METFORMIN HYDROCHLORIDE

Product NDC: 63629-2883
Requested package NDC: 63629-2883-4
11-digit product format: 636292883
Labeler code: 63629
Product ID: 63629-2883_e73ae694-f12f-45d1-b36a-e4a9b7e9fdb7
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: METFORMIN HYDROCHLORIDE
Dosage form: TABLET, EXTENDED RELEASE
Route: ORAL
Labeler: Bryant Ranch Prepack
Application: ANDA077336
Marketing category: ANDA
Marketing start: 2006-02-09
Marketing end: 0000-00-00
Substance: METFORMIN HYDROCHLORIDE
Active strength: 500 mg/1
Pharmacologic classes: Biguanide [EPC],Biguanides [CS]
NDC exclude flag: No
Listing certified through: 2021-12-31
Current FDA listing: Historical FDA.report record

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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	63629-2883	63629-2883-4	D	Discontinued by firm		2026-08-11

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 1 · 13 matching rows.

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

Captured / source date, Code, Status table
Captured / source date	Code	Status	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	D	Discontinued by firm	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	D	Discontinued by firm	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	D	Discontinued by firm	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	D	Discontinued by firm	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	D	Discontinued by firm	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	D	Discontinued by firm	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	D	Discontinued by firm	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	D	Discontinued by firm	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	D	Discontinued by firm	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	D	Discontinued by firm	`557ba5c1ecfa…`	`9c80585c8c6e…`
2020-06-10 20:45 UTC · source 2020-06-10	I	Inactivated by FDA	`9bebd1f3094a…`	`5416666fcb17…`

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

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
A077336-001	METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL			2006-02-09
A077336-002	METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	750MG	TABLET, EXTENDED RELEASE / ORAL			2006-02-09

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 · 82 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	A077336-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL		2006-02-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077336-002	METFORMIN HYDROCHLORIDE	750MG	TABLET, EXTENDED RELEASE / ORAL		2006-02-09	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077336-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL		2006-02-09	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077336-002	METFORMIN HYDROCHLORIDE	750MG	TABLET, EXTENDED RELEASE / ORAL		2006-02-09	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077336-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2006-02-09	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077336-002	METFORMIN HYDROCHLORIDE	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	2006-02-09	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077336-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2006-02-09	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077336-002	METFORMIN HYDROCHLORIDE	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	2006-02-09	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077336-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2006-02-09	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077336-002	METFORMIN HYDROCHLORIDE	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	2006-02-09	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077336-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2006-02-09	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077336-002	METFORMIN HYDROCHLORIDE	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	2006-02-09	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077336-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2006-02-09	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077336-002	METFORMIN HYDROCHLORIDE	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	2006-02-09	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077336-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2006-02-09	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077336-002	METFORMIN HYDROCHLORIDE	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	2006-02-09	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077336-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2006-02-09	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077336-002	METFORMIN HYDROCHLORIDE	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	2006-02-09	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077336-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2006-02-09	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077336-002	METFORMIN HYDROCHLORIDE	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	2006-02-09	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077336-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2006-02-09	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077336-002	METFORMIN HYDROCHLORIDE	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	2006-02-09	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077336-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2006-02-09	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077336-002	METFORMIN HYDROCHLORIDE	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	2006-02-09	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077336-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2006-02-09	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077336-002	METFORMIN HYDROCHLORIDE	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	2006-02-09	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A077336-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2006-02-09	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A077336-002	METFORMIN HYDROCHLORIDE	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	2006-02-09	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077336-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2006-02-09	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077336-002	METFORMIN HYDROCHLORIDE	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	2006-02-09	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A077336-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2006-02-09	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A077336-002	METFORMIN HYDROCHLORIDE	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	2006-02-09	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A077336-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2006-02-09	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A077336-002	METFORMIN HYDROCHLORIDE	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	2006-02-09	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A077336-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2006-02-09	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A077336-002	METFORMIN HYDROCHLORIDE	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	2006-02-09	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A077336-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2006-02-09	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A077336-002	METFORMIN HYDROCHLORIDE	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	2006-02-09	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A077336-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2006-02-09	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A077336-002	METFORMIN HYDROCHLORIDE	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	2006-02-09	`782e0a99824c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 76 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2025-08-23 18:47 UTC	2025-08	A077336-001	AB1	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077336-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077336-001	AB1	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077336-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077336-001	AB1	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077336-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077336-001	AB1	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077336-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077336-001	AB1	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077336-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077336-001	AB1	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077336-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077336-001	AB1	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077336-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077336-001	AB1	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077336-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077336-001	AB1	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077336-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077336-001	AB1	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077336-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077336-001	AB1	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077336-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A077336-001	AB1	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A077336-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077336-001	AB1	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077336-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A077336-001	AB1	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A077336-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A077336-001	AB1	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A077336-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A077336-001	AB1	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A077336-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A077336-001	AB1	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A077336-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A077336-001	AB1	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A077336-002	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A077336-001	AB1	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A077336-002	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A077336-001	AB1	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A077336-002	AB	1	`5aa47cf7b7d7…`

