Application 022044

Type: NDA
Sponsor: MERCK SHARP DOHME

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	JANUMET	METFORMIN HYDROCHLORIDE; SITAGLIPTIN PHOSPHATE	TABLET;ORAL	500MG;EQ 50MG BASE	Yes	No
002	JANUMET	METFORMIN HYDROCHLORIDE; SITAGLIPTIN PHOSPHATE	TABLET;ORAL	1GM;EQ 50MG BASE	Yes	Yes

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
N022044-001	JANUMET	METFORMIN HYDROCHLORIDE; SITAGLIPTIN PHOSPHATE	500MG;EQ 50MG BASE	TABLET / ORAL	AB	RLD	2007-03-30
N022044-002	JANUMET	METFORMIN HYDROCHLORIDE; SITAGLIPTIN PHOSPHATE	1GM;EQ 50MG BASE	TABLET / ORAL	AB	RLD, RS	2007-03-30

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
N022044-001	AB
N022044-002	AB

Orange Book patents#

Current patent rows page 1 of 1 · 8 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N022044-001	7326708	2026-11-24	U-802	Drug substance, Drug product
N022044-001	7326708*PED	2027-05-24		Pediatric extension
N022044-001	8414921	2028-07-21	U-1036	Drug product	2013-04-09
N022044-001	8414921*PED	2029-01-21		Pediatric extension
N022044-002	7326708	2026-11-24	U-802	Drug substance, Drug product
N022044-002	7326708*PED	2027-05-24		Pediatric extension
N022044-002	8414921	2028-07-21	U-1036	Drug product
N022044-002	8414921*PED	2029-01-21		Pediatric extension

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	N022044-001	JANUMET	500MG;EQ 50MG BASE	TABLET / ORAL	AB	RLD	2007-03-30	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N022044-002	JANUMET	1GM;EQ 50MG BASE	TABLET / ORAL	AB	RLD, RS	2007-03-30	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N022044-001	JANUMET	500MG;EQ 50MG BASE	TABLET / ORAL	AB	RLD	2007-03-30	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022044-002	JANUMET	1GM;EQ 50MG BASE	TABLET / ORAL	AB	RLD, RS	2007-03-30	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N022044-001	JANUMET	500MG;EQ 50MG BASE	TABLET / ORAL	AB	RLD	2007-03-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022044-002	JANUMET	1GM;EQ 50MG BASE	TABLET / ORAL	AB	RLD, RS	2007-03-30	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022044-001	JANUMET	500MG;EQ 50MG BASE	TABLET / ORAL	AB	RLD	2007-03-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022044-002	JANUMET	1GM;EQ 50MG BASE	TABLET / ORAL	AB	RLD, RS	2007-03-30	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N022044-001	JANUMET	500MG;EQ 50MG BASE	TABLET / ORAL		RLD	2007-03-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022044-002	JANUMET	1GM;EQ 50MG BASE	TABLET / ORAL		RLD, RS	2007-03-30	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022044-001	JANUMET	500MG;EQ 50MG BASE	TABLET / ORAL		RLD	2007-03-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022044-002	JANUMET	1GM;EQ 50MG BASE	TABLET / ORAL		RLD, RS	2007-03-30	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022044-001	JANUMET	500MG;EQ 50MG BASE	TABLET / ORAL		RLD	2007-03-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022044-002	JANUMET	1GM;EQ 50MG BASE	TABLET / ORAL		RLD, RS	2007-03-30	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022044-001	JANUMET	500MG;EQ 50MG BASE	TABLET / ORAL		RLD	2007-03-30	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022044-002	JANUMET	1GM;EQ 50MG BASE	TABLET / ORAL		RLD, RS	2007-03-30	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022044-001	JANUMET	500MG;EQ 50MG BASE	TABLET / ORAL		RLD	2007-03-30	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022044-002	JANUMET	1GM;EQ 50MG BASE	TABLET / ORAL		RLD, RS	2007-03-30	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022044-001	JANUMET	500MG;EQ 50MG BASE	TABLET / ORAL		RLD	2007-03-30	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022044-002	JANUMET	1GM;EQ 50MG BASE	TABLET / ORAL		RLD, RS	2007-03-30	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022044-001	JANUMET	500MG;EQ 50MG BASE	TABLET / ORAL		RLD	2007-03-30	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022044-002	JANUMET	1GM;EQ 50MG BASE	TABLET / ORAL		RLD, RS	2007-03-30	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N022044-001	JANUMET	500MG;EQ 50MG BASE	TABLET / ORAL		RLD	2007-03-30	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N022044-002	JANUMET	1GM;EQ 50MG BASE	TABLET / ORAL		RLD, RS	2007-03-30	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022044-001	JANUMET	500MG;EQ 50MG BASE	TABLET / ORAL		RLD	2007-03-30	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022044-002	JANUMET	1GM;EQ 50MG BASE	TABLET / ORAL		RLD, RS	2007-03-30	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022044-001	JANUMET	500MG;EQ 50MG BASE	TABLET / ORAL		RLD	2007-03-30	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022044-002	JANUMET	1GM;EQ 50MG BASE	TABLET / ORAL		RLD, RS	2007-03-30	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N022044-001	JANUMET	500MG;EQ 50MG BASE	TABLET / ORAL		RLD	2007-03-30	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N022044-002	JANUMET	1GM;EQ 50MG BASE	TABLET / ORAL		RLD, RS	2007-03-30	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N022044-001	JANUMET	500MG;EQ 50MG BASE	TABLET / ORAL		RLD	2007-03-30	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N022044-002	JANUMET	1GM;EQ 50MG BASE	TABLET / ORAL		RLD, RS	2007-03-30	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022044-001	JANUMET	500MG;EQ 50MG BASE	TABLET / ORAL		RLD	2007-03-30	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022044-002	JANUMET	1GM;EQ 50MG BASE	TABLET / ORAL		RLD, RS	2007-03-30	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N022044-001	JANUMET	500MG;EQ 50MG BASE	TABLET / ORAL		RLD	2007-03-30	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N022044-002	JANUMET	1GM;EQ 50MG BASE	TABLET / ORAL		RLD, RS	2007-03-30	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N022044-001	JANUMET	500MG;EQ 50MG BASE	TABLET / ORAL		RLD	2007-03-30	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N022044-002	JANUMET	1GM;EQ 50MG BASE	TABLET / ORAL		RLD, RS	2007-03-30	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N022044-001	JANUMET	500MG;EQ 50MG BASE	TABLET / ORAL		RLD	2007-03-30	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022044-002	JANUMET	1GM;EQ 50MG BASE	TABLET / ORAL		RLD, RS	2007-03-30	`74a2ff9319b5…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	N022044-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N022044-002	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N022044-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022044-002	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N022044-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022044-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022044-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022044-002	AB	1	`31067a03dcf5…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N022044-001	AB	1	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N022044-002	AB	1	`a50c72e98297…`

