SEGLUROMET

Product NDC: 50090-6217
11-digit product format: 500906217
Labeler code: 50090
Product ID: 50090-6217_32ba0cb1-9d15-4435-9374-92427d46c173
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: ertugliflozin and metformin hydrochloride
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: A-S Medication Solutions
Application: NDA209806
Marketing category: NDA
Marketing start: 2017-12-19
Marketing end: 0000-00-00
Substance: ERTUGLIFLOZIN PIDOLATE; METFORMIN HYDROCHLORIDE
Active strength: 3 mg/1; mg/1
Pharmacologic classes: Biguanide [EPC], Biguanides [CS]
NDC exclude flag: No
Listing certified through: 2023-12-31
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	50090-6217		I	Inactivated by FDA		2026-10-05
excluded package	package	50090-6217	50090-6217-0	I	Inactivated by FDA		2026-10-05

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 · 30 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	50090-6217-0	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	50090-6217-0	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	50090-6217-0	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	50090-6217-0	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	50090-6217-0	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	50090-6217-0	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	50090-6217-0	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	50090-6217-0	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	50090-6217-0	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	50090-6217-0	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	50090-6217-0	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	50090-6217-0	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	50090-6217-0	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	50090-6217-0	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	50090-6217-0	`1332a3947898…`	`d4bfe170f9cd…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	RLD / RS	Approval date
N209806-001	SEGLUROMET	ERTUGLIFLOZIN; METFORMIN HYDROCHLORIDE	2.5MG;500MG	TABLET / ORAL	RLD	2017-12-19
N209806-002	SEGLUROMET	ERTUGLIFLOZIN; METFORMIN HYDROCHLORIDE	2.5MG;1GM	TABLET / ORAL	RLD	2017-12-19
N209806-003	SEGLUROMET	ERTUGLIFLOZIN; METFORMIN HYDROCHLORIDE	7.5MG;500MG	TABLET / ORAL	RLD	2017-12-19
N209806-004	SEGLUROMET	ERTUGLIFLOZIN; METFORMIN HYDROCHLORIDE	7.5MG;1GM	TABLET / ORAL	RLD, RS	2017-12-19

Orange Book patents#

Current patent rows page 1 of 1 · 12 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N209806-001	9308204	2030-10-21		Drug product	2018-01-16
N209806-001	9439902	2030-10-21	U-2214		2018-01-16
N209806-001	8080580	2031-12-19	U-2214	Drug substance, Drug product	2018-01-16
N209806-002	9308204	2030-10-21		Drug product	2018-01-16
N209806-002	9439902	2030-10-21	U-2214		2018-01-16
N209806-002	8080580	2031-12-19	U-2214	Drug substance, Drug product	2018-01-16
N209806-003	9308204	2030-10-21		Drug product	2018-01-16
N209806-003	9439902	2030-10-21	U-2214		2018-01-16
N209806-003	8080580	2031-12-19	U-2214	Drug substance, Drug product	2018-01-16
N209806-004	9308204	2030-10-21		Drug product	2018-01-16
N209806-004	9439902	2030-10-21	U-2214		2018-01-16
N209806-004	8080580	2031-12-19	U-2214	Drug substance, Drug product	2018-01-16

