Metformin Hydrochloride

Product NDC: 0093-1049
11-digit product format: 000931049
Labeler code: 0093
Product ID: 0093-1049_fb4cc921-cebf-4294-87b7-df421d7e8892
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Metformin Hydrochloride
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Teva Pharmaceuticals USA, Inc.
Application: ANDA075978
Marketing category: ANDA
Marketing start: 2002-02-11
Marketing end: 2019-06-30
Substance: METFORMIN HYDROCHLORIDE
Active strength: 850 mg/1
Pharmacologic classes: Biguanide [EPC],Biguanides [CS]
NDC exclude flag: No
Listing certified through: 0000-00-00
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	0093-1049		D	Discontinued by firm	2026-08-11
excluded package	package	0093-1049	0093-1049-01	D	Discontinued by firm	2026-08-11
excluded package	package	0093-1049	0093-1049-10	D	Discontinued by firm	2026-08-11
excluded package	package	0093-1049	0093-1049-98	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 · 48 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	0093-1049-10	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	0093-1049-01	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	0093-1049-98	`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	0093-1049-10	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	0093-1049-01	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	0093-1049-98	`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	0093-1049-10	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	0093-1049-01	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	0093-1049-98	`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	0093-1049-10	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	0093-1049-01	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	0093-1049-98	`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	0093-1049-10	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	0093-1049-01	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	0093-1049-98	`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	0093-1049-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	0093-1049-01	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	0093-1049-98	`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	0093-1049-10	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	0093-1049-01	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	0093-1049-98	`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	0093-1049-10	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	0093-1049-01	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	0093-1049-98	`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	0093-1049-10	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	0093-1049-01	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	0093-1049-98	`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	0093-1049-10	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	0093-1049-01	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	0093-1049-98	`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	0093-1049-10	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	0093-1049-01	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	0093-1049-98	`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	0093-1049-10	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	0093-1049-01	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	0093-1049-98	`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…`

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0093-1049-01	EA - Each	0093-1049	8f3f5192-6e03-42de-9c09-f614a3c1e1dc	1	2012-07-24
0093-1049-10	EA - Each	0093-1049	2b6d40db-1027-45af-b49e-70866cb3e043	1	2012-07-24
0093-1049-98	EA - Each	0093-1049	9dde97be-f39c-440e-b696-a77a2b414d12	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, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	6
METFORMIN	ACTIVE MOIETY	9100L32L2N	METFORMIN HYDROCHLORIDE TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	6
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	METFORMIN HYDROCHLORIDE TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	6
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	METFORMIN HYDROCHLORIDE TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	6
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	METFORMIN HYDROCHLORIDE TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	6
POVIDONES	INACTIVE INGREDIENT	FZ989GH94E	METFORMIN HYDROCHLORIDE TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	6
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	METFORMIN HYDROCHLORIDE TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	6
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	METFORMIN HYDROCHLORIDE TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	6

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 HCI Tablet -Teva	NCS HealthCare of KY, Inc dba Vangard Labs	2015-12-09	HUMAN PRESCRIPTION DRUG LABEL	7