Prescription drug · ANDA
Sitagliptin Phosphate NDC 0781-5770
Sitagliptin phosphate 100 mg/1 · Tablet, Film coated · Oral · Sandoz Inc
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0781-5770-10 | 0078157701000781577010 | 1000 TABLET, FILM COATED in 1 BOTTLE (0781-5770-10)Marketed from Jan 14, 2026 | |
| 0781-5770-31 | 0078157703100781577031 | 30 TABLET, FILM COATED in 1 BOTTLE (0781-5770-31)Marketed from Jan 14, 2026 | |
| 0781-5770-92 | 0078157709200781577092 | 90 TABLET, FILM COATED in 1 BOTTLE (0781-5770-92)Marketed from Jan 14, 2026 |
How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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 Phosphate
- Generic name (nonproprietary)
- sitagliptin phosphate
- Active ingredients
- Sitagliptin phosphate — 100 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- Sandoz IncNDC labeler code 0781
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 202387
- Marketing start
- Listing expires
- Other FDA classes
- Dipeptidyl Peptidase 4 Inhibitors (Mechanism)
- Identifiers
- Product ID 0781-5770_dd07ef38-4a9b-46f4-90ed-dd520cc1d75eSPL ID dd07ef38-4a9b-46f4-90ed-dd520cc1d75eSPL set ID cebc8388-c9db-4e27-8d6b-0d9bdc9d766dRxCUI 2709603, 2709608, 2709612UNII TS63EW8X6F
- Pharmacologic class
- 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
N400781577010followed by a unit qualifier and the quantityPackage 00781-5770-10. 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 .
Indications (excerpt from the label)
Sitagliptin tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Limitations of Use Sitagliptin tablets should not be used in patients with type 1 diabetes. Sitagliptin tablets have not been studied in patients with a history of pancreatitis. It is unknown whether patients with a history of pancreatitis are at increased risk for the development of pancreatitis while using sitagliptin tablets. [See Warnings and Precautions ( 5.1 ).] Sitagliptin is a dipeptidyl peptidase-4 (DPP-4) inhibitor indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. ( 1 ) Limitations o…
Excerpt only. Read the full label for complete information.
About NDC 0781-5770
- What is NDC 0781-5770?
- 0781-5770 is the product NDC for Sitagliptin Phosphate, Sitagliptin phosphate 100 mg/1 tablet, film coated, listed with the FDA by Sandoz Inc. It has 3 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Sitagliptin Phosphate.
- What is the active ingredient?
- Sitagliptin phosphate.
- Who is the labeler?
- Sandoz Inc, NDC labeler code 0781. 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 Phosphate?
- 2 other product NDCs are listed under this name. See all Sitagliptin Phosphate NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Sitagliptin Phosphate 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 Phosphate | Sitagliptin phosphate 25 mg/1 | Tablet, Film coatedOral | Sandoz Inc | 0781-5766 | 00781-5766-3100781-5766-92 |
| Sitagliptin Phosphate | Sitagliptin phosphate 50 mg/1 | Tablet, Film coatedOral | Sandoz Inc | 0781-5768 | 00781-5768-3100781-5768-92 |
Other NDCs under ANDA 202387
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 Phosphate | Sitagliptin phosphate 25 mg/1 | Tablet, Film coatedOral | Sandoz Inc | 0781-5766 |
| Sitagliptin Phosphate | Sitagliptin phosphate 50 mg/1 | Tablet, Film coatedOral | Sandoz Inc | 0781-5768 |