Prescription drug · ANDA
Sitagliptin NDC 84677-049
Sitagliptin phosphate 25 mg/1 · Tablet, Film coated · Oral · Golden State Medical Supply, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 84677-049-30 | 84677004930 | 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (84677-049-30)Marketed from Jun 1, 2026 | |
| 84677-049-90 | 84677004990 | 90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (84677-049-90)Marketed from Jun 1, 2026 |
How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 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 — 25 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- 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 84677-049_58e20de7-3df2-d310-e063-6394a90abae0SPL ID 58e20de7-3df2-d310-e063-6394a90abae0SPL set ID 58e23b30-451c-f451-e063-6394a90a35a7RxCUI 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
N484677004930followed by a unit qualifier and the quantityPackage 84677-0049-30. 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 has 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 [See Warnings and Precautions ( 5.1 )]. Sitagliptin tablets are 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 Use: Sita…
Excerpt only. Read the full label for complete information.
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 100 mg/1 | Tablet, Film coatedOral | Apotex Corp. | 60505-3645 |
| 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 |