Prescription drug · NDA
Zituvio (sitagliptin) NDC 70771-1771
Sitagliptin 50 mg/1 · Tablet · Oral · Zydus Lifesciences Limited
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 70771-1771-3 | 70771177103 | 30 TABLET in 1 BOTTLE (70771-1771-3)Marketed from Nov 30, 2023 | |
| 70771-1771-9 | 70771177109 | 90 TABLET in 1 BOTTLE (70771-1771-9)Marketed from Nov 30, 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)
- Zituvio
- Generic name (nonproprietary)
- sitagliptin
- Active ingredients
- Sitagliptin — 50 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Zydus Lifesciences Limited
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 211566
- Marketing start
- Listing expires
- Other FDA classes
- Dipeptidyl Peptidase 4 Inhibitors (Mechanism)
- Identifiers
- Product ID 70771-1771_938530d0-f5ca-451d-a8d4-55384ae75e20SPL ID 938530d0-f5ca-451d-a8d4-55384ae75e20SPL set ID b2da9d77-154b-48f7-8793-3f4a24dfafc6RxCUI 665033, 665038, 665042, 2670447, 2670449, 2670451UNII QFP0P1DV7Z
- 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
N470771177103followed by a unit qualifier and the quantityPackage 70771-1771-03. 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)
ZITUVIO ® is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Limitations of Use ZITUVIO is not recommended in patients with type 1 diabetes mellitus. ZITUVIO 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 ZITUVIO. [see Warnings and Precautions (5.1) ]. ZITUVIO 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: ZITUVIO is not recommended in patient…
Excerpt only. Read the full label for complete information.
Other NDCs under NDA 211566
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 |
|---|---|---|---|---|
| Sitagliptin | Sitagliptin 50 mg/1 | TabletOral | Zydus Pharmaceuticals (USA) Inc. | 70710-1900 |
| Sitagliptin | Sitagliptin 25 mg/1 | TabletOral | Zydus Pharmaceuticals (USA) Inc. | 70710-1899 |
| Sitagliptin | Sitagliptin 100 mg/1 | TabletOral | Zydus Pharmaceuticals (USA) Inc. | 70710-1901 |
| Zituviositagliptin | Sitagliptin 50 mg/1 | TabletOral | Zydus Pharmaceuticals (USA) Inc. | 70710-1241 |
| Zituviositagliptin | Sitagliptin 25 mg/1 | TabletOral | Zydus Pharmaceuticals (USA) Inc. | 70710-1240 |
| Zituviositagliptin | Sitagliptin 100 mg/1 | TabletOral | Zydus Pharmaceuticals (USA) Inc. | 70710-1242 |
| Zituviositagliptin | Sitagliptin 25 mg/1 | TabletOral | Zydus Lifesciences Limited | 70771-1770 |
| Zituviositagliptin | Sitagliptin 100 mg/1 | TabletOral | Zydus Lifesciences Limited | 70771-1772 |
| Sitagliptin | Sitagliptin 25 mg/1 | TabletOral | Zydus Lifesciences Limited | 70771-1790 |
| Sitagliptin | Sitagliptin 50 mg/1 | TabletOral | Zydus Lifesciences Limited | 70771-1791 |
| Sitagliptin | Sitagliptin 100 mg/1 | TabletOral | Zydus Lifesciences Limited | 70771-1792 |