Application 212677

Type: ANDA
Sponsor: VISTAPHARM

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	SOLUTION;ORAL	500MG/5ML	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

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
A212677-001	METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	500MG/5ML	SOLUTION / ORAL	AB		2022-08-19

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A212677-001	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
2026-10-15 13:18:30	2026-09	A212677-001	METFORMIN HYDROCHLORIDE	500MG/5ML	SOLUTION / ORAL	AB	2022-08-19	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A212677-001	METFORMIN HYDROCHLORIDE	500MG/5ML	SOLUTION / ORAL	AB	2022-08-19	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A212677-001	METFORMIN HYDROCHLORIDE	500MG/5ML	SOLUTION / ORAL	AB	2022-08-19	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A212677-001	METFORMIN HYDROCHLORIDE	500MG/5ML	SOLUTION / ORAL	AB	2022-08-19	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212677-001	METFORMIN HYDROCHLORIDE	500MG/5ML	SOLUTION / ORAL	AB	2022-08-19	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A212677-001	METFORMIN HYDROCHLORIDE	500MG/5ML	SOLUTION / ORAL	AB	2022-08-19	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212677-001	METFORMIN HYDROCHLORIDE	500MG/5ML	SOLUTION / ORAL	AB	2022-08-19	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212677-001	METFORMIN HYDROCHLORIDE	500MG/5ML	SOLUTION / ORAL	AB	2022-08-19	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212677-001	METFORMIN HYDROCHLORIDE	500MG/5ML	SOLUTION / ORAL	AB	2022-08-19	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212677-001	METFORMIN HYDROCHLORIDE	500MG/5ML	SOLUTION / ORAL	AB	2022-08-19	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212677-001	METFORMIN HYDROCHLORIDE	500MG/5ML	SOLUTION / ORAL	AB	2022-08-19	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212677-001	METFORMIN HYDROCHLORIDE	500MG/5ML	SOLUTION / ORAL	AB	2022-08-19	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A212677-001	METFORMIN HYDROCHLORIDE	500MG/5ML	SOLUTION / ORAL	AB	2022-08-19	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A212677-001	METFORMIN HYDROCHLORIDE	500MG/5ML	SOLUTION / ORAL	AB	2022-08-19	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A212677-001	METFORMIN HYDROCHLORIDE	500MG/5ML	SOLUTION / ORAL	AB	2022-08-19	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A212677-001	METFORMIN HYDROCHLORIDE	500MG/5ML	SOLUTION / ORAL	AB	2022-08-19	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A212677-001	METFORMIN HYDROCHLORIDE	500MG/5ML	SOLUTION / ORAL	AB	2022-08-19	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A212677-001	METFORMIN HYDROCHLORIDE	500MG/5ML	SOLUTION / ORAL	AB	2022-08-19	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A212677-001	METFORMIN HYDROCHLORIDE	500MG/5ML	SOLUTION / ORAL	AB	2022-08-19	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A212677-001	METFORMIN HYDROCHLORIDE	500MG/5ML	SOLUTION / ORAL	AB	2022-08-19	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A212677-001	METFORMIN HYDROCHLORIDE	500MG/5ML	SOLUTION / ORAL	AB	2022-08-19	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A212677-001	METFORMIN HYDROCHLORIDE	500MG/5ML	SOLUTION / ORAL	AB	2022-08-19	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A212677-001	METFORMIN HYDROCHLORIDE	500MG/5ML	SOLUTION / ORAL	AB	2022-08-19	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A212677-001	METFORMIN HYDROCHLORIDE	500MG/5ML	SOLUTION / ORAL	AB	2022-08-19	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A212677-001	METFORMIN HYDROCHLORIDE	500MG/5ML	SOLUTION / ORAL	AB	2022-08-19	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A212677-001	METFORMIN HYDROCHLORIDE	500MG/5ML	SOLUTION / ORAL	AB	2022-08-19	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A212677-001	METFORMIN HYDROCHLORIDE	500MG/5ML	SOLUTION / ORAL	AB	2022-08-19	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A212677-001	METFORMIN HYDROCHLORIDE	500MG/5ML	SOLUTION / ORAL	AB	2022-08-19	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A212677-001	METFORMIN HYDROCHLORIDE	500MG/5ML	SOLUTION / ORAL	AB	2022-08-19	`e64feba35796…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A212677-001	METFORMIN HYDROCHLORIDE	500MG/5ML	SOLUTION / ORAL	AB	2022-08-19	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-10-15 13:18:30	2026-09	A212677-001	AB	1	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A212677-001	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A212677-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A212677-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212677-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A212677-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212677-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212677-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212677-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212677-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212677-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212677-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A212677-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A212677-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A212677-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A212677-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A212677-001	AB	1	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A212677-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A212677-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A212677-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A212677-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A212677-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A212677-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A212677-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A212677-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A212677-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A212677-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A212677-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A212677-001	AB	1	`e64feba35796…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A212677-001	AB	1	`a50c72e98297…`

