JANUMET

Product NDC: 0006-0078
11-digit product format: 000060078
Labeler code: 0006
Product ID: 0006-0078_4323fb1c-54a7-4648-bfe0-28fb4cb65f50
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: sitagliptin and metformin hydrochloride
Dosage form: TABLET, FILM COATED, EXTENDED RELEASE
Route: ORAL
Labeler: Merck Sharp & Dohme LLC
Application: NDA202270
Marketing category: NDA
Marketing start: 2012-02-02
Substance: METFORMIN HYDROCHLORIDE; SITAGLIPTIN PHOSPHATE
Active strength: 500; 50 mg/1; mg/1
Pharmacologic classes: Biguanide [EPC], Biguanides [CS], Dipeptidyl Peptidase 4 Inhibitor [EPC], Dipeptidyl Peptidase 4 Inhibitors [MoA]
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 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N202270-001	JANUMET XR	METFORMIN HYDROCHLORIDE; SITAGLIPTIN PHOSPHATE	500MG;EQ 50MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2012-02-02
N202270-002	JANUMET XR	METFORMIN HYDROCHLORIDE; SITAGLIPTIN PHOSPHATE	1GM;EQ 50MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2012-02-02
N202270-003	JANUMET XR	METFORMIN HYDROCHLORIDE; SITAGLIPTIN PHOSPHATE	1GM;EQ 100MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2012-02-02

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-product	TE code
N202270-001	AB
N202270-002	AB
N202270-003	AB

