydrochloride	Metformin Hydrochloride	Amneal Pharmaceuticals of New York LLC	ANDA	Current
53746-219	Metformin Hydrochloride	Metformin Hydrochloride	Amneal Pharmaceuticals of New York LLC	ANDA	Current
53746-219	Metformin Hydrochloride	Metformin Hydrochloride	Amneal Pharmaceuticals of New York LLC	ANDA	Current
53746-220	Metformin Hydrochloride	Metformin Hydrochloride	Amneal Pharmaceuticals of New York LLC	ANDA	Current
53746-220	Metformin Hydrochloride	Metformin Hydrochloride	Amneal Pharmaceuticals of New York LLC	ANDA	Current
53746-220	Metformin Hydrochloride	Metformin Hydrochloride	Amneal Pharmaceuticals of New York LLC	ANDA	Current
63739-640	METFORMIN HYDROCHLORIDE	Metformin Hydrochloride	McKesson Corporation	ANDA	Current
63739-640	METFORMIN HYDROCHLORIDE	Metformin Hydrochloride	McKesson Corporation dba SKY Packaging	ANDA	Current
63739-655	METFORMIN HYDROCHLORIDE	Metformin Hydrochloride	McKesson Corporation	ANDA	Current
63739-655	METFORMIN HYDROCHLORIDE	Metformin Hydrochloride	McKesson Corporation dba SKY Packaging	ANDA	Current
64205-218	Metformin Hydrochloride	Metformin Hydrochloride	ReadyMeds	ANDA	Current
64205-220	Metformin Hydrochloride	Metformin Hydrochloride	ReadyMeds	ANDA	Current
65162-174	Metformin Hydrochloride	Metformin	Amneal Pharmaceuticals	ANDA	Current
65162-175	Metformin Hydrochloride	Metformin	Amneal Pharmaceuticals	ANDA	Current
65162-177	Metformin Hydrochloride	Metformin	Amneal Pharmaceuticals	ANDA	Current
65162-218	Metformin Hydrochloride	Metformin Hydrochloride	Amneal Pharmaceuticals LLC	ANDA	Current
65162-218	Metformin Hydrochloride	Metformin Hydrochloride	Amneal Pharmaceuticals LLC	ANDA	Current
65162-218	Metformin Hydrochloride	Metformin Hydrochloride	Amneal Pharmaceuticals LLC	ANDA	Current
65162-218	Metformin Hydrochloride	Metformin Hydrochloride	Amneal Pharmaceuticals LLC	ANDA	Current
65162-219	Metformin Hydrochloride	Metformin Hydrochloride	Amneal Pharmaceuticals LLC	ANDA	Current
65162-219	Metformin Hydrochloride	Metformin Hydrochloride	Amneal Pharmaceuticals LLC	ANDA	Current
65162-219	Metformin Hydrochloride	Metformin Hydrochloride	Amneal Pharmaceuticals LLC	ANDA	Current
65162-219	Metformin Hydrochloride	Metformin Hydrochloride	Amneal Pharmaceuticals LLC	ANDA	Current
65162-220	Metformin Hydrochloride	Metformin Hydrochloride	Amneal Pharmaceuticals LLC	ANDA	Current
65162-220	Metformin Hydrochloride	Metformin Hydrochloride	Amneal Pharmaceuticals LLC	ANDA	Current
65162-220	Metformin Hydrochloride	Metformin Hydrochloride	Amneal Pharmaceuticals LLC	ANDA	Current
65162-220	Metformin Hydrochloride	Metformin Hydrochloride	Amneal Pharmaceuticals LLC	ANDA	Current