METFORMIN HYDROCHLORIDE

Product NDC: 68071-2490
Requested package NDC: 68071-2490-1
11-digit product format: 680712490
Labeler code: 68071
Product ID: 68071-2490_c8bec3df-8c81-35b2-e053-2a95a90a717d
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: METFORMIN HYDROCHLORIDE
Dosage form: TABLET
Route: ORAL
Labeler: NuCare Pharmaceuticals,Inc.
Application: ANDA203769
Marketing category: ANDA
Marketing start: 2015-02-01
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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	68071-2490	68071-2490-1	D	Discontinued by firm		2026-10-21

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 · 15 matching rows.

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

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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

Orange Book products#

Current product rows page 1 of 1 · 5 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A203769-001	METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	500MG	TABLET / ORAL	AB	2013-09-11
A203769-002	METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	850MG	TABLET / ORAL	AB	2013-09-11
A203769-003	METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	1GM	TABLET / ORAL	AB	2013-09-11
A203769-004	METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	625MG	TABLET / ORAL	AB	2026-02-09
A203769-005	METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	750MG	TABLET / ORAL	AB	2026-02-09

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 5 matching rows.

Application-product, TE code table
Application-product	TE code
A203769-001	AB
A203769-002	AB
A203769-003	AB
A203769-004	AB
A203769-005	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 4 · 142 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
2026-10-15 13:18:30	2026-09	A203769-001	METFORMIN HYDROCHLORIDE	500MG	TABLET / ORAL	AB	2013-09-11	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A203769-002	METFORMIN HYDROCHLORIDE	850MG	TABLET / ORAL	AB	2013-09-11	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A203769-003	METFORMIN HYDROCHLORIDE	1GM	TABLET / ORAL	AB	2013-09-11	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A203769-004	METFORMIN HYDROCHLORIDE	625MG	TABLET / ORAL	AB	2026-02-09	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A203769-005	METFORMIN HYDROCHLORIDE	750MG	TABLET / ORAL	AB	2026-02-09	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A203769-001	METFORMIN HYDROCHLORIDE	500MG	TABLET / ORAL	AB	2013-09-11	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A203769-002	METFORMIN HYDROCHLORIDE	850MG	TABLET / ORAL	AB	2013-09-11	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A203769-003	METFORMIN HYDROCHLORIDE	1GM	TABLET / ORAL	AB	2013-09-11	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A203769-004	METFORMIN HYDROCHLORIDE	625MG	TABLET / ORAL	AB	2026-02-09	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A203769-005	METFORMIN HYDROCHLORIDE	750MG	TABLET / ORAL	AB	2026-02-09	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A203769-001	METFORMIN HYDROCHLORIDE	500MG	TABLET / ORAL	AB	2013-09-11	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A203769-002	METFORMIN HYDROCHLORIDE	850MG	TABLET / ORAL	AB	2013-09-11	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A203769-003	METFORMIN HYDROCHLORIDE	1GM	TABLET / ORAL	AB	2013-09-11	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A203769-004	METFORMIN HYDROCHLORIDE	625MG	TABLET / ORAL	AB	2026-02-09	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A203769-005	METFORMIN HYDROCHLORIDE	750MG	TABLET / ORAL	AB	2026-02-09	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A203769-001	METFORMIN HYDROCHLORIDE	500MG	TABLET / ORAL	AB	2013-09-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203769-002	METFORMIN HYDROCHLORIDE	850MG	TABLET / ORAL	AB	2013-09-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203769-003	METFORMIN HYDROCHLORIDE	1GM	TABLET / ORAL	AB	2013-09-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203769-004	METFORMIN HYDROCHLORIDE	625MG	TABLET / ORAL	AB	2026-02-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203769-005	METFORMIN HYDROCHLORIDE	750MG	TABLET / ORAL	AB	2026-02-09	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203769-001	METFORMIN HYDROCHLORIDE	500MG	TABLET / ORAL	AB	2013-09-11	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203769-002	METFORMIN HYDROCHLORIDE	850MG	TABLET / ORAL	AB	2013-09-11	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203769-003	METFORMIN HYDROCHLORIDE	1GM	TABLET / ORAL	AB	2013-09-11	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A203769-001	METFORMIN HYDROCHLORIDE	500MG	TABLET / ORAL	AB	2013-09-11	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203769-002	METFORMIN HYDROCHLORIDE	850MG	TABLET / ORAL	AB	2013-09-11	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203769-003	METFORMIN HYDROCHLORIDE	1GM	TABLET / ORAL	AB	2013-09-11	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203769-001	METFORMIN HYDROCHLORIDE	500MG	TABLET / ORAL	AB	2013-09-11	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203769-002	METFORMIN HYDROCHLORIDE	850MG	TABLET / ORAL	AB	2013-09-11	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203769-003	METFORMIN HYDROCHLORIDE	1GM	TABLET / ORAL	AB	2013-09-11	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203769-001	METFORMIN HYDROCHLORIDE	500MG	TABLET / ORAL	AB	2013-09-11	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203769-002	METFORMIN HYDROCHLORIDE	850MG	TABLET / ORAL	AB	2013-09-11	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203769-003	METFORMIN HYDROCHLORIDE	1GM	TABLET / ORAL	AB	2013-09-11	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203769-001	METFORMIN HYDROCHLORIDE	500MG	TABLET / ORAL	AB	2013-09-11	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203769-002	METFORMIN HYDROCHLORIDE	850MG	TABLET / ORAL	AB	2013-09-11	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203769-003	METFORMIN HYDROCHLORIDE	1GM	TABLET / ORAL	AB	2013-09-11	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203769-001	METFORMIN HYDROCHLORIDE	500MG	TABLET / ORAL	AB	2013-09-11	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203769-002	METFORMIN HYDROCHLORIDE	850MG	TABLET / ORAL	AB	2013-09-11	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203769-003	METFORMIN HYDROCHLORIDE	1GM	TABLET / ORAL	AB	2013-09-11	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203769-001	METFORMIN HYDROCHLORIDE	500MG	TABLET / ORAL	AB	2013-09-11	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203769-002	METFORMIN HYDROCHLORIDE	850MG	TABLET / ORAL	AB	2013-09-11	`5bbf6a4d5a75…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 142 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-10-15 13:18:30	2026-09	A203769-001	AB	1	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A203769-002	AB	1	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A203769-003	AB	1	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A203769-004	AB	1	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A203769-005	AB	1	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A203769-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A203769-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A203769-003	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A203769-004	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A203769-005	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A203769-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A203769-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A203769-003	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A203769-004	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A203769-005	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A203769-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203769-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203769-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203769-004	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203769-005	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203769-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203769-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203769-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A203769-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203769-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203769-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203769-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203769-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203769-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203769-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203769-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203769-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203769-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203769-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203769-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203769-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203769-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203769-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203769-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203769-002	AB	1	`5bbf6a4d5a75…`

