Metformin Hydrochloride

Product NDC: 68071-3226
11-digit product format: 680713226
Labeler code: 68071
Product ID: 68071-3226_51c9dd57-e17e-5558-e054-00144ff8d46c
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Metformin Hydrochloride
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: NuCare Pharmaceuticals, Inc.
Application: ANDA075978
Marketing category: ANDA
Marketing start: 2002-01-28
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: 2019-12-31
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 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	68071-3226		D	Discontinued by firm		2026-08-11
excluded package	package	68071-3226	68071-3226-1	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 · 24 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	68071-3226-1	`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	68071-3226-1	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	68071-3226-1	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	68071-3226-1	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	68071-3226-1	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	68071-3226-1	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	68071-3226-1	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	68071-3226-1	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	68071-3226-1	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	68071-3226-1	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	68071-3226-1	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	68071-3226-1	`557ba5c1ecfa…`	`9c80585c8c6e…`

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

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
A075978-001	METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	500MG	TABLET / ORAL	2002-01-25
A075978-002	METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	850MG	TABLET / ORAL	2002-01-25
A075978-003	METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	1GM	TABLET / ORAL	2002-11-05

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 · 123 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A075978-001	METFORMIN HYDROCHLORIDE	500MG	TABLET / ORAL	2002-01-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075978-002	METFORMIN HYDROCHLORIDE	850MG	TABLET / ORAL	2002-01-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075978-003	METFORMIN HYDROCHLORIDE	1GM	TABLET / ORAL	2002-11-05	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075978-001	METFORMIN HYDROCHLORIDE	500MG	TABLET / ORAL	2002-01-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075978-002	METFORMIN HYDROCHLORIDE	850MG	TABLET / ORAL	2002-01-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075978-003	METFORMIN HYDROCHLORIDE	1GM	TABLET / ORAL	2002-11-05	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075978-001	METFORMIN HYDROCHLORIDE	500MG	TABLET / ORAL	2002-01-25	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075978-002	METFORMIN HYDROCHLORIDE	850MG	TABLET / ORAL	2002-01-25	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075978-003	METFORMIN HYDROCHLORIDE	1GM	TABLET / ORAL	2002-11-05	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075978-001	METFORMIN HYDROCHLORIDE	500MG	TABLET / ORAL	2002-01-25	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075978-002	METFORMIN HYDROCHLORIDE	850MG	TABLET / ORAL	2002-01-25	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075978-003	METFORMIN HYDROCHLORIDE	1GM	TABLET / ORAL	2002-11-05	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075978-001	METFORMIN HYDROCHLORIDE	500MG	TABLET / ORAL	2002-01-25	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075978-002	METFORMIN HYDROCHLORIDE	850MG	TABLET / ORAL	2002-01-25	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075978-003	METFORMIN HYDROCHLORIDE	1GM	TABLET / ORAL	2002-11-05	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075978-001	METFORMIN HYDROCHLORIDE	500MG	TABLET / ORAL	2002-01-25	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075978-002	METFORMIN HYDROCHLORIDE	850MG	TABLET / ORAL	2002-01-25	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075978-003	METFORMIN HYDROCHLORIDE	1GM	TABLET / ORAL	2002-11-05	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075978-001	METFORMIN HYDROCHLORIDE	500MG	TABLET / ORAL	2002-01-25	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075978-002	METFORMIN HYDROCHLORIDE	850MG	TABLET / ORAL	2002-01-25	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075978-003	METFORMIN HYDROCHLORIDE	1GM	TABLET / ORAL	2002-11-05	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075978-001	METFORMIN HYDROCHLORIDE	500MG	TABLET / ORAL	2002-01-25	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075978-002	METFORMIN HYDROCHLORIDE	850MG	TABLET / ORAL	2002-01-25	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075978-003	METFORMIN HYDROCHLORIDE	1GM	TABLET / ORAL	2002-11-05	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075978-001	METFORMIN HYDROCHLORIDE	500MG	TABLET / ORAL	2002-01-25	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075978-002	METFORMIN HYDROCHLORIDE	850MG	TABLET / ORAL	2002-01-25	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075978-003	METFORMIN HYDROCHLORIDE	1GM	TABLET / ORAL	2002-11-05	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075978-001	METFORMIN HYDROCHLORIDE	500MG	TABLET / ORAL	2002-01-25	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A075978-002	METFORMIN HYDROCHLORIDE	850MG	TABLET / ORAL	2002-01-25	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A075978-003	METFORMIN HYDROCHLORIDE	1GM	TABLET / ORAL	2002-11-05	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075978-001	METFORMIN HYDROCHLORIDE	500MG	TABLET / ORAL	2002-01-25	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075978-002	METFORMIN HYDROCHLORIDE	850MG	TABLET / ORAL	2002-01-25	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075978-003	METFORMIN HYDROCHLORIDE	1GM	TABLET / ORAL	2002-11-05	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075978-001	METFORMIN HYDROCHLORIDE	500MG	TABLET / ORAL	2002-01-25	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075978-002	METFORMIN HYDROCHLORIDE	850MG	TABLET / ORAL	2002-01-25	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075978-003	METFORMIN HYDROCHLORIDE	1GM	TABLET / ORAL	2002-11-05	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075978-001	METFORMIN HYDROCHLORIDE	500MG	TABLET / ORAL	2002-01-25	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075978-002	METFORMIN HYDROCHLORIDE	850MG	TABLET / ORAL	2002-01-25	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075978-003	METFORMIN HYDROCHLORIDE	1GM	TABLET / ORAL	2002-11-05	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A075978-001	METFORMIN HYDROCHLORIDE	500MG	TABLET / ORAL	2002-01-25	`8072bd15b7f6…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2019-12-13 00:20 UTC	2019-12	A075978-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A075978-002	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A075978-003	AB	1	`74a2ff9319b5…`
2019-12-14 00:12 UTC	2019-12	A075978-001	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A075978-002	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A075978-003	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A075978-001	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A075978-002	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A075978-003	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A075978-001	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A075978-002	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A075978-003	AB	1	`ea99ee380514…`

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
68071-3226-1	2020-05-07	C162847	48780-1	9d75b9d1-0f96-f424-e053-dadaa90a57ce	METFORMIN HYDROCHLORIDE TABLETS USP, 500 mg, 850 mg, and 1000 mg 1048 1049 7214 Rx only
68071-3226-1	2020-01-31	C162847	48780-1	9d75b9d1-0f96-f424-e053-dadaa90a57ce	METFORMIN HYDROCHLORIDE TABLETS USP, 500 mg, 850 mg, and 1000 mg 1048 1049 7214 Rx only

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

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
METFORMIN HYDROCHLORIDE TABLETS USP, 500 mg, 850 mg, and 1000 mg 1048 1049 7214 Rx only	NuCare Pharmaceuticals, Inc.	2017-06-12	HUMAN PRESCRIPTION DRUG LABEL	1