Prescription drug · NDA
Zituvio (Sitagliptin) NDC 70710-1242
Sitagliptin 100 mg/1 · Tablet · Oral · Zydus Pharmaceuticals (USA) Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 70710-1242-3 | 7071012420370710124203 | 30 TABLET in 1 BOTTLE (70710-1242-3)Marketed from Nov 30, 2023 | |
| 70710-1242-9 | 7071012420970710124209 | 90 TABLET in 1 BOTTLE (70710-1242-9)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 — 100 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Zydus Pharmaceuticals (USA) Inc.NDC labeler code 70710
- 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 70710-1242_1686e1de-8172-444b-a267-ad3bc7ca69f1SPL ID 1686e1de-8172-444b-a267-ad3bc7ca69f1SPL set ID abfdea45-c0ca-41e3-a510-e89810bc9cfeRxCUI 665033, 665038, 665042, 2670447, 2670449, 2670451UNII QFP0P1DV7ZUPC 0370710124090, 0370710124199, 0370710124298
- 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
N470710124203followed by a unit qualifier and the quantityPackage 70710-1242-03. 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.
About NDC 70710-1242
- What is NDC 70710-1242?
- 70710-1242 is the product NDC for Zituvio (sitagliptin), Sitagliptin 100 mg/1 tablet, listed with the FDA by Zydus Pharmaceuticals (USA) Inc.. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Zituvio (Sitagliptin).
- What is the active ingredient?
- Sitagliptin.
- Who is the labeler?
- Zydus Pharmaceuticals (USA) Inc., NDC labeler code 70710. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Zituvio?
- 5 other product NDCs are listed under this name. See all Zituvio NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Zituvio products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Zituviositagliptin | Sitagliptin 25 mg/1 | TabletOral | Zydus Pharmaceuticals (USA) Inc. | 70710-1240 | 70710-1240-0370710-1240-09 |
| Zituviositagliptin | Sitagliptin 50 mg/1 | TabletOral | Zydus Pharmaceuticals (USA) Inc. | 70710-1241 | 70710-1241-0370710-1241-09 |
| Zituviositagliptin | Sitagliptin 25 mg/1 | TabletOral | Zydus Lifesciences Limited | 70771-1770 | 70771-1770-0370771-1770-09 |
| Zituviositagliptin | Sitagliptin 50 mg/1 | TabletOral | Zydus Lifesciences Limited | 70771-1771 | 70771-1771-0370771-1771-09 |
| Zituviositagliptin | Sitagliptin 100 mg/1 | TabletOral | Zydus Lifesciences Limited | 70771-1772 | 70771-1772-0370771-1772-09 |
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 25 mg/1 | TabletOral | Zydus Pharmaceuticals (USA) Inc. | 70710-1899 |
| Sitagliptin | Sitagliptin 50 mg/1 | TabletOral | Zydus Pharmaceuticals (USA) Inc. | 70710-1900 |
| Sitagliptin | Sitagliptin 100 mg/1 | TabletOral | Zydus Pharmaceuticals (USA) Inc. | 70710-1901 |
| 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 |
| Zituviositagliptin | Sitagliptin 25 mg/1 | TabletOral | Zydus Pharmaceuticals (USA) Inc. | 70710-1240 |
| Zituviositagliptin | Sitagliptin 50 mg/1 | TabletOral | Zydus Pharmaceuticals (USA) Inc. | 70710-1241 |
| Zituviositagliptin | Sitagliptin 25 mg/1 | TabletOral | Zydus Lifesciences Limited | 70771-1770 |
| Zituviositagliptin | Sitagliptin 50 mg/1 | TabletOral | Zydus Lifesciences Limited | 70771-1771 |
| Zituviositagliptin | Sitagliptin 100 mg/1 | TabletOral | Zydus Lifesciences Limited | 70771-1772 |