Application 020357

Type: NDA
Sponsor: EMD SERONO INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	GLUCOPHAGE	METFORMIN HYDROCHLORIDE	TABLET;ORAL	500MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	Yes	No
002	GLUCOPHAGE	METFORMIN HYDROCHLORIDE	TABLET;ORAL	850MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	Yes	No
003	GLUCOPHAGE	METFORMIN HYDROCHLORIDE	TABLET;ORAL	625MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	Yes	No
004	GLUCOPHAGE	METFORMIN HYDROCHLORIDE	TABLET;ORAL	750MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	Yes	No
005	GLUCOPHAGE	METFORMIN HYDROCHLORIDE	TABLET;ORAL	1GM Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	Yes	No

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

Orange Book products#

Current product rows page 1 of 1 · 5 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	RLD / RS	Approval date
N020357-001	GLUCOPHAGE	METFORMIN HYDROCHLORIDE	500MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1995-03-03
N020357-002	GLUCOPHAGE	METFORMIN HYDROCHLORIDE	850MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1995-03-03
N020357-003	GLUCOPHAGE	METFORMIN HYDROCHLORIDE	625MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1998-11-05
N020357-004	GLUCOPHAGE	METFORMIN HYDROCHLORIDE	750MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1998-11-05
N020357-005	GLUCOPHAGE	METFORMIN HYDROCHLORIDE	1GM Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1998-11-05

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 6 · 215 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	N020357-001	GLUCOPHAGE	500MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1995-03-03	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N020357-002	GLUCOPHAGE	850MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1995-03-03	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N020357-003	GLUCOPHAGE	625MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1998-11-05	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N020357-004	GLUCOPHAGE	750MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1998-11-05	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N020357-005	GLUCOPHAGE	1GM Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1998-11-05	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N020357-001	GLUCOPHAGE	500MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1995-03-03	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N020357-002	GLUCOPHAGE	850MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1995-03-03	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N020357-003	GLUCOPHAGE	625MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1998-11-05	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N020357-004	GLUCOPHAGE	750MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1998-11-05	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N020357-005	GLUCOPHAGE	1GM Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1998-11-05	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N020357-001	GLUCOPHAGE	500MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1995-03-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020357-002	GLUCOPHAGE	850MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1995-03-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020357-003	GLUCOPHAGE	625MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1998-11-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020357-004	GLUCOPHAGE	750MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1998-11-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020357-005	GLUCOPHAGE	1GM Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1998-11-05	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020357-001	GLUCOPHAGE	500MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1995-03-03	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020357-002	GLUCOPHAGE	850MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1995-03-03	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020357-003	GLUCOPHAGE	625MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1998-11-05	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020357-004	GLUCOPHAGE	750MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1998-11-05	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020357-005	GLUCOPHAGE	1GM Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1998-11-05	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N020357-001	GLUCOPHAGE	500MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1995-03-03	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020357-002	GLUCOPHAGE	850MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1995-03-03	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020357-003	GLUCOPHAGE	625MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1998-11-05	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020357-004	GLUCOPHAGE	750MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1998-11-05	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020357-005	GLUCOPHAGE	1GM Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1998-11-05	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020357-001	GLUCOPHAGE	500MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1995-03-03	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020357-002	GLUCOPHAGE	850MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1995-03-03	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020357-003	GLUCOPHAGE	625MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1998-11-05	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020357-004	GLUCOPHAGE	750MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1998-11-05	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020357-005	GLUCOPHAGE	1GM Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1998-11-05	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020357-001	GLUCOPHAGE	500MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1995-03-03	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020357-002	GLUCOPHAGE	850MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1995-03-03	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020357-003	GLUCOPHAGE	625MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1998-11-05	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020357-004	GLUCOPHAGE	750MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1998-11-05	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020357-005	GLUCOPHAGE	1GM Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1998-11-05	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020357-001	GLUCOPHAGE	500MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1995-03-03	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020357-002	GLUCOPHAGE	850MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1995-03-03	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020357-003	GLUCOPHAGE	625MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1998-11-05	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020357-004	GLUCOPHAGE	750MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1998-11-05	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020357-005	GLUCOPHAGE	1GM Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1998-11-05	`03ed91905a0d…`

