Metformin Hydrochloride

Product NDC: 60687-640
11-digit product format: 606870640
Labeler code: 60687
Product ID: 60687-640_f1ec0615-f2e6-59c1-e053-2a95a90a3297
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Metformin Hydrochloride
Dosage form: TABLET, EXTENDED RELEASE
Route: ORAL
Labeler: American Health Packaging
Application: ANDA206145
Marketing category: ANDA
Marketing start: 2021-09-20
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: 2024-12-31
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	60687-640		D	Discontinued by firm		2026-08-17
excluded package	package	60687-640	60687-640-01	D	Discontinued by firm		2026-08-17

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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
A206145-001	METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB1		2018-10-22
A206145-002	METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2018-10-22

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A206145-001	AB1
A206145-002	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 · 84 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A206145-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB1		2018-10-22	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A206145-002	METFORMIN HYDROCHLORIDE	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2018-10-22	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A206145-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB1		2018-10-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A206145-002	METFORMIN HYDROCHLORIDE	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2018-10-22	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206145-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB1		2018-10-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206145-002	METFORMIN HYDROCHLORIDE	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2018-10-22	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A206145-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB1		2018-10-22	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A206145-002	METFORMIN HYDROCHLORIDE	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2018-10-22	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206145-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB1		2018-10-22	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206145-002	METFORMIN HYDROCHLORIDE	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2018-10-22	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206145-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB1		2018-10-22	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206145-002	METFORMIN HYDROCHLORIDE	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2018-10-22	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206145-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB1		2018-10-22	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206145-002	METFORMIN HYDROCHLORIDE	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2018-10-22	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206145-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB1		2018-10-22	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206145-002	METFORMIN HYDROCHLORIDE	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2018-10-22	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206145-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB1		2018-10-22	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206145-002	METFORMIN HYDROCHLORIDE	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2018-10-22	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206145-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB1		2018-10-22	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206145-002	METFORMIN HYDROCHLORIDE	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2018-10-22	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A206145-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB1		2018-10-22	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A206145-002	METFORMIN HYDROCHLORIDE	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2018-10-22	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A206145-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB1		2018-10-22	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A206145-002	METFORMIN HYDROCHLORIDE	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2018-10-22	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A206145-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB1		2018-10-22	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A206145-002	METFORMIN HYDROCHLORIDE	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2018-10-22	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A206145-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB1		2018-10-22	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A206145-002	METFORMIN HYDROCHLORIDE	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2018-10-22	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A206145-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB1		2018-10-22	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A206145-002	METFORMIN HYDROCHLORIDE	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2018-10-22	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A206145-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB1		2018-10-22	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A206145-002	METFORMIN HYDROCHLORIDE	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2018-10-22	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A206145-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB1		2018-10-22	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A206145-002	METFORMIN HYDROCHLORIDE	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2018-10-22	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A206145-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB1		2018-10-22	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A206145-002	METFORMIN HYDROCHLORIDE	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2018-10-22	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A206145-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB1		2018-10-22	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A206145-002	METFORMIN HYDROCHLORIDE	750MG	TABLET, EXTENDED RELEASE / ORAL	AB		2018-10-22	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A206145-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB1		2018-10-22	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A206145-002	METFORMIN HYDROCHLORIDE	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2018-10-22	`bb7c543d1eb4…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 84 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A206145-001	AB1	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A206145-002	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A206145-001	AB1	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A206145-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206145-001	AB1	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206145-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A206145-001	AB1	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A206145-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206145-001	AB1	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206145-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206145-001	AB1	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206145-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206145-001	AB1	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206145-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206145-001	AB1	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206145-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206145-001	AB1	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206145-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206145-001	AB1	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206145-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A206145-001	AB1	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A206145-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A206145-001	AB1	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A206145-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A206145-001	AB1	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A206145-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A206145-001	AB1	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A206145-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A206145-001	AB1	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A206145-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A206145-001	AB1	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A206145-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A206145-001	AB1	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A206145-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A206145-001	AB1	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A206145-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A206145-001	AB1	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A206145-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A206145-001	AB1	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A206145-002	AB	1	`bb7c543d1eb4…`

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
60687-640-01	EA - Each	60687-640	a41736dc-9cd9-4fe7-b160-af3885f3883b	1	2021-10-08
60687-640-11	EA - Each	60687-640	d6dc7311-316b-4e49-ad9a-f4c96430fa3b	1	2021-10-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
60687-640	METFORMIN HYDROCHLORIDE TABLET, EXTENDED RELEASE [AMERICAN HEALTH PACKAGING]	4	Legacy NDC	20240618_42e9644e-299d-4033-9a73-54c183d6ccea.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 1 of 1 · 11 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Metformin Hydrochloride	METFORMIN HYDROCHLORIDE	Quallent Pharmaceuticals Health LLC	6864ff5a-7512-4a4f-ad26-b2b9c5843414	2026-01-30	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206145 application number: ANDA206145
Metformin Hydrochloride	METFORMIN HYDROCHLORIDE	PD-Rx Pharmaceuticals, Inc.	64650d2c-2bec-4470-b250-29d01caa1ebe	2026-01-20	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206145 application number: ANDA206145
Metformin Hydrochloride	METFORMIN HYDROCHLORIDE	Northwind Health Company, LLC	f2a27d7a-ade4-421f-e053-2a95a90a01a9	2026-01-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206145 application number: ANDA206145
Metformin Hydrochloride	METFORMIN HYDROCHLORIDE	Northwind Health Company, LLC	f5ef117c-27ff-c21e-e053-2995a90ae145	2026-01-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206145 application number: ANDA206145
Metformin Hydrochloride	METFORMIN HYDROCHLORIDE	Ascend Laboratories, LLC	0ff1ba75-3c86-4baf-a6b1-1bb883839866	2025-12-18	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206145 application number: ANDA206145
Metformin Hydrochloride	METFORMIN HYDROCHLORIDE	A-S Medication Solutions	53ba7031-be87-47a5-ade7-494c6c489cc6	2025-08-18	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206145 application number: ANDA206145
Metformin Hydrochloride	METFORMIN HYDROCHLORIDE	A-S Medication Solutions	056072d8-6228-4914-831d-ee7c0661b742	2025-08-18	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206145 application number: ANDA206145
Metformin Hydrochloride	METFORMIN HYDROCHLORIDE	A-S Medication Solutions	d60139c2-fd35-4ab4-af7e-7410481edc2e	2023-09-18	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206145 application number: ANDA206145
Metformin Hydrochloride	METFORMIN HYDROCHLORIDE	A-S Medication Solutions	a57e2890-d83b-488c-b221-2e8f8a78ed16	2023-03-15	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206145 application number: ANDA206145
Metformin Hydrochloride	METFORMIN HYDROCHLORIDE	Proficient Rx LP	474e2900-43bf-4ebe-9d29-4a7adb8a9429	2022-11-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206145 application number: ANDA206145
Metformin Hydrochloride	METFORMIN HYDROCHLORIDE	Aphena Pharma Solutions - Tennessee, LLC	1e298db3-439e-4e91-8f9e-01c3cdc4d552	2021-08-02	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206145 application number: ANDA206145

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
60687-640-01	60687064001	100 BLISTER PACK in 1 BOX, UNIT-DOSE (60687-640-01) > 1 TABLET, EXTENDED RELEASE in 1 BLISTER PACK (60687-640-11)	100 blister pack	2021-09-20	0000-00-00	No	No	Current