Glumetza

Product NDC: 13913-002
11-digit product format: 139130002
Labeler code: 13913
Product ID: 13913-002_121fc3e0-33fe-41af-a7ef-e6b54ee60ef6
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: metformin hydrochloride
Dosage form: TABLET, FILM COATED, EXTENDED RELEASE
Route: ORAL
Labeler: Depomed, Inc.
Application: NDA021748
Marketing category: NDA
Marketing start: 2006-08-01
Marketing end: 0000-00-00
Substance: METFORMIN HYDROCHLORIDE
Active strength: 500 mg/1
Pharmacologic classes: Biguanide [EPC],Biguanides [CS]
NDC exclude flag: E
Listing certified through: 2017-12-31
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 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	13913-002		D	Discontinued by firm		2026-09-14
excluded package	package	13913-002	13913-002-13	D	Discontinued by firm		2026-09-14

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 38 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Code	Status	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	13913-002-13	D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	13913-002-13	D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		D	Discontinued by firm	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	13913-002-13	D	Discontinued by firm	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		D	Discontinued by firm	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	13913-002-13	D	Discontinued by firm	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		D	Discontinued by firm	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	13913-002-13	D	Discontinued by firm	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		D	Discontinued by firm	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	13913-002-13	D	Discontinued by firm	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		D	Discontinued by firm	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	13913-002-13	D	Discontinued by firm	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		D	Discontinued by firm	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	13913-002-13	D	Discontinued by firm	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		D	Discontinued by firm	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	13913-002-13	D	Discontinued by firm	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		D	Discontinued by firm	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	13913-002-13	D	Discontinued by firm	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		D	Discontinued by firm	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	13913-002-13	D	Discontinued by firm	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		D	Discontinued by firm	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	13913-002-13	D	Discontinued by firm	`557ba5c1ecfa…`	`9c80585c8c6e…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded product	product		I	Inactivated by FDA	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	13913-002-13	I	Inactivated by FDA	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded product	product		I	Inactivated by FDA	`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	13913-002-13	I	Inactivated by FDA	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded product	product		I	Inactivated by FDA	`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	13913-002-13	I	Inactivated by FDA	`bd6a592717d7…`	`303034d00443…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded product	product		I	Inactivated by FDA	`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	13913-002-13	I	Inactivated by FDA	`8dfbde2a14a4…`	`c9ff85d89658…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded product	product		I	Inactivated by FDA	`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	13913-002-13	I	Inactivated by FDA	`e2bbac7714bc…`	`27bdfed8d636…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded product	product		I	Inactivated by FDA	`9bebd1f3094a…`	`5416666fcb17…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded package	package	13913-002-13	I	Inactivated by FDA	`9bebd1f3094a…`	`5416666fcb17…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded product	product		I	Inactivated by FDA	`110d247fa046…`	`a55b01930146…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded package	package	13913-002-13	I	Inactivated by FDA	`110d247fa046…`	`a55b01930146…`

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
N021748-001	GLUMETZA	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL		RLD	2005-06-03
N021748-002	GLUMETZA	METFORMIN HYDROCHLORIDE	1GM	TABLET, EXTENDED RELEASE / ORAL		RLD	2005-06-03