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 4 of 13 · 253 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Metformin Hydrochloride	METFORMIN HYDROCHLORIDE	Coupler LLC	53e950f5-c58f-78e3-e063-6294a90a53e9	2026-06-10	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: METFORMIN HYDROCHLORIDE
Metformin Hydrochloride	METFORMIN HYDROCHLORIDE	Aurobindo Pharma Limited	ef77c7dd-a65f-4adc-a0d9-a93779b459a0	2026-06-09	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: METFORMIN HYDROCHLORIDE
Metformin Hydrochloride	METFORMIN HYDROCHLORIDE	MARKSANS PHARMA LIMITED	b8004451-7b26-425b-b5ea-cbb1b08e30e3	2026-06-09	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: METFORMIN HYDROCHLORIDE
METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	QPharma Inc	5269e91f-7e93-9405-e063-6294a90a3217	2026-06-08	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: METFORMIN HYDROCHLORIDE
METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	QPharma Inc	53bde438-4277-f418-e063-6394a90a5ea2	2026-06-08	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: METFORMIN HYDROCHLORIDE
Metformin Hydrochloride	METFORMIN HYDROCHLORIDE	Mylan Pharmaceuticals Inc.	4f70f907-08d5-4c2e-a4be-32c6124faa7b	2026-06-08	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: METFORMIN HYDROCHLORIDE
METFORMIN HYDROCHLORIDE EXTENDED RELEASE	METFORMIN HYDROCHLORIDE	PD-Rx Pharmaceuticals, Inc.	d1d7204a-7e8a-4f76-bf9f-3e798c2632ba	2026-05-22	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: METFORMIN HYDROCHLORIDE
Metformin Hydrochloride	METFORMIN HYDROCHLORIDE	Westminster Pharmaceuticals, LLC	836f3647-bfef-40d1-b475-c0d240241a67	2026-05-22	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: METFORMIN HYDROCHLORIDE
METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	Bryant Ranch Prepack	1e7ab8da-4ece-499c-b0fb-34e37d991c1c	2026-05-20	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: METFORMIN HYDROCHLORIDE
METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	Laurus Labs Limited	0e7b02cc-2ddc-4394-a80c-128e6452d697	2026-05-19	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: METFORMIN HYDROCHLORIDE
Metformin Hydrochloride	METFORMIN HYDROCHLORIDE	Laurus Labs Limited	c3dfa8a1-d10a-4a1a-8eba-5f4e2a5a2949	2026-05-15	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: METFORMIN HYDROCHLORIDE
Metformin Hydrochloride	METFORMIN HYDROCHLORIDE	Golden State Medical Supply, Inc.	1cb2b2be-595c-4e72-8d2c-c1edc7f85682	2026-05-14	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: METFORMIN HYDROCHLORIDE
Metformin hydrochloride	METFORMIN HYDROCHLORIDE	UNICHEM PHARMACEUTICALS (USA), INC.	93c8deae-3103-4cbf-a5d1-fe0d37e76df8	2026-05-11	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: METFORMIN HYDROCHLORIDE
Metformin Hydrochloride	METFORMIN HYDROCHLORIDE	Bryant Ranch Prepack	be023bca-511e-4801-bd2b-e30dd1408772	2026-05-07	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: METFORMIN HYDROCHLORIDE
Metformin Hydrochloride	METFORMIN HYDROCHLORIDE	Coupler LLC	51285096-e2ce-0f3c-e063-6394a90a35d4	2026-05-06	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: METFORMIN HYDROCHLORIDE
Metformin Hydrochloride	METFORMIN HYDROCHLORIDE	Granules Pharmaceuticals Inc.	2387a618-24d8-4813-aa83-9114edb35374	2026-04-16	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: METFORMIN HYDROCHLORIDE
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	Name fallback generic name: METFORMIN HYDROCHLORIDE
Metformin Hydrochloride	METFORMIN HYDROCHLORIDE	Precision Dose, Inc.	60142fb2-16da-4f54-a542-74f9a70b9c8b	2026-04-08	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: METFORMIN HYDROCHLORIDE
METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	Aphena Pharma Solutions - Tennessee, LLC	388ee1e0-a0d2-324d-e063-6394a90a1664	2026-03-25	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: METFORMIN HYDROCHLORIDE
Metformin Hydrochloride Oral Solution	METFORMIN HYDROCHLORIDE	MICRO LABS LIMITED	fb90693a-074a-45be-94f4-ed6298b1f4e4	2026-03-16	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: METFORMIN HYDROCHLORIDE

Reported adverse events (FAERS/openFDA)#

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

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 7 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0087-6060	GLUCOPHAGE	METFORMIN HYDROCHLORIDE	Bristol-Myers Squibb Company	NDA	Current
0087-6060	GLUCOPHAGE	METFORMIN HYDROCHLORIDE	Bristol-Myers Squibb Company	NDA	Current
0087-6070	GLUCOPHAGE	METFORMIN HYDROCHLORIDE	Bristol-Myers Squibb Company	NDA	Current
0087-6070	GLUCOPHAGE	METFORMIN HYDROCHLORIDE	Bristol-Myers Squibb Company	NDA	Current
0087-6071	GLUCOPHAGE	METFORMIN HYDROCHLORIDE	Bristol-Myers Squibb Company	NDA	Current
0087-6071	GLUCOPHAGE	METFORMIN HYDROCHLORIDE	Bristol-Myers Squibb Company	NDA	Current
55289-211	GLUCOPHAGE	METFORMIN HYDROCHLORIDE	PD-Rx Pharmaceuticals, Inc.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
54395	SUPPL	2018-05-31
54381	SUPPL	2018-05-31
47948	SUPPL	2017-04-12
47947	SUPPL	2017-04-12
47934	SUPPL	2017-04-11
47933	SUPPL	2017-04-11
34537	SUPPL	2008-08-29
2371	SUPPL	2008-08-28
41293	SUPPL	2007-04-11
34536	SUPPL	2006-11-06
24817	SUPPL	2006-11-06
24816	SUPPL	2004-03-24
2370	SUPPL	2004-03-24
24815	SUPPL	2002-01-08
24814	SUPPL	2001-04-23
41292	SUPPL	2000-12-15
2369	SUPPL	2000-12-15
34535	SUPPL	2000-02-15
20604	SUPPL	1999-09-22
41291	SUPPL	1998-10-22
2368	SUPPL	1998-10-22
41290	SUPPL	1997-11-06
57421	ORIG	1994-07-13