STEGLATRO

Product NDC: 0006-5363
11-digit product format: 000065363
Labeler code: 0006
Product ID: 0006-5363_1616eabd-2ed5-4a98-b255-964e73b63dc8
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: ertugliflozin
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Merck Sharp & Dohme LLC
Application: NDA209803
Marketing category: NDA
Marketing start: 2017-12-19
Substance: ERTUGLIFLOZIN PIDOLATE
Active strength: 5 mg/1
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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
N209803-001	STEGLATRO	ERTUGLIFLOZIN	5MG	TABLET / ORAL		RLD	2017-12-19
N209803-002	STEGLATRO	ERTUGLIFLOZIN	15MG	TABLET / ORAL		RLD, RS	2017-12-19

Orange Book patents#

Current patent rows page 1 of 1 · 2 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N209803-001	8080580	2031-12-19	U-2214	Drug substance, Drug product	2018-01-16
N209803-002	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 3 · 84 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
2026-08-18 06:07:40	2026-07	N209803-001	STEGLATRO	5MG	TABLET / ORAL		RLD	2017-12-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N209803-002	STEGLATRO	15MG	TABLET / ORAL		RLD, RS	2017-12-19	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N209803-001	STEGLATRO	5MG	TABLET / ORAL		RLD	2017-12-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209803-002	STEGLATRO	15MG	TABLET / ORAL		RLD, RS	2017-12-19	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N209803-001	STEGLATRO	5MG	TABLET / ORAL		RLD	2017-12-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N209803-002	STEGLATRO	15MG	TABLET / ORAL		RLD, RS	2017-12-19	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N209803-001	STEGLATRO	5MG	TABLET / ORAL		RLD	2017-12-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N209803-002	STEGLATRO	15MG	TABLET / ORAL		RLD, RS	2017-12-19	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N209803-001	STEGLATRO	5MG	TABLET / ORAL	AB	RLD	2017-12-19	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N209803-002	STEGLATRO	15MG	TABLET / ORAL	AB	RLD, RS	2017-12-19	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N209803-001	STEGLATRO	5MG	TABLET / ORAL	AB	RLD	2017-12-19	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N209803-002	STEGLATRO	15MG	TABLET / ORAL	AB	RLD, RS	2017-12-19	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N209803-001	STEGLATRO	5MG	TABLET / ORAL	AB	RLD	2017-12-19	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N209803-002	STEGLATRO	15MG	TABLET / ORAL	AB	RLD, RS	2017-12-19	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N209803-001	STEGLATRO	5MG	TABLET / ORAL	AB	RLD	2017-12-19	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N209803-002	STEGLATRO	15MG	TABLET / ORAL	AB	RLD, RS	2017-12-19	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N209803-001	STEGLATRO	5MG	TABLET / ORAL		RLD	2017-12-19	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N209803-002	STEGLATRO	15MG	TABLET / ORAL		RLD, RS	2017-12-19	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N209803-001	STEGLATRO	5MG	TABLET / ORAL	AB	RLD	2017-12-19	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N209803-002	STEGLATRO	15MG	TABLET / ORAL	AB	RLD, RS	2017-12-19	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N209803-001	STEGLATRO	5MG	TABLET / ORAL	AB	RLD	2017-12-19	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N209803-002	STEGLATRO	15MG	TABLET / ORAL	AB	RLD, RS	2017-12-19	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N209803-001	STEGLATRO	5MG	TABLET / ORAL		RLD	2017-12-19	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N209803-002	STEGLATRO	15MG	TABLET / ORAL		RLD, RS	2017-12-19	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N209803-001	STEGLATRO	5MG	TABLET / ORAL		RLD	2017-12-19	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N209803-002	STEGLATRO	15MG	TABLET / ORAL		RLD, RS	2017-12-19	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N209803-001	STEGLATRO	5MG	TABLET / ORAL		RLD	2017-12-19	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N209803-002	STEGLATRO	15MG	TABLET / ORAL		RLD, RS	2017-12-19	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N209803-001	STEGLATRO	5MG	TABLET / ORAL		RLD	2017-12-19	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N209803-002	STEGLATRO	15MG	TABLET / ORAL		RLD, RS	2017-12-19	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N209803-001	STEGLATRO	5MG	TABLET / ORAL		RLD	2017-12-19	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N209803-002	STEGLATRO	15MG	TABLET / ORAL		RLD, RS	2017-12-19	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N209803-001	STEGLATRO	5MG	TABLET / ORAL		RLD	2017-12-19	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N209803-002	STEGLATRO	15MG	TABLET / ORAL		RLD, RS	2017-12-19	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N209803-001	STEGLATRO	5MG	TABLET / ORAL		RLD	2017-12-19	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N209803-002	STEGLATRO	15MG	TABLET / ORAL		RLD, RS	2017-12-19	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N209803-001	STEGLATRO	5MG	TABLET / ORAL		RLD	2017-12-19	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N209803-002	STEGLATRO	15MG	TABLET / ORAL		RLD, RS	2017-12-19	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N209803-001	STEGLATRO	5MG	TABLET / ORAL		RLD	2017-12-19	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N209803-002	STEGLATRO	15MG	TABLET / ORAL		RLD, RS	2017-12-19	`bb7c543d1eb4…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N209803-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N209803-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N209803-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N209803-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N209803-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N209803-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N209803-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N209803-002	AB	1	`2680178bc6a6…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N209803-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N209803-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N209803-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N209803-002	AB	1	`d06236e962d9…`

