Metformin Hydrochloride

Product NDC: 68071-5313
11-digit product format: 680715313
Labeler code: 68071
Product ID: 68071-5313_583f2a3a-ff6d-4534-e063-6394a90abc48
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Metformin Hydrochloride
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: NuCare Pharmaceuticals, Inc.
Application: ANDA077095
Marketing category: ANDA
Marketing start: 2024-03-29
Substance: METFORMIN HYDROCHLORIDE
Active strength: 1000 mg/1
Pharmacologic classes: Biguanide [EPC]; Biguanides [CS]
Listing certified through: 2027-12-31
Current FDA listing: Yes

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	TE codes	Approval date
A077095-001	METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	500MG	TABLET / ORAL	AB	2005-01-14
A077095-002	METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	850MG	TABLET / ORAL	AB	2005-01-14
A077095-003	METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	1GM	TABLET / ORAL	AB	2005-01-14

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-product	TE code
A077095-001	AB
A077095-002	AB
A077095-003	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 · 123 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	A077095-001	METFORMIN HYDROCHLORIDE	500MG	TABLET / ORAL	AB	2005-01-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077095-002	METFORMIN HYDROCHLORIDE	850MG	TABLET / ORAL	AB	2005-01-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077095-003	METFORMIN HYDROCHLORIDE	1GM	TABLET / ORAL	AB	2005-01-14	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077095-001	METFORMIN HYDROCHLORIDE	500MG	TABLET / ORAL	AB	2005-01-14	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077095-002	METFORMIN HYDROCHLORIDE	850MG	TABLET / ORAL	AB	2005-01-14	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077095-003	METFORMIN HYDROCHLORIDE	1GM	TABLET / ORAL	AB	2005-01-14	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077095-001	METFORMIN HYDROCHLORIDE	500MG	TABLET / ORAL	AB	2005-01-14	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077095-002	METFORMIN HYDROCHLORIDE	850MG	TABLET / ORAL	AB	2005-01-14	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077095-003	METFORMIN HYDROCHLORIDE	1GM	TABLET / ORAL	AB	2005-01-14	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077095-001	METFORMIN HYDROCHLORIDE	500MG	TABLET / ORAL	AB	2005-01-14	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077095-002	METFORMIN HYDROCHLORIDE	850MG	TABLET / ORAL	AB	2005-01-14	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077095-003	METFORMIN HYDROCHLORIDE	1GM	TABLET / ORAL	AB	2005-01-14	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077095-001	METFORMIN HYDROCHLORIDE	500MG	TABLET / ORAL	AB	2005-01-14	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077095-002	METFORMIN HYDROCHLORIDE	850MG	TABLET / ORAL	AB	2005-01-14	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077095-003	METFORMIN HYDROCHLORIDE	1GM	TABLET / ORAL	AB	2005-01-14	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077095-001	METFORMIN HYDROCHLORIDE	500MG	TABLET / ORAL	AB	2005-01-14	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077095-002	METFORMIN HYDROCHLORIDE	850MG	TABLET / ORAL	AB	2005-01-14	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077095-003	METFORMIN HYDROCHLORIDE	1GM	TABLET / ORAL	AB	2005-01-14	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077095-001	METFORMIN HYDROCHLORIDE	500MG	TABLET / ORAL	AB	2005-01-14	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077095-002	METFORMIN HYDROCHLORIDE	850MG	TABLET / ORAL	AB	2005-01-14	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077095-003	METFORMIN HYDROCHLORIDE	1GM	TABLET / ORAL	AB	2005-01-14	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077095-001	METFORMIN HYDROCHLORIDE	500MG	TABLET / ORAL	AB	2005-01-14	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077095-002	METFORMIN HYDROCHLORIDE	850MG	TABLET / ORAL	AB	2005-01-14	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077095-003	METFORMIN HYDROCHLORIDE	1GM	TABLET / ORAL	AB	2005-01-14	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077095-001	METFORMIN HYDROCHLORIDE	500MG	TABLET / ORAL	AB	2005-01-14	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077095-002	METFORMIN HYDROCHLORIDE	850MG	TABLET / ORAL	AB	2005-01-14	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077095-003	METFORMIN HYDROCHLORIDE	1GM	TABLET / ORAL	AB	2005-01-14	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077095-001	METFORMIN HYDROCHLORIDE	500MG	TABLET / ORAL	AB	2005-01-14	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077095-002	METFORMIN HYDROCHLORIDE	850MG	TABLET / ORAL	AB	2005-01-14	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077095-003	METFORMIN HYDROCHLORIDE	1GM	TABLET / ORAL	AB	2005-01-14	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077095-001	METFORMIN HYDROCHLORIDE	500MG	TABLET / ORAL	AB	2005-01-14	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077095-002	METFORMIN HYDROCHLORIDE	850MG	TABLET / ORAL	AB	2005-01-14	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077095-003	METFORMIN HYDROCHLORIDE	1GM	TABLET / ORAL	AB	2005-01-14	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077095-001	METFORMIN HYDROCHLORIDE	500MG	TABLET / ORAL	AB	2005-01-14	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077095-002	METFORMIN HYDROCHLORIDE	850MG	TABLET / ORAL	AB	2005-01-14	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077095-003	METFORMIN HYDROCHLORIDE	1GM	TABLET / ORAL	AB	2005-01-14	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077095-001	METFORMIN HYDROCHLORIDE	500MG	TABLET / ORAL	AB	2005-01-14	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077095-002	METFORMIN HYDROCHLORIDE	850MG	TABLET / ORAL	AB	2005-01-14	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077095-003	METFORMIN HYDROCHLORIDE	1GM	TABLET / ORAL	AB	2005-01-14	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A077095-001	METFORMIN HYDROCHLORIDE	500MG	TABLET / ORAL	AB	2005-01-14	`8072bd15b7f6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 123 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	A077095-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077095-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077095-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077095-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077095-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077095-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077095-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077095-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077095-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077095-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077095-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077095-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077095-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077095-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077095-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077095-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077095-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077095-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077095-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077095-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077095-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077095-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077095-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077095-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077095-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077095-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077095-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077095-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077095-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077095-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077095-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077095-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077095-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077095-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077095-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077095-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077095-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077095-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077095-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A077095-001	AB	1	`8072bd15b7f6…`

