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HYDROCHLORIDE	TABLET, EXTENDED RELEASE;ORAL	500MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	Yes	No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HYDROCHLORIDE	TABLET, EXTENDED RELEASE;ORAL	750MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	Yes	No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GLUCOPHAGE XR	METFORMIN HYDROCHLORIDE	500MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL		RLD	2000-10-13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GLUCOPHAGE XR	METFORMIN HYDROCHLORIDE	750MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL		RLD	2003-04-11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N021202-001	GLUCOPHAGE XR	500MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	2000-10-13	`84e616aacf4f…`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N021202-004	GLUCOPHAGE XR	750MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	2003-04-11	`84e616aacf4f…`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 1 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	REMEDYREPACK INC.	d5228e81-9c86-4781-b984-20feaa2ae779	2026-09-09	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: METFORMIN HYDROCHLORIDE
Metformin Hydrochloride	METFORMIN HYDROCHLORIDE	Camber Pharmaceuticals, Inc.	7cc02a26-5c22-445b-ad8f-3e7570c143d3	2026-09-08	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: METFORMIN HYDROCHLORIDE
METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	Granules India Ltd	73197cb5-3e23-4ac0-b189-f9bc848bce66	2026-09-03	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: METFORMIN HYDROCHLORIDE
METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	A-S Medication Solutions	b6d7edc9-93d6-4480-906d-55c18d053600	2026-09-02	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: METFORMIN HYDROCHLORIDE
METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	A-S Medication Solutions	64f5b140-7ad8-4c07-bbfc-ae4618afa850	2026-09-01	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: METFORMIN HYDROCHLORIDE
Metformin Hydrochloride	METFORMIN HYDROCHLORIDE	REMEDYREPACK INC.	bfd6ec0f-8264-4877-aa6d-f347f53bc426	2026-09-01	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: METFORMIN HYDROCHLORIDE
Metformin Hydrochloride	METFORMIN HYDROCHLORIDE	REMEDYREPACK INC.	c568d49f-c040-4f1e-ad36-77b05ab659c3	2026-08-28	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: METFORMIN HYDROCHLORIDE
Metformin Hydrochloride	METFORMIN HYDROCHLORIDE	Preferred Pharmaceuticals Inc.	ba0379cb-824e-4798-9ff9-99bcd1bea5cb	2026-08-27	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: METFORMIN HYDROCHLORIDE
Metformin Hydrochloride	METFORMIN HYDROCHLORIDE	Bryant Ranch Prepack	fb296500-55cb-45ce-be0c-59aa2e3d4624	2026-08-26	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: METFORMIN HYDROCHLORIDE
METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	ScieGen Pharmaceuticals Inc	4e4c4ba9-65c6-4273-8f6b-2423ab521dad	2026-08-21	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: METFORMIN HYDROCHLORIDE
Metformin Hydrochloride	METFORMIN HYDROCHLORIDE	REMEDYREPACK INC.	073cf6d9-7142-4d8b-898e-174c62a1f76f	2026-08-21	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: METFORMIN HYDROCHLORIDE
METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	QPharma,Inc.	5866ca12-a28f-cbe7-e063-6294a90acc69	2026-08-20	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: METFORMIN HYDROCHLORIDE
METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	Quallent Pharmaceuticals Health LLC	25be863d-490c-47f6-9ad3-c828dc43fbf0	2026-08-12	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: METFORMIN HYDROCHLORIDE
METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	Redpharm Drug	58bec665-b648-6baf-e063-6394a90a1cbb	2026-08-11	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: METFORMIN HYDROCHLORIDE
Metformin Hydrochloride	METFORMIN HYDROCHLORIDE	REMEDYREPACK INC.	e22a8545-86a6-439e-a758-29c4d6ed8bfe	2026-08-11	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: METFORMIN HYDROCHLORIDE
Metformin Hydrochloride	METFORMIN HYDROCHLORIDE	Bryant Ranch Prepack	c1bfc7b5-c7e0-4353-b772-05d463c12886	2026-08-04	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: METFORMIN HYDROCHLORIDE
Metformin Hydrochloride	METFORMIN HYDROCHLORIDE	REMEDYREPACK INC.	1e8136e0-cc98-41e4-ad4b-a8fc27fb4daa	2026-08-04	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: METFORMIN HYDROCHLORIDE
METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	PD-Rx Pharmaceuticals, Inc.	4d087f00-580b-4b9d-80d9-f97930153e72	2026-08-04	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: METFORMIN HYDROCHLORIDE
Metformin Hydrochloride	METFORMIN HYDROCHLORIDE	REMEDYREPACK INC.	5d8d654a-9bb4-4c87-ab43-c21c4e874708	2026-08-04	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: METFORMIN HYDROCHLORIDE
Metformin Hydrochloride	METFORMIN HYDROCHLORIDE	NuCare Pharmaceuticals, Inc.	583f2a2e-a9d7-f266-e063-6294a90ad0ab	2026-08-04	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