Prescription drug · ANDA
Sitagliptin NDC 60505-3643
Sitagliptin phosphate 25 mg/1 · Tablet, Film coated · Oral · Apotex Corp.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 60505-3643-3 | 60505364303 | 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (60505-3643-3)Marketed from May 28, 2026 | |
| 60505-3643-9 | 60505364309 | 90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (60505-3643-9)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 — 25 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- Apotex Corp.
- 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 60505-3643_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
N460505364303followed by a unit qualifier and the quantityPackage 60505-3643-03. 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.
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 50 mg/1 | Tablet, Film coatedOral | Apotex Corp. | 60505-3644 |
| Sitagliptin | Sitagliptin phosphate 100 mg/1 | Tablet, Film coatedOral | Apotex Corp. | 60505-3645 |
| 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 |