Metformin

Product NDC: 67046-0437
11-digit product format: 670460437
Labeler code: 67046
Product ID: 67046-0437_54621fa0-7774-0487-e063-6294a90a722d
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Metformin ER 500 mg
Dosage form: TABLET, EXTENDED RELEASE
Route: ORAL
Labeler: Coupler LLC
Application: ANDA209313
Marketing category: ANDA
Marketing start: 2026-06-16
Substance: METFORMIN HYDROCHLORIDE
Active strength: 500 mg/1
Pharmacologic classes: Biguanide [EPC], Biguanides [CS]
NDC exclude flag: No
Listing certified through: 2027-12-31
Current FDA listing: Yes

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

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A209313-001	METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB1		2018-03-16
A209313-002	METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	750MG	TABLET, EXTENDED RELEASE / ORAL	AB		2018-03-16

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
A209313-001	AB1
A209313-002	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 3 · 86 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
2026-09-14 22:38:34	2026-08	A209313-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2018-03-16	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A209313-002	METFORMIN HYDROCHLORIDE	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-03-16	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A209313-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2018-03-16	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A209313-002	METFORMIN HYDROCHLORIDE	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-03-16	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A209313-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2018-03-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209313-002	METFORMIN HYDROCHLORIDE	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-03-16	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209313-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2018-03-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209313-002	METFORMIN HYDROCHLORIDE	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-03-16	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A209313-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2018-03-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A209313-002	METFORMIN HYDROCHLORIDE	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-03-16	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209313-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2018-03-16	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209313-002	METFORMIN HYDROCHLORIDE	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-03-16	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209313-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2018-03-16	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209313-002	METFORMIN HYDROCHLORIDE	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-03-16	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209313-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2018-03-16	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209313-002	METFORMIN HYDROCHLORIDE	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-03-16	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209313-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2018-03-16	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209313-002	METFORMIN HYDROCHLORIDE	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-03-16	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209313-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2018-03-16	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209313-002	METFORMIN HYDROCHLORIDE	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-03-16	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209313-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2018-03-16	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209313-002	METFORMIN HYDROCHLORIDE	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-03-16	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A209313-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2018-03-16	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A209313-002	METFORMIN HYDROCHLORIDE	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-03-16	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209313-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2018-03-16	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209313-002	METFORMIN HYDROCHLORIDE	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-03-16	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209313-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2018-03-16	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209313-002	METFORMIN HYDROCHLORIDE	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-03-16	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209313-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2018-03-16	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209313-002	METFORMIN HYDROCHLORIDE	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-03-16	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A209313-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2018-03-16	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A209313-002	METFORMIN HYDROCHLORIDE	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-03-16	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A209313-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2018-03-16	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A209313-002	METFORMIN HYDROCHLORIDE	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-03-16	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A209313-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2018-03-16	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A209313-002	METFORMIN HYDROCHLORIDE	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-03-16	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A209313-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2018-03-16	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A209313-002	METFORMIN HYDROCHLORIDE	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-03-16	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A209313-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2018-03-16	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A209313-002	METFORMIN HYDROCHLORIDE	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-03-16	`74a2ff9319b5…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 86 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A209313-001	AB1	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A209313-002	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A209313-001	AB1	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A209313-002	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A209313-001	AB1	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209313-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209313-001	AB1	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209313-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A209313-001	AB1	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A209313-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209313-001	AB1	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209313-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209313-001	AB1	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209313-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209313-001	AB1	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209313-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209313-001	AB1	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209313-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209313-001	AB1	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209313-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209313-001	AB1	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209313-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A209313-001	AB1	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A209313-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209313-001	AB1	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209313-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209313-001	AB1	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209313-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209313-001	AB1	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209313-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A209313-001	AB1	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A209313-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A209313-001	AB1	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A209313-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A209313-001	AB1	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A209313-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A209313-001	AB1	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A209313-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A209313-001	AB1	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A209313-002	AB	1	`74a2ff9319b5…`

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
METFORMIN HYDROCHLORIDE	500 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 RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
860975	Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
Identifier	FDA.report destination
54620ea3-da64-c5d7-e063-6394a90ad14a	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 · 15 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Metformin	METFORMIN ER 500 MG	REMEDYREPACK INC.	05999192-ebc6-4198-bd1e-f46abbfb4f8a	2026-09-09	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209313 application number: ANDA209313
Metformin ER 500 mg	METFORMIN ER 500 MG	Granules India Ltd	b857eccf-b9ff-45ba-8241-f47f5caada2a	2026-07-17	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209313 application number: ANDA209313
Metformin	METFORMIN ER 500 MG	Coupler LLC	54620ea3-da64-c5d7-e063-6394a90ad14a	2026-06-16	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209313 application number: ANDA209313 ndc (product): 67046-0437
Metformin	METFORMIN ER 500 MG	Granules Pharmaceuticals Inc.	6d6ee6f8-9650-ff4f-e053-2991aa0acf19	2026-04-30	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209313 application number: ANDA209313
Metformin	METFORMIN ER 500 MG	Bryant Ranch Prepack	c047cf64-467a-40f3-be46-a1926b3b8d56	2026-03-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209313 application number: ANDA209313
Metformin	METFORMIN ER 500 MG	Legacy Pharmaceutical Packaging, LLC	d9e0816d-fd61-1ac2-e053-2995a90a4054	2026-03-11	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209313 application number: ANDA209313
Metformin ER 500 mg	METFORMIN ER 500 MG	Quallent Pharmaceuticals Health LLC	ff196435-14f4-8b9d-e053-6294a90a4ee8	2025-12-04	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209313 application number: ANDA209313
Metformin	METFORMIN ER 500 MG	A-S Medication Solutions	fdd3481c-aaec-47ac-9790-01de68b2e253	2025-01-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209313 application number: ANDA209313
Metformin	METFORMIN ER 750 MG	Bryant Ranch Prepack	f1058475-1318-49a0-89ce-da06692b0e5b	2024-11-25	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209313 application number: ANDA209313
Metformin	METFORMIN ER 500 MG	Proficient Rx LP	92855c8d-59be-458b-97f1-2ff11b9bf6b0	2024-11-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209313 application number: ANDA209313
Metformin	METFORMIN ER 750 MG	A-S Medication Solutions	9e3791fb-9a34-4982-8164-0502fa398b01	2024-10-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209313 application number: ANDA209313
Metformin	METFORMIN ER 750 MG	A-S Medication Solutions	953404a4-0f03-42f1-8136-43238dad11f4	2024-10-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209313 application number: ANDA209313
Metformin	METFORMIN ER 500 MG	Bryant Ranch Prepack	1f823d36-c7a6-4cf8-b6f1-52b7a51c8fc4	2024-08-26	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209313 application number: ANDA209313
Metformin	METFORMIN ER 500 MG	A-S Medication Solutions	c6fddb05-6b9b-4088-8ce7-17fb94c13cc2	2024-06-14	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209313 application number: ANDA209313
Metformin	METFORMIN ER 500 MG	Aphena Pharma Solutions - Tennessee, LLC	5c10eaa2-d6ba-446a-8f16-f5a8ca7223d7	2024-06-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209313 application number: ANDA209313

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	Exclude flag	Status
67046-0437-3	67046043703	30 TABLET, EXTENDED RELEASE in 1 BLISTER PACK (67046-0437-3)	2026-06-16	No	No	Current