Orange Book patents#

Current patent rows page 1 of 1 · 6 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status
N202270-001	7326708	2026-11-24	U-1227	Drug substance, Drug product
N202270-001	7326708*PED	2027-05-24		Pediatric extension
N202270-002	7326708	2026-11-24	U-1227	Drug substance, Drug product
N202270-002	7326708*PED	2027-05-24		Pediatric extension
N202270-003	7326708	2026-11-24	U-1227	Drug substance, Drug product
N202270-003	7326708*PED	2027-05-24		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 4 · 126 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	N202270-001	JANUMET XR	500MG;EQ 50MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2012-02-02	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N202270-002	JANUMET XR	1GM;EQ 50MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2012-02-02	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N202270-003	JANUMET XR	1GM;EQ 100MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2012-02-02	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N202270-001	JANUMET XR	500MG;EQ 50MG BASE	TABLET, EXTENDED RELEASE / ORAL		RLD	2012-02-02	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N202270-002	JANUMET XR	1GM;EQ 50MG BASE	TABLET, EXTENDED RELEASE / ORAL		RLD	2012-02-02	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N202270-003	JANUMET XR	1GM;EQ 100MG BASE	TABLET, EXTENDED RELEASE / ORAL		RLD, RS	2012-02-02	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N202270-001	JANUMET XR	500MG;EQ 50MG BASE	TABLET, EXTENDED RELEASE / ORAL		RLD	2012-02-02	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N202270-002	JANUMET XR	1GM;EQ 50MG BASE	TABLET, EXTENDED RELEASE / ORAL		RLD	2012-02-02	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N202270-003	JANUMET XR	1GM;EQ 100MG BASE	TABLET, EXTENDED RELEASE / ORAL		RLD, RS	2012-02-02	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N202270-001	JANUMET XR	500MG;EQ 50MG BASE	TABLET, EXTENDED RELEASE / ORAL		RLD	2012-02-02	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N202270-002	JANUMET XR	1GM;EQ 50MG BASE	TABLET, EXTENDED RELEASE / ORAL		RLD	2012-02-02	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N202270-003	JANUMET XR	1GM;EQ 100MG BASE	TABLET, EXTENDED RELEASE / ORAL		RLD, RS	2012-02-02	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N202270-001	JANUMET XR	500MG;EQ 50MG BASE	TABLET, EXTENDED RELEASE / ORAL		RLD	2012-02-02	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N202270-002	JANUMET XR	1GM;EQ 50MG BASE	TABLET, EXTENDED RELEASE / ORAL		RLD	2012-02-02	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N202270-003	JANUMET XR	1GM;EQ 100MG BASE	TABLET, EXTENDED RELEASE / ORAL		RLD, RS	2012-02-02	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N202270-001	JANUMET XR	500MG;EQ 50MG BASE	TABLET, EXTENDED RELEASE / ORAL		RLD	2012-02-02	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N202270-002	JANUMET XR	1GM;EQ 50MG BASE	TABLET, EXTENDED RELEASE / ORAL		RLD	2012-02-02	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N202270-003	JANUMET XR	1GM;EQ 100MG BASE	TABLET, EXTENDED RELEASE / ORAL		RLD, RS	2012-02-02	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N202270-001	JANUMET XR	500MG;EQ 50MG BASE	TABLET, EXTENDED RELEASE / ORAL		RLD	2012-02-02	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N202270-002	JANUMET XR	1GM;EQ 50MG BASE	