Metformin Hydrochloride

Product NDC: 65862-008
11-digit product format: 658620008
Labeler code: 65862
Product ID: 65862-008_1c59d7bc-6118-4707-80c0-886ac00bab09
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Metformin Hydrochloride
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Aurobindo Pharma Limited
Application: ANDA077095
Marketing category: ANDA
Marketing start: 2005-01-14
Substance: METFORMIN HYDROCHLORIDE
Active strength: 500 mg/1
Pharmacologic classes: Biguanide [EPC], Biguanides [CS]
NDC exclude flag: No
Listing certified through: 2027-12-31
Current FDA listing: Yes

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 4 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
unfinished product	product	65862-008		UNFINISHED	Active or certified unfinished drug listing	2026-08-17
unfinished package	package	65862-008	65862-008-26	UNFINISHED	Active or certified unfinished drug listing	2026-08-17
unfinished package	package	65862-008	65862-008-49	UNFINISHED	Active or certified unfinished drug listing	2026-08-17
unfinished package	package	65862-008	65862-008-56	UNFINISHED	Active or certified unfinished drug listing	2026-08-17

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 2 · 77 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 21:27 UTC · source 2025-12-05	unfinished product	product		`a6255e0c9aa5…`	`a0211a219f2e…`
2025-12-14 21:27 UTC · source 2025-12-05	unfinished package	package	65862-008-56	`a6255e0c9aa5…`	`a0211a219f2e…`
2025-12-14 21:27 UTC · source 2025-12-05	unfinished package	package	65862-008-26	`a6255e0c9aa5…`	`a0211a219f2e…`
2025-12-14 21:27 UTC · source 2025-12-05	unfinished package	package	65862-008-49	`a6255e0c9aa5…`	`a0211a219f2e…`
2025-08-26 23:59 UTC · source 2025-08-26	unfinished product	product		`1d862106b807…`	`00c93037cd84…`
2025-08-26 23:59 UTC · source 2025-08-26	unfinished package	package	65862-008-56	`1d862106b807…`	`00c93037cd84…`
2025-08-26 23:59 UTC · source 2025-08-26	unfinished package	package	65862-008-26	`1d862106b807…`	`00c93037cd84…`
2025-08-26 23:59 UTC · source 2025-08-26	unfinished package	package	65862-008-49	`1d862106b807…`	`00c93037cd84…`
2025-05-15 14:59 UTC · source 2025-05-14	unfinished product	product		`390b4c401c3f…`	`2c692c2daee3…`
2025-05-15 14:59 UTC · source 2025-05-14	unfinished package	package	65862-008-56	`390b4c401c3f…`	`2c692c2daee3…`
2025-05-15 14:59 UTC · source 2025-05-14	unfinished package	package	65862-008-26	`390b4c401c3f…`	`2c692c2daee3…`
2025-05-15 14:59 UTC · source 2025-05-14	unfinished package	package	65862-008-49	`390b4c401c3f…`	`2c692c2daee3…`
2025-04-01 07:37 UTC · source 2025-03-31	unfinished product	product		`e30019b0c005…`	`a3f0b14938b7…`
2025-04-01 07:37 UTC · source 2025-03-31	unfinished package	package	65862-008-56	`e30019b0c005…`	`a3f0b14938b7…`
2025-04-01 07:37 UTC · source 2025-03-31	unfinished package	package	65862-008-26	`e30019b0c005…`	`a3f0b14938b7…`
2025-04-01 07:37 UTC · source 2025-03-31	unfinished package	package	65862-008-49	`e30019b0c005…`	`a3f0b14938b7…`
2025-03-01 13:19 UTC · source 2025-02-28	unfinished product	product		`bbbc9f937eca…`	`946b9c97cf81…`
2025-03-01 13:19 UTC · source 2025-02-28	unfinished package	package	65862-008-56	`bbbc9f937eca…`	`946b9c97cf81…`
2025-03-01 13:19 UTC · source 2025-02-28	unfinished package	package	65862-008-26	`bbbc9f937eca…`	`946b9c97cf81…`
2025-03-01 13:19 UTC · source 2025-02-28	unfinished package	package	65862-008-49	`bbbc9f937eca…`	`946b9c97cf81…`
2025-02-27 05:24 UTC · source 2025-02-26	unfinished product	product		`f268b84574a6…`	`26285f5ac5df…`
2025-02-27 05:24 UTC · source 2025-02-26	unfinished package	package	65862-008-56	`f268b84574a6…`	`26285f5ac5df…`
2025-02-27 05:24 UTC · source 2025-02-26	unfinished package	package	65862-008-26	`f268b84574a6…`	`26285f5ac5df…`
2025-02-27 05:24 UTC · source 2025-02-26	unfinished package	package	65862-008-49	`f268b84574a6…`	`26285f5ac5df…`
2025-02-01 13:13 UTC · source 2025-01-31	unfinished product	product		`f764e8902f78…`	`92046438deef…`
2025-02-01 13:13 UTC · source 2025-01-31	unfinished package	package	65862-008-56	`f764e8902f78…`	`92046438deef…`
