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NDC 50419-0540-02 Kerendia 10 mg/1 Details
Kerendia 10 mg/1
Kerendia is a ORAL TABLET, FILM COATED in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Bayer Healthcare Pharmaceuticals Inc.. The primary component is FINERENONE.
MedlinePlus Drug Summary
Finerenone is used to treat adults with chronic kidney disease (damage to the kidneys which may worsen over time and may cause the kidneys to stop working) due to type 2 diabetes. This treatment may reduce the risk of worsening kidney disease, needing to be hospitalized for heart failure, and life-threatening heart and blood vessel disease or a heart attack. Finerenone is in a class of medications called mineralocorticoid receptor (MR) antagonists. It works by blocking the activity of certain steroids made in the body that can damage the heart and kidneys.
Related Packages: 50419-0540-02Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Finerenone
Product Information
| NDC | 50419-0540 |
|---|---|
| Product ID | 50419-540_a02ada67-06d1-47f8-bdc9-8b8e692ff6b4 |
| Associated GPIs | 30354030000310 |
| GCN Sequence Number | 082499 |
| GCN Sequence Number Description | finerenone TABLET 10 MG ORAL |
| HIC3 | R1H |
| HIC3 Description | POTASSIUM SPARING DIURETICS |
| GCN | 49940 |
| HICL Sequence Number | 047487 |
| HICL Sequence Number Description | FINERENONE |
| Brand/Generic | Brand |
| Proprietary Name | Kerendia |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | finerenone |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | TABLET, FILM COATED |
| Route | ORAL |
| Active Ingredient Strength | 10 |
| Active Ingredient Units | mg/1 |
| Substance Name | FINERENONE |
| Labeler Name | Bayer Healthcare Pharmaceuticals Inc. |
| Pharmaceutical Class | Mineralocorticoid Receptor Antagonists [MoA], Nonsteroidal Mineralocorticoid-Receptor Antagonist [EPC] |
| DEA Schedule | n/a |
| Marketing Category | NDA |
| Application Number | NDA215341 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 50419-0540-02 (50419054002)
| NDC Package Code | 50419-540-02 |
|---|---|
| Billing NDC | 50419054002 |
| Package | 90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (50419-540-02) |
| Marketing Start Date | 2021-07-09 |
| NDC Exclude Flag | N |
| Pricing Information | |
| Price Per Unit | 21.0369 |
| Pricing Unit | EA |
| Effective Date | 2024-01-01 |
| NDC Description | KERENDIA 10 MG TABLET |
| Pharmacy Type Indicator | C/I |
| OTC | N |
| Explanation Code | 4 |
| Classification for Rate Setting | B |
| As of Date | 2024-02-21 |