Prescription drug · NDA
Kerendia (finerenone) NDC 50419-540
Finerenone 10 mg/1 · Tablet, Film coated · Oral · Bayer HealthCare Pharmaceuticals Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 50419-540-01 | 50419054001 | 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (50419-540-01)Marketed from Jul 9, 2021 | |
| 50419-540-02 | 50419054002 | 90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (50419-540-02)Marketed from Jul 9, 2021 | |
| 50419-540-06 | 50419054006 | 10 TABLET, FILM COATED in 1 BLISTER PACK (50419-540-06)Marketed from Aug 23, 2025 | |
| 50419-540-70 | 50419054070 | 7 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (50419-540-70)Marketed from Jul 9, 2021 |
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)
- Kerendia
- Generic name (nonproprietary)
- finerenone
- Active ingredients
- Finerenone — 10 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 215341
- Marketing start
- Listing expires
- Other FDA classes
- Mineralocorticoid Receptor Antagonists (Mechanism)
- Identifiers
- Product ID 50419-540_28aa9af2-2939-46e0-8c9c-af939e81b551SPL ID 28aa9af2-2939-46e0-8c9c-af939e81b551SPL set ID fc726765-5d5a-4d6e-b037-b847bda9fb7cRxCUI 2562816, 2562822, 2562824, 2562826, 2720069, 2720071UNII DE2O63YV8R
- Pharmacologic class
- Nonsteroidal Mineralocorticoid-Receptor Antagonist
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
N450419054001followed by a unit qualifier and the quantityPackage 50419-0540-01. 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)
Kerendia is indicated to reduce the risk of: sustained estimated glomerular filtration rate (eGFR) decline, end-stage kidney disease, cardiovascular death, non-fatal myocardial infarction, and hospitalization for heart failure in adult patients with chronic kidney disease (CKD) associated with type 2 diabetes (T2DM). cardiovascular death, hospitalization for heart failure, and urgent heart failure visits in adult patients with heart failure with left ventricular ejection fraction (LVEF) ≥ 40%. Kerendia is a non-steroidal mineralocorticoid receptor antagonist (nsMRA) indicated to reduce the risk of: sustained estimated glomerular filtration rate (eGFR) decline, end stage kidney disease, cardi…
Excerpt only. Read the full label for complete information.
Other NDCs under NDA 215341
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.