Reported adverse events (FAERS/openFDA)#

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
68071-2490-1	2023-01-30	C162847	48780-1	f386c649-a924-0266-e053-dadaa90a7c1a	These highlights do not include all the information needed to use METFORMIN HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for METFORMIN HYDROCHLORIDE TABLETS. METFORMIN HYDROCHLORIDE tablets, for oral use Initial U.S. Approval: 1995

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68071-2490	METFORMIN HYDROCHLORIDE TABLET [NUCARE PHARMACEUTICALS,INC.]	1	Legacy NDC	20210805_c8bead24-46f8-d06d-e053-2a95a90a2037.zip

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 2 of 2 · 27 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	Bryant Ranch Prepack	76879512-3ab4-4acf-92e6-bba0fb75dd0e	2023-03-10	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203769 application number: ANDA203769
METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	Bryant Ranch Prepack	a59327bd-a3ba-417b-9e91-4cd3a941e640	2023-03-10	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203769 application number: ANDA203769
METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	Bryant Ranch Prepack	a79d2674-071f-4641-9b11-406e02c5530a	2023-03-10	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203769 application number: ANDA203769
METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	Aphena Pharma Solutions - Tennessee, LLC	d0bee456-c8cd-46a1-acb3-5313a8cddd30	2022-11-03	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203769 application number: ANDA203769
Metformin Hydrochloride	METFORMIN HYDROCHLORIDE	Proficient Rx LP	738402d6-3700-46b2-a90c-2e8f2c354a39	2022-03-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203769 application number: ANDA203769
METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	Bryant Ranch Prepack	9632456f-57c2-444b-9f43-d9ca862681fe	2021-03-10	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203769 application number: ANDA203769
METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	ACI Healthcare USA, Inc.	e18b60f9-721e-4db6-9f61-d3437e18faf2	2020-12-26	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203769 application number: ANDA203769

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
68071-2490-1	68071249001	100 TABLET in 1 BOTTLE (68071-2490-1)	100 tablet	2021-08-04	0000-00-00	No	No	Current