Observed Orange Book patent history#

Patent history page 1 of 3 · 84 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-08-18 06:07:40	2026-07	N209803-001	8080580	2031-12-19	U-2214	Drug substance, Drug product	2018-01-16	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N209803-002	8080580	2031-12-19	U-2214	Drug substance, Drug product	2018-01-16	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N209803-001	8080580	2030-07-13	U-2214	Drug substance, Drug product	2018-01-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209803-002	8080580	2030-07-13	U-2214	Drug substance, Drug product	2018-01-16	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N209803-001	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	N209803-002	8080580	2030-07-13	U-2214	Drug substance, Drug product	2018-01-16	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N209803-001	8080580	2030-07-13	U-2214	Drug substance, Drug product	2018-01-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N209803-002	8080580	2030-07-13	U-2214	Drug substance, Drug product	2018-01-16	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N209803-001	8080580	2030-07-13	U-2214	Drug substance, Drug product	2018-01-16	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N209803-002	8080580	2030-07-13	U-2214	Drug substance, Drug product	2018-01-16	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N209803-001	8080580	2030-07-13	U-2214	Drug substance, Drug product	2018-01-16	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N209803-002	8080580	2030-07-13	U-2214	Drug substance, Drug product	2018-01-16	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N209803-001	8080580	2030-07-13	U-2214	Drug substance, Drug product	2018-01-16	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N209803-002	8080580	2030-07-13	U-2214	Drug substance, Drug product	2018-01-16	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N209803-001	8080580	2030-07-13	U-2214	Drug substance, Drug product	2018-01-16	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N209803-002	8080580	2030-07-13	U-2214	Drug substance, Drug product	2018-01-16	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N209803-001	8080580	2030-07-13	U-2214	Drug substance, Drug product	2018-01-16	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N209803-002	8080580	2030-07-13	U-2214	Drug substance, Drug product	2018-01-16	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N209803-001	8080580	2030-07-13	U-2214	Drug substance, Drug product	2018-01-16	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N209803-002	8080580	2030-07-13	U-2214	Drug substance, Drug product	2018-01-16	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N209803-001	8080580	2030-07-13	U-2214	Drug substance, Drug product	2018-01-16	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N209803-002	8080580	2030-07-13	U-2214	Drug substance, Drug product	2018-01-16	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N209803-001	8080580	2030-07-13	U-2214	Drug substance, Drug product	2018-01-16	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N209803-002	8080580	2030-07-13	U-2214	Drug substance, Drug product	2018-01-16	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N209803-001	8080580	2030-07-13	U-2214	Drug substance, Drug product	2018-01-16	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N209803-002	8080580	2030-07-13	U-2214	Drug substance, Drug product	2018-01-16	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N209803-001	8080580	2030-07-13	U-2214	Drug substance, Drug product	2018-01-16	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N209803-002	8080580	2030-07-13	U-2214	Drug substance, Drug product	2018-01-16	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N209803-001	8080580	2030-07-13	U-2214	Drug substance, Drug product	2018-01-16	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N209803-002	8080580	2030-07-13	U-2214	Drug substance, Drug product	2018-01-16	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N209803-001	8080580	2030-07-13	U-2214	Drug substance, Drug product	2018-01-16	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N209803-002	8080580	2030-07-13	U-2214	Drug substance, Drug product	2018-01-16	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N209803-001	8080580	2030-07-13	U-2214	Drug substance, Drug product	2018-01-16	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N209803-002	8080580	2030-07-13	U-2214	Drug substance, Drug product	2018-01-16	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N209803-001	8080580	2030-07-13	U-2214	Drug substance, Drug product	2018-01-16	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N209803-002	8080580	2030-07-13	U-2214	Drug substance, Drug product	2018-01-16	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N209803-001	8080580	2030-07-13	U-2214	Drug substance, Drug product	2018-01-16	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N209803-002	8080580	2030-07-13	U-2214	Drug substance, Drug product	2018-01-16	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N209803-001	8080580	2030-07-13	U-2214	Drug substance, Drug product	2018-01-16	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N209803-002	8080580	2030-07-13	U-2214	Drug substance, Drug product	2018-01-16	`bb7c543d1eb4…`

