Prescription drug · ANDA
Sitagliptin and Metformin Hydrochloride NDC 60505-3658
Sitagliptin phosphate 50 mg/1; Metformin hydrochloride 500 mg/1 · Tablet, Film coated · Oral · Apotex Corp.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 60505-3658-6 | 60505365806 | 60 TABLET, FILM COATED in 1 BOTTLE (60505-3658-6)Marketed from May 28, 2026 | |
| 60505-3658-7 | 60505365807 | 180 TABLET, FILM COATED in 1 BOTTLE (60505-3658-7)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 and Metformin Hydrochloride
- Generic name (nonproprietary)
- sitagliptin and metformin hydrochloride
- Active ingredients
- Sitagliptin phosphate — 50 mg/1Metformin hydrochloride — 500 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 202426
- Marketing start
- Listing expires
- Other FDA classes
- Biguanides (Chemical structure)Dipeptidyl Peptidase 4 Inhibitors (Mechanism)
- Identifiers
- Product ID 60505-3658_15cfffcf-3241-3e53-1f1e-ad300900662eSPL ID 15cfffcf-3241-3e53-1f1e-ad300900662eSPL set ID 950613e2-e959-6b57-e172-251ddc53c64cRxCUI 2709488, 2709491UNII TS63EW8X6F, 786Z46389EUPC 0360505365869, 0360505365968
- Pharmacologic class
- Biguanide; 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
N460505365806followed by a unit qualifier and the quantityPackage 60505-3658-06. 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 . This label includes a boxed warning.
Indications (excerpt from the label)
Sitagliptin and metformin hydrochloride 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 and metformin hydrochloride tablets should not be used in patients with type 1 diabetes mellitus. Sitagliptin and metformin hydrochloride 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 and metformin hydrochloride tablets [see Warnings and Precautions (5.2)]. Sitagliptin and metformin hydrochloride tablets is a combination of sitag…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 202426
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 and Metformin Hydrochloride | Sitagliptin phosphate 50 mg/1; Metformin hydrochloride 1000 mg/1 | Tablet, Film coatedOral | Apotex Corp. | 60505-3659 |
| Sitagliptin and Metformin Hydrochloride | Sitagliptin phosphate 50 mg/1; Metformin hydrochloride 500 mg/1 | Tablet, Film coatedOral | Golden State Medical Supply, Inc. | 84677-052 |
| Sitagliptin and Metformin Hydrochloride | Sitagliptin phosphate 50 mg/1; Metformin hydrochloride 1000 mg/1 | Tablet, Film coatedOral | Golden State Medical Supply, Inc. | 84677-053 |