2025-02-01 13:13 UTC · source 2025-01-31	unfinished package	package	65862-008-26	`f764e8902f78…`	`92046438deef…`
2025-02-01 13:13 UTC · source 2025-01-31	unfinished package	package	65862-008-49	`f764e8902f78…`	`92046438deef…`
2025-01-20 13:05 UTC · source 2025-01-17	unfinished product	product		`68b1e3bced9e…`	`98a755eb8bc6…`
2025-01-20 13:05 UTC · source 2025-01-17	unfinished package	package	65862-008-56	`68b1e3bced9e…`	`98a755eb8bc6…`
2025-01-20 13:05 UTC · source 2025-01-17	unfinished package	package	65862-008-26	`68b1e3bced9e…`	`98a755eb8bc6…`
2025-01-20 13:05 UTC · source 2025-01-17	unfinished package	package	65862-008-49	`68b1e3bced9e…`	`98a755eb8bc6…`
2024-11-29 20:42 UTC · source 2024-11-29	unfinished product	product		`05c55d027831…`	`ca05dca9dc4c…`
2024-11-29 20:42 UTC · source 2024-11-29	unfinished package	package	65862-008-56	`05c55d027831…`	`ca05dca9dc4c…`
2024-11-29 20:42 UTC · source 2024-11-29	unfinished package	package	65862-008-26	`05c55d027831…`	`ca05dca9dc4c…`
2024-11-29 20:42 UTC · source 2024-11-29	unfinished package	package	65862-008-49	`05c55d027831…`	`ca05dca9dc4c…`
2024-11-09 02:36 UTC · source 2024-11-08	unfinished product	product		`48b4f40e6753…`	`c7c7a00d2afa…`
2024-11-09 02:36 UTC · source 2024-11-08	unfinished package	package	65862-008-56	`48b4f40e6753…`	`c7c7a00d2afa…`
2024-11-09 02:36 UTC · source 2024-11-08	unfinished package	package	65862-008-26	`48b4f40e6753…`	`c7c7a00d2afa…`
2024-11-09 02:36 UTC · source 2024-11-08	unfinished package	package	65862-008-49	`48b4f40e6753…`	`c7c7a00d2afa…`
2024-10-09 02:27 UTC · source 2024-10-08	unfinished product	product		`27f29a85d7e4…`	`1372111e901f…`
2024-10-09 02:27 UTC · source 2024-10-08	unfinished package	package	65862-008-56	`27f29a85d7e4…`	`1372111e901f…`
2024-10-09 02:27 UTC · source 2024-10-08	unfinished package	package	65862-008-26	`27f29a85d7e4…`	`1372111e901f…`
2024-10-09 02:27 UTC · source 2024-10-08	unfinished package	package	65862-008-49	`27f29a85d7e4…`	`1372111e901f…`
2024-07-10 04:00 UTC · source 2024-07-09	unfinished product	product		`8d62ce987f31…`	`9fe9ef23e30d…`
2024-07-10 04:00 UTC · source 2024-07-09	unfinished package	package	65862-008-49	`8d62ce987f31…`	`9fe9ef23e30d…`
2024-07-10 04:00 UTC · source 2024-07-09	unfinished package	package	65862-008-26	`8d62ce987f31…`	`9fe9ef23e30d…`
2024-07-10 04:00 UTC · source 2024-07-09	unfinished package	package	65862-008-56	`8d62ce987f31…`	`9fe9ef23e30d…`
2024-05-28 21:11 UTC · source 2024-05-28	unfinished product	product		`d1e113ab4d42…`	`063ee3eb0a1d…`
2024-05-28 21:11 UTC · source 2024-05-28	unfinished package	package	65862-008-49	`d1e113ab4d42…`	`063ee3eb0a1d…`
2024-05-28 21:11 UTC · source 2024-05-28	unfinished package	package	65862-008-26	`d1e113ab4d42…`	`063ee3eb0a1d…`
2024-05-28 21:11 UTC · source 2024-05-28	unfinished package	package	65862-008-56	`d1e113ab4d42…`	`063ee3eb0a1d…`
2024-05-15 03:51 UTC · source 2024-05-14	unfinished product	product		`50b4072663b7…`	`eae3003ed65e…`
2024-05-15 03:51 UTC · source 2024-05-14	unfinished package	package	65862-008-49	`50b4072663b7…`	`eae3003ed65e…`
2024-05-15 03:51 UTC · source 2024-05-14	unfinished package	package	65862-008-26	`50b4072663b7…`	`eae3003ed65e…`
2024-05-15 03:51 UTC · source 2024-05-14	unfinished package	package	65862-008-56	`50b4072663b7…`	`eae3003ed65e…`
2022-04-09 23:13 UTC · source 2022-04-08	unfinished product	product		`906f6e251498…`	`bf70b80e44f0…`
2022-04-09 23:13 UTC · source 2022-04-08	unfinished package	package	65862-008-26	`906f6e251498…`	`bf70b80e44f0…`
2022-04-09 23:13 UTC · source 2022-04-08	unfinished package	package	65862-008-49	`906f6e251498…`	`bf70b80e44f0…`
2021-12-27 23:28 UTC · source 2021-12-27	unfinished product	product		`6db9cb8d1e19…`	`3449e1ec5b70…`

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

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	TE codes	Approval date
A077095-001	METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	500MG	TABLET / ORAL	AB	2005-01-14
A077095-002	METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	850MG	TABLET / ORAL	AB	2005-01-14
