Prescription drug · NDA
Zituvimet (Sitagliptin and metformin hydrochloride) NDC 70771-1860
Sitagliptin 50 mg/1; Metformin hydrochloride 1000 mg/1 · Tablet, Film coated · Oral · Zydus Lifesciences Limited
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 70771-1860-6 | 7077118600670771186006 | 60 TABLET, FILM COATED in 1 BOTTLE (70771-1860-6)Marketed from Mar 14, 2024 | |
| 70771-1860-8 | 7077118600870771186008 | 180 TABLET, FILM COATED in 1 BOTTLE (70771-1860-8)Marketed from Mar 14, 2024 |
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)
- Zituvimet
- Generic name (nonproprietary)
- sitagliptin and metformin hydrochloride
- Active ingredients
- Sitagliptin — 50 mg/1Metformin hydrochloride — 1000 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- Zydus Lifesciences LimitedNDC labeler code 70771
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 216743
- Marketing start
- Listing expires
- Other FDA classes
- Biguanides (Chemical structure)Dipeptidyl Peptidase 4 Inhibitors (Mechanism)
- Identifiers
- Product ID 70771-1860_8c26dc1a-fba3-4266-bfaf-624b0941ef8bSPL ID 8c26dc1a-fba3-4266-bfaf-624b0941ef8bSPL set ID 0098dec4-f0e5-45d5-8aa4-5d0faf9ab142RxCUI 861769, 861819, 2677162, 2677164UNII 786Z46389E, QFP0P1DV7Z
- 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
N470771186006followed by a unit qualifier and the quantityPackage 70771-1860-06. 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)
ZITUVIMET 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: ZITUVIMET is not recommended in patients with type 1 diabetes mellitus. ( 1 ) ZITUVIMET has not been studied in patients with a history of pancreatitis. ( 1 ) ZITUVIMET is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Limitations of Use ZITUVIMET is not recommended in patients with type 1 diabetes mellitus. ZITUVIMET has not been studied in patients with …
Excerpt only. Read the full label for complete information.
About NDC 70771-1860
- What is NDC 70771-1860?
- 70771-1860 is the product NDC for Zituvimet, Sitagliptin 50 mg/1; Metformin hydrochloride 1000 mg/1 tablet, film coated, listed with the FDA by Zydus Lifesciences Limited. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Zituvimet (Sitagliptin and Metformin Hydrochloride).
- What is the active ingredient?
- Sitagliptin, Metformin hydrochloride.
- Who is the labeler?
- Zydus Lifesciences Limited, NDC labeler code 70771. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Zituvimet?
- 3 other product NDCs are listed under this name. See all Zituvimet NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Zituvimet products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Zituvimetsitagliptin and metformin hydrochloride | Sitagliptin 50 mg/1; Metformin hydrochloride 500 mg/1 | Tablet, Film coatedOral | Zydus Pharmaceuticals (USA) Inc. | 70710-1786 | 70710-1786-0670710-1786-08 |
| Zituvimetsitagliptin and metformin hydrochloride | Sitagliptin 50 mg/1; Metformin hydrochloride 1000 mg/1 | Tablet, Film coatedOral | Zydus Pharmaceuticals (USA) Inc. | 70710-1787 | 70710-1787-0670710-1787-08 |
| Zituvimetsitagliptin and metformin hydrochloride | Sitagliptin 50 mg/1; Metformin hydrochloride 500 mg/1 | Tablet, Film coatedOral | Zydus Lifesciences Limited | 70771-1859 | 70771-1859-0670771-1859-08 |
Other NDCs under NDA 216743
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 and metformin hydrochloride | Sitagliptin 50 mg/1; Metformin hydrochloride 500 mg/1 | Tablet, Film coatedOral | Zydus Pharmaceuticals (USA) Inc. | 70710-1986 |
| Sitagliptin and metformin hydrochloride | Sitagliptin 50 mg/1; Metformin hydrochloride 1000 mg/1 | Tablet, Film coatedOral | Zydus Pharmaceuticals (USA) Inc. | 70710-1987 |
| Sitagliptin and metformin hydrochloride | Sitagliptin 50 mg/1; Metformin hydrochloride 500 mg/1 | Tablet, Film coatedOral | Zydus Lifesciences Limited | 70771-1869 |
| Sitagliptin and metformin hydrochloride | Sitagliptin 50 mg/1; Metformin hydrochloride 1000 mg/1 | Tablet, Film coatedOral | Zydus Lifesciences Limited | 70771-1870 |
| Zituvimetsitagliptin and metformin hydrochloride | Sitagliptin 50 mg/1; Metformin hydrochloride 500 mg/1 | Tablet, Film coatedOral | Zydus Pharmaceuticals (USA) Inc. | 70710-1786 |
| Zituvimetsitagliptin and metformin hydrochloride | Sitagliptin 50 mg/1; Metformin hydrochloride 1000 mg/1 | Tablet, Film coatedOral | Zydus Pharmaceuticals (USA) Inc. | 70710-1787 |
| Zituvimetsitagliptin and metformin hydrochloride | Sitagliptin 50 mg/1; Metformin hydrochloride 500 mg/1 | Tablet, Film coatedOral | Zydus Lifesciences Limited | 70771-1859 |