Observed Orange Book exclusivity history#

Exclusivity history page 1 of 3 · 82 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	N209803-001	M-275	2024-09-17	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N209803-002	M-275	2024-09-17	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N209803-001	M-275	2024-09-17	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N209803-002	M-275	2024-09-17	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N209803-001	M-275	2024-09-17	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N209803-002	M-275	2024-09-17	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N209803-001	M-275	2024-09-17	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N209803-002	M-275	2024-09-17	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N209803-001	M-275	2024-09-17	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N209803-002	M-275	2024-09-17	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N209803-001	M-275	2024-09-17	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N209803-002	M-275	2024-09-17	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N209803-001	M-275	2024-09-17	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N209803-002	M-275	2024-09-17	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N209803-001	M-275	2024-09-17	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N209803-002	M-275	2024-09-17	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N209803-001	M-275	2024-09-17	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N209803-002	M-275	2024-09-17	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N209803-001	NCE	2022-12-19	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N209803-001	M-275	2024-09-17	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N209803-002	NCE	2022-12-19	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N209803-002	M-275	2024-09-17	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N209803-001	NCE	2022-12-19	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N209803-002	NCE	2022-12-19	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N209803-001	NCE	2022-12-19	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N209803-002	NCE	2022-12-19	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N209803-001	NCE	2022-12-19	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N209803-002	NCE	2022-12-19	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N209803-001	NCE	2022-12-19	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N209803-002	NCE	2022-12-19	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N209803-001	NCE	2022-12-19	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N209803-002	NCE	2022-12-19	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N209803-001	NCE	2022-12-19	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N209803-002	NCE	2022-12-19	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N209803-001	NCE	2022-12-19	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N209803-002	NCE	2022-12-19	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N209803-001	NCE	2022-12-19	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N209803-002	NCE	2022-12-19	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N209803-001	NCE	2022-12-19	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N209803-002	NCE	2022-12-19	`c0c555d07b60…`

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
ERTUGLIFLOZIN PIDOLATE	5 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
MLU731K321	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1992810	Internal RxNorm lookup
1992816	Internal RxNorm lookup
1992819	Internal RxNorm lookup
1992821	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
e6f3e718-bb99-48f1-ab94-b9f0af05fed6	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
63c50ce2-9db8-486b-bf11-659e923f6f07	Product name	2	20250331
362d7abb-94e6-4c60-9a58-266894157713	Product name	1	20231023
816b97af-edc5-4060-aff1-b814bdbcad50	Product name	1	20190415
e1ede89f-54c8-428f-ae84-9e8a2deb67db	Product name	1	20180306
fd232072-39c4-4416-9b66-265d18a7bd93	Product name	1	20180306
419aab54-5d5a-4146-9453-026d4a9991be	Product name	2	20170525
89dac932-b90a-4410-9ab1-84c53e57de25	Product name	1	20150316
d723478e-ad4a-ec23-6bd7-cfe33e1e3840	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
0006-5363-03	STEGLATRO	30 in 1 BOTTLE	TABLET, FILM COATED	30	16
0006-5363-06	STEGLATRO	90 in 1 BOTTLE	TABLET, FILM COATED	90	16
0006-5363-07	STEGLATRO	500 in 1 BOTTLE	TABLET, FILM COATED	500	16
0006-5363-08	STEGLATRO	7 in 1 BOTTLE	TABLET, FILM COATED	7	16
0006-5363-09	STEGLATRO	2 in 1 CARTON	TABLET, FILM COATED	2	16
0006-5363-10	STEGLATRO	30 in 1 BOTTLE	TABLET, FILM COATED	30	16