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 5 · 172 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	N209806-001	SEGLUROMET	2.5MG;500MG	TABLET / ORAL	RLD	2017-12-19	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N209806-002	SEGLUROMET	2.5MG;1GM	TABLET / ORAL	RLD	2017-12-19	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N209806-003	SEGLUROMET	7.5MG;500MG	TABLET / ORAL	RLD	2017-12-19	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N209806-004	SEGLUROMET	7.5MG;1GM	TABLET / ORAL	RLD, RS	2017-12-19	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N209806-001	SEGLUROMET	2.5MG;500MG	TABLET / ORAL	RLD	2017-12-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N209806-002	SEGLUROMET	2.5MG;1GM	TABLET / ORAL	RLD	2017-12-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N209806-003	SEGLUROMET	7.5MG;500MG	TABLET / ORAL	RLD	2017-12-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N209806-004	SEGLUROMET	7.5MG;1GM	TABLET / ORAL	RLD, RS	2017-12-19	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N209806-001	SEGLUROMET	2.5MG;500MG	TABLET / ORAL	RLD	2017-12-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209806-002	SEGLUROMET	2.5MG;1GM	TABLET / ORAL	RLD	2017-12-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209806-003	SEGLUROMET	7.5MG;500MG	TABLET / ORAL	RLD	2017-12-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209806-004	SEGLUROMET	7.5MG;1GM	TABLET / ORAL	RLD, RS	2017-12-19	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N209806-001	SEGLUROMET	2.5MG;500MG	TABLET / ORAL	RLD	2017-12-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N209806-002	SEGLUROMET	2.5MG;1GM	TABLET / ORAL	RLD	2017-12-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N209806-003	SEGLUROMET	7.5MG;500MG	TABLET / ORAL	RLD	2017-12-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N209806-004	SEGLUROMET	7.5MG;1GM	TABLET / ORAL	RLD, RS	2017-12-19	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N209806-001	SEGLUROMET	2.5MG;500MG	TABLET / ORAL	RLD	2017-12-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N209806-002	SEGLUROMET	2.5MG;1GM	TABLET / ORAL	RLD	2017-12-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N209806-003	SEGLUROMET	7.5MG;500MG	TABLET / ORAL	RLD	2017-12-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N209806-004	SEGLUROMET	7.5MG;1GM	TABLET / ORAL	RLD, RS	2017-12-19	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N209806-001	SEGLUROMET	2.5MG;500MG	TABLET / ORAL	RLD	2017-12-19	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N209806-002	SEGLUROMET	2.5MG;1GM	TABLET / ORAL	RLD	2017-12-19	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N209806-003	SEGLUROMET	7.5MG;500MG	TABLET / ORAL	RLD	2017-12-19	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N209806-004	SEGLUROMET	7.5MG;1GM	TABLET / ORAL	RLD, RS	2017-12-19	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N209806-001	SEGLUROMET	2.5MG;500MG	TABLET / ORAL	RLD	2017-12-19	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N209806-002	SEGLUROMET	2.5MG;1GM	TABLET / ORAL	RLD	2017-12-19	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N209806-003	SEGLUROMET	7.5MG;500MG	TABLET / ORAL	RLD	2017-12-19	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N209806-004	SEGLUROMET	7.5MG;1GM	TABLET / ORAL	RLD, RS	2017-12-19	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N209806-001	SEGLUROMET	2.5MG;500MG	TABLET / ORAL	RLD	2017-12-19	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N209806-002	SEGLUROMET	2.5MG;1GM	TABLET / ORAL	RLD	2017-12-19	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N209806-003	SEGLUROMET	7.5MG;500MG	TABLET / ORAL	RLD	2017-12-19	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N209806-004	SEGLUROMET	7.5MG;1GM	TABLET / ORAL	RLD, RS	2017-12-19	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N209806-001	SEGLUROMET	2.5MG;500MG	TABLET / ORAL	RLD	2017-12-19	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N209806-002	SEGLUROMET	2.5MG;1GM	TABLET / ORAL	RLD	2017-12-19	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N209806-003	SEGLUROMET	7.5MG;500MG	TABLET / ORAL	RLD	2017-12-19	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N209806-004	SEGLUROMET	7.5MG;1GM	TABLET / ORAL	RLD, RS	2017-12-19	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N209806-001	SEGLUROMET	2.5MG;500MG	TABLET / ORAL	RLD	2017-12-19	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N209806-002	SEGLUROMET	2.5MG;1GM	TABLET / ORAL	RLD	2017-12-19	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N209806-003	SEGLUROMET	7.5MG;500MG	TABLET / ORAL	RLD	2017-12-19	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N209806-004	SEGLUROMET	7.5MG;1GM	TABLET / ORAL	RLD, RS	2017-12-19	`5bbf6a4d5a75…`

