FDA.reportPublic FDA data

Kerendia

Product NDC
50419-542
11-digit product format
504190542
Labeler code
50419
Product ID
50419-542_28aa9af2-2939-46e0-8c9c-af939e81b551
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
finerenone
Dosage form
TABLET
Route
ORAL
Labeler
Bayer HealthCare Pharmaceuticals Inc.
Application
NDA215341
Marketing category
NDA
Marketing start
2021-07-09
Substance
FINERENONE
Active strength
40 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
IngredientStrength
FINERENONE40 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiDE2O63YV8R
Rxcui2562816, 2562822, 2562824, 2562826, 2720069, 2720071

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
fa46b598-c230-45e9-929b-261545cf6b50Product name120220125

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50419-542-01Kerendia30 in 1 BOTTLE, PLASTICTABLET3013
50419-542-02Kerendia90 in 1 BOTTLE, PLASTICTABLET9013
50419-542-06Kerendia10 in 1 BLISTER PACKTABLET1013
50419-542-70Kerendia7 in 1 BOTTLE, PLASTICTABLET713

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50419-542-01EA - Each50419-542f2ceddfc-2f95-423c-99db-0f5d989b6aae12025-08-11
50419-542-02EA - Each50419-54257c8d14c-4ca8-4eff-99d6-12903a2ec9b412025-08-11
50419-542-05EA - Each50419-5420d729f27-a81d-4068-bfe6-deabe23d7be112025-08-11
50419-542-06EA - Each50419-5425495cad8-b457-4516-9101-005288d1aa0412025-08-11

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2562816finerenone 10 MG Oral TabletPSNfc726765-5d5a-4d6e-b037-b847bda9fb7c13
2562824finerenone 20 MG Oral TabletPSNfc726765-5d5a-4d6e-b037-b847bda9fb7c13
2720069finerenone 40 MG Oral TabletPSNfc726765-5d5a-4d6e-b037-b847bda9fb7c13
2562822Kerendia 10 MG Oral TabletPSNfc726765-5d5a-4d6e-b037-b847bda9fb7c13
2562826Kerendia 20 MG Oral TabletPSNfc726765-5d5a-4d6e-b037-b847bda9fb7c13
2720071Kerendia 40 MG Oral TabletPSNfc726765-5d5a-4d6e-b037-b847bda9fb7c13
2562822finerenone 10 MG Oral Tablet [Kerendia]SBDfc726765-5d5a-4d6e-b037-b847bda9fb7c13
2562826finerenone 20 MG Oral Tablet [Kerendia]SBDfc726765-5d5a-4d6e-b037-b847bda9fb7c13
2720071finerenone 40 MG Oral Tablet [Kerendia]SBDfc726765-5d5a-4d6e-b037-b847bda9fb7c13
2562816finerenone 10 MG Oral TabletSCDfc726765-5d5a-4d6e-b037-b847bda9fb7c13
2562824finerenone 20 MG Oral TabletSCDfc726765-5d5a-4d6e-b037-b847bda9fb7c13
2720069finerenone 40 MG Oral TabletSCDfc726765-5d5a-4d6e-b037-b847bda9fb7c13
2562822Kerendia 10 MG Oral TabletSYfc726765-5d5a-4d6e-b037-b847bda9fb7c13
2562826Kerendia 20 MG Oral TabletSYfc726765-5d5a-4d6e-b037-b847bda9fb7c13
2720071Kerendia 40 MG Oral TabletSYfc726765-5d5a-4d6e-b037-b847bda9fb7c13

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
50419-542-015041905420130 TABLET in 1 BOTTLE, PLASTIC (50419-542-01) 30 tablet2025-07-11NoNoCurrent
50419-542-025041905420290 TABLET in 1 BOTTLE, PLASTIC (50419-542-02) 90 tablet2025-07-11NoNoCurrent
50419-542-055041905420510 BLISTER PACK in 1 CARTON (50419-542-05) / 10 TABLET in 1 BLISTER PACK10 blister pack13-JUL-25Current
50419-542-065041905420610 TABLET in 1 BLISTER PACK (50419-542-06) 10 tablet2025-07-11NoNoCurrent
50419-542-70504190542707 TABLET in 1 BOTTLE, PLASTIC (50419-542-70) 7 tablet2025-07-11NoNoCurrent