Prescription drug · NDA
Jardiance (empagliflozin) NDC 50090-6457
Empagliflozin 25 mg/1 · Tablet, Film coated · Oral · A-S Medication Solutions
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 50090-6457-0 | 50090645700 | 90 TABLET, FILM COATED in 1 BOTTLE (50090-6457-0)Marketed from May 1, 2023 |
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)
- Jardiance
- Generic name (nonproprietary)
- empagliflozin
- Active ingredients
- Empagliflozin — 25 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 204629
- Marketing start
- Listing expires
- Other FDA classes
- Sodium-Glucose Transporter 2 Inhibitors (Mechanism)
- Identifiers
- Product ID 50090-6457_e9b4a4d9-03dd-4591-9af5-2af49d56717dSPL ID e9b4a4d9-03dd-4591-9af5-2af49d56717dSPL set ID f2b41c77-0abb-40ee-8578-86a748d0e19eRxCUI 1545666, 1545668UNII HDC1R2M35U
- 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
N450090645700followed by a unit qualifier and the quantityPackage 50090-6457-00. 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)
JARDIANCE is indicated: to reduce the risk of cardiovascular death and hospitalization for heart failure in adults with heart failure. to reduce the risk of cardiovascular death in adults with type 2 diabetes mellitus and established cardiovascular disease. as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. JARDIANCE is a sodium-glucose co-transporter 2 (SGLT2) inhibitor indicated: To reduce the risk of cardiovascular death and hospitalization for heart failure in adults with heart failure. ( 1 ) To reduce the risk of cardiovascular death in adults with type 2 diabetes mellitus and established cardiovascular disease. ( 1 ) As an adjunct to…
Excerpt only. Read the full label for complete information.
Other NDCs under NDA 204629
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 |
|---|---|---|---|---|
| Jardianceempagliflozin | Empagliflozin 10 mg/1 | Tablet, Film coatedOral | A-S Medication Solutions | 50090-4492 |
| Jardianceempagliflozin | Empagliflozin 10 mg/1 | Tablet, Film coatedOral | A-S Medication Solutions | 50090-6452 |
| Jardianceempagliflozin | Empagliflozin 25 mg/1 | Tablet, Film coatedOral | Aphena Pharma Solutions - Tennessee, LLC | 71610-177 |
| Jardianceempagliflozin | Empagliflozin 10 mg/1 | Tablet, Film coatedOral | Cardinal Health 107, LLC | 55154-0411 |
| Jardianceempagliflozin | Empagliflozin 25 mg/1 | Tablet, Film coatedOral | Cardinal Health 107, LLC | 55154-0412 |
| Jardianceempagliflozin | Empagliflozin 10 mg/1 | Tablet, Film coatedOral | Aphena Pharma Solutions - Tennessee, LLC | 71610-900 |
| Jardianceempagliflozin | Empagliflozin 25 mg/1 | Tablet, Film coatedOral | Redpharm Drug | 67296-2324 |
| Jardianceempagliflozin | Empagliflozin 10 mg/1 | Tablet, Film coatedOral | Boehringer Ingelheim Pharmaceuticals, Inc. | 0597-0152 |
| Jardianceempagliflozin | Empagliflozin 25 mg/1 | Tablet, Film coatedOral | Boehringer Ingelheim Pharmaceuticals, Inc. | 0597-0153 |
| Jardianceempagliflozin | Empagliflozin 25 mg/1 | Tablet, Film coatedOral | A-S Medication Solutions | 50090-4384 |