Metformin Hydrochloride

Product NDC: 50090-0771
11-digit product format: 500900771
Labeler code: 50090
Product ID: 50090-0771_dac7a5c5-35ac-444d-a40e-a46c0bb39952
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Metformin Hydrochloride
Dosage form: TABLET
Route: ORAL
Labeler: A-S Medication Solutions
Application: ANDA075967
Marketing category: ANDA
Marketing start: 2002-01-29
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 · 4 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	50090-0771		D	Discontinued by firm	2026-10-05
excluded package	package	50090-0771	50090-0771-3	D	Discontinued by firm	2026-10-05
excluded package	package	50090-0771	50090-0771-5	D	Discontinued by firm	2026-10-05
excluded package	package	50090-0771	50090-0771-6	D	Discontinued by firm	2026-10-05

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 · 28 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 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	50090-0771-6	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	50090-0771-5	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	50090-0771-3	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	50090-0771-6	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	50090-0771-5	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	50090-0771-3	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	50090-0771-5	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	50090-0771-6	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	50090-0771-5	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	50090-0771-6	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	50090-0771-5	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	50090-0771-6	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	50090-0771-5	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	50090-0771-6	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	50090-0771-5	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	50090-0771-6	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	50090-0771-5	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	50090-0771-6	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	50090-0771-5	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	50090-0771-6	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	50090-0771-5	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	50090-0771-6	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	50090-0771-5	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	50090-0771-6	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	50090-0771-5	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	50090-0771-6	`557ba5c1ecfa…`	`9c80585c8c6e…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	Approval date
A075967-001	METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	500MG	TABLET / ORAL	2002-01-29
A075967-002	METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	850MG	TABLET / ORAL	2002-01-29
A075967-003	METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	1GM	TABLET / ORAL	2002-01-29

