Prescription drug · NDA
Janumet XR NDC 50090-5504
sitagliptin and metformin hydrochloride · Sitagliptin phosphate 50 mg/1; Metformin hydrochloride 1000 mg/1 · Tablet, Film coated, Extended release · Oral · A-S Medication Solutions
NDC codes
FDA NDC Directory| 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
- Listing expires
- 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
N450090550400followed by a unit qualifier and the quantityPackage 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
Current FDA label (SPL), effective . 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.
Other NDCs under NDA 202270
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| 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 |