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#

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 · 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		2026-07-31
excluded package	package	50090-5618	50090-5618-0	D	Discontinued by firm		2026-07-31

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

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.

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
2026-08-01 22:54:32	2026-06	N022044-001	JANUMET	500MG;EQ 50MG BASE	TABLET / ORAL	AB	RLD	2007-03-30	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N022044-002	JANUMET	1GM;EQ 50MG BASE	TABLET / ORAL	AB	RLD, RS	2007-03-30	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-01 22:54:32	2026-06	N022044-001	AB	1	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N022044-002	AB	1	`a50c72e98297…`

Observed Orange Book patent history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-08-01 22:54:32	2026-06	N022044-001	7326708	2026-11-24	U-802	Drug substance, Drug product		`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N022044-001	7326708*PED	2027-05-24		Pediatric extension		`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N022044-001	8414921	2028-07-21	U-1036	Drug product	2013-04-09	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N022044-001	8414921*PED	2029-01-21		Pediatric extension		`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N022044-002	7326708	2026-11-24	U-802	Drug substance, Drug product		`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N022044-002	7326708*PED	2027-05-24		Pediatric extension		`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N022044-002	8414921	2028-07-21	U-1036	Drug product		`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N022044-002	8414921*PED	2029-01-21		Pediatric extension		`a50c72e98297…`

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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
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
JANUMET	SITAGLIPTIN AND METFORMIN HYDROCHLORIDE	Merck Sharp & Dohme LLC	d19c7ed0-ad5c-426e-b2df-722508f97d67	2025-03-25	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 022044 application number: NDA022044

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

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