Janumet XR NDC 0006-0081

NDC codes

FDA NDC Directory

Product NDC (as listed)0006-0081Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00006-0081Add 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
0006-0081-14	00006008114	2 BOTTLE in 1 CARTON (0006-0081-14) / 7 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (0006-0081-07)Marketed from Feb 2, 2012 · Sample package
0006-0081-31	00006008131	30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (0006-0081-31)Marketed from Feb 2, 2012
0006-0081-54	00006008154	90 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (0006-0081-54)Marketed from Feb 2, 2012
0006-0081-82	00006008182	1000 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (0006-0081-82)Marketed from Feb 2, 2012

How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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 — 100 mg/1Metformin hydrochloride — 1000 mg/1
Dosage form: Tablet, Film coated, Extended release
Route: Oral
Labeler: Merck Sharp & Dohme LLC
Product type: Prescription drug
Marketing category: NDA — New Drug ApplicationApplication NDA 202270
Marketing start: Feb 2, 2012
Listing expires: Dec 31, 2027
Other FDA classes: Biguanides (Chemical structure)Dipeptidyl Peptidase 4 Inhibitors (Mechanism)
Identifiers: Product ID 0006-0081_44f3c6c6-160a-4cc8-8961-b4f7200b5ce5SPL ID 44f3c6c6-160a-4cc8-8961-b4f7200b5ce5SPL set ID 64beb3d2-3aeb-4cd5-ba11-dacf6c9a5b50RxCUI 1243833, 1243843, 1243848, 2709470, 2709477, 2709482UNII 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

N400006008114 followed by a unit qualifier and the quantity

Package 00006-0081-14. 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 Aug 11, 2026. This label includes a boxed warning.

Indications (excerpt from the label)

JANUMET ® XR is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. JANUMET XR 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 diabetes mellitus. ( 1 ) Limitations of Use: Not for the treatment of type 1 diabetes. ( 1 ) Has not been studied in patients with a history of pancreatitis. ( 1 , 5.2 ) Limitations of Use JANUMET XR should not be used in patients with type 1 diabetes mellitus. JANUMET XR has not been studied in patients with a history of pancreatitis. It…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

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 50 mg/1; Metformin hydrochloride 1000 mg/1	Tablet, Film coated, Extended releaseOral	A-S Medication Solutions	50090-5504
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