A077095-003	METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	1GM	TABLET / ORAL	AB	2005-01-14

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-product	TE code
A077095-001	AB
A077095-002	AB
A077095-003	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 4 · 126 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	A077095-001	METFORMIN HYDROCHLORIDE	500MG	TABLET / ORAL	AB	2005-01-14	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077095-002	METFORMIN HYDROCHLORIDE	850MG	TABLET / ORAL	AB	2005-01-14	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077095-003	METFORMIN HYDROCHLORIDE	1GM	TABLET / ORAL	AB	2005-01-14	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A077095-001	METFORMIN HYDROCHLORIDE	500MG	TABLET / ORAL	AB	2005-01-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077095-002	METFORMIN HYDROCHLORIDE	850MG	TABLET / ORAL	AB	2005-01-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077095-003	METFORMIN HYDROCHLORIDE	1GM	TABLET / ORAL	AB	2005-01-14	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077095-001	METFORMIN HYDROCHLORIDE	500MG	TABLET / ORAL	AB	2005-01-14	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077095-002	METFORMIN HYDROCHLORIDE	850MG	TABLET / ORAL	AB	2005-01-14	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077095-003	METFORMIN HYDROCHLORIDE	1GM	TABLET / ORAL	AB	2005-01-14	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077095-001	METFORMIN HYDROCHLORIDE	500MG	TABLET / ORAL	AB	2005-01-14	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077095-002	METFORMIN HYDROCHLORIDE	850MG	TABLET / ORAL	AB	2005-01-14	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077095-003	METFORMIN HYDROCHLORIDE	1GM	TABLET / ORAL	AB	2005-01-14	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077095-001	METFORMIN HYDROCHLORIDE	500MG	TABLET / ORAL	AB	2005-01-14	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077095-002	METFORMIN HYDROCHLORIDE	850MG	TABLET / ORAL	AB	2005-01-14	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077095-003	METFORMIN HYDROCHLORIDE	1GM	TABLET / ORAL	AB	2005-01-14	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077095-001	METFORMIN HYDROCHLORIDE	500MG	TABLET / ORAL	AB	2005-01-14	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077095-002	METFORMIN HYDROCHLORIDE	850MG	TABLET / ORAL	AB	2005-01-14	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077095-003	METFORMIN HYDROCHLORIDE	1GM	TABLET / ORAL	AB	2005-01-14	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077095-001	METFORMIN HYDROCHLORIDE	500MG	TABLET / ORAL	AB	2005-01-14	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077095-002	METFORMIN HYDROCHLORIDE	850MG	TABLET / ORAL	AB	2005-01-14	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077095-003	METFORMIN HYDROCHLORIDE	1GM	TABLET / ORAL	AB	2005-01-14	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077095-001	METFORMIN HYDROCHLORIDE	500MG	TABLET / ORAL	AB	2005-01-14	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077095-002	METFORMIN HYDROCHLORIDE	850MG	TABLET / ORAL	AB	2005-01-14	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077095-003	METFORMIN HYDROCHLORIDE	1GM	TABLET / ORAL	AB	2005-01-14	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077095-001	METFORMIN HYDROCHLORIDE	500MG	TABLET / ORAL	AB	2005-01-14	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077095-002	METFORMIN HYDROCHLORIDE	850MG	TABLET / ORAL	AB	2005-01-14	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077095-003	METFORMIN HYDROCHLORIDE	1GM	TABLET / ORAL	AB	2005-01-14	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077095-001	METFORMIN HYDROCHLORIDE	500MG	TABLET / ORAL	AB	2005-01-14	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077095-002	METFORMIN HYDROCHLORIDE	850MG	TABLET / ORAL	AB	2005-01-14	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077095-003	METFORMIN HYDROCHLORIDE	1GM	TABLET / ORAL	AB	2005-01-14	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077095-001	METFORMIN HYDROCHLORIDE	500MG	TABLET / ORAL	AB	2005-01-14	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077095-002	