Metformin Hydrochloride

Product NDC: 55700-734
11-digit product format: 557000734
Labeler code: 55700
Product ID: 55700-734_483ff25d-a252-42e9-974d-d5d4912a80dc
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Metformin Hydrochloride
Dosage form: TABLET, EXTENDED RELEASE
Route: ORAL
Labeler: Quality Care Products, LLC
Application: ANDA078321
Marketing category: ANDA
Marketing start: 2019-03-15
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: 2022-12-31
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 · 3 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	55700-734		D	Discontinued by firm	2026-08-03
excluded package	package	55700-734	55700-734-60	D	Discontinued by firm	2026-08-03
excluded package	package	55700-734	55700-734-90	D	Discontinued by firm	2026-08-03

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 · 45 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Code	Status	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	55700-734-60	D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	55700-734-90	D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	55700-734-60	D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	55700-734-90	D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		D	Discontinued by firm	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	55700-734-60	D	Discontinued by firm	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	55700-734-90	D	Discontinued by firm	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		D	Discontinued by firm	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	55700-734-60	D	Discontinued by firm	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	55700-734-90	D	Discontinued by firm	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		D	Discontinued by firm	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	55700-734-60	D	Discontinued by firm	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	55700-734-90	D	Discontinued by firm	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		D	Discontinued by firm	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	55700-734-60	D	Discontinued by firm	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	55700-734-90	D	Discontinued by firm	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		D	Discontinued by firm	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	55700-734-60	D	Discontinued by firm	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	55700-734-90	D	Discontinued by firm	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		D	Discontinued by firm	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	55700-734-60	D	Discontinued by firm	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	55700-734-90	D	Discontinued by firm	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		I	Inactivated by FDA	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	55700-734-60	I	Inactivated by FDA	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	55700-734-90	I	Inactivated by FDA	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		I	Inactivated by FDA	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	55700-734-60	I	Inactivated by FDA	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	55700-734-90	I	Inactivated by FDA	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		I	Inactivated by FDA	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	55700-734-60	I	Inactivated by FDA	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	55700-734-90	I	Inactivated by FDA	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		I	Inactivated by FDA	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	55700-734-60	I	Inactivated by FDA	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	55700-734-90	I	Inactivated by FDA	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		I	Inactivated by FDA	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	55700-734-60	I	Inactivated by FDA	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	55700-734-90	I	Inactivated by FDA	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		I	Inactivated by FDA	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	55700-734-60	I	Inactivated by FDA	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	55700-734-90	I	Inactivated by FDA	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		I	Inactivated by FDA	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	55700-734-60	I	Inactivated by FDA	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	55700-734-90	I	Inactivated by FDA	`1332a3947898…`	`d4bfe170f9cd…`

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
A078321-001	METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB1		2008-04-17
A078321-002	METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	750MG	TABLET, EXTENDED RELEASE / ORAL	AB		2008-04-17

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
A078321-001	AB1
A078321-002	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 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	A078321-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2008-04-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078321-002	METFORMIN HYDROCHLORIDE	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	2008-04-17	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078321-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2008-04-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078321-002	METFORMIN HYDROCHLORIDE	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	2008-04-17	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078321-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2008-04-17	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078321-002	METFORMIN HYDROCHLORIDE	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	2008-04-17	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078321-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2008-04-17	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078321-002	METFORMIN HYDROCHLORIDE	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	2008-04-17	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078321-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2008-04-17	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078321-002	METFORMIN HYDROCHLORIDE	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	2008-04-17	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078321-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2008-04-17	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078321-002	METFORMIN HYDROCHLORIDE	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	2008-04-17	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078321-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2008-04-17	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078321-002	METFORMIN HYDROCHLORIDE	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	2008-04-17	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078321-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2008-04-17	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078321-002	METFORMIN HYDROCHLORIDE	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	2008-04-17	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078321-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2008-04-17	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078321-002	METFORMIN HYDROCHLORIDE	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	2008-04-17	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078321-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2008-04-17	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078321-002	METFORMIN HYDROCHLORIDE	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	2008-04-17	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078321-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2008-04-17	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078321-002	METFORMIN HYDROCHLORIDE	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	2008-04-17	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078321-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2008-04-17	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078321-002	METFORMIN HYDROCHLORIDE	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	2008-04-17	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078321-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2008-04-17	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078321-002	METFORMIN HYDROCHLORIDE	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	2008-04-17	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A078321-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2008-04-17	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A078321-002	METFORMIN HYDROCHLORIDE	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	2008-04-17	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078321-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2008-04-17	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078321-002	METFORMIN HYDROCHLORIDE	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	2008-04-17	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A078321-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2008-04-17	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A078321-002	METFORMIN HYDROCHLORIDE	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	2008-04-17	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A078321-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2008-04-17	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A078321-002	METFORMIN HYDROCHLORIDE	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	2008-04-17	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A078321-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2008-04-17	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A078321-002	METFORMIN HYDROCHLORIDE	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	2008-04-17	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A078321-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2008-04-17	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A078321-002	METFORMIN HYDROCHLORIDE	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	2008-04-17	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A078321-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2008-04-17	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A078321-002	METFORMIN HYDROCHLORIDE	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	2008-04-17	`782e0a99824c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 82 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	A078321-001	AB1	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078321-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078321-001	AB1	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078321-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078321-001	AB1	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078321-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078321-001	AB1	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078321-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078321-001	AB1	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078321-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078321-001	AB1	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078321-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078321-001	AB1	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078321-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078321-001	AB1	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078321-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078321-001	AB1	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078321-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078321-001	AB1	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078321-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078321-001	AB1	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078321-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078321-001	AB1	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078321-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078321-001	AB1	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078321-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A078321-001	AB1	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A078321-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078321-001	AB1	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078321-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A078321-001	AB1	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A078321-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A078321-001	AB1	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A078321-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A078321-001	AB1	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A078321-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A078321-001	AB1	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A078321-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A078321-001	AB1	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A078321-002	AB	1	`782e0a99824c…`