Observed Orange Book patent history#

Patent history page 1 of 13 · 516 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-09-14 22:38:34	2026-08	N209806-001	9308204	2030-10-21		Drug product	2018-01-16	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N209806-001	9439902	2030-10-21	U-2214		2018-01-16	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N209806-001	8080580	2031-12-19	U-2214	Drug substance, Drug product	2018-01-16	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N209806-002	9308204	2030-10-21		Drug product	2018-01-16	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N209806-002	9439902	2030-10-21	U-2214		2018-01-16	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N209806-002	8080580	2031-12-19	U-2214	Drug substance, Drug product	2018-01-16	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N209806-003	9308204	2030-10-21		Drug product	2018-01-16	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N209806-003	9439902	2030-10-21	U-2214		2018-01-16	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N209806-003	8080580	2031-12-19	U-2214	Drug substance, Drug product	2018-01-16	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N209806-004	9308204	2030-10-21		Drug product	2018-01-16	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N209806-004	9439902	2030-10-21	U-2214		2018-01-16	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N209806-004	8080580	2031-12-19	U-2214	Drug substance, Drug product	2018-01-16	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N209806-001	9308204	2030-10-21		Drug product	2018-01-16	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N209806-001	9439902	2030-10-21	U-2214		2018-01-16	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N209806-001	8080580	2031-12-19	U-2214	Drug substance, Drug product	2018-01-16	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N209806-002	9308204	2030-10-21		Drug product	2018-01-16	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N209806-002	9439902	2030-10-21	U-2214		2018-01-16	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N209806-002	8080580	2031-12-19	U-2214	Drug substance, Drug product	2018-01-16	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N209806-003	9308204	2030-10-21		Drug product	2018-01-16	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N209806-003	9439902	2030-10-21	U-2214		2018-01-16	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N209806-003	8080580	2031-12-19	U-2214	Drug substance, Drug product	2018-01-16	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N209806-004	9308204	2030-10-21		Drug product	2018-01-16	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N209806-004	9439902	2030-10-21	U-2214		2018-01-16	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N209806-004	8080580	2031-12-19	U-2214	Drug substance, Drug product	2018-01-16	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N209806-001	8080580	2030-07-13	U-2214	Drug substance, Drug product	2018-01-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209806-001	9308204	2030-10-21		Drug product	2018-01-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209806-001	9439902	2030-10-21	U-2214		2018-01-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209806-002	8080580	2030-07-13	U-2214	Drug substance, Drug product	2018-01-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209806-002	9308204	2030-10-21		Drug product	2018-01-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209806-002	9439902	2030-10-21	U-2214		2018-01-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209806-003	8080580	2030-07-13	U-2214	Drug substance, Drug product	2018-01-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209806-003	9308204	2030-10-21		Drug product	2018-01-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209806-003	9439902	2030-10-21	U-2214		2018-01-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209806-004	8080580	2030-07-13	U-2214	Drug substance, Drug product	2018-01-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209806-004	9308204	2030-10-21		Drug product	2018-01-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209806-004	9439902	2030-10-21	U-2214		2018-01-16	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N209806-001	8080580	2030-07-13	U-2214	Drug substance, Drug product	2018-01-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N209806-001	9308204	2030-10-21		Drug product	2018-01-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N209806-001	9439902	2030-10-21	U-2214		2018-01-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N209806-002	8080580	2030-07-13	U-2214	Drug substance, Drug product	2018-01-16	`31067a03dcf5…`