METFORMIN HYDROCHLORIDE	850MG	TABLET / ORAL	AB	2005-01-14	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077095-003	METFORMIN HYDROCHLORIDE	1GM	TABLET / ORAL	AB	2005-01-14	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077095-001	METFORMIN HYDROCHLORIDE	500MG	TABLET / ORAL	AB	2005-01-14	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077095-002	METFORMIN HYDROCHLORIDE	850MG	TABLET / ORAL	AB	2005-01-14	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077095-003	METFORMIN HYDROCHLORIDE	1GM	TABLET / ORAL	AB	2005-01-14	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077095-001	METFORMIN HYDROCHLORIDE	500MG	TABLET / ORAL	AB	2005-01-14	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077095-002	METFORMIN HYDROCHLORIDE	850MG	TABLET / ORAL	AB	2005-01-14	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077095-003	METFORMIN HYDROCHLORIDE	1GM	TABLET / ORAL	AB	2005-01-14	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077095-001	METFORMIN HYDROCHLORIDE	500MG	TABLET / ORAL	AB	2005-01-14	`1e350fbaab3a…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 126 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	A077095-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077095-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077095-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A077095-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077095-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077095-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077095-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077095-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077095-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077095-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077095-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077095-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077095-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077095-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077095-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077095-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077095-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077095-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077095-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077095-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077095-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077095-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077095-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077095-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077095-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077095-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077095-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077095-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077095-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077095-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077095-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077095-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077095-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077095-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077095-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077095-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077095-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077095-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077095-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077095-001	AB	1	`1e350fbaab3a…`

Additional Listing Data#

Finished product: Yes
Brand name base: Metformin Hydrochloride
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
METFORMIN HYDROCHLORIDE	500 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
786Z46389E	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
861004	Internal RxNorm lookup
861007	Internal RxNorm lookup
861010	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
4ac6d01a-af26-44e7-ae2e-3618de0080aa	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
6a29d87d-f465-752d-5fa9-bd728c608ca2	Product name	4	20251215