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDC	Effective	Related label
63629-2883-1	2020-10-12	These highlights do not include all the information needed to use METFORMIN HYDROCHLORIDE EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for METFORMIN HYDROCHLORIDE EXTENDED-RELEASE TABLETS. METFORMIN HYDROCHLORIDE extended-release tablets, for oral use Initial U.S. Approval: 1995
63629-2883-2	2020-10-12	These highlights do not include all the information needed to use METFORMIN HYDROCHLORIDE EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for METFORMIN HYDROCHLORIDE EXTENDED-RELEASE TABLETS. METFORMIN HYDROCHLORIDE extended-release tablets, for oral use Initial U.S. Approval: 1995
63629-2883-3	2020-10-12	These highlights do not include all the information needed to use METFORMIN HYDROCHLORIDE EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for METFORMIN HYDROCHLORIDE EXTENDED-RELEASE TABLETS. METFORMIN HYDROCHLORIDE extended-release tablets, for oral use Initial U.S. Approval: 1995
63629-2883-4	2020-10-12	These highlights do not include all the information needed to use METFORMIN HYDROCHLORIDE EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for METFORMIN HYDROCHLORIDE EXTENDED-RELEASE TABLETS. METFORMIN HYDROCHLORIDE extended-release tablets, for oral use Initial U.S. Approval: 1995
63629-2883-5	2020-10-12	These highlights do not include all the information needed to use METFORMIN HYDROCHLORIDE EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for METFORMIN HYDROCHLORIDE EXTENDED-RELEASE TABLETS. METFORMIN HYDROCHLORIDE extended-release tablets, for oral use Initial U.S. Approval: 1995
63629-2883-6	2020-10-12	These highlights do not include all the information needed to use METFORMIN HYDROCHLORIDE EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for METFORMIN HYDROCHLORIDE EXTENDED-RELEASE TABLETS. METFORMIN HYDROCHLORIDE extended-release tablets, for oral use Initial U.S. Approval: 1995
63629-2883-7	2020-10-12	These highlights do not include all the information needed to use METFORMIN HYDROCHLORIDE EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for METFORMIN HYDROCHLORIDE EXTENDED-RELEASE TABLETS. METFORMIN HYDROCHLORIDE extended-release tablets, for oral use Initial U.S. Approval: 1995
63629-2883-8	2020-10-12	These highlights do not include all the information needed to use METFORMIN HYDROCHLORIDE EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for METFORMIN HYDROCHLORIDE EXTENDED-RELEASE TABLETS. METFORMIN HYDROCHLORIDE extended-release tablets, for oral use Initial U.S. Approval: 1995
63629-2883-1	2020-01-31	These highlights do not include all the information needed to use METFORMIN HYDROCHLORIDE EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for METFORMIN HYDROCHLORIDE EXTENDED-RELEASE TABLETS. METFORMIN HYDROCHLORIDE extended-release tablets, for oral use Initial U.S. Approval: 1995
63629-2883-2	2020-01-31	These highlights do not include all the information needed to use METFORMIN HYDROCHLORIDE EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for METFORMIN HYDROCHLORIDE EXTENDED-RELEASE TABLETS. METFORMIN HYDROCHLORIDE extended-release tablets, for oral use Initial U.S. Approval: 1995
63629-2883-3	2020-01-31	These highlights do not include all the information needed to use METFORMIN HYDROCHLORIDE EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for METFORMIN HYDROCHLORIDE EXTENDED-RELEASE TABLETS. METFORMIN HYDROCHLORIDE extended-release tablets, for oral use Initial U.S. Approval: 1995
63629-2883-4	2020-01-31	These highlights do not include all the information needed to use METFORMIN HYDROCHLORIDE EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for METFORMIN HYDROCHLORIDE EXTENDED-RELEASE TABLETS. METFORMIN HYDROCHLORIDE extended-release tablets, for oral use Initial U.S. Approval: 1995
63629-2883-5	2020-01-31	These highlights do not include all the information needed to use METFORMIN HYDROCHLORIDE EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for METFORMIN HYDROCHLORIDE EXTENDED-RELEASE TABLETS. METFORMIN HYDROCHLORIDE extended-release tablets, for oral use Initial U.S. Approval: 1995
63629-2883-6	2020-01-31	These highlights do not include all the information needed to use METFORMIN HYDROCHLORIDE EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for METFORMIN HYDROCHLORIDE EXTENDED-RELEASE TABLETS. METFORMIN HYDROCHLORIDE extended-release tablets, for oral use Initial U.S. Approval: 1995
63629-2883-7	2020-01-31	These highlights do not include all the information needed to use METFORMIN HYDROCHLORIDE EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for METFORMIN HYDROCHLORIDE EXTENDED-RELEASE TABLETS. METFORMIN HYDROCHLORIDE extended-release tablets, for oral use Initial U.S. Approval: 1995
63629-2883-8	2020-01-31	These highlights do not include all the information needed to use METFORMIN HYDROCHLORIDE EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for METFORMIN HYDROCHLORIDE EXTENDED-RELEASE TABLETS. METFORMIN HYDROCHLORIDE extended-release tablets, for oral use Initial U.S. Approval: 1995