TABLET, EXTENDED RELEASE / ORAL		RLD	2012-02-02	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N202270-003	JANUMET XR	1GM;EQ 100MG BASE	TABLET, EXTENDED RELEASE / ORAL		RLD, RS	2012-02-02	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N202270-001	JANUMET XR	500MG;EQ 50MG BASE	TABLET, EXTENDED RELEASE / ORAL		RLD	2012-02-02	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N202270-002	JANUMET XR	1GM;EQ 50MG BASE	TABLET, EXTENDED RELEASE / ORAL		RLD	2012-02-02	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N202270-003	JANUMET XR	1GM;EQ 100MG BASE	TABLET, EXTENDED RELEASE / ORAL		RLD, RS	2012-02-02	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N202270-001	JANUMET XR	500MG;EQ 50MG BASE	TABLET, EXTENDED RELEASE / ORAL		RLD	2012-02-02	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N202270-002	JANUMET XR	1GM;EQ 50MG BASE	TABLET, EXTENDED RELEASE / ORAL		RLD	2012-02-02	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N202270-003	JANUMET XR	1GM;EQ 100MG BASE	TABLET, EXTENDED RELEASE / ORAL		RLD, RS	2012-02-02	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N202270-001	JANUMET XR	500MG;EQ 50MG BASE	TABLET, EXTENDED RELEASE / ORAL		RLD	2012-02-02	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N202270-002	JANUMET XR	1GM;EQ 50MG BASE	TABLET, EXTENDED RELEASE / ORAL		RLD	2012-02-02	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N202270-003	JANUMET XR	1GM;EQ 100MG BASE	TABLET, EXTENDED RELEASE / ORAL		RLD, RS	2012-02-02	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N202270-001	JANUMET XR	500MG;EQ 50MG BASE	TABLET, EXTENDED RELEASE / ORAL		RLD	2012-02-02	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N202270-002	JANUMET XR	1GM;EQ 50MG BASE	TABLET, EXTENDED RELEASE / ORAL		RLD	2012-02-02	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N202270-003	JANUMET XR	1GM;EQ 100MG BASE	TABLET, EXTENDED RELEASE / ORAL		RLD, RS	2012-02-02	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N202270-001	JANUMET XR	500MG;EQ 50MG BASE	TABLET, EXTENDED RELEASE / ORAL		RLD	2012-02-02	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N202270-002	JANUMET XR	1GM;EQ 50MG BASE	TABLET, EXTENDED RELEASE / ORAL		RLD	2012-02-02	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N202270-003	JANUMET XR	1GM;EQ 100MG BASE	TABLET, EXTENDED RELEASE / ORAL		RLD, RS	2012-02-02	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N202270-001	JANUMET XR	500MG;EQ 50MG BASE	TABLET, EXTENDED RELEASE / ORAL		RLD	2012-02-02	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N202270-002	JANUMET XR	1GM;EQ 50MG BASE	TABLET, EXTENDED RELEASE / ORAL		RLD	2012-02-02	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N202270-003	JANUMET XR	1GM;EQ 100MG BASE	TABLET, EXTENDED RELEASE / ORAL		RLD, RS	2012-02-02	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N202270-001	JANUMET XR	500MG;EQ 50MG BASE	TABLET, EXTENDED RELEASE / ORAL		RLD	2012-02-02	`1e350fbaab3a…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	N202270-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N202270-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N202270-003	AB	1	`caaa826d4ba7…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N202270-001	AB	1	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N202270-002	AB	1	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N202270-003	AB	1	`a50c72e98297…`

