Prescription drug · NDA AUTHORIZED GENERIC
Sitagliptin and Metformin Hydrochloride NDC 70771-1888
Sitagliptin 100 mg/1; Metformin hydrochloride 1000 mg/1 · Tablet, Film coated, Extended release · Oral · Zydus Lifesciences Limited
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 70771-1888-3 | 70771188803 | 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (70771-1888-3)Marketed from Oct 31, 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 — 100 mg/1Metformin hydrochloride — 1000 mg/1
- Dosage form
- Tablet, Film coated, Extended release
- Route
- Oral
- Labeler
- Zydus Lifesciences Limited
- Product type
- Prescription drug
- Marketing category
- NDA authorized genericApplication NDA 216778
- Marketing start
- Listing expires
- Other FDA classes
- Biguanides (Chemical structure)Dipeptidyl Peptidase 4 Inhibitors (Mechanism)
- Identifiers
- Product ID 70771-1888_586136d7-1c08-4507-a8fc-946d5cbefebbSPL ID 586136d7-1c08-4507-a8fc-946d5cbefebbSPL set ID a07fa1d9-7171-4f2a-ab34-f8fa410364a6RxCUI 1243827, 1243842, 1243846UNII 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
N470771188803followed by a unit qualifier and the quantityPackage 70771-1888-03. 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 .
Other NDCs under NDA 216778
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 |
|---|---|---|---|---|
| Zituvimet XRsitagliptin and metformin hydrochloride | Sitagliptin 50 mg/1; Metformin hydrochloride 500 mg/1 | Tablet, Film coated, Extended releaseOral | Zydus Pharmaceuticals USA Inc. | 70710-1804 |
| Zituvimet XRsitagliptin and metformin hydrochloride | Sitagliptin 50 mg/1; Metformin hydrochloride 1000 mg/1 | Tablet, Film coated, Extended releaseOral | Zydus Pharmaceuticals USA Inc. | 70710-1805 |
| Zituvimet XRsitagliptin and metformin hydrochloride | Sitagliptin 100 mg/1; Metformin hydrochloride 1000 mg/1 | Tablet, Film coated, Extended releaseOral | Zydus Pharmaceuticals USA Inc. | 70710-1806 |
| Sitagliptin and Metformin Hydrochloride | Sitagliptin 100 mg/1; Metformin hydrochloride 1000 mg/1 | Tablet, Film coated, Extended releaseOral | Zydus Pharmaceuticals USA Inc. | 70710-2038 |
| Sitagliptin and Metformin Hydrochloride | Sitagliptin 50 mg/1; Metformin hydrochloride 500 mg/1 | Tablet, Film coated, Extended releaseOral | Zydus Pharmaceuticals USA Inc. | 70710-2036 |
| Sitagliptin and Metformin Hydrochloride | Sitagliptin 50 mg/1; Metformin hydrochloride 1000 mg/1 | Tablet, Film coated, Extended releaseOral | Zydus Pharmaceuticals USA Inc. | 70710-2037 |
| Zituvimet XRsitagliptin and metformin hydrochloride | Sitagliptin 50 mg/1; Metformin hydrochloride 500 mg/1 | Tablet, Film coated, Extended releaseOral | Zydus Lifesciences Limited | 70771-1879 |
| Zituvimet XRsitagliptin and metformin hydrochloride | Sitagliptin 50 mg/1; Metformin hydrochloride 1000 mg/1 | Tablet, Film coated, Extended releaseOral | Zydus Lifesciences Limited | 70771-1880 |
| Zituvimet XRsitagliptin and metformin hydrochloride | Sitagliptin 100 mg/1; Metformin hydrochloride 1000 mg/1 | Tablet, Film coated, Extended releaseOral | Zydus Lifesciences Limited | 70771-1881 |
| Sitagliptin and Metformin Hydrochloride | Sitagliptin 50 mg/1; Metformin hydrochloride 500 mg/1 | Tablet, Film coated, Extended releaseOral | Zydus Lifesciences Limited | 70771-1887 |
| Sitagliptin and Metformin Hydrochloride | Sitagliptin 50 mg/1; Metformin hydrochloride 1000 mg/1 | Tablet, Film coated, Extended releaseOral | Zydus Lifesciences Limited | 70771-1886 |
- openFDA data updated
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