METFORMIN HYDROCHLORIDE

Product NDC: 71610-441
11-digit product format: 716100441
Labeler code: 71610
Product ID: 71610-441_26bddffb-91bc-4305-a698-3df35d7b15d8
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: METFORMIN HYDROCHLORIDE
Dosage form: TABLET, EXTENDED RELEASE
Route: ORAL
Labeler: Aphena Pharma Solutions - Tennessee, LLC
Application: ANDA077336
Marketing category: ANDA
Marketing start: 2006-02-09
Marketing end: 0000-00-00
Substance: METFORMIN HYDROCHLORIDE
Active strength: 750 mg/1
Pharmacologic classes: Biguanide [EPC],Biguanides [CS]
NDC exclude flag: No
Listing certified through: 2021-12-31
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	71610-441		D	Discontinued by firm		2026-08-11
excluded package	package	71610-441	71610-441-53	D	Discontinued by firm		2026-08-11

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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
A077336-001	METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL			2006-02-09
A077336-002	METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	750MG	TABLET, EXTENDED RELEASE / ORAL			2006-02-09

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 · 82 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	A077336-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL		2006-02-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077336-002	METFORMIN HYDROCHLORIDE	750MG	TABLET, EXTENDED RELEASE / ORAL		2006-02-09	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077336-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL		2006-02-09	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077336-002	METFORMIN HYDROCHLORIDE	750MG	TABLET, EXTENDED RELEASE / ORAL		2006-02-09	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077336-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2006-02-09	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077336-002	METFORMIN HYDROCHLORIDE	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	2006-02-09	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077336-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2006-02-09	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077336-002	METFORMIN HYDROCHLORIDE	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	2006-02-09	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077336-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2006-02-09	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077336-002	METFORMIN HYDROCHLORIDE	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	2006-02-09	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077336-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2006-02-09	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077336-002	METFORMIN HYDROCHLORIDE	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	2006-02-09	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077336-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2006-02-09	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077336-002	METFORMIN HYDROCHLORIDE	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	2006-02-09	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077336-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2006-02-09	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077336-002	METFORMIN HYDROCHLORIDE	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	2006-02-09	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077336-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2006-02-09	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077336-002	METFORMIN HYDROCHLORIDE	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	2006-02-09	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077336-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2006-02-09	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077336-002	METFORMIN HYDROCHLORIDE	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	2006-02-09	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077336-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2006-02-09	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077336-002	METFORMIN HYDROCHLORIDE	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	2006-02-09	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077336-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2006-02-09	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077336-002	METFORMIN HYDROCHLORIDE	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	2006-02-09	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077336-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2006-02-09	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077336-002	METFORMIN HYDROCHLORIDE	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	2006-02-09	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A077336-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2006-02-09	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A077336-002	METFORMIN HYDROCHLORIDE	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	2006-02-09	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077336-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2006-02-09	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077336-002	METFORMIN HYDROCHLORIDE	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	2006-02-09	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A077336-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2006-02-09	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A077336-002	METFORMIN HYDROCHLORIDE	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	2006-02-09	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A077336-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2006-02-09	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A077336-002	METFORMIN HYDROCHLORIDE	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	2006-02-09	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A077336-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2006-02-09	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A077336-002	METFORMIN HYDROCHLORIDE	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	2006-02-09	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A077336-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2006-02-09	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A077336-002	METFORMIN HYDROCHLORIDE	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	2006-02-09	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A077336-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2006-02-09	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A077336-002	METFORMIN HYDROCHLORIDE	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	2006-02-09	`782e0a99824c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 76 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2025-08-23 18:47 UTC	2025-08	A077336-001	AB1	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077336-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077336-001	AB1	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077336-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077336-001	AB1	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077336-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077336-001	AB1	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077336-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077336-001	AB1	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077336-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077336-001	AB1	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077336-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077336-001	AB1	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077336-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077336-001	AB1	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077336-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077336-001	AB1	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077336-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077336-001	AB1	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077336-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077336-001	AB1	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077336-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A077336-001	AB1	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A077336-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077336-001	AB1	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077336-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A077336-001	AB1	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A077336-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A077336-001	AB1	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A077336-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A077336-001	AB1	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A077336-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A077336-001	AB1	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A077336-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A077336-001	AB1	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A077336-002	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A077336-001	AB1	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A077336-002	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A077336-001	AB1	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A077336-002	AB	1	`5aa47cf7b7d7…`

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
71610-441-53	EA - Each	71610-441	540e3376-26e4-414f-b326-6f3ed38e4084	1	2020-08-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
71610-441	METFORMIN HYDROCHLORIDE TABLET, EXTENDED RELEASE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	1	Legacy NDC	20200709_e97fd756-b5ee-4b6d-a7a9-8fe7fb3c091b.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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	Sun Pharmaceutical Industries, Inc.	41a8bb80-7b0b-476c-8134-5d161c3239c8	2026-06-25	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077336 application number: ANDA077336
METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	Aphena Pharma Solutions - Tennessee, LLC	439bb230-94d8-4522-ad79-5cce5fad965b	2021-04-27	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077336 application number: ANDA077336

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	Marketing end	Sample	Exclude flag	Status
71610-441-53	71610044153	60 TABLET, EXTENDED RELEASE in 1 BOTTLE (71610-441-53)	2020-06-24	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
METFORMIN HYDROCHLORIDE	Aphena Pharma Solutions - Tennessee, LLC	2020-07-08	Human Prescription Drug Label	1