Observed Orange Book patent history#

Patent history page 1 of 13 · 495 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Source SHA-256
2026-08-18 06:07:40	2026-07	N202270-001	7326708	2026-11-24	U-1227	Drug substance, Drug product	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N202270-001	7326708*PED	2027-05-24		Pediatric extension	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N202270-002	7326708	2026-11-24	U-1227	Drug substance, Drug product	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N202270-002	7326708*PED	2027-05-24		Pediatric extension	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N202270-003	7326708	2026-11-24	U-1227	Drug substance, Drug product	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N202270-003	7326708*PED	2027-05-24		Pediatric extension	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N202270-001	7326708	2026-11-24	U-1227	Drug substance, Drug product	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N202270-001	7326708*PED	2027-05-24		Pediatric extension	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N202270-002	7326708	2026-11-24	U-1227	Drug substance, Drug product	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N202270-002	7326708*PED	2027-05-24		Pediatric extension	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N202270-003	7326708	2026-11-24	U-1227	Drug substance, Drug product	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N202270-003	7326708*PED	2027-05-24		Pediatric extension	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N202270-001	7326708	2026-11-24	U-1227	Drug substance, Drug product	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N202270-001	7326708*PED	2027-05-24		Pediatric extension	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N202270-002	7326708	2026-11-24	U-1227	Drug substance, Drug product	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N202270-002	7326708*PED	2027-05-24		Pediatric extension	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N202270-003	7326708	2026-11-24	U-1227	Drug substance, Drug product	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N202270-003	7326708*PED	2027-05-24		Pediatric extension	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N202270-001	7326708	2026-11-24	U-1227	Drug substance, Drug product	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N202270-001	7326708*PED	2027-05-24		Pediatric extension	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N202270-002	7326708	2026-11-24	U-1227	Drug substance, Drug product	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N202270-002	7326708*PED	2027-05-24		Pediatric extension	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N202270-003	7326708	2026-11-24	U-1227	Drug substance, Drug product	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N202270-003	7326708*PED	2027-05-24		Pediatric extension	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N202270-001	7326708	2026-11-24	U-1227	Drug substance, Drug product	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N202270-001	7326708*PED	2027-05-24		Pediatric extension	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N202270-002	7326708	2026-11-24	U-1227	Drug substance, Drug product	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N202270-002	7326708*PED	2027-05-24		Pediatric extension	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N202270-003	7326708	2026-11-24	U-1227	Drug substance, Drug product	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N202270-003	7326708*PED	2027-05-24		Pediatric extension	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N202270-001	7326708	2026-11-24	U-1227	Drug substance, Drug product	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N202270-001	7326708*PED	2027-05-24		Pediatric extension	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N202270-002	7326708	2026-11-24	U-1227	Drug substance, Drug product	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N202270-002	7326708*PED	2027-05-24		Pediatric extension	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N202270-003	7326708	2026-11-24	U-1227	Drug substance, Drug product	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N202270-003	7326708*PED	2027-05-24		Pediatric extension	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N202270-001	7326708	2026-11-24	U-1227	Drug substance, Drug product	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N202270-001	7326708*PED	2027-05-24		Pediatric extension	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N202270-002	7326708	2026-11-24	U-1227	Drug substance, Drug product	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N202270-002	7326708*PED	2027-05-24		Pediatric extension	`03ed91905a0d…`

