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METFORMIN HYDROCHLORIDE	TABLET;ORAL	500MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	Yes	No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METFORMIN HYDROCHLORIDE	TABLET;ORAL	850MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	Yes	No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METFORMIN HYDROCHLORIDE	TABLET;ORAL	625MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	Yes	No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METFORMIN HYDROCHLORIDE	TABLET;ORAL	750MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	Yes	No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GLUCOPHAGE	METFORMIN HYDROCHLORIDE	TABLET;ORAL	1GM Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	Yes	No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GLUCOPHAGE	METFORMIN HYDROCHLORIDE	500MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1995-03-03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GLUCOPHAGE	METFORMIN HYDROCHLORIDE	850MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1995-03-03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GLUCOPHAGE	METFORMIN HYDROCHLORIDE	625MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1998-11-05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GLUCOPHAGE	METFORMIN HYDROCHLORIDE	750MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1998-11-05
N020357-005	GLUCOPHAGE	METFORMIN HYDROCHLORIDE	1GM Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1998-11-05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 6 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	AvPAK	d9bac244-1725-5bf3-e053-2a95a90ac823	2026-01-08	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: METFORMIN HYDROCHLORIDE
Metformin Hydrochloride	METFORMIN HYDROCHLORIDE	AvPAK	de09f7a1-1e9f-60f4-e053-2a95a90a93d8	2026-01-08	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: METFORMIN HYDROCHLORIDE
Metformin hydrochloride	METFORMIN HYDROCHLORIDE	Proficient Rx LP	3ba957ea-28ed-4a61-a318-98064ea4944d	2026-01-01	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: METFORMIN HYDROCHLORIDE
Metformin Hydrochloride	METFORMIN HYDROCHLORIDE	Northwind Health Company, LLC	ab80521b-5014-cc2a-e053-2a95a90a2003	2026-01-01	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: METFORMIN HYDROCHLORIDE
Metformin Hydrochloride	METFORMIN HYDROCHLORIDE	Northwind Health Company, LLC	f31c08fc-cda1-349c-e053-2a95a90aba15	2026-01-01	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: METFORMIN HYDROCHLORIDE
Metformin Hydrochloride	METFORMIN HYDROCHLORIDE	Northwind Health Company, LLC	dae7b1c1-7ff1-883c-e053-2a95a90a1a2b	2026-01-01	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: METFORMIN HYDROCHLORIDE
Metformin Hydrochloride	METFORMIN HYDROCHLORIDE	Northwind Health Company, LLC	f2a27d7a-ade4-421f-e053-2a95a90a01a9	2026-01-01	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: METFORMIN HYDROCHLORIDE
METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	Northwind Health Company, LLC	07d8a69f-30d9-7511-e063-6394a90a95ca	2026-01-01	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: METFORMIN HYDROCHLORIDE
Metformin Hydrochloride	METFORMIN HYDROCHLORIDE	Northwind Health Company, LLC	0178b9dd-bafa-9e81-e063-6294a90a88b0	2026-01-01	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: METFORMIN HYDROCHLORIDE
Metformin Hydrochloride	METFORMIN HYDROCHLORIDE	Northwind Health Company, LLC	f5ef117c-27ff-c21e-e053-2995a90ae145	2026-01-01	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: METFORMIN HYDROCHLORIDE
Metformin Hydrochloride	METFORMIN HYDROCHLORIDE	Northwind Health Company, LLC	db113f46-6fac-9005-e053-2995a90a017a	2026-01-01	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: METFORMIN HYDROCHLORIDE
METFORMIN HYDROCHLORIDE EXTENDED RELEASE	METFORMIN HYDROCHLORIDE	Northwind Health Company, LLC	4e5a19c6-6ac6-ffc0-e063-6394a90a9827	2026-01-01	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: METFORMIN HYDROCHLORIDE
Metformin Hydrochloride	METFORMIN HYDROCHLORIDE	Micro Labs Limited	cc070735-5e8d-4bb3-9caa-e84d29bb8943	2025-12-21	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: METFORMIN HYDROCHLORIDE
Metformin Hydrochloride	METFORMIN HYDROCHLORIDE	Ascend Laboratories, LLC	0ff1ba75-3c86-4baf-a6b1-1bb883839866	2025-12-18	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: METFORMIN HYDROCHLORIDE
METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.	b63bfafa-db4c-4fb8-84cd-ff73a5e7d320	2025-12-17	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: METFORMIN HYDROCHLORIDE
Metformin Hydrochloride	METFORMIN HYDROCHLORIDE	Precision Dose, Inc.	37ff1b8e-a434-41c0-82e1-4583842921a5	2025-12-02	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: METFORMIN HYDROCHLORIDE
Metformin hydrochloride ER	METFORMIN HYDROCHLORIDE	AvKARE	1aa40000-877f-8ea4-e063-6394a90a0e31	2025-11-04	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: METFORMIN HYDROCHLORIDE
Metformin Hydrochloride	METFORMIN HYDROCHLORIDE	Mullan Pharmaceutical Inc.	082b4de9-e452-fe71-e063-6394a90ac863	2025-10-28	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: METFORMIN HYDROCHLORIDE
Metformin Hydrochloride	METFORMIN HYDROCHLORIDE	PD-Rx Pharmaceuticals, Inc.	0230a3c3-34cf-478b-88c3-4d96e5300018	2025-10-15	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: METFORMIN HYDROCHLORIDE
Metformin Hydrochloride	METFORMIN HYDROCHLORIDE	PD-Rx Pharmaceuticals, Inc.	c72cfd1a-dce9-43a3-88e2-3cf1d9078b52	2025-10-15	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