JANUMET

Product NDC: 50090-5618
11-digit product format: 500905618
Labeler code: 50090
Product ID: 50090-5618_c078d91a-3a2c-4344-aa9e-415b63157d02
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: SITAGLIPTIN and METFORMIN HYDROCHLORIDE
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: A-S Medication Solutions
Application: NDA022044
Marketing category: NDA
Marketing start: 2007-03-30
Marketing end: 0000-00-00
Substance: SITAGLIPTIN PHOSPHATE; METFORMIN HYDROCHLORIDE
Active strength: 50 mg/1; mg/1
Pharmacologic classes: Dipeptidyl Peptidase 4 Inhibitor [EPC],Dipeptidyl Peptidase 4 Inhibitors [MoA],Biguanide [EPC],Biguanides [CS]
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 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	50090-5618		D	Discontinued by firm		2026-09-09
excluded package	package	50090-5618	50090-5618-0	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 · 18 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	50090-5618-0	`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	50090-5618-0	`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	50090-5618-0	`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	50090-5618-0	`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	50090-5618-0	`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	50090-5618-0	`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	50090-5618-0	`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	50090-5618-0	`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	50090-5618-0	`0efc9e666f02…`	`f202fb6c5f17…`

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

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N022044-001	JANUMET	METFORMIN HYDROCHLORIDE; SITAGLIPTIN PHOSPHATE	500MG;EQ 50MG BASE	TABLET / ORAL	AB	RLD	2007-03-30
N022044-002	JANUMET	METFORMIN HYDROCHLORIDE; SITAGLIPTIN PHOSPHATE	1GM;EQ 50MG BASE	TABLET / ORAL	AB	RLD, RS	2007-03-30

Therapeutic equivalence codes#

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

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

Orange Book patents#

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

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

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 3 · 84 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	N022044-001	JANUMET	500MG;EQ 50MG BASE	TABLET / ORAL	AB	RLD	2007-03-30	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022044-002	JANUMET	1GM;EQ 50MG BASE	TABLET / ORAL	AB	RLD, RS	2007-03-30	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N022044-001	JANUMET	500MG;EQ 50MG BASE	TABLET / ORAL	AB	RLD	2007-03-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022044-002	JANUMET	1GM;EQ 50MG BASE	TABLET / ORAL	AB	RLD, RS	2007-03-30	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022044-001	JANUMET	500MG;EQ 50MG BASE	TABLET / ORAL	AB	RLD	2007-03-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022044-002	JANUMET	1GM;EQ 50MG BASE	TABLET / ORAL	AB	RLD, RS	2007-03-30	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N022044-001	JANUMET	500MG;EQ 50MG BASE	TABLET / ORAL		RLD	2007-03-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022044-002	JANUMET	1GM;EQ 50MG BASE	TABLET / ORAL		RLD, RS	2007-03-30	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022044-001	JANUMET	500MG;EQ 50MG BASE	TABLET / ORAL		RLD	2007-03-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022044-002	JANUMET	1GM;EQ 50MG BASE	TABLET / ORAL		RLD, RS	2007-03-30	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022044-001	JANUMET	500MG;EQ 50MG BASE	TABLET / ORAL		RLD	2007-03-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022044-002	JANUMET	1GM;EQ 50MG BASE	TABLET / ORAL		RLD, RS	2007-03-30	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022044-001	JANUMET	500MG;EQ 50MG BASE	TABLET / ORAL		RLD	2007-03-30	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022044-002	JANUMET	1GM;EQ 50MG BASE	TABLET / ORAL		RLD, RS	2007-03-30	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022044-001	JANUMET	500MG;EQ 50MG BASE	TABLET / ORAL		RLD	2007-03-30	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022044-002	JANUMET	1GM;EQ 50MG BASE	TABLET / ORAL		RLD, RS	2007-03-30	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022044-001	JANUMET	500MG;EQ 50MG BASE	TABLET / ORAL		RLD	2007-03-30	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022044-002	JANUMET	1GM;EQ 50MG BASE	TABLET / ORAL		RLD, RS	2007-03-30	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022044-001	JANUMET	500MG;EQ 50MG BASE	TABLET / ORAL		RLD	2007-03-30	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022044-002	JANUMET	1GM;EQ 50MG BASE	TABLET / ORAL		RLD, RS	2007-03-30	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N022044-001	JANUMET	500MG;EQ 50MG BASE	TABLET / ORAL		RLD	2007-03-30	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N022044-002	JANUMET	1GM;EQ 50MG BASE	TABLET / ORAL		RLD, RS	2007-03-30	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022044-001	JANUMET	500MG;EQ 50MG BASE	TABLET / ORAL		RLD	2007-03-30	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022044-002	JANUMET	1GM;EQ 50MG BASE	TABLET / ORAL		RLD, RS	2007-03-30	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022044-001	JANUMET	500MG;EQ 50MG BASE	TABLET / ORAL		RLD	2007-03-30	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022044-002	JANUMET	1GM;EQ 50MG BASE	TABLET / ORAL		RLD, RS	2007-03-30	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N022044-001	JANUMET	500MG;EQ 50MG BASE	TABLET / ORAL		RLD	2007-03-30	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N022044-002	JANUMET	1GM;EQ 50MG BASE	TABLET / ORAL		RLD, RS	2007-03-30	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N022044-001	JANUMET	500MG;EQ 50MG BASE	TABLET / ORAL		RLD	2007-03-30	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N022044-002	JANUMET	1GM;EQ 50MG BASE	TABLET / ORAL		RLD, RS	2007-03-30	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022044-001	JANUMET	500MG;EQ 50MG BASE	TABLET / ORAL		RLD	2007-03-30	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022044-002	JANUMET	1GM;EQ 50MG BASE	TABLET / ORAL		RLD, RS	2007-03-30	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N022044-001	JANUMET	500MG;EQ 50MG BASE	TABLET / ORAL		RLD	2007-03-30	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N022044-002	JANUMET	1GM;EQ 50MG BASE	TABLET / ORAL		RLD, RS	2007-03-30	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N022044-001	JANUMET	500MG;EQ 50MG BASE	TABLET / ORAL		RLD	2007-03-30	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N022044-002	JANUMET	1GM;EQ 50MG BASE	TABLET / ORAL		RLD, RS	2007-03-30	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N022044-001	JANUMET	500MG;EQ 50MG BASE	TABLET / ORAL		RLD	2007-03-30	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022044-002	JANUMET	1GM;EQ 50MG BASE	TABLET / ORAL		RLD, RS	2007-03-30	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N022044-001	JANUMET	500MG;EQ 50MG BASE	TABLET / ORAL		RLD	2007-03-30	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N022044-002	JANUMET	1GM;EQ 50MG BASE	TABLET / ORAL		RLD, RS	2007-03-30	`bb7c543d1eb4…`