Observed Orange Book exclusivity history#

Exclusivity history page 1 of 6 · 213 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	N202270-001	M-187	2023-12-04	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N202270-001	PED	2024-06-04	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N202270-002	M-187	2023-12-04	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N202270-002	PED	2024-06-04	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N202270-001	M-187	2023-12-04	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N202270-001	PED	2024-06-04	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N202270-002	M-187	2023-12-04	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N202270-002	PED	2024-06-04	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N202270-001	M-187	2023-12-04	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N202270-001	PED	2024-06-04	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N202270-002	M-187	2023-12-04	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N202270-002	PED	2024-06-04	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N202270-001	M-187	2023-12-04	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N202270-001	PED	2024-06-04	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N202270-002	M-187	2023-12-04	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N202270-002	PED	2024-06-04	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N202270-001	M-187	2023-12-04	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N202270-001	PED	2024-06-04	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N202270-002	M-187	2023-12-04	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N202270-002	PED	2024-06-04	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N202270-001	M-187	2023-12-04	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N202270-001	PED	2024-06-04	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N202270-002	M-187	2023-12-04	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N202270-002	PED	2024-06-04	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N202270-001	M-187	2023-12-04	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N202270-001	PED	2024-06-04	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N202270-002	M-187	2023-12-04	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N202270-002	PED	2024-06-04	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N202270-001	M-187	2023-12-04	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N202270-001	PED	2024-06-04	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N202270-002	M-187	2023-12-04	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N202270-002	PED	2024-06-04	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N202270-001	M-187	2023-12-04	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N202270-001	PED	2024-06-04	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N202270-002	M-187	2023-12-04	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N202270-002	PED	2024-06-04	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N202270-001	M-244	2022-08-12	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N202270-001	PED	2023-02-12	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N202270-001	M-187	2023-12-04	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N202270-001	PED	2024-06-04	`5c6f7cd8ea54…`

Additional Listing Data#

Finished product: Yes
Brand name base: JANUMET
Brand name suffix: XR
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
SITAGLIPTIN PHOSPHATE	500 mg/1
METFORMIN HYDROCHLORIDE	50 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
TS63EW8X6F	Internal UNII lookup
786Z46389E	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 6 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1243833	Internal RxNorm lookup
1243843	Internal RxNorm lookup
1243848	Internal RxNorm lookup
2709470	Internal RxNorm lookup
2709477	Internal RxNorm lookup
2709482	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
64beb3d2-3aeb-4cd5-ba11-dacf6c9a5b50	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
19a549d9-1cb9-4833-ba02-91db3dcb07ba	Product name	1	20251107
f6d21fb1-2c09-48ab-8d89-eeadf5a9698e	Product name	1	20250724
ff2e6e82-af62-4b84-b1ca-09520f6c5a79	Product name	1	20250630
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
362d7abb-94e6-4c60-9a58-266894157713	Product name	1	20231023
351abe41-466c-4dd8-840a-0fdb68318bd5	Product name	1	20230316
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
816b97af-edc5-4060-aff1-b814bdbcad50	Product name	1	20190415
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
419aab54-5d5a-4146-9453-026d4a9991be	Product name	2	20170525
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
89dac932-b90a-4410-9ab1-84c53e57de25	Product name	1	20150316
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
9fa860f8-41a8-caa8-93ae-a5bdc7b15db7	Product name	1	20140508
ce63c1f8-ba50-8a17-9290-94522d75daff	Product name	1	20140508
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
0006-0078-14	JANUMET XR	14 in 1 BOTTLE	TABLET, FILM COATED, EXTENDED RE	14	43
0006-0078-28	JANUMET XR	2 in 1 CARTON	TABLET, FILM COATED, EXTENDED RE	2	43
0006-0078-61	JANUMET XR	60 in 1 BOTTLE	TABLET, FILM COATED, EXTENDED RE	60	43
0006-0078-62	JANUMET XR	180 in 1 BOTTLE	TABLET, FILM COATED, EXTENDED RE	180	43
0006-0078-82	JANUMET XR	1000 in 1 BOTTLE	TABLET, FILM COATED, EXTENDED RE	1000	43