Additional Listing Data#

Finished product: Yes
Brand name base: Metformin Hydrochloride
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
METFORMIN HYDROCHLORIDE	1000 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
786Z46389E	Internal UNII lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
583f2a2e-a9d7-f266-e063-6294a90ad0ab	Available on FDA.report

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 1 · 17 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Metformin Hydrochloride	METFORMIN HYDROCHLORIDE	REMEDYREPACK INC.	5d8d654a-9bb4-4c87-ab43-c21c4e874708	2026-08-04	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077095 application number: ANDA077095
Metformin Hydrochloride	METFORMIN HYDROCHLORIDE	NuCare Pharmaceuticals, Inc.	583f2a2e-a9d7-f266-e063-6294a90ad0ab	2026-08-04	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077095 application number: ANDA077095 ndc (product): 68071-5313
Metformin Hydrochloride	METFORMIN HYDROCHLORIDE	Aurobindo Pharma Limited	4ac6d01a-af26-44e7-ae2e-3618de0080aa	2026-07-15	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077095 application number: ANDA077095
Metformin Hydrochloride	METFORMIN HYDROCHLORIDE	Aurobindo Pharma Limited	fc466c46-abaa-4675-aef2-4b1a1adfd912	2026-07-08	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077095 application number: ANDA077095
Metformin Hydrochloride	METFORMIN HYDROCHLORIDE	Bryant Ranch Prepack	fb296500-55cb-45ce-be0c-59aa2e3d4624	2026-05-21	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077095 application number: ANDA077095
Metformin Hydrochloride	METFORMIN HYDROCHLORIDE	REMEDYREPACK INC.	073cf6d9-7142-4d8b-898e-174c62a1f76f	2026-05-19	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077095 application number: ANDA077095
Metformin Hydrochloride	METFORMIN HYDROCHLORIDE	NCS HealthCare of KY, LLC dba Vangard Labs	0448c618-2f0d-4ed3-866f-74b413cf902d	2026-04-16	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077095 application number: ANDA077095
Metformin Hydrochloride	METFORMIN HYDROCHLORIDE	A-S Medication Solutions	1d7556eb-82b4-4085-b0b1-dc061b216feb	2026-02-02	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077095 application number: ANDA077095
Metformin Hydrochloride	METFORMIN HYDROCHLORIDE	Northwind Health Company, LLC	db113f46-6fac-9005-e053-2995a90a017a	2026-01-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077095 application number: ANDA077095
Metformin Hydrochloride	METFORMIN HYDROCHLORIDE	Aphena Pharma Solutions - Tennessee, LLC	3d450933-8d9d-27de-e063-6294a90ae6d9	2025-08-26	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077095 application number: ANDA077095
Metformin Hydrochloride	METFORMIN HYDROCHLORIDE	Aphena Pharma Solutions - Tennessee, LLC	3ab4efb6-bd30-2583-e063-6294a90a415b	2025-07-24	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077095 application number: ANDA077095
Metformin Hydrochloride	METFORMIN HYDROCHLORIDE	A-S Medication Solutions	23aa50c5-28fe-4322-b5c6-1f1c48409b16	2025-07-18	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077095 application number: ANDA077095
Metformin Hydrochloride	METFORMIN HYDROCHLORIDE	Aphena Pharma Solutions - Tennessee, LLC	390c3bdf-bfaf-203e-e063-6394a90a7d20	2025-07-03	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077095 application number: ANDA077095
Metformin Hydrochloride	METFORMIN HYDROCHLORIDE	NCS HealthCare of KY, LLC dba Vangard Labs	23aa0072-365c-4d13-9aa7-ae23f7e00ee4	2024-09-18	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077095 application number: ANDA077095
Metformin Hydrochloride	METFORMIN HYDROCHLORIDE	A-S Medication Solutions	1a7f7ef3-a94b-4ff6-a9f2-f5de4a99c7f6	2024-04-28	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077095 application number: ANDA077095
Metformin Hydrochloride	METFORMIN HYDROCHLORIDE	A-S Medication Solutions	afb183f6-a13c-4f00-82d5-9fe336173d34	2024-04-28	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077095 application number: ANDA077095
Metformin Hydrochloride	METFORMIN HYDROCHLORIDE	Proficient Rx LP	1b9b6db9-1bac-4252-a03c-18dc0271f05f	2023-06-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077095 application number: ANDA077095

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	Sample	Status
68071-5313-9	68071531309	90 TABLET, FILM COATED in 1 BOTTLE (68071-5313-9)	2026-08-04	0	Current