METFORMIN HYDROCHLORIDE

Product NDC: 71610-457
11-digit product format: 716100457
Labeler code: 71610
Product ID: 71610-457_26802a69-e56c-4a63-add0-178b560cce98
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: metformin hydrochloride
Dosage form: TABLET, EXTENDED RELEASE
Route: ORAL
Labeler: Aphena Pharma Solutions - Tennessee, LLC
Application: ANDA201991
Marketing category: ANDA
Marketing start: 2013-11-01
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: 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 · 8 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	71610-457		D	Discontinued by firm	2026-08-03
excluded package	package	71610-457	71610-457-30	D	Discontinued by firm	2026-08-03
excluded package	package	71610-457	71610-457-53	D	Discontinued by firm	2026-08-03
excluded package	package	71610-457	71610-457-60	D	Discontinued by firm	2026-08-03
excluded package	package	71610-457	71610-457-70	D	Discontinued by firm	2026-08-03
excluded package	package	71610-457	71610-457-80	D	Discontinued by firm	2026-08-03
excluded package	package	71610-457	71610-457-92	D	Discontinued by firm	2026-08-03
excluded package	package	71610-457	71610-457-94	D	Discontinued by firm	2026-08-03

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

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A201991-001	METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB1		2012-01-18

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A201991-001	AB1

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 2 · 41 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	A201991-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2012-01-18	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201991-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2012-01-18	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A201991-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2012-01-18	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201991-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2012-01-18	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201991-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2012-01-18	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A201991-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2012-01-18	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A201991-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2012-01-18	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A201991-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2012-01-18	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A201991-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2012-01-18	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A201991-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2012-01-18	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A201991-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2012-01-18	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A201991-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2012-01-18	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A201991-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2012-01-18	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A201991-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2012-01-18	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A201991-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2012-01-18	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A201991-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2012-01-18	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A201991-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2012-01-18	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A201991-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2012-01-18	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A201991-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2012-01-18	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A201991-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2012-01-18	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A201991-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2012-01-18	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A201991-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2012-01-18	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A201991-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2012-01-18	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A201991-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2012-01-18	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A201991-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2012-01-18	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A201991-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2012-01-18	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A201991-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2012-01-18	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A201991-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2012-01-18	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A201991-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2012-01-18	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A201991-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2012-01-18	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A201991-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2012-01-18	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A201991-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2012-01-18	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A201991-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2012-01-18	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A201991-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2012-01-18	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A201991-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2012-01-18	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A201991-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2012-01-18	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A201991-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2012-01-18	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A201991-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2012-01-18	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A201991-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2012-01-18	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A201991-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2012-01-18	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 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	A201991-001	AB1	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201991-001	AB1	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A201991-001	AB1	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201991-001	AB1	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201991-001	AB1	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A201991-001	AB1	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A201991-001	AB1	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A201991-001	AB1	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A201991-001	AB1	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A201991-001	AB1	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A201991-001	AB1	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A201991-001	AB1	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A201991-001	AB1	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A201991-001	AB1	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A201991-001	AB1	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A201991-001	AB1	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A201991-001	AB1	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A201991-001	AB1	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A201991-001	AB1	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A201991-001	AB1	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A201991-001	AB1	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A201991-001	AB1	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A201991-001	AB1	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A201991-001	AB1	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A201991-001	AB1	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A201991-001	AB1	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A201991-001	AB1	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A201991-001	AB1	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A201991-001	AB1	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A201991-001	AB1	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A201991-001	AB1	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A201991-001	AB1	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A201991-001	AB1	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A201991-001	AB1	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A201991-001	AB1	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A201991-001	AB1	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A201991-001	AB1	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A201991-001	AB1	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A201991-001	AB1	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A201991-001	AB1	1	`cb3db0bc1861…`