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0006-0078-61	EA - Each	0006-0078	8df8f293-3f4e-418f-89cd-64408a56622d	1	2012-07-24
0006-0078-62	EA - Each	0006-0078	894309b7-197b-4207-8fb7-a35a1e72d069	1	2012-07-24
0006-0078-82	EA - Each	0006-0078	91ab02c4-542d-4436-bbc7-9ec068bb5f33	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
METFORMIN HYDROCHLORIDE	ACTIVE INGREDIENT	786Z46389E	JANUMET XR (SITAGLIPTIN AND METFORMIN HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [MERCK SHARP & DOHME CORP.]	16
SITAGLIPTIN PHOSPHATE	ACTIVE INGREDIENT	TS63EW8X6F	JANUMET XR (SITAGLIPTIN AND METFORMIN HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [MERCK SHARP & DOHME CORP.]	16
METFORMIN	ACTIVE MOIETY	9100L32L2N	JANUMET XR (SITAGLIPTIN AND METFORMIN HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [MERCK SHARP & DOHME CORP.]	16
SITAGLIPTIN	ACTIVE MOIETY	QFP0P1DV7Z	JANUMET XR (SITAGLIPTIN AND METFORMIN HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [MERCK SHARP & DOHME CORP.]	16
ALUMINUM OXIDE	INACTIVE INGREDIENT	LMI26O6933	JANUMET XR (SITAGLIPTIN AND METFORMIN HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [MERCK SHARP & DOHME CORP.]	16
CARNAUBA WAX	INACTIVE INGREDIENT	R12CBM0EIZ	JANUMET XR (SITAGLIPTIN AND METFORMIN HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [MERCK SHARP & DOHME CORP.]	16
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	JANUMET XR (SITAGLIPTIN AND METFORMIN HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [MERCK SHARP & DOHME CORP.]	16
FD&C BLUE NO. 2	INACTIVE INGREDIENT	L06K8R7DQK	JANUMET XR (SITAGLIPTIN AND METFORMIN HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [MERCK SHARP & DOHME CORP.]	16
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	JANUMET XR (SITAGLIPTIN AND METFORMIN HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [MERCK SHARP & DOHME CORP.]	16
HYDROXYPROPYL CELLULOSE (TYPE H)	INACTIVE INGREDIENT	RFW2ET671P	JANUMET XR (SITAGLIPTIN AND METFORMIN HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [MERCK SHARP & DOHME CORP.]	16
HYPROMELLOSE 2208 (100000 MPA.S)	INACTIVE INGREDIENT	VM7F0B23ZI	JANUMET XR (SITAGLIPTIN AND METFORMIN HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [MERCK SHARP & DOHME CORP.]	16
HYPROMELLOSE 2910 (6 MPA.S)	INACTIVE INGREDIENT	0WZ8WG20P6	JANUMET XR (SITAGLIPTIN AND METFORMIN HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [MERCK SHARP & DOHME CORP.]	16
INDIGOTINDISULFONATE SODIUM	INACTIVE INGREDIENT	D3741U8K7L	JANUMET XR (SITAGLIPTIN AND METFORMIN HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [MERCK SHARP & DOHME CORP.]	16
KAOLIN	INACTIVE INGREDIENT	24H4NWX5CO	JANUMET XR (SITAGLIPTIN AND METFORMIN HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [MERCK SHARP & DOHME CORP.]	16
POLYETHYLENE GLYCOL 3350	INACTIVE INGREDIENT	G2M7P15E5P	JANUMET XR (SITAGLIPTIN AND METFORMIN HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [MERCK SHARP & DOHME CORP.]	16
POVIDONE K29/32	INACTIVE INGREDIENT	390RMW2PEQ	JANUMET XR (SITAGLIPTIN AND METFORMIN HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [MERCK SHARP & DOHME CORP.]	16
PROPYL GALLATE	INACTIVE INGREDIENT	8D4SNN7V92	JANUMET XR (SITAGLIPTIN AND METFORMIN HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [MERCK SHARP & DOHME CORP.]	16
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	JANUMET XR (SITAGLIPTIN AND METFORMIN HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [MERCK SHARP & DOHME CORP.]	16
SODIUM STEARYL FUMARATE	INACTIVE INGREDIENT	7CV7WJK4UI	JANUMET XR (SITAGLIPTIN AND METFORMIN HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [MERCK SHARP & DOHME CORP.]	16
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	JANUMET XR (SITAGLIPTIN AND METFORMIN HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [MERCK SHARP & DOHME CORP.]	16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0006-0078	JANUMET XR (SITAGLIPTIN AND METFORMIN HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [MERCK SHARP & DOHME LLC]	43	Current NDC, Legacy NDC, 5 package rows	20250331_64beb3d2-3aeb-4cd5-ba11-dacf6c9a5b50.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
JANUMET XR	SITAGLIPTIN AND METFORMIN HYDROCHLORIDE	Merck Sharp & Dohme LLC	64beb3d2-3aeb-4cd5-ba11-dacf6c9a5b50	2025-03-25	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 202270 application number: NDA202270 ndc (product): 0006-0078
JANUMET XR	SITAGLIPTIN AND METFORMIN HYDROCHLORIDE	A-S Medication Solutions	90c0244b-afb3-4e69-b79f-486d002ca432	2023-06-16	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 202270 application number: NDA202270

