JANUMET

Product NDC: 50090-4411
Requested package NDC: 50090-4411-1
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#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	50090-4411	50090-4411-1	D	Discontinued by firm		2026-08-03

Observed NDC auxiliary status history#

Observed captured status history: Rows come only from successfully parsed FDA auxiliary ZIP captures. They show the state present in that artifact, not a continuous regulatory timeline. Absence before, after, or between captures is not proof of status, and a known non-data HTTP 403 capture is preserved in backfill provenance but cannot produce a status row.

Historic NDC status page 1 of 1 · 15 matching rows.

Browse every current auxiliary row. · Browse the complete NDC auxiliary source catalog.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Product NDC	Package NDC	Code	Status	Archive	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	50090-4411	50090-4411-1	I	Inactivated by FDA	excluded / ndc_excluded.zip	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	50090-4411	50090-4411-1	I	Inactivated by FDA	excluded / ndc_excluded.zip	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	50090-4411	50090-4411-1	I	Inactivated by FDA	excluded / ndc_excluded.zip	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	50090-4411	50090-4411-1	I	Inactivated by FDA	excluded / ndc_excluded.zip	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	50090-4411	50090-4411-1	I	Inactivated by FDA	excluded / ndc_excluded.zip	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	50090-4411	50090-4411-1	I	Inactivated by FDA	excluded / ndc_excluded.zip	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	50090-4411	50090-4411-1	I	Inactivated by FDA	excluded / ndc_excluded.zip	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	50090-4411	50090-4411-1	I	Inactivated by FDA	excluded / ndc_excluded.zip	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	50090-4411	50090-4411-1	I	Inactivated by FDA	excluded / ndc_excluded.zip	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	50090-4411	50090-4411-1	I	Inactivated by FDA	excluded / ndc_excluded.zip	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	50090-4411	50090-4411-1	I	Inactivated by FDA	excluded / ndc_excluded.zip	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	50090-4411	50090-4411-1	I	Inactivated by FDA	excluded / ndc_excluded.zip	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	50090-4411	50090-4411-1	I	Inactivated by FDA	excluded / ndc_excluded.zip	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	50090-4411	50090-4411-1	I	Inactivated by FDA	excluded / ndc_excluded.zip	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	50090-4411	50090-4411-1	I	Inactivated by FDA	excluded / ndc_excluded.zip	`1332a3947898…`	`d4bfe170f9cd…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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 · 123 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-02-19 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…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N202270-002	JANUMET XR	1GM;EQ 50MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2012-02-02	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N202270-003	JANUMET XR	1GM;EQ 100MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2012-02-02	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N202270-001	JANUMET XR	500MG;EQ 50MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2012-02-02	`8072bd15b7f6…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
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 · 489 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Source SHA-256
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…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N202270-003	7326708	2026-11-24	U-1227	Drug substance, Drug product	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N202270-003	7326708*PED	2027-05-24		Pediatric extension	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N202270-001	7326708	2026-11-24	U-1227	Drug substance, Drug product	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N202270-001	7326708*PED	2027-05-24		Pediatric extension	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N202270-002	7326708	2026-11-24	U-1227	Drug substance, Drug product	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N202270-002	7326708*PED	2027-05-24		Pediatric extension	`2680178bc6a6…`

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…`

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated 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
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

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

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
50090-4411-1	50090441101	180 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (50090-4411-1)	2019-08-09	0000-00-00	No	No	Current