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	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	N021748-001	GLUMETZA	500MG	TABLET, EXTENDED RELEASE / ORAL		RLD	2005-06-03	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021748-002	GLUMETZA	1GM	TABLET, EXTENDED RELEASE / ORAL		RLD	2005-06-03	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N021748-001	GLUMETZA	500MG	TABLET, EXTENDED RELEASE / ORAL		RLD	2005-06-03	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021748-002	GLUMETZA	1GM	TABLET, EXTENDED RELEASE / ORAL		RLD	2005-06-03	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N021748-001	GLUMETZA	500MG	TABLET, EXTENDED RELEASE / ORAL		RLD	2005-06-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021748-002	GLUMETZA	1GM	TABLET, EXTENDED RELEASE / ORAL		RLD	2005-06-03	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021748-001	GLUMETZA	500MG	TABLET, EXTENDED RELEASE / ORAL		RLD	2005-06-03	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021748-002	GLUMETZA	1GM	TABLET, EXTENDED RELEASE / ORAL		RLD	2005-06-03	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021748-001	GLUMETZA	500MG	TABLET, EXTENDED RELEASE / ORAL	AB3	RLD	2005-06-03	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021748-002	GLUMETZA	1GM	TABLET, EXTENDED RELEASE / ORAL	AB3	RLD, RS	2005-06-03	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021748-001	GLUMETZA	500MG	TABLET, EXTENDED RELEASE / ORAL	AB3	RLD	2005-06-03	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021748-002	GLUMETZA	1GM	TABLET, EXTENDED RELEASE / ORAL	AB3	RLD, RS	2005-06-03	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021748-001	GLUMETZA	500MG	TABLET, EXTENDED RELEASE / ORAL	AB3	RLD	2005-06-03	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021748-002	GLUMETZA	1GM	TABLET, EXTENDED RELEASE / ORAL	AB3	RLD, RS	2005-06-03	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021748-001	GLUMETZA	500MG	TABLET, EXTENDED RELEASE / ORAL	AB3	RLD	2005-06-03	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021748-002	GLUMETZA	1GM	TABLET, EXTENDED RELEASE / ORAL	AB3	RLD, RS	2005-06-03	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021748-001	GLUMETZA	500MG	TABLET, EXTENDED RELEASE / ORAL	AB3	RLD	2005-06-03	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021748-002	GLUMETZA	1GM	TABLET, EXTENDED RELEASE / ORAL	AB3	RLD, RS	2005-06-03	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021748-001	GLUMETZA	500MG	TABLET, EXTENDED RELEASE / ORAL	AB3	RLD	2005-06-03	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021748-002	GLUMETZA	1GM	TABLET, EXTENDED RELEASE / ORAL	AB3	RLD, RS	2005-06-03	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021748-001	GLUMETZA	500MG	TABLET, EXTENDED RELEASE / ORAL	AB3	RLD	2005-06-03	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021748-002	GLUMETZA	1GM	TABLET, EXTENDED RELEASE / ORAL	AB3	RLD, RS	2005-06-03	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021748-001	GLUMETZA	500MG	TABLET, EXTENDED RELEASE / ORAL	AB3	RLD	2005-06-03	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N021748-002	GLUMETZA	1GM	TABLET, EXTENDED RELEASE / ORAL	AB3	RLD, RS	2005-06-03	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021748-001	GLUMETZA	500MG	TABLET, EXTENDED RELEASE / ORAL	AB3	RLD	2005-06-03	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021748-002	GLUMETZA	1GM	TABLET, EXTENDED RELEASE / ORAL	AB3	RLD, RS	2005-06-03	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021748-001	GLUMETZA	500MG	TABLET, EXTENDED RELEASE / ORAL	AB3	RLD	2005-06-03	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021748-002	GLUMETZA	1GM	TABLET, EXTENDED RELEASE / ORAL	AB3	RLD, RS	2005-06-03	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021748-001	GLUMETZA	500MG	TABLET, EXTENDED RELEASE / ORAL	AB3	RLD	2005-06-03	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021748-002	GLUMETZA	1GM	TABLET, EXTENDED RELEASE / ORAL	AB3	RLD, RS	2005-06-03	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N021748-001	GLUMETZA	500MG	TABLET, EXTENDED RELEASE / ORAL	AB3	RLD	2005-06-03	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N021748-002	GLUMETZA	1GM	TABLET, EXTENDED RELEASE / ORAL	AB3	RLD, RS	2005-06-03	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021748-001	GLUMETZA	500MG	TABLET, EXTENDED RELEASE / ORAL	AB3	RLD	2005-06-03	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021748-002	GLUMETZA	1GM	TABLET, EXTENDED RELEASE / ORAL	AB3	RLD, RS	2005-06-03	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N021748-001	GLUMETZA	500MG	TABLET, EXTENDED RELEASE / ORAL	AB3	RLD	2005-06-03	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N021748-002	GLUMETZA	1GM	TABLET, EXTENDED RELEASE / ORAL	AB3	RLD, RS	2005-06-03	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N021748-001	GLUMETZA	500MG	TABLET, EXTENDED RELEASE / ORAL	AB3	RLD	2005-06-03	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N021748-002	GLUMETZA	1GM	TABLET, EXTENDED RELEASE / ORAL	AB3	RLD, RS	2005-06-03	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N021748-001	GLUMETZA	500MG	TABLET, EXTENDED RELEASE / ORAL	AB3	RLD	2005-06-03	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021748-002	GLUMETZA	1GM	TABLET, EXTENDED RELEASE / ORAL	AB3	RLD, RS	2005-06-03	`74a2ff9319b5…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 76 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2025-08-23 18:47 UTC	2025-08	N021748-001	AB3	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021748-002	AB3	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021748-001	AB3	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021748-002	AB3	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021748-001	AB3	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021748-002	AB3	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021748-001	AB3	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021748-002	AB3	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021748-001	AB3	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021748-002	AB3	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021748-001	AB3	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021748-002	AB3	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021748-001	AB3	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021748-002	AB3	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021748-001	AB3	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N021748-002	AB3	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021748-001	AB3	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021748-002	AB3	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021748-001	AB3	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021748-002	AB3	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021748-001	AB3	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021748-002	AB3	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N021748-001	AB3	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N021748-002	AB3	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021748-001	AB3	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021748-002	AB3	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N021748-001	AB3	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N021748-002	AB3	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N021748-001	AB3	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N021748-002	AB3	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N021748-001	AB3	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021748-002	AB3	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N021748-001	AB3	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N021748-002	AB3	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N021748-001	AB3	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N021748-002	AB3	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021748-001	AB3	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021748-002	AB3	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N021748-001	AB3	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N021748-002	AB3	1	`5aa47cf7b7d7…`

