Janumet NDC 50090-5616

NDC codes

FDA NDC Directory

Product NDC (as listed)50090-5616Labeler and product segments. Claims need a package NDC.

Product NDC at billing width50090-5616Add the package segment from the table below.

Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC	11-digit (billing)	Package	Copy
50090-5616-0	50090561600	60 TABLET, FILM COATED in 1 BOTTLE (50090-5616-0)Marketed from Aug 23, 2021
50090-5616-1	50090561601	180 TABLET, FILM COATED in 1 BOTTLE (50090-5616-1)Marketed from Jul 17, 2023

How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules

Product information

Brand name (proprietary): Janumet
Generic name (nonproprietary): sitagliptin and metformin hydrochloride
Active ingredients: Sitagliptin phosphate — 50 mg/1Metformin hydrochloride — 500 mg/1
Dosage form: Tablet, Film coated
Route: Oral
Labeler: A-S Medication Solutions
Product type: Prescription drug
Marketing category: NDA — New Drug ApplicationApplication NDA 022044
Marketing start: Mar 30, 2007
Listing expires: Dec 31, 2027
Other FDA classes: Biguanides (Chemical structure)Dipeptidyl Peptidase 4 Inhibitors (Mechanism)
Identifiers: Product ID 50090-5616_baa669a4-264f-43fa-8a72-bf48fe998729SPL ID baa669a4-264f-43fa-8a72-bf48fe998729SPL set ID b55ee3d9-7f0b-4dd9-9213-fbc69f09f567RxCUI 861821, 2709491UNII TS63EW8X6F, 786Z46389E
Pharmacologic class: Biguanide; Dipeptidyl Peptidase 4 Inhibitor

Billing references

What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.

HCPCS codeNo match

No HCPCS code in Med-Code's directory. Oral products like this are usually dispensed by a pharmacy and billed by NDC.

NDC on a medical claim

N450090561600 followed by a unit qualifier and the quantity

Package 50090-5616-00. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier

Product label

Current FDA label (SPL), effective Jul 9, 2026. This label includes a boxed warning.

Indications (excerpt from the label)

JANUMET is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Limitations of Use JANUMET should not be used in patients with type 1 diabetes mellitus. JANUMET has not been studied in patients with a history of pancreatitis. It is unknown whether patients with a history of pancreatitis are at increased risk for the development of pancreatitis while using JANUMET. [See Warnings and Precautions (5.2) .] JANUMET is a combination of sitagliptin, a dipeptidyl peptidase-4 (DPP-4) inhibitor, and metformin hydrochloride (HCl), a biguanide, indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabe…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under NDA 022044

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under NDA 022044
Product	Strength	Form · route	Labeler	Product NDC
Janumetsitagliptin and metformin hydrochloride	Sitagliptin phosphate 50 mg/1; Metformin hydrochloride 1000 mg/1	Tablet, Film coatedOral	A-S Medication Solutions	50090-5502
Janumetsitagliptin and metformin hydrochloride	Sitagliptin phosphate 50 mg/1; Metformin hydrochloride 1000 mg/1	Tablet, Film coatedOral	Merck Sharp & Dohme LLC	0006-0577
Janumetsitagliptin and metformin hydrochloride	Sitagliptin phosphate 50 mg/1; Metformin hydrochloride 500 mg/1	Tablet, Film coatedOral	Merck Sharp & Dohme LLC	0006-0575