Prescription drug · ANDA
Sitagliptin NDC 0480-2608
Sitagliptin phosphate 50 mg/1 · Tablet, Film coated · Oral · Teva Pharmaceuticals, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0480-2608-56 | 0048026085600480260856 | 30 TABLET, FILM COATED in 1 BOTTLE (0480-2608-56)Marketed from May 28, 2026 | |
| 0480-2608-98 | 0048026089800480260898 | 90 TABLET, FILM COATED in 1 BOTTLE (0480-2608-98)Marketed from May 28, 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
- Generic name (nonproprietary)
- sitagliptin
- Active ingredients
- Sitagliptin phosphate — 50 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- Teva Pharmaceuticals, Inc.NDC labeler code 0480
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 202327
- Marketing start
- Listing expires
- Other FDA classes
- Dipeptidyl Peptidase 4 Inhibitors (Mechanism)
- Identifiers
- Product ID 0480-2608_ab518e96-e35b-40b1-b7e8-b4e01ada32ebSPL ID ab518e96-e35b-40b1-b7e8-b4e01ada32ebSPL set ID 5fa5aa67-455e-4ac6-864d-268a91286432RxCUI 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
N400480260856followed by a unit qualifier and the quantityPackage 00480-2608-56. 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 of…
Excerpt only. Read the full label for complete information.
About NDC 0480-2608
- What is NDC 0480-2608?
- 0480-2608 is the product NDC for Sitagliptin, Sitagliptin phosphate 50 mg/1 tablet, film coated, listed with the FDA by Teva Pharmaceuticals, Inc.. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Sitagliptin.
- What is the active ingredient?
- Sitagliptin phosphate.
- Who is the labeler?
- Teva Pharmaceuticals, Inc., NDC labeler code 0480. 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?
- 14 other product NDCs are listed under this name. See all Sitagliptin NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Sitagliptin 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 | Sitagliptin phosphate 25 mg/1 | Tablet, Film coatedOral | Teva Pharmaceuticals, Inc. | 0480-2607 | 00480-2607-5600480-2607-98 |
| Sitagliptin | Sitagliptin phosphate 100 mg/1 | Tablet, Film coatedOral | Teva Pharmaceuticals, Inc. | 0480-2609 | 00480-2609-1000480-2609-5600480-2609-98 |
| Sitagliptin | Sitagliptin phosphate 25 mg/1 | Tablet, Film coatedOral | Apotex Corp. | 60505-3643 | 60505-3643-0360505-3643-09 |
| Sitagliptin | Sitagliptin phosphate 50 mg/1 | Tablet, Film coatedOral | Apotex Corp. | 60505-3644 | 60505-3644-0360505-3644-09 |
| Sitagliptin | Sitagliptin phosphate 100 mg/1 | Tablet, Film coatedOral | Apotex Corp. | 60505-3645 | 60505-3645-0360505-3645-09 |
| Sitagliptin | Sitagliptin phosphate 25 mg/1 | Tablet, Film coatedOral | Golden State Medical Supply, Inc. | 84677-049 | 84677-0049-3084677-0049-90 |
| Sitagliptin | Sitagliptin phosphate 50 mg/1 | Tablet, Film coatedOral | Golden State Medical Supply, Inc. | 84677-050 | 84677-0050-90 |
| Sitagliptin | Sitagliptin phosphate 100 mg/1 | Tablet, Film coatedOral | Golden State Medical Supply, Inc. | 84677-051 | 84677-0051-3084677-0051-90 |
| Sitagliptin | Sitagliptin 25 mg/1 | TabletOral | Zydus Pharmaceuticals (USA) Inc. | 70710-1899 | 70710-1899-0370710-1899-09 |
| Sitagliptin | Sitagliptin 50 mg/1 | TabletOral | Zydus Pharmaceuticals (USA) Inc. | 70710-1900 | 70710-1900-0370710-1900-09 |
Other NDCs under ANDA 202327
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 | Sitagliptin phosphate 25 mg/1 | Tablet, Film coatedOral | Teva Pharmaceuticals, Inc. | 0480-2607 |
| Sitagliptin | Sitagliptin phosphate 100 mg/1 | Tablet, Film coatedOral | Teva Pharmaceuticals, Inc. | 0480-2609 |