Prescription drug · NDA
Janumet NDC 50090-5502
sitagliptin and metformin hydrochloride · Sitagliptin phosphate 50 mg/1; Metformin hydrochloride 1000 mg/1 · Tablet, Film coated · Oral · A-S Medication Solutions
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 50090-5502-0 | 50090550200 | 60 TABLET, FILM COATED in 1 BOTTLE (50090-5502-0)Marketed from Mar 31, 2021 | |
| 50090-5502-1 | 50090550201 | 180 TABLET, FILM COATED in 1 BOTTLE (50090-5502-1)Marketed from Jul 19, 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 — 1000 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
- Listing expires
- Other FDA classes
- Biguanides (Chemical structure)Dipeptidyl Peptidase 4 Inhibitors (Mechanism)
- Identifiers
- Product ID 50090-5502_e60a2c11-c521-495d-bc7c-10612ea7b2faSPL ID e60a2c11-c521-495d-bc7c-10612ea7b2faSPL set ID c603b844-2019-4ef4-8385-7bc3f96a2565RxCUI 861771, 2709488UNII 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
N450090550200followed by a unit qualifier and the quantityPackage 50090-5502-00. 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 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.
Other NDCs under NDA 022044
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 |
|---|---|---|---|---|
| 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 | A-S Medication Solutions | 50090-5616 |
| Janumetsitagliptin and metformin hydrochloride | Sitagliptin phosphate 50 mg/1; Metformin hydrochloride 500 mg/1 | Tablet, Film coatedOral | Merck Sharp & Dohme LLC | 0006-0575 |