Kerendia
- Product NDC
- 50419-540
- 11-digit product format
- 504190540
- Labeler code
- 50419
- Product ID
- 50419-540_28aa9af2-2939-46e0-8c9c-af939e81b551
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- finerenone
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Bayer HealthCare Pharmaceuticals Inc.
- Application
- NDA215341
- Marketing category
- NDA
- Marketing start
- 2021-07-09
- Substance
- FINERENONE
- Active strength
- 10 mg/1
- Pharmacologic classes
- Mineralocorticoid Receptor Antagonists [MoA], Nonsteroidal Mineralocorticoid-Receptor Antagonist [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Kerendia
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| FINERENONE | 10 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | DE2O63YV8R |
| Rxcui | 2562816, 2562822, 2562824, 2562826, 2720069, 2720071 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 50419-540-01 | Kerendia | 30 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 30 | | 13 |
| 50419-540-02 | Kerendia | 90 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 90 | | 13 |
| 50419-540-06 | Kerendia | 10 in 1 BLISTER PACK | TABLET, FILM COATED | 10 | | 13 |
| 50419-540-70 | Kerendia | 7 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 7 | | 13 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 50419-540 | KERENDIA (FINERENONE) TABLET, FILM COATED [BAYER HEALTHCARE PHARMACEUTICALS INC.] | 7 | Current NDC, Legacy NDC, 4 package rows | 20240716_fc726765-5d5a-4d6e-b037-b847bda9fb7c.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 50419-540-01 | 50419054001 | 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (50419-540-01) | 2021-07-09 | 0000-00-00 | No | No | Current |
| 50419-540-02 | 50419054002 | 90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (50419-540-02) | 2021-07-09 | 0000-00-00 | No | No | Current |
| 50419-540-06 | 50419054006 | 10 TABLET, FILM COATED in 1 BLISTER PACK (50419-540-06) | 2025-08-23 | | No | No | Current |
| 50419-540-70 | 50419054070 | 7 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (50419-540-70) | 2021-07-09 | 0000-00-00 | No | No | Current |