Prescription drug · ANDA
Sitagliptin and Metformin Hydrochloride NDC 60505-3659
Sitagliptin phosphate 50 mg/1; Metformin hydrochloride 1000 mg/1 · Tablet, Film coated · Oral · Apotex Corp.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 60505-3659-6 | 6050536590660505365906 | 60 TABLET, FILM COATED in 1 BOTTLE (60505-3659-6)Marketed from May 28, 2026 | |
| 60505-3659-7 | 6050536590760505365907 | 180 TABLET, FILM COATED in 1 BOTTLE (60505-3659-7)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 — 1000 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 202426
- Marketing start
- Listing expires
- Other FDA classes
- Biguanides (Chemical structure)Dipeptidyl Peptidase 4 Inhibitors (Mechanism)
- Identifiers
- Product ID 60505-3659_36ef9eed-221e-a76c-c2a3-80ab897bac8aSPL ID 36ef9eed-221e-a76c-c2a3-80ab897bac8a
- 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
N460505365906followed by a unit qualifier and the quantityPackage 60505-3659-06. 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
The FDA listing for this product does not reference a label (SPL) set.
About NDC 60505-3659
- What is NDC 60505-3659?
- 60505-3659 is the product NDC for Sitagliptin and Metformin Hydrochloride, Sitagliptin phosphate 50 mg/1; Metformin hydrochloride 1000 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 and Metformin Hydrochloride.
- What is the active ingredient?
- Sitagliptin phosphate, Metformin hydrochloride.
- 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 and Metformin Hydrochloride?
- 18 other product NDCs are listed under this name. See all Sitagliptin and Metformin Hydrochloride NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Sitagliptin and Metformin Hydrochloride 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 and Metformin hydrochloride | Sitagliptin phosphate 50 mg/1; Metformin hydrochloride 500 mg/1 | Tablet, Film coated, Extended releaseOral | Par Health USA, LLC | 10370-317 | 10370-0317-02 |
| Sitagliptin and Metformin hydrochloride | Sitagliptin phosphate 50 mg/1; Metformin hydrochloride 1000 mg/1 | Tablet, Film coated, Extended releaseOral | Par Health USA, LLC | 10370-318 | 10370-0318-02 |
| Sitagliptin and Metformin hydrochloride | Sitagliptin phosphate 100 mg/1; Metformin hydrochloride 1000 mg/1 | Tablet, Film coated, Extended releaseOral | Par Health USA, LLC | 10370-351 | 10370-0351-11 |
| Sitagliptin and Metformin Hydrochloride | Sitagliptin phosphate 50 mg/1; Metformin hydrochloride 500 mg/1 | Tablet, Film coatedOral | Apotex Corp. | 60505-3658 | 60505-3658-0660505-3658-07 |
| Sitagliptin and Metformin Hydrochloride | Sitagliptin phosphate 50 mg/1; Metformin hydrochloride 500 mg/1 | Tablet, Film coatedOral | Golden State Medical Supply, Inc. | 84677-052 | 84677-0052-1884677-0052-60 |
| Sitagliptin and Metformin Hydrochloride | Sitagliptin phosphate 50 mg/1; Metformin hydrochloride 1000 mg/1 | Tablet, Film coatedOral | Golden State Medical Supply, Inc. | 84677-053 | 84677-0053-1884677-0053-60 |
| Sitagliptin and Metformin Hydrochloride | Sitagliptin phosphate 50 mg/1; Metformin hydrochloride 500 mg/1 | Tablet, Film coatedOral | Sandoz Inc | 0781-5801 | 00781-5801-0500781-5801-6000781-5801-71 |
| Sitagliptin and Metformin Hydrochloride | Sitagliptin phosphate 50 mg/1; Metformin hydrochloride 1000 mg/1 | Tablet, Film coatedOral | Sandoz Inc | 0781-5802 | 00781-5802-6000781-5802-7100781-5802-73 |
| Sitagliptin and Metformin Hydrochloride | Sitagliptin 50 mg/1; Metformin hydrochloride 500 mg/1 | Tablet, Film coated, Extended releaseOral | Zydus Pharmaceuticals USA Inc. | 70710-2036 | 70710-2036-06 |
| Sitagliptin and Metformin Hydrochloride | Sitagliptin 50 mg/1; Metformin hydrochloride 1000 mg/1 | Tablet, Film coated, Extended releaseOral | Zydus Pharmaceuticals USA Inc. | 70710-2037 | 70710-2037-06 |
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 500 mg/1 | Tablet, Film coatedOral | Apotex Corp. | 60505-3658 |
| 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 |