Observed Orange Book patent history#

Patent history page 1 of 2 · 78 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Coverage / status	Submission date	Source SHA-256
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021748-002	7780987	2025-03-23	Drug substance, Drug product		`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021748-002	7780987	2025-03-23	Drug substance, Drug product		`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021748-002	7780987	2025-03-23	Drug substance, Drug product		`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021748-002	7780987	2025-03-23	Drug substance, Drug product		`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021748-002	7780987	2025-03-23	Drug substance, Drug product		`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021748-002	7780987	2025-03-23	Drug substance, Drug product		`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021748-002	7780987	2025-03-23	Drug substance, Drug product		`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021748-002	7780987	2025-03-23	Drug substance, Drug product		`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021748-002	7780987	2025-03-23	Drug substance, Drug product		`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021748-002	7780987	2025-03-23	Drug substance, Drug product		`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021748-002	7780987	2025-03-23	Drug substance, Drug product		`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021748-002	7780987	2025-03-23	Drug substance, Drug product		`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N021748-002	7780987	2025-03-23	Drug substance, Drug product		`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021748-002	8323692	2023-03-30	Drug product	2012-12-12	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021748-002	7780987	2025-03-23	Drug substance, Drug product		`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N021748-002	8323692	2023-03-30	Drug product	2012-12-12	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N021748-002	7780987	2025-03-23	Drug substance, Drug product		`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N021748-002	8323692	2023-03-30	Drug product	2012-12-12	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N021748-002	7780987	2025-03-23	Drug substance, Drug product		`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N021748-001	6488962	2020-06-20	Drug substance, Drug product		`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021748-001	6723340	2021-10-25	Drug substance, Drug product		`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021748-002	8323692	2023-03-30	Drug product	2012-12-12	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021748-002	7780987	2025-03-23	Drug substance, Drug product		`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N021748-002	8323692	2023-03-30	Drug product	2012-12-12	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N021748-002	7780987	2025-03-23	Drug substance, Drug product		`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N021748-001	6723340	2021-10-25	Drug substance, Drug product		`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N021748-002	8323692	2023-03-30	Drug product	2012-12-12	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N021748-002	7780987	2025-03-23	Drug substance, Drug product		`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021748-001	6723340	2021-10-25	Drug substance, Drug product		`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021748-002	8323692	2023-03-30	Drug product	2012-12-12	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021748-002	7780987	2025-03-23	Drug substance, Drug product		`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N021748-001	6723340	2021-10-25	Drug substance, Drug product		`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N021748-002	8323692	2023-03-30	Drug product	2012-12-12	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N021748-002	7780987	2025-03-23	Drug substance, Drug product		`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N021748-001	6488962	2020-06-20	Drug substance, Drug product		`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N021748-001	6723340	2021-10-25	Drug substance, Drug product		`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N021748-002	8323692	2023-03-30	Drug product	2012-12-12	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N021748-002	7780987	2025-03-23	Drug substance, Drug product		`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N021748-001	6488962	2020-06-20	Drug substance, Drug product		`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N021748-001	6723340	2021-10-25	Drug substance, Drug product		`c0c555d07b60…`