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	N022044-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022044-002	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N022044-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022044-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022044-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022044-002	AB	1	`31067a03dcf5…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N022044-001	AB	1	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N022044-002	AB	1	`a50c72e98297…`

Observed Orange Book patent history#

Patent history page 1 of 14 · 560 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-08-18 06:07:40	2026-07	N022044-001	7326708	2026-11-24	U-802	Drug substance, Drug product		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022044-001	7326708*PED	2027-05-24		Pediatric extension		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022044-001	8414921	2028-07-21	U-1036	Drug product	2013-04-09	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022044-001	8414921*PED	2029-01-21		Pediatric extension		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022044-002	7326708	2026-11-24	U-802	Drug substance, Drug product		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022044-002	7326708*PED	2027-05-24		Pediatric extension		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022044-002	8414921	2028-07-21	U-1036	Drug product		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022044-002	8414921*PED	2029-01-21		Pediatric extension		`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N022044-001	7326708	2026-11-24	U-802	Drug substance, Drug product		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022044-001	7326708*PED	2027-05-24		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022044-001	8414921	2028-07-21	U-1036	Drug product	2013-04-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022044-001	8414921*PED	2029-01-21		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022044-002	7326708	2026-11-24	U-802	Drug substance, Drug product		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022044-002	7326708*PED	2027-05-24		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022044-002	8414921	2028-07-21	U-1036	Drug product		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022044-002	8414921*PED	2029-01-21		Pediatric extension		`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022044-001	7326708	2026-11-24	U-802	Drug substance, Drug product		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022044-001	7326708*PED	2027-05-24		Pediatric extension		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022044-001	8414921	2028-07-21	U-1036	Drug product	2013-04-09	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022044-001	8414921*PED	2029-01-21		Pediatric extension		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022044-002	7326708	2026-11-24	U-802	Drug substance, Drug product		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022044-002	7326708*PED	2027-05-24		Pediatric extension		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022044-002	8414921	2028-07-21	U-1036	Drug product		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022044-002	8414921*PED	2029-01-21		Pediatric extension		`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N022044-001	7326708	2026-11-24	U-802	Drug substance, Drug product		`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022044-001	7326708*PED	2027-05-24		Pediatric extension		`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022044-001	8414921	2028-07-21	U-1036	Drug product	2013-04-09	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022044-001	8414921*PED	2029-01-21		Pediatric extension		`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022044-002	7326708	2026-11-24	U-802	Drug substance, Drug product		`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022044-002	7326708*PED	2027-05-24		Pediatric extension		`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022044-002	8414921	2028-07-21	U-1036	Drug product		`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022044-002	8414921*PED	2029-01-21		Pediatric extension		`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022044-001	7326708	2026-11-24	U-802	Drug substance, Drug product		`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022044-001	7326708*PED	2027-05-24		Pediatric extension		`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022044-001	8414921	2028-07-21	U-1036	Drug product	2013-04-09	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022044-001	8414921*PED	2029-01-21		Pediatric extension		`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022044-002	7326708	2026-11-24	U-802	Drug substance, Drug product		`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022044-002	7326708*PED	2027-05-24		Pediatric extension		`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022044-002	8414921	2028-07-21	U-1036	Drug product		`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022044-002	8414921*PED	2029-01-21		Pediatric extension		`fd3edfee7708…`

