Application 021202

Type: NDA
Sponsor: EMD SERONO INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	GLUCOPHAGE XR	METFORMIN HYDROCHLORIDE	TABLET, EXTENDED RELEASE;ORAL	500MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	Yes	No
004	GLUCOPHAGE XR	METFORMIN HYDROCHLORIDE	TABLET, EXTENDED RELEASE;ORAL	750MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	Yes	No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 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N021202-001	GLUCOPHAGE XR	METFORMIN HYDROCHLORIDE	500MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL		RLD	2000-10-13
N021202-004	GLUCOPHAGE XR	METFORMIN HYDROCHLORIDE	750MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL		RLD	2003-04-11

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 · 86 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	N021202-001	GLUCOPHAGE XR	500MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	2000-10-13	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021202-004	GLUCOPHAGE XR	750MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	2003-04-11	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N021202-001	GLUCOPHAGE XR	500MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	2000-10-13	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021202-004	GLUCOPHAGE XR	750MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	2003-04-11	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N021202-001	GLUCOPHAGE XR	500MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	2000-10-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021202-004	GLUCOPHAGE XR	750MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	2003-04-11	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021202-001	GLUCOPHAGE XR	500MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	2000-10-13	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021202-004	GLUCOPHAGE XR	750MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	2003-04-11	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021202-001	GLUCOPHAGE XR	500MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	2000-10-13	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021202-004	GLUCOPHAGE XR	750MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	2003-04-11	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021202-001	GLUCOPHAGE XR	500MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	2000-10-13	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021202-004	GLUCOPHAGE XR	750MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	2003-04-11	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021202-001	GLUCOPHAGE XR	500MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	2000-10-13	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021202-004	GLUCOPHAGE XR	750MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	2003-04-11	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021202-001	GLUCOPHAGE XR	500MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	2000-10-13	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021202-004	GLUCOPHAGE XR	750MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	2003-04-11	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021202-001	GLUCOPHAGE XR	500MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	2000-10-13	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021202-004	GLUCOPHAGE XR	750MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	2003-04-11	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021202-001	GLUCOPHAGE XR	500MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	2000-10-13	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021202-004	GLUCOPHAGE XR	750MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	2003-04-11	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021202-001	GLUCOPHAGE XR	500MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	2000-10-13	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021202-004	GLUCOPHAGE XR	750MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	2003-04-11	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021202-001	GLUCOPHAGE XR	500MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	2000-10-13	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N021202-004	GLUCOPHAGE XR	750MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	2003-04-11	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021202-001	GLUCOPHAGE XR	500MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	2000-10-13	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021202-004	GLUCOPHAGE XR	750MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	2003-04-11	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021202-001	GLUCOPHAGE XR	500MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	2000-10-13	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021202-004	GLUCOPHAGE XR	750MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	2003-04-11	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021202-001	GLUCOPHAGE XR	500MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	2000-10-13	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021202-004	GLUCOPHAGE XR	750MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	2003-04-11	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N021202-001	GLUCOPHAGE XR	500MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	2000-10-13	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N021202-004	GLUCOPHAGE XR	750MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	2003-04-11	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021202-001	GLUCOPHAGE XR	500MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	2000-10-13	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021202-004	GLUCOPHAGE XR	750MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	2003-04-11	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N021202-001	GLUCOPHAGE XR	500MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2000-10-13	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N021202-004	GLUCOPHAGE XR	750MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2003-04-11	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N021202-001	GLUCOPHAGE XR	500MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2000-10-13	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N021202-004	GLUCOPHAGE XR	750MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2003-04-11	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N021202-001	GLUCOPHAGE XR	500MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2000-10-13	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021202-004	GLUCOPHAGE XR	750MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2003-04-11	`74a2ff9319b5…`

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 · 4 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0087-6063	GLUCOPHAGE	METFORMIN HYDROCHLORIDE	Bristol-Myers Squibb Company	NDA	Current
0087-6063	GLUCOPHAGE	METFORMIN HYDROCHLORIDE	Bristol-Myers Squibb Company	NDA	Current
0087-6064	GLUCOPHAGE	METFORMIN HYDROCHLORIDE	Bristol-Myers Squibb Company	NDA	Current
0087-6064	GLUCOPHAGE	METFORMIN HYDROCHLORIDE	Bristol-Myers Squibb Company	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
54396	SUPPL	2018-05-31
54382	SUPPL	2018-05-31
47946	SUPPL	2017-04-12
47945	SUPPL	2017-04-12
47936	SUPPL	2017-04-11
47935	SUPPL	2017-04-11
14628	SUPPL	2008-08-29
27051	SUPPL	2008-08-28
36336	SUPPL	2006-11-06
4628	SUPPL	2006-11-06
42018	ORIG	2004-06-04
4627	SUPPL	2004-03-24
4626	SUPPL	2004-03-24
4625	SUPPL	2003-04-18
14627	SUPPL	2003-04-17
4624	SUPPL	2002-01-08
4623	SUPPL	2001-04-19
14626	ORIG	2000-10-13
4622	ORIG	2000-10-13