JANUMET

Product NDC: 50090-4411
11-digit product format: 500904411
Labeler code: 50090
Product ID: 50090-4411_4af91363-ea59-4586-9fff-5520215b1b25
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: sitagliptin and metformin hydrochloride
Dosage form: TABLET, FILM COATED, EXTENDED RELEASE
Route: ORAL
Labeler: A-S Medication Solutions
Application: NDA202270
Marketing category: NDA
Marketing start: 2012-02-02
Marketing end: 0000-00-00
Substance: SITAGLIPTIN PHOSPHATE; METFORMIN HYDROCHLORIDE
Active strength: 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: 2022-12-31
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 · 3 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	50090-4411		D	Discontinued by firm	2026-09-09
excluded package	package	50090-4411	50090-4411-0	D	Discontinued by firm	2026-09-09
excluded package	package	50090-4411	50090-4411-1	D	Discontinued by firm	2026-09-09

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 · 45 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	50090-4411-1	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	50090-4411-0	`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	50090-4411-1	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	50090-4411-0	`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	50090-4411-1	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	50090-4411-0	`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	50090-4411-1	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	50090-4411-0	`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	50090-4411-1	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	50090-4411-0	`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	50090-4411-1	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	50090-4411-0	`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	50090-4411-1	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	50090-4411-0	`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	50090-4411-1	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	50090-4411-0	`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	50090-4411-1	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	50090-4411-0	`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	50090-4411-1	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	50090-4411-0	`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	50090-4411-1	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	50090-4411-0	`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	50090-4411-1	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	50090-4411-0	`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	50090-4411-1	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	50090-4411-0	`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	50090-4411-1	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	50090-4411-0	`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	50090-4411-1	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	50090-4411-0	`1332a3947898…`	`d4bfe170f9cd…`

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…`

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
50090-4411-0	2023-01-30	C162847	48780-1	f386c649-9be8-0266-e053-dadaa90a7c1a	These highlights do not include all the information needed to use JANUMET XR safely and effectively. See full prescribing information for JANUMET XR. JANUMET ® XR (sitagliptin and metformin hydrochloride extended-release) tablets, for oral use Initial U.S. Approval: 2012
50090-4411-1	2023-01-30	C162847	48780-1	f386c649-9be8-0266-e053-dadaa90a7c1a	These highlights do not include all the information needed to use JANUMET XR safely and effectively. See full prescribing information for JANUMET XR. JANUMET ® XR (sitagliptin and metformin hydrochloride extended-release) tablets, for oral use Initial U.S. Approval: 2012

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
50090-4411-0	JANUMET XR	90 in 1 BOTTLE	TABLET, FILM COATED, EXTENDED RE	90		4
50090-4411-1	JANUMET XR	180 in 1 BOTTLE	TABLET, FILM COATED, EXTENDED RE	180		4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
50090-4411	JANUMET XR (SITAGLIPTIN AND METFORMIN HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [A-S MEDICATION SOLUTIONS]	4	Legacy NDC, 2 package rows	20210207_6d1c5225-a457-438c-93fa-15697db02363.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
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
TS63EW8X6F	SITAGLIPTIN PHOSPHATE	654671-77-9	SITAGLIPTIN PHOSPHATE
786Z46389E	METFORMIN HYDROCHLORIDE	1115-70-4	METFORMIN HYDROCHLORIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1243843	Janumet XR 50 MG / 1000 MG 24HR Extended Release Oral Tablet	PSN	6d1c5225-a457-438c-93fa-15697db02363	4
2709477	metFORMIN hydrochloride 1000 MG / SITagliptin phosphate 50 MG 24HR Extended Release Oral Tablet	PSN	6d1c5225-a457-438c-93fa-15697db02363	4
1243843	24 HR metformin hydrochloride 1000 MG / sitagliptin phosphate 50 MG Extended Release Oral Tablet [Janumet]	SBD	6d1c5225-a457-438c-93fa-15697db02363	4
2709477	24 HR metformin hydrochloride 1000 MG / sitagliptin phosphate 50 MG Extended Release Oral Tablet	SCD	6d1c5225-a457-438c-93fa-15697db02363	4
1243843	Janumet XR 50/1000 (sitagliptin (sitagliptin phosphate monohydrate 64.25 MG) / metformin hydrochloride) 24 HR Extended Release Oral Tablet	SY	6d1c5225-a457-438c-93fa-15697db02363	4
1243843	Janumet XR 50/1000 (sitagliptin / metformin hydrochloride) 24 HR Extended Release Oral Tablet	SY	6d1c5225-a457-438c-93fa-15697db02363	4
1243843	Janumet XR 50/1000 24 HR Extended Release Oral Tablet	SY	6d1c5225-a457-438c-93fa-15697db02363	4
2709477	metformin hydrochloride 1000 MG / sitagliptin phosphate 50 MG 24 HR Extended Release Oral Tablet	SY	6d1c5225-a457-438c-93fa-15697db02363	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
50090-4411-0	50090441100	90 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (50090-4411-0)	2019-07-16	0000-00-00	No	No	Current
50090-4411-1	50090441101	180 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (50090-4411-1)	2019-08-09	0000-00-00	No	No	Current