Observed Orange Book patent history#

Patent history page 1 of 15 · 568 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	N022044-001	7326708	2026-11-24	U-802	Drug substance, Drug product		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N022044-001	7326708*PED	2027-05-24		Pediatric extension		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N022044-001	8414921	2028-07-21	U-1036	Drug product	2013-04-09	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N022044-001	8414921*PED	2029-01-21		Pediatric extension		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N022044-002	7326708	2026-11-24	U-802	Drug substance, Drug product		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N022044-002	7326708*PED	2027-05-24		Pediatric extension		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N022044-002	8414921	2028-07-21	U-1036	Drug product		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N022044-002	8414921*PED	2029-01-21		Pediatric extension		`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N022044-001	7326708	2026-11-24	U-802	Drug substance, Drug product		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022044-001	7326708*PED	2027-05-24		Pediatric extension		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022044-001	8414921	2028-07-21	U-1036	Drug product	2013-04-09	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022044-001	8414921*PED	2029-01-21		Pediatric extension		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022044-002	7326708	2026-11-24	U-802	Drug substance, Drug product		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022044-002	7326708*PED	2027-05-24		Pediatric extension		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022044-002	8414921	2028-07-21	U-1036	Drug product		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022044-002	8414921*PED	2029-01-21		Pediatric extension		`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N022044-001	7326708	2026-11-24	U-802	Drug substance, Drug product		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022044-001	7326708*PED	2027-05-24		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022044-001	8414921	2028-07-21	U-1036	Drug product	2013-04-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022044-001	8414921*PED	2029-01-21		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022044-002	7326708	2026-11-24	U-802	Drug substance, Drug product		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022044-002	7326708*PED	2027-05-24		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022044-002	8414921	2028-07-21	U-1036	Drug product		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022044-002	8414921*PED	2029-01-21		Pediatric extension		`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022044-001	7326708	2026-11-24	U-802	Drug substance, Drug product		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022044-001	7326708*PED	2027-05-24		Pediatric extension		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022044-001	8414921	2028-07-21	U-1036	Drug product	2013-04-09	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022044-001	8414921*PED	2029-01-21		Pediatric extension		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022044-002	7326708	2026-11-24	U-802	Drug substance, Drug product		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022044-002	7326708*PED	2027-05-24		Pediatric extension		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022044-002	8414921	2028-07-21	U-1036	Drug product		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022044-002	8414921*PED	2029-01-21		Pediatric extension		`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N022044-001	7326708	2026-11-24	U-802	Drug substance, Drug product		`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022044-001	7326708*PED	2027-05-24		Pediatric extension		`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022044-001	8414921	2028-07-21	U-1036	Drug product	2013-04-09	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022044-001	8414921*PED	2029-01-21		Pediatric extension		`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022044-002	7326708	2026-11-24	U-802	Drug substance, Drug product		`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022044-002	7326708*PED	2027-05-24		Pediatric extension		`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022044-002	8414921	2028-07-21	U-1036	Drug product		`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022044-002	8414921*PED	2029-01-21		Pediatric extension		`6a471c1ec25d…`

