Janumet XR NDC 50090-5504

NDC codes

FDA NDC Directory

Product NDC (as listed)50090-5504Labeler and product segments. Claims need a package NDC.

Product NDC at billing width50090-5504Add 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
50090-5504-0	50090550400	60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (50090-5504-0)Marketed from Mar 31, 2021
50090-5504-1	50090550401	180 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (50090-5504-1)Marketed from Sep 1, 2021

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 XRSuffix: XR
Generic name (nonproprietary): sitagliptin and metformin hydrochloride
Active ingredients: Sitagliptin phosphate — 50 mg/1Metformin hydrochloride — 1000 mg/1
Dosage form: Tablet, Film coated, Extended release
Route: Oral
Labeler: A-S Medication Solutions
Product type: Prescription drug
Marketing category: NDA — New Drug ApplicationApplication NDA 202270
Marketing start: Feb 2, 2012
Listing expires: Dec 31, 2026
Other FDA classes: Biguanides (Chemical structure)Dipeptidyl Peptidase 4 Inhibitors (Mechanism)
Identifiers: Product ID 50090-5504_daeedefc-b17c-4c81-8677-dc75b1eb8af2SPL ID daeedefc-b17c-4c81-8677-dc75b1eb8af2SPL set ID 90c0244b-afb3-4e69-b79f-486d002ca432RxCUI 1243843, 2709477UNII 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

N450090550400 followed by a unit qualifier and the quantity

Package 50090-5504-00. 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

Label details couldn’t be retrieved right now. Open the label on DailyMed.

Other NDCs under NDA 202270

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

FDA NDC Directory listings under NDA 202270
Product	Strength	Form · route	Labeler	Product NDC
Janumet XRsitagliptin and metformin hydrochloride	Sitagliptin phosphate 100 mg/1; Metformin hydrochloride 1000 mg/1	Tablet, Film coated, Extended releaseOral	Merck Sharp & Dohme LLC	0006-0081
Janumet XRsitagliptin and metformin hydrochloride	Sitagliptin phosphate 50 mg/1; Metformin hydrochloride 500 mg/1	Tablet, Film coated, Extended releaseOral	Merck Sharp & Dohme LLC	0006-0078
Janumet XRsitagliptin and metformin hydrochloride	Sitagliptin phosphate 50 mg/1; Metformin hydrochloride 1000 mg/1	Tablet, Film coated, Extended releaseOral	Merck Sharp & Dohme LLC	0006-0080