Prescription drug · ANDA
Sitagliptin NDC 60505-3645
Sitagliptin phosphate 100 mg/1 · Tablet, Film coated · Oral · Apotex Corp.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 60505-3645-3 | 6050536450360505364503 | 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (60505-3645-3)Marketed from May 28, 2026 | |
| 60505-3645-9 | 6050536450960505364509 | 90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (60505-3645-9)Marketed from May 28, 2026 |
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
- Generic name (nonproprietary)
- sitagliptin
- Active ingredients
- Sitagliptin phosphate — 100 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- Apotex Corp.NDC labeler code 60505
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 202425
- Marketing start
- Listing expires
- Other FDA classes
- Dipeptidyl Peptidase 4 Inhibitors (Mechanism)
- Identifiers
- Product ID 60505-3645_70a9a9c7-ce7d-fdee-0b71-3db55d04f032SPL ID 70a9a9c7-ce7d-fdee-0b71-3db55d04f032
- 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
N460505364503followed by a unit qualifier and the quantityPackage 60505-3645-03. 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
The FDA listing for this product does not reference a label (SPL) set.
About NDC 60505-3645
- What is NDC 60505-3645?
- 60505-3645 is the product NDC for Sitagliptin, Sitagliptin phosphate 100 mg/1 tablet, film coated, listed with the FDA by Apotex Corp.. 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?
- Apotex Corp., NDC labeler code 60505. 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 50 mg/1 | Tablet, Film coatedOral | Teva Pharmaceuticals, Inc. | 0480-2608 | 00480-2608-5600480-2608-98 |
| 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 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 202425
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 | Apotex Corp. | 60505-3643 |
| Sitagliptin | Sitagliptin phosphate 50 mg/1 | Tablet, Film coatedOral | Apotex Corp. | 60505-3644 |
| Sitagliptin | Sitagliptin phosphate 25 mg/1 | Tablet, Film coatedOral | Golden State Medical Supply, Inc. | 84677-049 |
| Sitagliptin | Sitagliptin phosphate 50 mg/1 | Tablet, Film coatedOral | Golden State Medical Supply, Inc. | 84677-050 |
| Sitagliptin | Sitagliptin phosphate 100 mg/1 | Tablet, Film coatedOral | Golden State Medical Supply, Inc. | 84677-051 |