Glumetza

Product NDC: 68012-002
11-digit product format: 680120002
Labeler code: 68012
Product ID: 68012-002_41eb528d-e235-4563-833a-5cf36381d6db
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: metformin hydrochloride
Dosage form: TABLET, FILM COATED, EXTENDED RELEASE
Route: ORAL
Labeler: Santarus, Inc.
Application: NDA021748
Marketing category: NDA
Marketing start: 2006-08-01
Substance: METFORMIN HYDROCHLORIDE
Active strength: 500 mg/1
Pharmacologic classes: Biguanide [EPC], Biguanides [CS]
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	68012-002	68012-002-92	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 · 12 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	`557ba5c1ecfa…`	`9c80585c8c6e…`

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…`

Additional Listing Data#

Finished product: Yes
Brand name base: Glumetza
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
METFORMIN HYDROCHLORIDE	500 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
786Z46389E	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
861015	Internal RxNorm lookup
861018	Internal RxNorm lookup
1807888	Internal RxNorm lookup
1807915	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
fb832474-88d9-4e29-95cd-fbc446944cc4	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
6a29d87d-f465-752d-5fa9-bd728c608ca2	Product name	4	20251215
f6d21fb1-2c09-48ab-8d89-eeadf5a9698e	Product name	1	20250724
a985afd1-89a8-bfab-0231-b59db1a3a9b5	Product name	7	20250515
25bfaa4d-02a1-402c-96ec-9bf6e625484c	Product name	1	20250307
08b60e13-e5d0-74ca-b5a8-e6df9cb1dca0	Product name	2	20240829
16dbe107-66d5-47b3-57ed-0cba6a8dfccc	Product name	6	20240215
08b3e508-8c7e-3b95-0275-113510642fc6	Product name	2	20220309
3a90349e-ff2e-41bd-a106-b368fbc1c1f8	Product name	1	20200612
5ab9c07d-ba46-4f19-88f9-a3bc7929fb86	Product name	1	20200214
1dc427fa-8c3b-4309-981e-ea1ff01326e5	Product name	1	20190731
ca3f036c-6c06-b829-b379-1a3a4097099c	Product name	9	20180605
e1ede89f-54c8-428f-ae84-9e8a2deb67db	Product name	1	20180306
5ec207a9-fa56-4ff7-8fae-9a7d9a6bf52c	Product name	2	20170824
bea938a6-c880-985b-d27b-b59b0d8b5a77	Product name	3	20170626
0600b0d3-c32a-40bb-8d87-3a2934cd8f2f	Product name	1	20170616
e2382c7e-9e14-4196-aeff-98e2cfaf63cb	Product name	1	20170224
988f737f-e7e9-4613-8558-824b1ab755f9	Product name	1	20161128
58b66776-50d5-434f-916f-958ccf131e0e	Product name	1	20160713
3e9b6ece-066b-2ac3-28f7-5e13060e5934	Product name	2	20151109
2988466d-5fc4-4430-9cee-fc9132f02d2c	Product name	1	20150910
85cbb42f-1a8d-f945-f85e-188e823b7f5b	Product name	2	20150731
e740bf83-275a-4f0c-adf4-ec60ebd882b7	Product name	1	20150105
8d7b9e2e-c1f8-4f6e-a1f3-e4ce405be5f0	Product name	1	20141205
0d79b284-47e8-e90c-f249-892b9b251003	Product name	1	20140508
25391a6f-d1ba-6bff-d36e-050dc68ef0e6	Product name	1	20140508
2de6e143-c970-2061-1b77-61c3aa8f4026	Product name	1	20140508
2dee091b-3b8c-d27a-b1ba-fcb0d32e776a	Product name	1	20140508
ce63c1f8-ba50-8a17-9290-94522d75daff	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Related label table
NDC	Related label
68012-002-13	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, for oral use Initial U.S. Approval: 1995
68012-002-13	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, for oral use Initial U.S. Approval: 1995
68012-002-13	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, for oral use Initial U.S. Approval: 1995
68012-002-92	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, for oral use Initial U.S. Approval: 1995
68012-002-92	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, for oral use Initial U.S. Approval: 1995
68012-002-92	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, for oral use Initial U.S. Approval: 1995

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
68012-002-13	Glumetza	100 in 1 BOTTLE	TABLET, FILM COATED, EXTENDED RE	100		30
68012-002-92	Glumetza	21 in 1 BOTTLE	TABLET, FILM COATED, EXTENDED RE	21		30

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
68012-002-13	EA - Each	68012-002	e4d17f45-d43b-4c9c-a517-f2bb9c73f008	1	2012-07-24

