Prescription drug · ANDA
Dapagliflozin NDC 72205-433
Dapagliflozin 10 mg/1 · Tablet, Film coated · Oral · Novadoz Pharmaceuticals LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 72205-433-01 | 72205043301 | 30 TABLET, FILM COATED in 1 BOTTLE (72205-433-01)Marketed from Apr 7, 2026 | |
| 72205-433-02 | 72205043302 | 500 TABLET, FILM COATED in 1 BOTTLE (72205-433-02)Marketed from Apr 7, 2026 | |
| 72205-433-03 | 72205043303 | 90 TABLET, FILM COATED in 1 BOTTLE (72205-433-03)Marketed from Apr 7, 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
- Generic name (nonproprietary)
- dapagliflozin
- Active ingredients
- Dapagliflozin — 10 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 211478
- Marketing start
- Listing expires
- Other FDA classes
- Sodium-Glucose Transporter 2 Inhibitors (Mechanism)
- Identifiers
- Product ID 72205-433_7f52c2d6-0201-4a51-bfbf-b58460fd7eddSPL ID 7f52c2d6-0201-4a51-bfbf-b58460fd7eddSPL set ID 107b4d25-4764-42b7-80e3-9aaff20865edRxCUI 1488569, 1488574UNII 1ULL0QJ8UCUPC 0372205432024, 0372205432017, 0372205432031, 0372205433014, 0372205433038, 0372205433021
- 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
N472205043301followed by a unit qualifier and the quantityPackage 72205-0433-01. 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 tablet is indicated: To reduce the risk of hospitalization for heart failure in adults with type 2 diabetes mellitus and either established cardiovascular disease or multiple cardiovascular risk factors. As an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Limitations of Use Dapagliflozin tablet is not recommended for use to improve glycemic control in patients with type 1 diabetes mellitus [see Warnings and Precautions (5.1) ] . Dapagliflozin tablet is not recommended for use to improve glycemic control in patients with type 2 diabetes mellitus with an eGFR less than 45 mL/min/1.73 m 2 . Dapagliflozin tablet is likely to be in…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 211478
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 |
|---|---|---|---|---|
| Dapagliflozin | Dapagliflozin 5 mg/1 | Tablet, Film coatedOral | AvKARE | 73190-072 |
| Dapagliflozin | Dapagliflozin 10 mg/1 | Tablet, Film coatedOral | AvKARE | 73190-073 |
| Dapagliflozin | Dapagliflozin 5 mg/1 | Tablet, Film coatedOral | Novadoz Pharmaceuticals LLC | 72205-432 |