Prescription drug · NDA AUTHORIZED GENERIC
Sitagliptin and metformin hydrochloride NDC 70710-1986
Sitagliptin 50 mg/1; Metformin hydrochloride 500 mg/1 · Tablet, Film coated · Oral · Zydus Pharmaceuticals (USA) Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 70710-1986-6 | 70710198606 | 60 TABLET, FILM COATED in 1 BOTTLE (70710-1986-6)Marketed from Mar 14, 2024 | |
| 70710-1986-8 | 70710198608 | 180 TABLET, FILM COATED in 1 BOTTLE (70710-1986-8)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)
- Sitagliptin and metformin hydrochloride
- Generic name (nonproprietary)
- sitagliptin and metformin hydrochloride
- Active ingredients
- Sitagliptin — 50 mg/1Metformin hydrochloride — 500 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Product type
- Prescription drug
- Marketing category
- NDA authorized genericApplication NDA 216743
- Marketing start
- Listing expires
- Other FDA classes
- Biguanides (Chemical structure)Dipeptidyl Peptidase 4 Inhibitors (Mechanism)
- Identifiers
- Product ID 70710-1986_6c6865d9-b997-4c50-bb00-0b188ae0d2c0SPL ID 6c6865d9-b997-4c50-bb00-0b188ae0d2c0SPL set ID 4d812277-21a8-4de3-b728-e3fdd01305b5RxCUI 861769, 861819UNII 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
N470710198606followed by a unit qualifier and the quantityPackage 70710-1986-06. 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)
Sitagliptin and metformin hydrochloride tablets 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: Sitagliptin and metformin hydrochloride tablets is not recommended in patients with type 1 diabetes mellitus. ( 1 ) Sitagliptin and metformin hydrochloride tablets has not been studied in patients with a history of pancreatitis. ( 1 ) Sitagliptin and metformin hydrochloride tablets is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabet…
Excerpt only. Read the full label for complete information.
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 1000 mg/1 | Tablet, Film coatedOral | Zydus Pharmaceuticals (USA) Inc. | 70710-1987 |
| 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 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 |