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDC	Effective	Related label
55700-734-60	2025-01-10	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
55700-734-90	2025-01-10	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
55700-734-60	2024-01-30	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
55700-734-90	2024-01-30	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
55700-734-60	EA - Each	55700-734	b4fd0bc1-ed97-40f7-886f-44b881ca6420	1	2019-06-19
55700-734-90	EA - Each	55700-734	19551865-ef51-41fd-bb6e-cea3f0dbf26f	1	2019-04-11

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 2 · 21 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.	41408f64-d366-403e-9595-464ab25c6f97	2026-07-30	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078321 application number: ANDA078321
Metformin Hydrochloride	METFORMIN HYDROCHLORIDE	PD-Rx Pharmaceuticals, Inc.	68d0b1a6-c99e-42cf-afdf-b71ee73c4424	2026-07-30	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078321 application number: ANDA078321
Metformin Hydrochloride	METFORMIN HYDROCHLORIDE	REMEDYREPACK INC.	1503bbe4-0ac5-479b-9900-d38e49236bf0	2026-07-28	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078321 application number: ANDA078321
Metformin Hydrochloride	METFORMIN HYDROCHLORIDE	Bryant Ranch Prepack	4d245bc3-0add-4651-b441-86b93c5ac681	2026-06-11	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078321 application number: ANDA078321
Metformin Hydrochloride	METFORMIN HYDROCHLORIDE	Precision Dose, Inc.	60142fb2-16da-4f54-a542-74f9a70b9c8b	2026-04-08	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078321 application number: ANDA078321
Metformin Hydrochloride	METFORMIN HYDROCHLORIDE	PD-Rx Pharmaceuticals, Inc.	1d0b74de-ef4c-4dd2-8019-2ddb409c60b4	2026-01-09	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078321 application number: ANDA078321
Metformin Hydrochloride	METFORMIN HYDROCHLORIDE	AvPAK	d9bac244-1725-5bf3-e053-2a95a90ac823	2026-01-08	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078321 application number: ANDA078321
Metformin Hydrochloride	METFORMIN HYDROCHLORIDE	AvPAK	de09f7a1-1e9f-60f4-e053-2a95a90a93d8	2026-01-08	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078321 application number: ANDA078321
Metformin Hydrochloride	METFORMIN HYDROCHLORIDE	Northwind Health Company, LLC	ab80521b-5014-cc2a-e053-2a95a90a2003	2026-01-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078321 application number: ANDA078321
Metformin Hydrochloride	METFORMIN HYDROCHLORIDE	REMEDYREPACK INC.	c568d49f-c040-4f1e-ad36-77b05ab659c3	2025-09-26	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078321 application number: ANDA078321
Metformin Hydrochloride	METFORMIN HYDROCHLORIDE	Preferred Pharmaceuticals Inc.	bf918d78-3fb6-4d8d-b42d-538ea10bc3e4	2025-08-06	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078321 application number: ANDA078321
Metformin Hydrochloride	METFORMIN HYDROCHLORIDE	Preferred Pharmaceuticals Inc.	e55ee270-5eb9-4848-8529-9af2a79669c0	2025-07-31	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078321 application number: ANDA078321
Metformin Hydrochloride	METFORMIN HYDROCHLORIDE	TAGI Pharma, Inc.	dd0ee2bf-f658-42dc-976d-49af0b1f32b5	2025-04-18	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078321 application number: ANDA078321
Metformin Hydrochloride	METFORMIN HYDROCHLORIDE	Bryant Ranch Prepack	de4a660b-172b-4c72-9e38-5634fd03cfa7	2025-03-10	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078321 application number: ANDA078321
Metformin Hydrochloride	METFORMIN HYDROCHLORIDE	Proficient Rx LP	7cb47c3e-6657-4c11-8aa2-ae172e5a8529	2025-02-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078321 application number: ANDA078321
Metformin Hydrochloride	METFORMIN HYDROCHLORIDE	RedPharm Drug, Inc.	fc61bafa-a506-14ae-e053-6394a90a9c7d	2025-01-23	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078321 application number: ANDA078321
METFORMIN HYDROCHLORIDE EXTENDED RELEASE	METFORMIN HYDROCHLORIDE	direct rx	a84cf1a3-3820-cd1b-e053-2995a90acf45	2025-01-22	Warnings	Exact identifier application applno (ANDA): 078321 application number: ANDA078321
Metformin Hydrochloride Extended-Release 500mg	METFORMIN HYDROCHLORIDE	Calvin Scott & Co., Inc.	e9cd0d23-56eb-40dd-abf4-9e681ec220f5	2023-02-07	Warnings	Exact identifier application applno (ANDA): 078321 application number: ANDA078321
Metformin Hydrochloride	METFORMIN HYDROCHLORIDE	Proficient Rx LP	d80aa4af-a8ce-4cae-b71c-05e1de829551	2022-04-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078321 application number: ANDA078321
Metformin Hydrochloride	METFORMIN HYDROCHLORIDE	Aphena Pharma Solutions - Tennessee, LLC	4d89a4ab-6cdd-4c39-92f9-a137fa27a070	2021-07-02	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078321 application number: ANDA078321

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
55700-734-60	55700073460	60 TABLET, EXTENDED RELEASE in 1 BOTTLE (55700-734-60)	2019-03-15	0000-00-00	No	No	Current
55700-734-90	55700073490	90 TABLET, EXTENDED RELEASE in 1 BOTTLE (55700-734-90)	2019-03-15	0000-00-00	No	No	Current