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
13913-002-13	2023-02-16	C162847	48780-1	960f7f55-d463-8e05-e053-dbdaa90a074a	These highlights do not include all the information needed to use GLUMETZA safely and effectively. See full prescribing information for GLUMETZA. GLUMETZA ® (metformin hydrochloride extended-release tablets), 500 mg and 1000 mg Initial U.S. Approval: 1995
13913-002-13	2019-10-29	C162847	48780-1	960f7f55-d463-8e05-e053-dbdaa90a074a	These highlights do not include all the information needed to use GLUMETZA safely and effectively. See full prescribing information for GLUMETZA. GLUMETZA ® (metformin hydrochloride extended-release tablets), 500 mg and 1000 mg Initial U.S. Approval: 1995

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
METFORMIN HYDROCHLORIDE	ACTIVE INGREDIENT	786Z46389E	GLUMETZA (METFORMIN HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [DEPOMED, INC.]	14
METFORMIN	ACTIVE MOIETY	9100L32L2N	GLUMETZA (METFORMIN HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [DEPOMED, INC.]	14
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	GLUMETZA (METFORMIN HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [DEPOMED, INC.]	14
CROSPOVIDONE	INACTIVE INGREDIENT	68401960MK	GLUMETZA (METFORMIN HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [DEPOMED, INC.]	14
GLYCERYL BEHENATE	INACTIVE INGREDIENT	R8WTH25YS2	GLUMETZA (METFORMIN HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [DEPOMED, INC.]	14
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	GLUMETZA (METFORMIN HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [DEPOMED, INC.]	14
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	GLUMETZA (METFORMIN HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [DEPOMED, INC.]	14
POLYETHYLENE GLYCOL	INACTIVE INGREDIENT	3WJQ0SDW1A	GLUMETZA (METFORMIN HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [DEPOMED, INC.]	14
POLYSORBATE 80	INACTIVE INGREDIENT	6OZP39ZG8H	GLUMETZA (METFORMIN HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [DEPOMED, INC.]	14
POLYVINYL ALCOHOL	INACTIVE INGREDIENT	532B59J990	GLUMETZA (METFORMIN HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [DEPOMED, INC.]	14
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	GLUMETZA (METFORMIN HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [DEPOMED, INC.]	14
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	GLUMETZA (METFORMIN HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [DEPOMED, INC.]	14
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	GLUMETZA (METFORMIN HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [DEPOMED, INC.]	14

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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Glumetza	METFORMIN HYDROCHLORIDE	Santarus, Inc.	fb832474-88d9-4e29-95cd-fbc446944cc4	2026-09-02	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 021748 application number: NDA021748
Metformin hydrochloride	METFORMIN HYDROCHLORIDE	Oceanside Pharmaceuticals	74d32a8a-c4c2-4dbb-b376-eea3f8fa64d7	2024-11-14	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 021748 application number: NDA021748

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
786Z46389E	METFORMIN HYDROCHLORIDE	1115-70-4	METFORMIN HYDROCHLORIDE

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Glumetza	Depomed, Inc. \| Patheon Puerto Rico, Inc. \| Valeant Pharmaceuticals International, Inc	2011-04-30	HUMAN PRESCRIPTION DRUG LABEL	14