Prescription drug · NDA AUTHORIZED GENERIC
Sitagliptin and metformin hydrochloride NDC 70771-1869
Sitagliptin 50 mg/1; Metformin hydrochloride 500 mg/1 · Tablet, Film coated · Oral · Zydus Lifesciences Limited
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 70771-1869-6 | 7077118690670771186906 | 60 TABLET, FILM COATED in 1 BOTTLE (70771-1869-6)Marketed from Mar 14, 2024 | |
| 70771-1869-8 | 7077118690870771186908 | 180 TABLET, FILM COATED in 1 BOTTLE (70771-1869-8)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
- Labeler
- Zydus Lifesciences LimitedNDC labeler code 70771
- 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 70771-1869_708d9a82-e708-4403-8011-1671023a4c09SPL ID 708d9a82-e708-4403-8011-1671023a4c09SPL set ID e07abcb1-1f0c-4cad-8405-8eedba4b8ff8RxCUI 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
N470771186906followed by a unit qualifier and the quantityPackage 70771-1869-06. 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.
About NDC 70771-1869
- What is NDC 70771-1869?
- 70771-1869 is the product NDC for Sitagliptin and metformin hydrochloride, Sitagliptin 50 mg/1; Metformin hydrochloride 500 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?
- 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 Sitagliptin and metformin hydrochloride?
- 18 other product NDCs are listed under this name. See all Sitagliptin and metformin hydrochloride NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Sitagliptin and metformin hydrochloride products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Sitagliptin and Metformin hydrochloride | Sitagliptin phosphate 50 mg/1; Metformin hydrochloride 500 mg/1 | Tablet, Film coated, Extended releaseOral | Par Health USA, LLC | 10370-317 | 10370-0317-02 |
| Sitagliptin and Metformin hydrochloride | Sitagliptin phosphate 50 mg/1; Metformin hydrochloride 1000 mg/1 | Tablet, Film coated, Extended releaseOral | Par Health USA, LLC | 10370-318 | 10370-0318-02 |
| Sitagliptin and Metformin hydrochloride | Sitagliptin phosphate 100 mg/1; Metformin hydrochloride 1000 mg/1 | Tablet, Film coated, Extended releaseOral | Par Health USA, LLC | 10370-351 | 10370-0351-11 |
| Sitagliptin and Metformin Hydrochloride | Sitagliptin phosphate 50 mg/1; Metformin hydrochloride 500 mg/1 | Tablet, Film coatedOral | Apotex Corp. | 60505-3658 | 60505-3658-0660505-3658-07 |
| Sitagliptin and Metformin Hydrochloride | Sitagliptin phosphate 50 mg/1; Metformin hydrochloride 1000 mg/1 | Tablet, Film coatedOral | Apotex Corp. | 60505-3659 | 60505-3659-0660505-3659-07 |
| Sitagliptin and Metformin Hydrochloride | Sitagliptin phosphate 50 mg/1; Metformin hydrochloride 500 mg/1 | Tablet, Film coatedOral | Golden State Medical Supply, Inc. | 84677-052 | 84677-0052-1884677-0052-60 |
| Sitagliptin and Metformin Hydrochloride | Sitagliptin phosphate 50 mg/1; Metformin hydrochloride 1000 mg/1 | Tablet, Film coatedOral | Golden State Medical Supply, Inc. | 84677-053 | 84677-0053-1884677-0053-60 |
| Sitagliptin and Metformin Hydrochloride | Sitagliptin phosphate 50 mg/1; Metformin hydrochloride 500 mg/1 | Tablet, Film coatedOral | Sandoz Inc | 0781-5801 | 00781-5801-0500781-5801-6000781-5801-71 |
| Sitagliptin and Metformin Hydrochloride | Sitagliptin phosphate 50 mg/1; Metformin hydrochloride 1000 mg/1 | Tablet, Film coatedOral | Sandoz Inc | 0781-5802 | 00781-5802-6000781-5802-7100781-5802-73 |
| Sitagliptin and Metformin Hydrochloride | Sitagliptin 50 mg/1; Metformin hydrochloride 500 mg/1 | Tablet, Film coated, Extended releaseOral | Zydus Pharmaceuticals USA Inc. | 70710-2036 | 70710-2036-06 |
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 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 |
| Zituvimetsitagliptin and metformin hydrochloride | Sitagliptin 50 mg/1; Metformin hydrochloride 1000 mg/1 | Tablet, Film coatedOral | Zydus Lifesciences Limited | 70771-1860 |