f6d21fb1-2c09-48ab-8d89-eeadf5a9698e	Product name	1	20250724
a985afd1-89a8-bfab-0231-b59db1a3a9b5	Product name	7	20250515
25bfaa4d-02a1-402c-96ec-9bf6e625484c	Product name	1	20250307
08b60e13-e5d0-74ca-b5a8-e6df9cb1dca0	Product name	2	20240829
16dbe107-66d5-47b3-57ed-0cba6a8dfccc	Product name	6	20240215
08b3e508-8c7e-3b95-0275-113510642fc6	Product name	2	20220309
3a90349e-ff2e-41bd-a106-b368fbc1c1f8	Product name	1	20200612
5ab9c07d-ba46-4f19-88f9-a3bc7929fb86	Product name	1	20200214
1dc427fa-8c3b-4309-981e-ea1ff01326e5	Product name	1	20190731
ca3f036c-6c06-b829-b379-1a3a4097099c	Product name	9	20180605
e1ede89f-54c8-428f-ae84-9e8a2deb67db	Product name	1	20180306
5ec207a9-fa56-4ff7-8fae-9a7d9a6bf52c	Product name	2	20170824
bea938a6-c880-985b-d27b-b59b0d8b5a77	Product name	3	20170626
0600b0d3-c32a-40bb-8d87-3a2934cd8f2f	Product name	1	20170616
e2382c7e-9e14-4196-aeff-98e2cfaf63cb	Product name	1	20170224
988f737f-e7e9-4613-8558-824b1ab755f9	Product name	1	20161128
58b66776-50d5-434f-916f-958ccf131e0e	Product name	1	20160713
3e9b6ece-066b-2ac3-28f7-5e13060e5934	Product name	2	20151109
2988466d-5fc4-4430-9cee-fc9132f02d2c	Product name	1	20150910
85cbb42f-1a8d-f945-f85e-188e823b7f5b	Product name	2	20150731
e740bf83-275a-4f0c-adf4-ec60ebd882b7	Product name	1	20150105
8d7b9e2e-c1f8-4f6e-a1f3-e4ce405be5f0	Product name	1	20141205
0d79b284-47e8-e90c-f249-892b9b251003	Product name	1	20140508
25391a6f-d1ba-6bff-d36e-050dc68ef0e6	Product name	1	20140508
2de6e143-c970-2061-1b77-61c3aa8f4026	Product name	1	20140508
2dee091b-3b8c-d27a-b1ba-fcb0d32e776a	Product name	1	20140508
ce63c1f8-ba50-8a17-9290-94522d75daff	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
65862-008-01	Metformin Hydrochloride	100 in 1 BOTTLE	TABLET, FILM COATED	100	16
65862-008-05	Metformin Hydrochloride	500 in 1 BOTTLE	TABLET, FILM COATED	500	16
65862-008-33	Metformin Hydrochloride	300 in 1 BOTTLE	TABLET, FILM COATED	300	16
65862-008-45	Metformin Hydrochloride	4500 in 1 BOTTLE	TABLET, FILM COATED	4500	16
65862-008-50	Metformin Hydrochloride	50 in 1 BOTTLE	TABLET, FILM COATED	50	16
65862-008-60	Metformin Hydrochloride	60 in 1 BOTTLE	TABLET, FILM COATED	60	16
65862-008-90	Metformin Hydrochloride	90 in 1 BOTTLE	TABLET, FILM COATED	90	16
65862-008-99	Metformin Hydrochloride	1000 in 1 BOTTLE	TABLET, FILM COATED	1000	16

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
65862-008-01	EA - Each	65862-008	49e7fa08-e030-4c01-b32d-46fe0ee1a34c	1	2012-07-24
65862-008-05	EA - Each	65862-008	2e301e1a-6076-4be6-a9c7-655948c3e10d	1	2012-07-24
65862-008-90	EA - Each	65862-008	5dfe1855-7a7e-43dc-bc0b-779231596e1f	1	2012-07-24
65862-008-99	EA - Each	65862-008	30a94890-de62-4295-aec3-55158c780e26	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
METFORMIN HYDROCHLORIDE	ACTIVE INGREDIENT	786Z46389E	METFORMIN HYDROCHLORIDE (METFORMIN HYDROCHLORIDE) TABLET, FILM COATED [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]	3282
METFORMIN	ACTIVE MOIETY	9100L32L2N	METFORMIN HYDROCHLORIDE (METFORMIN HYDROCHLORIDE) TABLET, FILM COATED [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]	3282
HYPROMELLOSE 2910 (5 MPA.S)	INACTIVE INGREDIENT	R75537T0T4	METFORMIN HYDROCHLORIDE (METFORMIN HYDROCHLORIDE) TABLET, FILM COATED [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]	3282
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	METFORMIN HYDROCHLORIDE (METFORMIN HYDROCHLORIDE) TABLET, FILM COATED [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]	3282
POLYETHYLENE GLYCOL 400	INACTIVE INGREDIENT	B697894SGQ	METFORMIN HYDROCHLORIDE (METFORMIN HYDROCHLORIDE) TABLET, FILM COATED [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]	3282
POLYETHYLENE GLYCOL 6000	INACTIVE INGREDIENT	30IQX730WE	METFORMIN HYDROCHLORIDE (METFORMIN HYDROCHLORIDE) TABLET, FILM COATED [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]	3282
POVIDONE K90	INACTIVE INGREDIENT	RDH86HJV5Z	METFORMIN HYDROCHLORIDE (METFORMIN HYDROCHLORIDE) TABLET, FILM COATED [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]	3282
METFORMIN HYDROCHLORIDE	ACTIVE INGREDIENT	786Z46389E	METFORMIN HYDROCHLORIDE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]	6