Observed Orange Book exclusivity history#

Exclusivity history page 1 of 5 · 164 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N209806-001	M-275	2024-09-17	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N209806-002	M-275	2024-09-17	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N209806-003	M-275	2024-09-17	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N209806-004	M-275	2024-09-17	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N209806-001	M-275	2024-09-17	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N209806-002	M-275	2024-09-17	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N209806-003	M-275	2024-09-17	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N209806-004	M-275	2024-09-17	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N209806-001	M-275	2024-09-17	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N209806-002	M-275	2024-09-17	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N209806-003	M-275	2024-09-17	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N209806-004	M-275	2024-09-17	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N209806-001	M-275	2024-09-17	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N209806-002	M-275	2024-09-17	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N209806-003	M-275	2024-09-17	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N209806-004	M-275	2024-09-17	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N209806-001	M-275	2024-09-17	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N209806-002	M-275	2024-09-17	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N209806-003	M-275	2024-09-17	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N209806-004	M-275	2024-09-17	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N209806-001	M-275	2024-09-17	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N209806-002	M-275	2024-09-17	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N209806-003	M-275	2024-09-17	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N209806-004	M-275	2024-09-17	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N209806-001	M-275	2024-09-17	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N209806-002	M-275	2024-09-17	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N209806-003	M-275	2024-09-17	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N209806-004	M-275	2024-09-17	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N209806-001	M-275	2024-09-17	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N209806-002	M-275	2024-09-17	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N209806-003	M-275	2024-09-17	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N209806-004	M-275	2024-09-17	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N209806-001	M-275	2024-09-17	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N209806-002	M-275	2024-09-17	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N209806-003	M-275	2024-09-17	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N209806-004	M-275	2024-09-17	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N209806-001	NCE	2022-12-19	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N209806-001	M-275	2024-09-17	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N209806-002	NCE	2022-12-19	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N209806-002	M-275	2024-09-17	`5c6f7cd8ea54…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

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
63c50ce2-9db8-486b-bf11-659e923f6f07	Product name	2	20250331
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
fd232072-39c4-4416-9b66-265d18a7bd93	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, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
50090-6217-0	2024-01-30	C162847	48780-1	1030e365-3e82-111a-e063-dadaa90a10e2	These highlights do not include all the information needed to use SEGLUROMET safely and effectively. See full prescribing information for SEGLUROMET. SEGLUROMET ® (ertugliflozin and metformin hydrochloride) tablets, for oral use Initial U.S. Approval: 2017

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
50090-6217-0	SEGLUROMET	60 in 1 BOTTLE	TABLET, FILM COATED	60		2

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
50090-6217-0	EA - Each	50090-6217	6ec13230-a093-4a30-b746-25daa16128a7	1	2022-12-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
50090-6217	SEGLUROMET (ERTUGLIFLOZIN AND METFORMIN HYDROCHLORIDE) TABLET, FILM COATED [A-S MEDICATION SOLUTIONS]	2	Legacy NDC, 1 package rows	20221114_b0451c1c-2b3b-4032-bb49-157425686754.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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
SEGLUROMET	ERTUGLIFLOZIN AND METFORMIN HYDROCHLORIDE	Merck Sharp & Dohme LLC	a6aeb99a-ce49-4125-90ce-642df3f1ebad	2026-08-11	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 209806 application number: NDA209806

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
MLU731K321	ERTUGLIFLOZIN PIDOLATE	1210344-83-4	ERTUGLIFLOZIN PIDOLATE
786Z46389E	METFORMIN HYDROCHLORIDE	1115-70-4	METFORMIN HYDROCHLORIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1992693	ertugliflozin 2.5 MG / metFORMIN hydrochloride 500 MG Oral Tablet	PSN	b0451c1c-2b3b-4032-bb49-157425686754	2
1992695	Segluromet 2.5 MG / 500 MG Oral Tablet	PSN	b0451c1c-2b3b-4032-bb49-157425686754	2
1992695	ertugliflozin 2.5 MG / metformin hydrochloride 500 MG Oral Tablet [Segluromet]	SBD	b0451c1c-2b3b-4032-bb49-157425686754	2
1992693	ertugliflozin 2.5 MG / metformin hydrochloride 500 MG Oral Tablet	SCD	b0451c1c-2b3b-4032-bb49-157425686754	2
1992695	Segluromet 2.5/500 (ertugliflozin 2.5 MG / metformin hydrochloride 500 MG) MG Oral Tablet	SY	b0451c1c-2b3b-4032-bb49-157425686754	2
1992695	Segluromet 2.5/500 Oral Tablet	SY	b0451c1c-2b3b-4032-bb49-157425686754	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
50090-6217-0	50090621700	60 TABLET, FILM COATED in 1 BOTTLE (50090-6217-0)	2022-11-10	0000-00-00	No	No	Current