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0006-5363-03	EA - Each	0006-5363	39535e37-f5d0-48ba-a708-85f6a4a58189	1	2018-01-12
0006-5363-06	EA - Each	0006-5363	b540f2ad-1847-4e7a-b0e7-c67f6c33be74	1	2018-01-12
0006-5363-07	EA - Each	0006-5363	73213a19-039e-4928-88b2-2fde2b6550f1	1	2018-01-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0006-5363	STEGLATRO (ERTUGLIFLOZIN) TABLET, FILM COATED [MERCK SHARP & DOHME LLC]	16	Current NDC, Legacy NDC, 6 package rows	20250112_e6f3e718-bb99-48f1-ab94-b9f0af05fed6.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
STEGLATRO	ERTUGLIFLOZIN	Merck Sharp & Dohme LLC	e6f3e718-bb99-48f1-ab94-b9f0af05fed6	2026-06-03	Warnings, Adverse reactions	Exact identifier application applno (NDA): 209803 application number: NDA209803 ndc (product): 0006-5363

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
MLU731K321	ERTUGLIFLOZIN PIDOLATE	1210344-83-4	ERTUGLIFLOZIN PIDOLATE
6C282481IP	ERTUGLIFLOZIN	1210344-57-2	ertugliflozin

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1992819	ertugliflozin 15 MG Oral Tablet	PSN	e6f3e718-bb99-48f1-ab94-b9f0af05fed6	16
1992810	ertugliflozin 5 MG Oral Tablet	PSN	e6f3e718-bb99-48f1-ab94-b9f0af05fed6	16
1992821	Steglatro 15 MG Oral Tablet	PSN	e6f3e718-bb99-48f1-ab94-b9f0af05fed6	16
1992816	Steglatro 5 MG Oral Tablet	PSN	e6f3e718-bb99-48f1-ab94-b9f0af05fed6	16
1992821	ertugliflozin 15 MG Oral Tablet [Steglatro]	SBD	e6f3e718-bb99-48f1-ab94-b9f0af05fed6	16
1992816	ertugliflozin 5 MG Oral Tablet [Steglatro]	SBD	e6f3e718-bb99-48f1-ab94-b9f0af05fed6	16
1992819	ertugliflozin 15 MG Oral Tablet	SCD	e6f3e718-bb99-48f1-ab94-b9f0af05fed6	16
1992810	ertugliflozin 5 MG Oral Tablet	SCD	e6f3e718-bb99-48f1-ab94-b9f0af05fed6	16
1992821	Steglatro 15 MG Oral Tablet	SY	e6f3e718-bb99-48f1-ab94-b9f0af05fed6	16
1992816	Steglatro 5 MG Oral Tablet	SY	e6f3e718-bb99-48f1-ab94-b9f0af05fed6	16

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0006-5363-03	00006536303	30 TABLET, FILM COATED in 1 BOTTLE (0006-5363-03)		2017-12-19	0000-00-00	No	No	Current
0006-5363-06	00006536306	90 TABLET, FILM COATED in 1 BOTTLE (0006-5363-06)		2017-12-19	0000-00-00	No	No	Current
0006-5363-07	00006536307	500 TABLET, FILM COATED in 1 BOTTLE (0006-5363-07)		2017-12-19	0000-00-00	No	No	Current
0006-5363-08	00006536308	7 in 1 BOTTLE						Historical
0006-5363-09	00006536309	2 BOTTLE in 1 CARTON (0006-5363-09) / 7 TABLET, FILM COATED in 1 BOTTLE (0006-5363-08)	2 bottle	2017-12-19	0000-00-00	No	No	Current
0006-5363-10	00006536310	30 TABLET, FILM COATED in 1 BOTTLE (0006-5363-10)		2017-12-19	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
STEGLATRO	Merck Sharp & Dohme LLC	2026-06-03	HUMAN PRESCRIPTION DRUG LABEL	17
STEGLATRO	A-S Medication Solutions	2024-01-08	HUMAN PRESCRIPTION DRUG LABEL	4