METFORMIN	ACTIVE MOIETY	9100L32L2N	METFORMIN HYDROCHLORIDE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]	6
HYPROMELLOSE 2910 (5 MPA.S)	INACTIVE INGREDIENT	R75537T0T4	METFORMIN HYDROCHLORIDE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]	6
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	METFORMIN HYDROCHLORIDE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]	6
POLYETHYLENE GLYCOL 400	INACTIVE INGREDIENT	B697894SGQ	METFORMIN HYDROCHLORIDE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]	6
POLYETHYLENE GLYCOL 6000	INACTIVE INGREDIENT	30IQX730WE	METFORMIN HYDROCHLORIDE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]	6
POVIDONE K90	INACTIVE INGREDIENT	RDH86HJV5Z	METFORMIN HYDROCHLORIDE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]	6
METFORMIN HYDROCHLORIDE	ACTIVE INGREDIENT	786Z46389E	METFORMIN HYDROCHLORIDE TABLET, FILM COATED [PROFICIENT RX LP]	1
METFORMIN	ACTIVE MOIETY	9100L32L2N	METFORMIN HYDROCHLORIDE TABLET, FILM COATED [PROFICIENT RX LP]	1
HYPROMELLOSE 2910 (5 MPA.S)	INACTIVE INGREDIENT	R75537T0T4	METFORMIN HYDROCHLORIDE TABLET, FILM COATED [PROFICIENT RX LP]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	METFORMIN HYDROCHLORIDE TABLET, FILM COATED [PROFICIENT RX LP]	1
POLYETHYLENE GLYCOL 400	INACTIVE INGREDIENT	B697894SGQ	METFORMIN HYDROCHLORIDE TABLET, FILM COATED [PROFICIENT RX LP]	1
POLYETHYLENE GLYCOL 6000	INACTIVE INGREDIENT	30IQX730WE	METFORMIN HYDROCHLORIDE TABLET, FILM COATED [PROFICIENT RX LP]	1
POVIDONE K90	INACTIVE INGREDIENT	RDH86HJV5Z	METFORMIN HYDROCHLORIDE TABLET, FILM COATED [PROFICIENT RX LP]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
65862-008	METFORMIN HYDROCHLORIDE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]	15	Current NDC, Legacy NDC, 8 package rows	20240104_4ac6d01a-af26-44e7-ae2e-3618de0080aa.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 · 17 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Metformin Hydrochloride	METFORMIN HYDROCHLORIDE	REMEDYREPACK INC.	5d8d654a-9bb4-4c87-ab43-c21c4e874708	2026-08-04	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077095 application number: ANDA077095
Metformin Hydrochloride	METFORMIN HYDROCHLORIDE	NuCare Pharmaceuticals, Inc.	583f2a2e-a9d7-f266-e063-6294a90ad0ab	2026-08-04	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077095 application number: ANDA077095
Metformin Hydrochloride	METFORMIN HYDROCHLORIDE	Aurobindo Pharma Limited	4ac6d01a-af26-44e7-ae2e-3618de0080aa	2026-07-15	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077095 application number: ANDA077095 ndc (product): 65862-008
Metformin Hydrochloride	METFORMIN HYDROCHLORIDE	Aurobindo Pharma Limited	fc466c46-abaa-4675-aef2-4b1a1adfd912	2026-07-08	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077095 application number: ANDA077095
Metformin Hydrochloride	METFORMIN HYDROCHLORIDE	Bryant Ranch Prepack	fb296500-55cb-45ce-be0c-59aa2e3d4624	2026-05-21	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077095 application number: ANDA077095
Metformin Hydrochloride	METFORMIN HYDROCHLORIDE	REMEDYREPACK INC.	073cf6d9-7142-4d8b-898e-174c62a1f76f	2026-05-19	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077095 application number: ANDA077095
Metformin Hydrochloride	METFORMIN HYDROCHLORIDE	NCS HealthCare of KY, LLC dba Vangard Labs	0448c618-2f0d-4ed3-866f-74b413cf902d	2026-04-16	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077095 application number: ANDA077095
Metformin Hydrochloride	METFORMIN HYDROCHLORIDE	A-S Medication Solutions	1d7556eb-82b4-4085-b0b1-dc061b216feb	2026-02-02	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077095 application number: ANDA077095
Metformin Hydrochloride	METFORMIN HYDROCHLORIDE	Northwind Health Company, LLC	db113f46-6fac-9005-e053-2995a90a017a	2026-01-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077095 application number: ANDA077095
Metformin Hydrochloride	METFORMIN HYDROCHLORIDE	Aphena Pharma Solutions - Tennessee, LLC	3d450933-8d9d-27de-e063-6294a90ae6d9	2025-08-26	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077095 application number: ANDA077095
