Prescription drug · ANDA
Dapagliflozin NDC 71921-420
Dapagliflozin 5 mg/1 · Tablet · Oral · Florida Pharmaceutical Products, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 71921-420-09 | 71921042009 | 90 TABLET in 1 BOTTLE (71921-420-09)Marketed from Apr 6, 2026 | |
| 71921-420-33 | 71921042033 | 30 TABLET in 1 BOTTLE (71921-420-33)Marketed from Apr 6, 2026 | |
| 71921-420-50 | 71921042050 | 500 TABLET in 1 BOTTLE (71921-420-50)Marketed from Apr 6, 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 — 5 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 211156
- Marketing start
- Listing expires
- Other FDA classes
- Sodium-Glucose Transporter 2 Inhibitors (Mechanism)
- Identifiers
- Product ID 71921-420_556192c0-e928-2fe6-e063-6394a90a9312SPL ID 556192c0-e928-2fe6-e063-6394a90a9312SPL set ID 20a83ea2-6ad8-4bbb-b516-73c0a9e37399RxCUI 1488569, 1488574UNII 1ULL0QJ8UCUPC 0371921420339, 0371921421091, 0371921421503, 0371921420506, 0371921421336
- 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
N471921042009followed by a unit qualifier and the quantityPackage 71921-0420-09. 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 tablets are indicated: To reduce the risk of hospitalization for heart failure in adults with type 2 diabetes mellitus and either established CV disease or multiple CV risk factors. As an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Limitations of Use Dapagliflozin tablets are not recommended for use to improve glycemic control in patients with type 1 diabetes mellitus [see Warnings and Precautions (5.1) ]. Dapagliflozin tablets are 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 tablets are likely to be ineffective in this…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 211156
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 | ANI Pharmaceuticals, Inc. | 70954-856 |
| Dapagliflozin | Dapagliflozin 10 mg/1 | Tablet, Film coatedOral | ANI Pharmaceuticals, Inc. | 70954-857 |
| Dapagliflozin | Dapagliflozin 10 mg/1 | TabletOral | Florida Pharmaceutical Products, LLC | 71921-421 |