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 [SANTARUS, INC.]	6
metformin	ACTIVE MOIETY	9100L32L2N	GLUMETZA (METFORMIN HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [SANTARUS, INC.]	6
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	GLUMETZA (METFORMIN HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [SANTARUS, INC.]	6
crospovidone	INACTIVE INGREDIENT	68401960MK	GLUMETZA (METFORMIN HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [SANTARUS, INC.]	6
glyceryl behenate	INACTIVE INGREDIENT	R8WTH25YS2	GLUMETZA (METFORMIN HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [SANTARUS, INC.]	6
hypromelloses	INACTIVE INGREDIENT	3NXW29V3WO	GLUMETZA (METFORMIN HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [SANTARUS, INC.]	6
magnesium stearate	INACTIVE INGREDIENT	70097M6I30	GLUMETZA (METFORMIN HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [SANTARUS, INC.]	6
polyethylene glycols	INACTIVE INGREDIENT	3WJQ0SDW1A	GLUMETZA (METFORMIN HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [SANTARUS, INC.]	6
polysorbate 80	INACTIVE INGREDIENT	6OZP39ZG8H	GLUMETZA (METFORMIN HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [SANTARUS, INC.]	6
polyvinyl alcohol	INACTIVE INGREDIENT	532B59J990	GLUMETZA (METFORMIN HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [SANTARUS, INC.]	6
silicon dioxide	INACTIVE INGREDIENT	ETJ7Z6XBU4	GLUMETZA (METFORMIN HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [SANTARUS, INC.]	6
talc	INACTIVE INGREDIENT	7SEV7J4R1U	GLUMETZA (METFORMIN HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [SANTARUS, INC.]	6
titanium dioxide	INACTIVE INGREDIENT	15FIX9V2JP	GLUMETZA (METFORMIN HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [SANTARUS, INC.]	6

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68012-002	GLUMETZA (METFORMIN HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [SANTARUS, INC.]	27	Current NDC, Legacy NDC, 2 package rows	20240328_fb832474-88d9-4e29-95cd-fbc446944cc4.zip

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 ndc (product): 68012-002
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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
861015	Glumetza 1000 MG 24HR Extended Release Oral Tablet	PSN	fb832474-88d9-4e29-95cd-fbc446944cc4	30
861018	Glumetza 500 MG Modified 24HR Extended Release Oral Tablet	PSN	fb832474-88d9-4e29-95cd-fbc446944cc4	30
1807888	metFORMIN HCl 1000 MG Modified 24HR Extended Release Oral Tablet	PSN	fb832474-88d9-4e29-95cd-fbc446944cc4	30
1807915	metFORMIN HCl 500 MG Modified 24HR Extended Release Oral Tablet	PSN	fb832474-88d9-4e29-95cd-fbc446944cc4	30
861015	Modified 24 HR metformin hydrochloride 1000 MG Extended Release Oral Tablet [Glumetza]	SBD	fb832474-88d9-4e29-95cd-fbc446944cc4	30
861018	Modified 24 HR metformin hydrochloride 500 MG Extended Release Oral Tablet [Glumetza]	SBD	fb832474-88d9-4e29-95cd-fbc446944cc4	30
1807888	Modified 24 HR metformin hydrochloride 1000 MG Extended Release Oral Tablet	SCD	fb832474-88d9-4e29-95cd-fbc446944cc4	30
1807915	Modified 24 HR metformin hydrochloride 500 MG Extended Release Oral Tablet	SCD	fb832474-88d9-4e29-95cd-fbc446944cc4	30
861015	Glumetza 1000 MG 24HR Extended Release Oral Tablet	SY	fb832474-88d9-4e29-95cd-fbc446944cc4	30
861018	Glumetza 500 MG Modified 24 HR Extended Release Oral Tablet	SY	fb832474-88d9-4e29-95cd-fbc446944cc4	30
1807888	metformin HCl 1000 MG Modified 24 HR Extended Release Oral Tablet	SY	fb832474-88d9-4e29-95cd-fbc446944cc4	30
1807915	metformin HCl 500 MG Modified 24 HR Extended Release Oral Tablet	SY	fb832474-88d9-4e29-95cd-fbc446944cc4	30
861015	Modified 24 HR Glumetza 1000 MG Extended Release Oral Tablet	SY	fb832474-88d9-4e29-95cd-fbc446944cc4	30

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
68012-002-13	68012000213	100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (68012-002-13)	2006-08-01	0000-00-00	No	No	Current
68012-002-92	68012000292	21 in 1 BOTTLE					Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Glumetza	Santarus, Inc. \| Patheon Puerto Rico, Inc. \| Bausch Health Companies Inc.	2026-09-02	HUMAN PRESCRIPTION DRUG LABEL	31