Metformin Hydrochloride	METFORMIN HYDROCHLORIDE	Aphena Pharma Solutions - Tennessee, LLC	3ab4efb6-bd30-2583-e063-6294a90a415b	2025-07-24	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077095 application number: ANDA077095
Metformin Hydrochloride	METFORMIN HYDROCHLORIDE	A-S Medication Solutions	23aa50c5-28fe-4322-b5c6-1f1c48409b16	2025-07-18	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077095 application number: ANDA077095
Metformin Hydrochloride	METFORMIN HYDROCHLORIDE	Aphena Pharma Solutions - Tennessee, LLC	390c3bdf-bfaf-203e-e063-6394a90a7d20	2025-07-03	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077095 application number: ANDA077095
Metformin Hydrochloride	METFORMIN HYDROCHLORIDE	NCS HealthCare of KY, LLC dba Vangard Labs	23aa0072-365c-4d13-9aa7-ae23f7e00ee4	2024-09-18	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077095 application number: ANDA077095
Metformin Hydrochloride	METFORMIN HYDROCHLORIDE	A-S Medication Solutions	1a7f7ef3-a94b-4ff6-a9f2-f5de4a99c7f6	2024-04-28	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077095 application number: ANDA077095
Metformin Hydrochloride	METFORMIN HYDROCHLORIDE	A-S Medication Solutions	afb183f6-a13c-4f00-82d5-9fe336173d34	2024-04-28	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077095 application number: ANDA077095
Metformin Hydrochloride	METFORMIN HYDROCHLORIDE	Proficient Rx LP	1b9b6db9-1bac-4252-a03c-18dc0271f05f	2023-06-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077095 application number: ANDA077095

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
786Z46389E	METFORMIN HYDROCHLORIDE	1115-70-4	METFORMIN HYDROCHLORIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
861004	metFORMIN HCl 1000 MG Oral Tablet	PSN	23aa50c5-28fe-4322-b5c6-1f1c48409b16	38
861007	metFORMIN HCl 500 MG Oral Tablet	PSN	23aa50c5-28fe-4322-b5c6-1f1c48409b16	38
861010	metFORMIN HCl 850 MG Oral Tablet	PSN	23aa50c5-28fe-4322-b5c6-1f1c48409b16	38
861004	metformin hydrochloride 1000 MG Oral Tablet	SCD	23aa50c5-28fe-4322-b5c6-1f1c48409b16	38
861007	metformin hydrochloride 500 MG Oral Tablet	SCD	23aa50c5-28fe-4322-b5c6-1f1c48409b16	38
861010	metformin hydrochloride 850 MG Oral Tablet	SCD	23aa50c5-28fe-4322-b5c6-1f1c48409b16	38
861004	metformin HCl 1 GM Oral Tablet	SY	23aa50c5-28fe-4322-b5c6-1f1c48409b16	38
861004	metFORMIN HCl 1000 MG Oral Tablet	PSN	4ac6d01a-af26-44e7-ae2e-3618de0080aa	16
861007	metFORMIN HCl 500 MG Oral Tablet	PSN	4ac6d01a-af26-44e7-ae2e-3618de0080aa	16
861010	metFORMIN HCl 850 MG Oral Tablet	PSN	4ac6d01a-af26-44e7-ae2e-3618de0080aa	16
861004	metformin hydrochloride 1000 MG Oral Tablet	SCD	4ac6d01a-af26-44e7-ae2e-3618de0080aa	16
861007	metformin hydrochloride 500 MG Oral Tablet	SCD	4ac6d01a-af26-44e7-ae2e-3618de0080aa	16
861010	metformin hydrochloride 850 MG Oral Tablet	SCD	4ac6d01a-af26-44e7-ae2e-3618de0080aa	16
861004	metformin HCl 1 GM Oral Tablet	SY	4ac6d01a-af26-44e7-ae2e-3618de0080aa	16
861004	metFORMIN HCl 1000 MG Oral Tablet	PSN	23aa0072-365c-4d13-9aa7-ae23f7e00ee4	15
861007	metFORMIN HCl 500 MG Oral Tablet	PSN	23aa0072-365c-4d13-9aa7-ae23f7e00ee4	15
861010	metFORMIN HCl 850 MG Oral Tablet	PSN	23aa0072-365c-4d13-9aa7-ae23f7e00ee4	15
861004	metformin hydrochloride 1000 MG Oral Tablet	SCD	23aa0072-365c-4d13-9aa7-ae23f7e00ee4	15
861007	metformin hydrochloride 500 MG Oral Tablet	SCD	23aa0072-365c-4d13-9aa7-ae23f7e00ee4	15
861010	metformin hydrochloride 850 MG Oral Tablet	SCD	23aa0072-365c-4d13-9aa7-ae23f7e00ee4	15
861004	metformin HCl 1 GM Oral Tablet	SY	23aa0072-365c-4d13-9aa7-ae23f7e00ee4	15
861007	metFORMIN HCl 500 MG Oral Tablet	PSN	073cf6d9-7142-4d8b-898e-174c62a1f76f	14
861007	metformin hydrochloride 500 MG Oral Tablet	SCD	073cf6d9-7142-4d8b-898e-174c62a1f76f	14
861007	metFORMIN HCl 500 MG Oral Tablet	PSN	1a7f7ef3-a94b-4ff6-a9f2-f5de4a99c7f6	5
861007	metformin hydrochloride 500 MG Oral Tablet	SCD	1a7f7ef3-a94b-4ff6-a9f2-f5de4a99c7f6	5
861004	metFORMIN HCl 1000 MG Oral Tablet	PSN	1b9b6db9-1bac-4252-a03c-18dc0271f05f	4
861007	metFORMIN HCl 500 MG Oral Tablet	PSN	1b9b6db9-1bac-4252-a03c-18dc0271f05f	4