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
786Z46389E	METFORMIN HYDROCHLORIDE	1115-70-4	METFORMIN HYDROCHLORIDE
TS63EW8X6F	SITAGLIPTIN PHOSPHATE	654671-77-9	SITAGLIPTIN PHOSPHATE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1243833	Janumet XR 100 MG / 1000 MG 24HR Extended Release Oral Tablet	PSN	64beb3d2-3aeb-4cd5-ba11-dacf6c9a5b50	43
1243843	Janumet XR 50 MG / 1000 MG 24HR Extended Release Oral Tablet	PSN	64beb3d2-3aeb-4cd5-ba11-dacf6c9a5b50	43
1243848	Janumet XR 50 MG / 500 MG 24HR Extended Release Oral Tablet	PSN	64beb3d2-3aeb-4cd5-ba11-dacf6c9a5b50	43
2709470	metFORMIN hydrochloride 1000 MG / SITagliptin phosphate 100 MG 24HR Extended Release Oral Tablet	PSN	64beb3d2-3aeb-4cd5-ba11-dacf6c9a5b50	43
2709477	metFORMIN hydrochloride 1000 MG / SITagliptin phosphate 50 MG 24HR Extended Release Oral Tablet	PSN	64beb3d2-3aeb-4cd5-ba11-dacf6c9a5b50	43
2709482	metFORMIN hydrochloride 500 MG / SITagliptin phosphate 50 MG 24HR Extended Release Oral Tablet	PSN	64beb3d2-3aeb-4cd5-ba11-dacf6c9a5b50	43
1243833	24 HR metformin hydrochloride 1000 MG / sitagliptin phosphate 100 MG Extended Release Oral Tablet [Janumet]	SBD	64beb3d2-3aeb-4cd5-ba11-dacf6c9a5b50	43
1243843	24 HR metformin hydrochloride 1000 MG / sitagliptin phosphate 50 MG Extended Release Oral Tablet [Janumet]	SBD	64beb3d2-3aeb-4cd5-ba11-dacf6c9a5b50	43
1243848	24 HR metformin hydrochloride 500 MG / sitagliptin phosphate 50 MG Extended Release Oral Tablet [Janumet]	SBD	64beb3d2-3aeb-4cd5-ba11-dacf6c9a5b50	43
2709470	24 HR metformin hydrochloride 1000 MG / sitagliptin phosphate 100 MG Extended Release Oral Tablet	SCD	64beb3d2-3aeb-4cd5-ba11-dacf6c9a5b50	43
2709477	24 HR metformin hydrochloride 1000 MG / sitagliptin phosphate 50 MG Extended Release Oral Tablet	SCD	64beb3d2-3aeb-4cd5-ba11-dacf6c9a5b50	43
2709482	24 HR metformin hydrochloride 500 MG / sitagliptin phosphate 50 MG Extended Release Oral Tablet	SCD	64beb3d2-3aeb-4cd5-ba11-dacf6c9a5b50	43
1243833	Janumet XR 100/1000 (sitagliptin (sitagliptin phosphate monohydrate 128.5 MG) / metformin hydrochloride) 24 HR Extended Release Oral Tablet	SY	64beb3d2-3aeb-4cd5-ba11-dacf6c9a5b50	43
1243833	Janumet XR 100/1000 (sitagliptin / metformin hydrochloride) 24 HR Extended Release Oral Tablet	SY	64beb3d2-3aeb-4cd5-ba11-dacf6c9a5b50	43
1243833	Janumet XR 100/1000 24 HR Extended Release Oral Tablet	SY	64beb3d2-3aeb-4cd5-ba11-dacf6c9a5b50	43
1243843	Janumet XR 50/1000 (sitagliptin (sitagliptin phosphate monohydrate 64.25 MG) / metformin hydrochloride) 24 HR Extended Release Oral Tablet	SY	64beb3d2-3aeb-4cd5-ba11-dacf6c9a5b50	43
1243843	Janumet XR 50/1000 (sitagliptin / metformin hydrochloride) 24 HR Extended Release Oral Tablet	SY	64beb3d2-3aeb-4cd5-ba11-dacf6c9a5b50	43
1243843	Janumet XR 50/1000 24 HR Extended Release Oral Tablet	SY	64beb3d2-3aeb-4cd5-ba11-dacf6c9a5b50	43
1243848	Janumet XR 50/500 (sitagliptin (sitagliptin phosphate monohydrate 64.25 MG) / metformin hydrochloride) 24 HR Extended Release Oral Tablet	SY	64beb3d2-3aeb-4cd5-ba11-dacf6c9a5b50	43
1243848	Janumet XR 50/500 (sitagliptin / metformin hydrochloride) 24 HR Extended Release Oral Tablet	SY	64beb3d2-3aeb-4cd5-ba11-dacf6c9a5b50	43
1243848	Janumet XR 50/500 24 HR Extended Release Oral Tablet	SY	64beb3d2-3aeb-4cd5-ba11-dacf6c9a5b50	43
2709470	metformin hydrochloride 1000 MG / sitagliptin phosphate 100 MG 24 HR Extended Release Oral Tablet	SY	64beb3d2-3aeb-4cd5-ba11-dacf6c9a5b50	43
2709477	metformin hydrochloride 1000 MG / sitagliptin phosphate 50 MG 24 HR Extended Release Oral Tablet	SY	64beb3d2-3aeb-4cd5-ba11-dacf6c9a5b50	43
2709482	metformin hydrochloride 500 MG / sitagliptin phosphate 50 MG 24 HR Extended Release Oral Tablet	SY	64beb3d2-3aeb-4cd5-ba11-dacf6c9a5b50	43

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0006-0078-14	00006007814	14 in 1 BOTTLE						Historical
0006-0078-28	00006007828	2 BOTTLE in 1 CARTON (0006-0078-28) / 14 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (0006-0078-14)	2 bottle	2012-02-02	0000-00-00	Yes	No	Current
0006-0078-61	00006007861	60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (0006-0078-61)		2012-02-02	0000-00-00	No	No	Current
0006-0078-62	00006007862	180 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (0006-0078-62)		2012-02-02	0000-00-00	No	No	Current
0006-0078-82	00006007882	1000 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (0006-0078-82)		2012-02-02	0000-00-00	No	No	Current