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
71610-457	METFORMIN HYDROCHLORIDE ER (METFORMIN HYDROCHLORIDE) TABLET, EXTENDED RELEASE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	2	Legacy NDC	20201009_f0371d2a-276b-4acb-80f8-e24fb8ceae19.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 · 15 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	PD-Rx Pharmaceuticals, Inc.	9171d369-d35a-40e4-a9ad-26484e66fc5e	2026-07-29	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201991 application number: ANDA201991
METFORMIN HYDROCHLORIDE ER	METFORMIN HYDROCHLORIDE	Leading Pharma, LLC	3dca884d-ec44-496f-9eeb-31fd8fa3f574	2026-07-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201991 application number: ANDA201991
METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	Ascend Laboratories, LLC	a944a167-e3ac-4084-af1c-22b48713471c	2026-07-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201991 application number: ANDA201991
METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	QPharma Inc	5269e91f-7e93-9405-e063-6294a90a3217	2026-06-08	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201991 application number: ANDA201991
Metformin hydrochloride	METFORMIN HYDROCHLORIDE	Proficient Rx LP	3ba957ea-28ed-4a61-a318-98064ea4944d	2026-01-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201991 application number: ANDA201991
METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	Northwind Health Company, LLC	07d8a69f-30d9-7511-e063-6394a90a95ca	2026-01-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201991 application number: ANDA201991
Metformin hydrochloride	METFORMIN HYDROCHLORIDE	NuCare Pharmaceuticals, Inc.	4be72741-4f6d-6689-e054-00144ff8d46c	2025-09-22	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201991 application number: ANDA201991
METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	Bryant Ranch Prepack	f2318509-9a49-4c99-a08b-22381f17aacd	2025-08-25	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201991 application number: ANDA201991
METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	PD-Rx Pharmaceuticals, Inc.	f55a245b-a786-4a4a-b11c-c61d48294b01	2025-08-22	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201991 application number: ANDA201991
METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	A-S Medication Solutions	0cd086d6-3ae2-476e-b93e-29055e67e8fc	2025-06-18	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201991 application number: ANDA201991
METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	A-S Medication Solutions	a434b937-2648-4509-8ce8-94a28582ec77	2025-06-17	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201991 application number: ANDA201991
METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	A-S Medication Solutions	784a6bbd-4f13-45ed-89c1-154b06721ed0	2025-06-17	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201991 application number: ANDA201991
METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	Preferred Pharmaceuticals Inc.	4adeddf2-f449-4a61-9658-dfbff7c50230	2025-01-21	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201991 application number: ANDA201991
METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	NCS HealthCare of KY, LLC dba Vangard Labs	5bb945c1-954a-4d43-aa24-33767d19c57c	2024-08-23	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201991 application number: ANDA201991
METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	Aphena Pharma Solutions - Tennessee, LLC	1a047fc0-196e-79af-e063-6394a90a1e0d	2024-06-03	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201991 application number: ANDA201991

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
71610-457-30	71610045730	30 TABLET, EXTENDED RELEASE in 1 BOTTLE (71610-457-30)	2020-09-11	0000-00-00	No	No	Current
71610-457-53	71610045753	60 TABLET, EXTENDED RELEASE in 1 BOTTLE (71610-457-53)	2020-09-02	0000-00-00	No	No	Current
71610-457-60	71610045760	90 TABLET, EXTENDED RELEASE in 1 BOTTLE (71610-457-60)	2020-08-27	0000-00-00	No	No	Current
71610-457-70	71610045770	120 TABLET, EXTENDED RELEASE in 1 BOTTLE (71610-457-70)	2020-08-27	0000-00-00	No	No	Current
71610-457-80	71610045780	180 TABLET, EXTENDED RELEASE in 1 BOTTLE (71610-457-80)	2020-08-27	0000-00-00	No	No	Current
71610-457-92	71610045792	270 TABLET, EXTENDED RELEASE in 1 BOTTLE (71610-457-92)	2020-08-27	0000-00-00	No	No	Current
71610-457-94	71610045794	360 TABLET, EXTENDED RELEASE in 1 BOTTLE (71610-457-94)	2020-09-11	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
METFORMIN HYDROCHLORIDE ER	Aphena Pharma Solutions - Tennessee, LLC	2020-10-08	HUMAN PRESCRIPTION DRUG LABEL	2