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
63629-2883-1	EA - Each	63629-2883	585dc830-e28d-471a-a859-f345ccd513c9	1	2012-07-24
63629-2883-2	EA - Each	63629-2883	624350d4-57f6-46bc-b0f5-f36d61f70f3e	1	2012-07-24
63629-2883-3	EA - Each	63629-2883	d18806cf-aabb-425b-b00f-9654bc6a3591	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 TABLET, EXTENDED RELEASE [BRYANT RANCH PREPACK]	2
METFORMIN	ACTIVE MOIETY	9100L32L2N	METFORMIN HYDROCHLORIDE TABLET, EXTENDED RELEASE [BRYANT RANCH PREPACK]	2
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	METFORMIN HYDROCHLORIDE TABLET, EXTENDED RELEASE [BRYANT RANCH PREPACK]	2
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	METFORMIN HYDROCHLORIDE TABLET, EXTENDED RELEASE [BRYANT RANCH PREPACK]	2
POVIDONES	INACTIVE INGREDIENT	FZ989GH94E	METFORMIN HYDROCHLORIDE TABLET, EXTENDED RELEASE [BRYANT RANCH PREPACK]	2
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	METFORMIN HYDROCHLORIDE TABLET, EXTENDED RELEASE [BRYANT RANCH PREPACK]	2
SODIUM CARBONATE	INACTIVE INGREDIENT	45P3261C7T	METFORMIN HYDROCHLORIDE TABLET, EXTENDED RELEASE [BRYANT RANCH PREPACK]	2
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	METFORMIN HYDROCHLORIDE TABLET, EXTENDED RELEASE [BRYANT RANCH PREPACK]	2
XANTHAN GUM	INACTIVE INGREDIENT	TTV12P4NEE	METFORMIN HYDROCHLORIDE TABLET, EXTENDED RELEASE [BRYANT RANCH PREPACK]	2

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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	Sun Pharmaceutical Industries, Inc.	41a8bb80-7b0b-476c-8134-5d161c3239c8	2026-06-25	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077336 application number: ANDA077336
METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	Aphena Pharma Solutions - Tennessee, LLC	439bb230-94d8-4522-ad79-5cce5fad965b	2021-04-27	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077336 application number: ANDA077336

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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
63629-2883-4	63629288304	90 TABLET, EXTENDED RELEASE in 1 BOTTLE (63629-2883-4)	2010-07-01	0000-00-00	No	No	Current