Observed Orange Book exclusivity history#

Exclusivity history page 1 of 5 · 180 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022044-001	M-187	2023-12-04	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022044-001	PED	2024-06-04	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022044-002	M-187	2023-12-04	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022044-002	PED	2024-06-04	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022044-001	M-187	2023-12-04	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022044-001	PED	2024-06-04	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022044-002	M-187	2023-12-04	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022044-002	PED	2024-06-04	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022044-001	M-187	2023-12-04	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022044-001	PED	2024-06-04	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022044-002	M-187	2023-12-04	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022044-002	PED	2024-06-04	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022044-001	M-187	2023-12-04	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022044-001	PED	2024-06-04	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022044-002	M-187	2023-12-04	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022044-002	PED	2024-06-04	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N022044-001	M-187	2023-12-04	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N022044-001	PED	2024-06-04	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N022044-002	M-187	2023-12-04	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N022044-002	PED	2024-06-04	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022044-001	M-187	2023-12-04	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022044-001	PED	2024-06-04	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022044-002	M-187	2023-12-04	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022044-002	PED	2024-06-04	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022044-001	M-187	2023-12-04	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022044-001	PED	2024-06-04	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022044-002	M-187	2023-12-04	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022044-002	PED	2024-06-04	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N022044-001	M-187	2023-12-04	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N022044-001	PED	2024-06-04	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N022044-002	M-187	2023-12-04	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N022044-002	PED	2024-06-04	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N022044-001	M-187	2023-12-04	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N022044-001	PED	2024-06-04	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N022044-002	M-187	2023-12-04	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N022044-002	PED	2024-06-04	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022044-001	M-244	2022-08-12	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022044-001	PED	2023-02-12	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022044-001	M-187	2023-12-04	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022044-001	PED	2024-06-04	`5c6f7cd8ea54…`

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
50090-5618-0	2023-02-06	C162847	48780-1	f386c649-9990-0266-e053-dadaa90a7c1a	These highlights do not include all the information needed to use JANUMET safely and effectively. See full prescribing information for JANUMET. JANUMET ® (sitagliptin and metformin hydrochloride) tablets, for oral use Initial U.S. Approval: 2007
50090-5618-0	2023-01-30	C162847	48780-1	f386c649-9990-0266-e053-dadaa90a7c1a	These highlights do not include all the information needed to use JANUMET safely and effectively. See full prescribing information for JANUMET. JANUMET ® (sitagliptin and metformin hydrochloride) tablets, for oral use Initial U.S. Approval: 2007

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
50090-5618-0	EA - Each	50090-5618	f08afde8-e4c3-430f-a508-7f524c7c9da7	1	2022-04-06

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 3 matching rows.

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

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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
50090-5618-0	50090561800	60 TABLET, FILM COATED in 1 BOTTLE (50090-5618-0)	2021-08-24	0000-00-00	No	No	Current