Prescription drug · ANDA
Dapagliflozin NDC 50090-7971
Dapagliflozin 5 mg/1 · Tablet, Film coated · Oral · A-S Medication Solutions
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 50090-7971-0 | 50090797100 | 30 TABLET, FILM COATED in 1 BOTTLE (50090-7971-0)Marketed from May 14, 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)
- Dapagliflozin
- Generic name (nonproprietary)
- dapagliflozin
- Active ingredients
- Dapagliflozin — 5 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- A-S Medication Solutions
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 211468
- Marketing start
- Listing expires
- Other FDA classes
- Sodium-Glucose Transporter 2 Inhibitors (Mechanism)
- Identifiers
- Product ID 50090-7971_a927d507-82ba-4f9b-bb5a-6ee0f6cba923SPL ID a927d507-82ba-4f9b-bb5a-6ee0f6cba923SPL set ID c4264ff6-5199-49e9-91d3-3ad67b42f88dRxCUI 1488574UNII 1ULL0QJ8UC
- 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
N450090797100followed by a unit qualifier and the quantityPackage 50090-7971-00. 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)
Dapagliflozin tablets are 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 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 t…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 211468
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 10 mg/1 | Tablet, Film coatedOral | A-S Medication Solutions | 50090-7972 |
| Dapagliflozin | Dapagliflozin 10 mg/1 | Tablet, Film coatedOral | Aurobindo Pharma Limited | 59651-160 |
| Dapagliflozin | Dapagliflozin 5 mg/1 | Tablet, Film coatedOral | Aurobindo Pharma Limited | 59651-159 |