Observed Orange Book exclusivity history#

Exclusivity history page 1 of 5 · 180 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	N022044-001	M-187	2023-12-04	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022044-001	PED	2024-06-04	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022044-002	M-187	2023-12-04	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022044-002	PED	2024-06-04	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022044-001	M-187	2023-12-04	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022044-001	PED	2024-06-04	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022044-002	M-187	2023-12-04	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022044-002	PED	2024-06-04	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022044-001	M-187	2023-12-04	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022044-001	PED	2024-06-04	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022044-002	M-187	2023-12-04	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022044-002	PED	2024-06-04	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022044-001	M-187	2023-12-04	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022044-001	PED	2024-06-04	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022044-002	M-187	2023-12-04	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022044-002	PED	2024-06-04	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N022044-001	M-187	2023-12-04	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N022044-001	PED	2024-06-04	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N022044-002	M-187	2023-12-04	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N022044-002	PED	2024-06-04	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022044-001	M-187	2023-12-04	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022044-001	PED	2024-06-04	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022044-002	M-187	2023-12-04	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022044-002	PED	2024-06-04	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022044-001	M-187	2023-12-04	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022044-001	PED	2024-06-04	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022044-002	M-187	2023-12-04	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022044-002	PED	2024-06-04	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N022044-001	M-187	2023-12-04	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N022044-001	PED	2024-06-04	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N022044-002	M-187	2023-12-04	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N022044-002	PED	2024-06-04	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N022044-001	M-187	2023-12-04	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N022044-001	PED	2024-06-04	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N022044-002	M-187	2023-12-04	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N022044-002	PED	2024-06-04	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022044-001	M-244	2022-08-12	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022044-001	PED	2023-02-12	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022044-001	M-187	2023-12-04	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022044-001	PED	2024-06-04	`5c6f7cd8ea54…`

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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
JANUMET	SITAGLIPTIN AND METFORMIN HYDROCHLORIDE	Merck Sharp & Dohme LLC	d19c7ed0-ad5c-426e-b2df-722508f97d67	2026-08-11	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 022044 application number: NDA022044 ndc (product): 0006-0575 ndc (product): 0006-0577
JANUMET	SITAGLIPTIN AND METFORMIN HYDROCHLORIDE	A-S Medication Solutions	c603b844-2019-4ef4-8385-7bc3f96a2565	2026-07-13	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 022044 application number: NDA022044
JANUMET	SITAGLIPTIN AND METFORMIN HYDROCHLORIDE	A-S Medication Solutions	b55ee3d9-7f0b-4dd9-9213-fbc69f09f567	2026-07-09	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 022044 application number: NDA022044