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 8 of 13 · 251 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
METFORMIN HYDROCHLORIDE EXTENDED RELEASE	METFORMIN HYDROCHLORIDE	TIME CAP LABORATORIES, INC	1d8b8970-c2a1-4780-be87-ab8ccfd401fa	2025-06-30	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: METFORMIN HYDROCHLORIDE
METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	A-S Medication Solutions	0cd086d6-3ae2-476e-b93e-29055e67e8fc	2025-06-18	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: METFORMIN HYDROCHLORIDE generic name: METFORMIN HYDROCHLORIDE
METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	A-S Medication Solutions	a434b937-2648-4509-8ce8-94a28582ec77	2025-06-17	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: METFORMIN HYDROCHLORIDE generic name: METFORMIN HYDROCHLORIDE
METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	A-S Medication Solutions	784a6bbd-4f13-45ed-89c1-154b06721ed0	2025-06-17	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: METFORMIN HYDROCHLORIDE generic name: METFORMIN HYDROCHLORIDE
Metformin Hydrochloride	METFORMIN HYDROCHLORIDE	A-S Medication Solutions	f6581ce6-0f9f-4887-ae83-4c6ecde619f3	2025-06-17	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Metformin Hydrochloride generic name: METFORMIN HYDROCHLORIDE
METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	A-S Medication Solutions	9fed67ea-7a15-4634-80cf-c975b8812ebe	2025-06-11	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: METFORMIN HYDROCHLORIDE generic name: METFORMIN HYDROCHLORIDE
METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	A-S Medication Solutions	2d68fd88-c591-4577-a7c3-901338bdaf90	2025-06-11	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: METFORMIN HYDROCHLORIDE generic name: METFORMIN HYDROCHLORIDE
Metformin Hydrochloride	METFORMIN HYDROCHLORIDE	Bryant Ranch Prepack	52eecdbd-e07e-447f-bf38-b3c347b60662	2025-06-02	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Metformin Hydrochloride generic name: METFORMIN HYDROCHLORIDE
METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	Coupler LLC	33ec9f6e-16d9-40ba-e063-6294a90ae87b	2025-04-29	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: METFORMIN HYDROCHLORIDE generic name: METFORMIN HYDROCHLORIDE
METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	Preferred Pharmaceuticals Inc.	103080cb-6381-44f6-8a31-1fc81e7c890f	2025-04-23	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: METFORMIN HYDROCHLORIDE generic name: METFORMIN HYDROCHLORIDE
Metformin Hydrochloride	METFORMIN HYDROCHLORIDE	NuCare Pharmaceuticals,Inc.	33155746-c2ef-12f4-e063-6294a90a039c	2025-04-18	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Metformin Hydrochloride generic name: METFORMIN HYDROCHLORIDE
Metformin Hydrochloride	METFORMIN HYDROCHLORIDE	TAGI Pharma, Inc.	dd0ee2bf-f658-42dc-976d-49af0b1f32b5	2025-04-18	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Metformin Hydrochloride generic name: METFORMIN HYDROCHLORIDE
Metformin Hydrochloride	METFORMIN HYDROCHLORIDE	Coupler, LLC	32ff33ed-89ed-c391-e063-6294a90ae414	2025-04-17	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Metformin Hydrochloride generic name: METFORMIN HYDROCHLORIDE
METFORMIN HYDROCHLORIDE EXTENDED RELEASE	METFORMIN HYDROCHLORIDE	Bryant Ranch Prepack	d7c1ff9e-4faa-4f65-9c87-e8108499791f	2025-03-28	Warnings	Name fallback generic name: METFORMIN HYDROCHLORIDE
METFORMIN HYDROCHLORIDE EXTENDED RELEASE	METFORMIN HYDROCHLORIDE	Bryant Ranch Prepack	3e55944a-ed5b-4892-804f-abbe15b0d70c	2025-03-28	Warnings	Name fallback generic name: METFORMIN HYDROCHLORIDE
Metformin Hydrochloride	METFORMIN HYDROCHLORIDE	Bryant Ranch Prepack	de4a660b-172b-4c72-9e38-5634fd03cfa7	2025-03-10	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Metformin Hydrochloride generic name: METFORMIN HYDROCHLORIDE
METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	Coupler LLC	2d7d9364-e71d-4ef6-e063-6394a90af841	2025-02-06	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: METFORMIN HYDROCHLORIDE generic name: METFORMIN HYDROCHLORIDE
METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	Bryant Ranch Prepack	4db5551b-04f6-4921-9dee-68acb41f7f71	2025-02-05	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: METFORMIN HYDROCHLORIDE generic name: METFORMIN HYDROCHLORIDE
METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	NuCare Pharmaceuticals,Inc.	0865f83f-0f34-0690-e063-6294a90abf04	2025-02-03	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: METFORMIN HYDROCHLORIDE generic name: METFORMIN HYDROCHLORIDE
METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	NuCare Pharmaceuticals,Inc.	0b3d5420-d60c-8385-e063-6394a90abb6c	2025-02-03	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: METFORMIN HYDROCHLORIDE generic name: METFORMIN HYDROCHLORIDE

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

NDC Listings For This Application#

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

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
66689-318	Metformin Hydrochloride	Metformin Hydrochloride	VistaPharm, LLC	ANDA	Current