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 · 129 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A075967-001	METFORMIN HYDROCHLORIDE	500MG	TABLET / ORAL	2002-01-29	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A075967-002	METFORMIN HYDROCHLORIDE	850MG	TABLET / ORAL	2002-01-29	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A075967-003	METFORMIN HYDROCHLORIDE	1GM	TABLET / ORAL	2002-01-29	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A075967-001	METFORMIN HYDROCHLORIDE	500MG	TABLET / ORAL	2002-01-29	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A075967-002	METFORMIN HYDROCHLORIDE	850MG	TABLET / ORAL	2002-01-29	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A075967-003	METFORMIN HYDROCHLORIDE	1GM	TABLET / ORAL	2002-01-29	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A075967-001	METFORMIN HYDROCHLORIDE	500MG	TABLET / ORAL	2002-01-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075967-002	METFORMIN HYDROCHLORIDE	850MG	TABLET / ORAL	2002-01-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075967-003	METFORMIN HYDROCHLORIDE	1GM	TABLET / ORAL	2002-01-29	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075967-001	METFORMIN HYDROCHLORIDE	500MG	TABLET / ORAL	2002-01-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075967-002	METFORMIN HYDROCHLORIDE	850MG	TABLET / ORAL	2002-01-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075967-003	METFORMIN HYDROCHLORIDE	1GM	TABLET / ORAL	2002-01-29	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075967-001	METFORMIN HYDROCHLORIDE	500MG	TABLET / ORAL	2002-01-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075967-002	METFORMIN HYDROCHLORIDE	850MG	TABLET / ORAL	2002-01-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075967-003	METFORMIN HYDROCHLORIDE	1GM	TABLET / ORAL	2002-01-29	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075967-001	METFORMIN HYDROCHLORIDE	500MG	TABLET / ORAL	2002-01-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075967-002	METFORMIN HYDROCHLORIDE	850MG	TABLET / ORAL	2002-01-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075967-003	METFORMIN HYDROCHLORIDE	1GM	TABLET / ORAL	2002-01-29	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075967-001	METFORMIN HYDROCHLORIDE	500MG	TABLET / ORAL	2002-01-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075967-002	METFORMIN HYDROCHLORIDE	850MG	TABLET / ORAL	2002-01-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075967-003	METFORMIN HYDROCHLORIDE	1GM	TABLET / ORAL	2002-01-29	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075967-001	METFORMIN HYDROCHLORIDE	500MG	TABLET / ORAL	2002-01-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075967-002	METFORMIN HYDROCHLORIDE	850MG	TABLET / ORAL	2002-01-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075967-003	METFORMIN HYDROCHLORIDE	1GM	TABLET / ORAL	2002-01-29	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075967-001	METFORMIN HYDROCHLORIDE	500MG	TABLET / ORAL	2002-01-29	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075967-002	METFORMIN HYDROCHLORIDE	850MG	TABLET / ORAL	2002-01-29	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075967-003	METFORMIN HYDROCHLORIDE	1GM	TABLET / ORAL	2002-01-29	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075967-001	METFORMIN HYDROCHLORIDE	500MG	TABLET / ORAL	2002-01-29	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075967-002	METFORMIN HYDROCHLORIDE	850MG	TABLET / ORAL	2002-01-29	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075967-003	METFORMIN HYDROCHLORIDE	1GM	TABLET / ORAL	2002-01-29	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075967-001	METFORMIN HYDROCHLORIDE	500MG	TABLET / ORAL	2002-01-29	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075967-002	METFORMIN HYDROCHLORIDE	850MG	TABLET / ORAL	2002-01-29	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075967-003	METFORMIN HYDROCHLORIDE	1GM	TABLET / ORAL	2002-01-29	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075967-001	METFORMIN HYDROCHLORIDE	500MG	TABLET / ORAL	2002-01-29	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A075967-002	METFORMIN HYDROCHLORIDE	850MG	TABLET / ORAL	2002-01-29	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A075967-003	METFORMIN HYDROCHLORIDE	1GM	TABLET / ORAL	2002-01-29	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075967-001	METFORMIN HYDROCHLORIDE	500MG	TABLET / ORAL	2002-01-29	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075967-002	METFORMIN HYDROCHLORIDE	850MG	TABLET / ORAL	2002-01-29	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075967-003	METFORMIN HYDROCHLORIDE	1GM	TABLET / ORAL	2002-01-29	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075967-001	METFORMIN HYDROCHLORIDE	500MG	TABLET / ORAL	2002-01-29	`301d65b070ca…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 63 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075967-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075967-002	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075967-003	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A075967-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A075967-002	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A075967-003	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A075967-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A075967-002	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A075967-003	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A075967-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A075967-002	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A075967-003	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A075967-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A075967-002	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A075967-003	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A075967-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A075967-002	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A075967-003	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A075967-001	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A075967-002	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A075967-003	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A075967-001	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A075967-002	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A075967-003	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A075967-001	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A075967-002	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A075967-003	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A075967-001	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A075967-002	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A075967-003	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A075967-001	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A075967-002	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A075967-003	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A075967-001	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A075967-002	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A075967-003	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A075967-001	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A075967-002	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A075967-003	AB	1	`ea99ee380514…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A075967-001	AB	1	`a67488948f0b…`

Reported adverse events (FAERS/openFDA)#

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDC	Effective	Related label
50090-0771-3	2023-02-07	Metformin Hydrochloride Tablets, USP
50090-0771-5	2023-02-07	Metformin Hydrochloride Tablets, USP
50090-0771-6	2023-02-07	Metformin Hydrochloride Tablets, USP
50090-0771-3	2023-01-30	Metformin Hydrochloride Tablets, USP
50090-0771-5	2023-01-30	Metformin Hydrochloride Tablets, USP
50090-0771-6	2023-01-30	Metformin Hydrochloride Tablets, USP

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
50090-0771	METFORMIN HYDROCHLORIDE TABLET [A-S MEDICATION SOLUTIONS]	19	Legacy NDC	20230208_ceaf66c9-2aaf-4a5c-a390-1228d7d19838.zip

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	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
50090-0771-3	50090077103	100 TABLET in 1 BOTTLE (50090-0771-3)	100 tablet	2014-11-28	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Metformin Hydrochloride Tablets, USP	A-S Medication Solutions	2023-02-04	HUMAN PRESCRIPTION DRUG LABEL	19