Reported adverse events (FAERS/openFDA)#

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

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 20 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0006-0575	JANUMET	SITAGLIPTIN and METFORMIN HYDROCHLORIDE	Merck Sharp & Dohme Corp.	NDA	Current
0006-0575	JANUMET	SITAGLIPTIN and METFORMIN HYDROCHLORIDE	Merck Sharp & Dohme Corp.	NDA	Current
0006-0575	JANUMET	SITAGLIPTIN and METFORMIN HYDROCHLORIDE	Merck Sharp & Dohme Corp.	NDA	Current
0006-0575	JANUMET	SITAGLIPTIN and METFORMIN HYDROCHLORIDE	Merck Sharp & Dohme LLC	NDA	Current
0006-0575	JANUMET	SITAGLIPTIN and METFORMIN HYDROCHLORIDE	Merck Sharp & Dohme LLC	NDA	Current
0006-0575	JANUMET	SITAGLIPTIN and METFORMIN HYDROCHLORIDE	Merck Sharp & Dohme Corp.	NDA	Current
0006-0575	JANUMET	SITAGLIPTIN and METFORMIN HYDROCHLORIDE	Merck Sharp & Dohme Corp.	NDA	Current
0006-0575	JANUMET	SITAGLIPTIN and METFORMIN HYDROCHLORIDE	Merck Sharp & Dohme Corp.	NDA	Current
0006-0577	JANUMET	SITAGLIPTIN and METFORMIN HYDROCHLORIDE	Merck Sharp & Dohme Corp.	NDA	Current
0006-0577	JANUMET	SITAGLIPTIN and METFORMIN HYDROCHLORIDE	Merck Sharp & Dohme Corp.	NDA	Current
0006-0577	JANUMET	SITAGLIPTIN and METFORMIN HYDROCHLORIDE	Merck Sharp & Dohme Corp.	NDA	Current
0006-0577	JANUMET	SITAGLIPTIN and METFORMIN HYDROCHLORIDE	Merck Sharp & Dohme LLC	NDA	Current
0006-0577	JANUMET	SITAGLIPTIN and METFORMIN HYDROCHLORIDE	Merck Sharp & Dohme LLC	NDA	Current
0006-0577	JANUMET	SITAGLIPTIN and METFORMIN HYDROCHLORIDE	Merck Sharp & Dohme Corp.	NDA	Current
0006-0577	JANUMET	SITAGLIPTIN and METFORMIN HYDROCHLORIDE	Merck Sharp & Dohme Corp.	NDA	Current
0006-0577	JANUMET	SITAGLIPTIN and METFORMIN HYDROCHLORIDE	Merck Sharp & Dohme Corp.	NDA	Current
50090-5618	JANUMET	SITAGLIPTIN and METFORMIN HYDROCHLORIDE	A-S Medication Solutions	NDA	Current
70518-2548	JANUMET	SITAGLIPTIN and METFORMIN HYDROCHLORIDE	REMEDYREPACK INC.	NDA	Current
70518-2548	JANUMET	SITAGLIPTIN and METFORMIN HYDROCHLORIDE	REMEDYREPACK INC.	NDA	Current
70518-2548	JANUMET	SITAGLIPTIN and METFORMIN HYDROCHLORIDE	REMEDYREPACK INC.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
71440	SUPPL	2022-06-24
71439	SUPPL	2022-06-24
71426	SUPPL	2022-06-22
69428	SUPPL	2021-12-01
69261	SUPPL	2021-11-05
65547	SUPPL	2020-12-09
65521	SUPPL	2020-12-08
65502	SUPPL	2020-12-04
59689	SUPPL	2019-08-13
59688	SUPPL	2019-08-13
59683	SUPPL	2019-08-13
59281	SUPPL	2019-07-09
59280	SUPPL	2019-07-09
59208	SUPPL	2019-07-02
52634	SUPPL	2018-02-14
52559	SUPPL	2018-02-12
52555	SUPPL	2018-02-12
49406	SUPPL	2017-08-15
49350	SUPPL	2017-08-14
46944	SUPPL	2017-01-24
46943	SUPPL	2017-01-24
46923	SUPPL	2017-01-18
46922	SUPPL	2017-01-18
38134	SUPPL	2015-09-04
29138	SUPPL	2015-09-01
38133	SUPPL	2015-05-04
29137	SUPPL	2015-04-29
29136	SUPPL	2013-09-24
38132	SUPPL	2013-09-17
44168	ORIG	2013-04-29
38131	SUPPL	2013-02-08
29135	SUPPL	2013-02-08
16828	SUPPL	2012-10-22
6757	SUPPL	2012-10-22
29134	SUPPL	2012-03-27
16827	SUPPL	2012-03-27
6753	SUPPL	2011-06-17
16825	SUPPL	2011-05-16
6754	SUPPL	2011-05-16
6755	SUPPL	2011-04-19
16824	SUPPL	2011-04-18
38130	SUPPL	2010-09-29
29133	SUPPL	2010-09-29
16826	SUPPL	2010-09-29
6756	SUPPL	2010-09-29
29132	SUPPL	2010-03-04
6752	SUPPL	2010-03-04
6750	SUPPL	2010-03-04
38129	SUPPL	2010-03-02
16823	SUPPL	2010-03-02
16822	SUPPL	2010-03-02
6751	SUPPL	2010-01-14
38128	SUPPL	2009-12-31
29131	SUPPL	2008-10-23
21916	ORIG	2008-07-08
6749	SUPPL	2008-05-07
29129	SUPPL	2008-02-29
6747	SUPPL	2008-02-29
38126	SUPPL	2008-02-28
38125	SUPPL	2008-02-28
29130	SUPPL	2008-01-09
6748	SUPPL	2008-01-09
6746	SUPPL	2008-01-09
38127	SUPPL	2008-01-08
16821	SUPPL	2008-01-08
16820	SUPPL	2008-01-08
29128	ORIG	2007-04-09
16819	ORIG	2007-04-06