861004	metformin hydrochloride 1000 MG Oral Tablet	SCD	1b9b6db9-1bac-4252-a03c-18dc0271f05f	4
861007	metformin hydrochloride 500 MG Oral Tablet	SCD	1b9b6db9-1bac-4252-a03c-18dc0271f05f	4
861004	metformin HCl 1 GM Oral Tablet	SY	1b9b6db9-1bac-4252-a03c-18dc0271f05f	4
861007	metFORMIN HCl 500 MG Oral Tablet	PSN	6440960f-9b8d-021c-e053-2a91aa0a3eed	3
861007	metformin hydrochloride 500 MG Oral Tablet	SCD	6440960f-9b8d-021c-e053-2a91aa0a3eed	3
860975	metFORMIN HCl 500 MG 24HR Extended Release Oral Tablet	PSN	a7999fa7-886f-33c7-e053-2995a90aa3f5	1
861007	metFORMIN HCl 500 MG Oral Tablet	PSN	390c3bdf-bfaf-203e-e063-6394a90a7d20	1
861007	metFORMIN HCl 500 MG Oral Tablet	PSN	40e35fa9-9cfe-04f1-e054-00144ff8d46c	1
860975	24 HR metformin hydrochloride 500 MG Extended Release Oral Tablet	SCD	a7999fa7-886f-33c7-e053-2995a90aa3f5	1
861007	metformin hydrochloride 500 MG Oral Tablet	SCD	390c3bdf-bfaf-203e-e063-6394a90a7d20	1
861007	metformin hydrochloride 500 MG Oral Tablet	SCD	40e35fa9-9cfe-04f1-e054-00144ff8d46c	1
860975	metformin HCl 500 MG 24 HR Extended Release Oral Tablet	SY	a7999fa7-886f-33c7-e053-2995a90aa3f5	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
65862-008-01	65862000801	100 TABLET, FILM COATED in 1 BOTTLE (65862-008-01)	2005-01-14	0000-00-00	No	No	Current
65862-008-05	65862000805	500 TABLET, FILM COATED in 1 BOTTLE (65862-008-05)	2005-01-14	0000-00-00	No	No	Current
65862-008-26	65862000826	2500 TABLET, FILM COATED in 1 BAG (65862-008-26)	14-JAN-05				Current
65862-008-33	65862000833	300 TABLET, FILM COATED in 1 BOTTLE (65862-008-33)	2005-01-14	0000-00-00	No	No	Current
65862-008-45	65862000845	4500 TABLET, FILM COATED in 1 BOTTLE (65862-008-45)	2005-01-14	0000-00-00	No	No	Current
65862-008-49	65862000849	4000 TABLET, FILM COATED in 1 BAG (65862-008-49)	14-JAN-05				Current
65862-008-50	65862000850	50 TABLET, FILM COATED in 1 BOTTLE (65862-008-50)	2005-01-14	0000-00-00	No	No	Current
65862-008-56	65862000856	56000 TABLET, FILM COATED in 1 BAG (65862-008-56)	14-JAN-05				Current
65862-008-60	65862000860	60 TABLET, FILM COATED in 1 BOTTLE (65862-008-60)	2005-01-14	0000-00-00	No	No	Current
65862-008-90	65862000890	90 TABLET, FILM COATED in 1 BOTTLE (65862-008-90)	2005-01-14	0000-00-00	No	No	Current
65862-008-99	65862000899	1000 TABLET, FILM COATED in 1 BOTTLE (65862-008-99)	2005-01-14	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Metformin Hydrochloride	REMEDYREPACK INC.	2026-08-21	HUMAN PRESCRIPTION DRUG LABEL	15
Metformin Hydrochloride	Aurobindo Pharma Limited	2026-07-15	Human Prescription Drug Label	17
Metformin Hydrochloride	A-S Medication Solutions	2025-07-18	Human Prescription Drug Label	38
Metformin Hydrochloride	Aphena Pharma Solutions - Tennessee, LLC	2025-07-03	HUMAN PRESCRIPTION DRUG LABEL	1
Metformin Hydrochloride	RPK Pharmaceuticals, Inc.	2024-12-19	Human Prescription Drug Label	2
Metformin Hydrochloride Tablets, USP 500 mg, 850 mg & 1000 mg Rx only	NCS HealthCare of KY, LLC dba Vangard Labs	2024-09-18	HUMAN PRESCRIPTION DRUG LABEL	15
Metformin Hydrochloride	A-S Medication Solutions	2024-04-28	Human Prescription Drug Label	5
Metformin Hydrochloride Tablets, USP	Proficient Rx LP	2023-06-01	HUMAN PRESCRIPTION DRUG LABEL	4
Metformin Hydrochloride Tablets, USP Rx only	NuCare Pharmarmaceuticals, Inc. \| NuCare Pharmaceuticals, Inc.	2021-02-11	HUMAN PRESCRIPTION DRUG LABEL	2
Metformin Hydrochloride Tablets, USP Rx only	Denton Pharma, Inc. DBA Northwind Pharmaceuticals	2021-01-19	HUMAN PRESCRIPTION DRUG LABEL	3
Metformin Hydrochloride	Bryant Ranch Prepack	2020-10-16	Human Prescription Drug Label	4
METFORMIN HYDROCHLORIDE - UNYTER ENTERPRISES	UNYTER ENTERPRISES	2020-07-13	HUMAN PRESCRIPTION DRUG LABEL	1
Metformin Hydrochloride Tablets, USP	Lake Erie Medical DBA Quality Care Products LLC	2020-01-27	Human Prescription Drug Label	3285
Metformin Hydrochloride Tablets, USP Rx only	QPharma Inc \| Aurobindo Pharma Limited \| Denton Pharma, Inc.	2019-11-13	HUMAN PRESCRIPTION DRUG LABEL	2
Metformin Hydrochloride - RedPharm Drug, Inc.	RedPharm Drug, Inc.	2005-01-14	HUMAN PRESCRIPTION DRUG LABEL	1