Prescription drug · ANDA
Dapagliflozin And Saxagliptin NDC 72205-438
Dapagliflozin 10 mg/1; Saxagliptin hydrochloride dihydrate 5 mg/1 · Tablet, Film coated · Oral · Novadoz Pharmaceuticals LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 72205-438-01 | 72205043801 | 30 TABLET, FILM COATED in 1 BOTTLE (72205-438-01)Marketed from Apr 9, 2026 | |
| 72205-438-02 | 72205043802 | 90 TABLET, FILM COATED in 1 BOTTLE (72205-438-02)Marketed from Apr 9, 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)
- Dapagliflozin And Saxagliptin
- Generic name (nonproprietary)
- dapagliflozin and saxagliptin
- Active ingredients
- Dapagliflozin — 10 mg/1Saxagliptin hydrochloride dihydrate — 5 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- Novadoz Pharmaceuticals LLC
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 211533
- Marketing start
- Listing expires
- Other FDA classes
- Sodium-Glucose Transporter 2 Inhibitors (Mechanism)
- Identifiers
- Product ID 72205-438_1cfa51fd-8406-404c-b2a8-0fc1068675fbSPL ID 1cfa51fd-8406-404c-b2a8-0fc1068675fbSPL set ID 1cfa51fd-8406-404c-b2a8-0fc1068675fbRxCUI 1925498UNII 1ULL0QJ8UC, 4N19ON48ZNUPC 0372205438026, 0372205438019
- Pharmacologic class
- Sodium-Glucose Cotransporter 2 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
N472205043801followed by a unit qualifier and the quantityPackage 72205-0438-01. 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)
Dapagliflozin and saxagliptin tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Limitations of Use Dapagliflozin and saxagliptin tablets are not recommended for use to improve glycemic control in patients with type 1 diabetes mellitus [ see WARNINGS AND PRECAUTIONS (5.1) ]. Dapagliflozin and saxagliptin tablets is a combination of dapagliflozin, a sodium-glucose cotransporter 2 (SGLT2) inhibitor and saxagliptin 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: Not recommended for use to…
Excerpt only. Read the full label for complete information.