Prescription drug · NDA
Farxiga (dapagliflozin) NDC 50090-3482
Dapagliflozin propanediol 5 mg/1 · Tablet, Film coated · Oral · A-S Medication Solutions
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 50090-3482-0 | 50090348200 | 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (50090-3482-0)Marketed from Jun 15, 2018 |
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)
- Farxiga
- Generic name (nonproprietary)
- dapagliflozin
- Active ingredients
- Dapagliflozin propanediol — 5 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- A-S Medication Solutions
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 202293
- Marketing start
- Listing expires
- Other FDA classes
- Sodium-Glucose Transporter 2 Inhibitors (Mechanism)
- Identifiers
- Product ID 50090-3482_03e8f7a3-552c-4b8e-94df-8668108baeeaSPL ID 03e8f7a3-552c-4b8e-94df-8668108baeeaSPL set ID 01f90c94-71cb-4a1f-81ff-8004b850529bRxCUI 1486977, 1486981, 1488569, 1488574UNII 887K2391VH
- 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
N450090348200followed by a unit qualifier and the quantityPackage 50090-3482-00. 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)
FARXIGA (dapagliflozin) is indicated: • To reduce the risk of sustained eGFR decline, end-stage kidney disease, cardiovascular (CV) death, and hospitalization for heart failure in adults with chronic kidney disease at risk of progression. • To reduce the risk of CV death, hospitalization for heart failure, and urgent heart failure visit in adults with heart failure. • 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 and pediatric patients aged 10 years and older with type 2 diabetes mellitus. Limitations of Us…
Excerpt only. Read the full label for complete information.
Other NDCs under NDA 202293
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 propanediol 10 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 63629-3253 |
| Dapagliflozin | Dapagliflozin propanediol 10 mg/1 | Tablet, Film coatedOral | A-S Medication Solutions | 50090-7057 |
| Dapagliflozin | Dapagliflozin propanediol 5 mg/1 | Tablet, Film coatedOral | A-S Medication Solutions | 50090-7056 |
| Farxigadapagliflozin | Dapagliflozin propanediol 5 mg/1 | Tablet, Film coatedOral | AstraZeneca Pharmaceuticals LP | 0310-6205 |
| Farxigadapagliflozin | Dapagliflozin propanediol 10 mg/1 | Tablet, Film coatedOral | AstraZeneca Pharmaceuticals LP | 0310-6210 |
| Farxigadapagliflozin | Dapagliflozin propanediol 10 mg/1 | Tablet, Film coatedOral | A-S Medication Solutions | 50090-3481 |
| Farxigadapagliflozin | Dapagliflozin propanediol 5 mg/1 | Tablet, Film coatedOral | REMEDYREPACK INC. | 70518-4614 |
| Dapagliflozin | Dapagliflozin propanediol 5 mg/1 | Tablet, Film coatedOral | Prasco Laboratories | 66993-456 |
| Dapagliflozin | Dapagliflozin propanediol 10 mg/1 | Tablet, Film coatedOral | Prasco Laboratories | 66993-457 |