Zituvimet NDC 70710-1786

NDC codes

FDA NDC Directory

Product NDC (as listed)70710-1786Labeler and product segments. Claims need a package NDC.

Product NDC at billing width70710-1786Add the package segment from the table below.

Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC	11-digit (billing)	Package	Copy
70710-1786-6	70710178606	60 TABLET, FILM COATED in 1 BOTTLE (70710-1786-6)Marketed from Mar 14, 2024
70710-1786-8	70710178608	180 TABLET, FILM COATED in 1 BOTTLE (70710-1786-8)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 — 500 mg/1
Dosage form: Tablet, Film coated
Route: Oral
Labeler: Zydus Pharmaceuticals (USA) Inc.
Product type: Prescription drug
Marketing category: NDA — New Drug ApplicationApplication NDA 216743
Marketing start: Mar 14, 2024
Listing expires: Dec 31, 2027
Other FDA classes: Biguanides (Chemical structure)Dipeptidyl Peptidase 4 Inhibitors (Mechanism)
Identifiers: Product ID 70710-1786_1d3e00f1-4ed0-4d56-87b9-7b4c8c3d7144SPL ID 1d3e00f1-4ed0-4d56-87b9-7b4c8c3d7144SPL set ID eeda90a0-4941-4716-8684-f9f12cbdf3afRxCUI 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

N470710178606 followed by a unit qualifier and the quantity

Package 70710-1786-06. 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 Jul 15, 2026. 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.

Full label on DailyMed (opens in a new tab)

Other NDCs under NDA 216743

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under NDA 216743
Product	Strength	Form · route	Labeler	Product NDC
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 Pharmaceuticals (USA) Inc.	70710-1986
Zituvimetsitagliptin and metformin hydrochloride	Sitagliptin 50 mg/1; Metformin hydrochloride 500 mg/1	Tablet, Film coatedOral	Zydus Lifesciences Limited	70771-1859
Zituvimetsitagliptin and metformin hydrochloride	Sitagliptin 50 mg/1; Metformin hydrochloride 1000 mg/1	Tablet, Film coatedOral	Zydus Lifesciences Limited	70771-1860
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 1000 mg/1	Tablet, Film coatedOral	Zydus Pharmaceuticals (USA) Inc.	70710-1787