Prescription drug · NDA
Januvia (sitagliptin) NDC 50090-3527
Sitagliptin phosphate 25 mg/1 · Tablet, Film coated · Oral · A-S Medication Solutions
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 50090-3527-0 | 50090352700 | 90 TABLET, FILM COATED in 1 BOTTLE (50090-3527-0)Marketed from Aug 1, 2018 | |
| 50090-3527-1 | 50090352701 | 30 TABLET, FILM COATED in 1 BOTTLE (50090-3527-1)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)
- Januvia
- Generic name (nonproprietary)
- sitagliptin
- Active ingredients
- Sitagliptin phosphate — 25 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 021995
- Marketing start
- Listing expires
- Other FDA classes
- Dipeptidyl Peptidase 4 Inhibitors (Mechanism)
- Identifiers
- Product ID 50090-3527_a8fb9fdc-d34e-45db-8ecf-f9de43c069adSPL ID a8fb9fdc-d34e-45db-8ecf-f9de43c069adSPL set ID 1b03c82f-b52e-4092-b9dc-f2c9b0d6ab40RxCUI 665040, 2709612UNII TS63EW8X6F
- Pharmacologic class
- 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
N450090352700followed by a unit qualifier and the quantityPackage 50090-3527-00. 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 .
Indications (excerpt from the label)
JANUVIA ® is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. JANUVIA is a dipeptidyl peptidase-4 (DPP-4) inhibitor indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. ( 1 ) Limitations of Use: JANUVIA should not be used in patients with type 1 diabetes ( 1 ) JANUVIA has not been studied in patients with a history of pancreatitis. ( 1 , 5.1 ) Limitations of Use JANUVIA should not be used in patients with type 1 diabetes. JANUVIA has not been studied in patients with a history of pancreatitis. It is unknown whether patients with a history of pancreatitis are at increa…
Excerpt only. Read the full label for complete information.
Other NDCs under NDA 021995
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 |
|---|---|---|---|---|
| Januviasitagliptin | Sitagliptin phosphate 100 mg/1 | Tablet, Film coatedOral | Merck Sharp & Dohme LLC | 0006-0277 |
| Januviasitagliptin | Sitagliptin phosphate 50 mg/1 | Tablet, Film coatedOral | A-S Medication Solutions | 50090-3472 |
| Januviasitagliptin | Sitagliptin phosphate 100 mg/1 | Tablet, Film coatedOral | A-S Medication Solutions | 50090-1036 |
| Januviasitagliptin | Sitagliptin phosphate 50 mg/1 | Tablet, Film coatedOral | Cardinal Health 107, LLC | 55154-5040 |
| Januviasitagliptin | Sitagliptin phosphate 100 mg/1 | Tablet, Film coatedOral | Cardinal Health 107, LLC | 55154-5042 |
| Januviasitagliptin | Sitagliptin phosphate 25 mg/1 | Tablet, Film coatedOral | Merck Sharp & Dohme LLC | 0006-0221 |
| Januviasitagliptin | Sitagliptin phosphate 50 mg/1 | Tablet, Film coatedOral | Merck Sharp & Dohme LLC | 0006-0112 |
| Januviasitagliptin | Sitagliptin phosphate 100 mg/1 | Tablet, Film coatedOral | A-S Medication Solutions | 50090-4084 |
| Januviasitagliptin | Sitagliptin phosphate 50 mg/1 | Tablet, Film coatedOral | A-S Medication Solutions | 50090-4086 |
| Januviasitagliptin | Sitagliptin phosphate 25 mg/1 | Tablet, Film coatedOral | A-S Medication Solutions | 50090-4087 |