Inspra

Product NDC
58151-142
11-digit product format
581510142
Labeler code
58151
Product ID
58151-142_77698b88-befe-44ae-b67d-03c56dcbbdf6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
eplerenone
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Viatris Specialty LLC
Application
NDA021437
Marketing category
NDA
Marketing start
2024-04-19
Marketing end
2027-01-31
Substance
EPLERENONE
Active strength
25 mg/1
Pharmacologic classes
Aldosterone Antagonist [EPC], Aldosterone Antagonists [MoA]
NDC exclude flag
No
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Inspra

Active Ingredients#

Ingredient, Strength table
IngredientStrength
EPLERENONE25 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii6995V82D0B
Rxcui351256, 351257, 402105, 402106

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6c046e2c-42d6-3179-f149-f207119f6ad5Product name620240530
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58151-142-93Inspra30 in 1 BOTTLETABLET, FILM COATED306

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
58151-142-93EA - Each58151-1424a1aea41-b59f-4f69-bb51-7d2b05c5e10312024-05-16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58151-142INSPRA (EPLERENONE) TABLET, FILM COATED [VIATRIS SPECIALTY LLC]2Current NDC, 1 package rows20240919_1a52bedc-8e2c-4116-a296-a87770676b4a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
351256eplerenone 25 MG Oral TabletPSN1a52bedc-8e2c-4116-a296-a87770676b4a6
351257eplerenone 50 MG Oral TabletPSN1a52bedc-8e2c-4116-a296-a87770676b4a6
402106INSPRA 25 MG Oral TabletPSN1a52bedc-8e2c-4116-a296-a87770676b4a6
402105INSPRA 50 MG Oral TabletPSN1a52bedc-8e2c-4116-a296-a87770676b4a6
402106eplerenone 25 MG Oral Tablet [Inspra]SBD1a52bedc-8e2c-4116-a296-a87770676b4a6
402105eplerenone 50 MG Oral Tablet [Inspra]SBD1a52bedc-8e2c-4116-a296-a87770676b4a6
351256eplerenone 25 MG Oral TabletSCD1a52bedc-8e2c-4116-a296-a87770676b4a6
351257eplerenone 50 MG Oral TabletSCD1a52bedc-8e2c-4116-a296-a87770676b4a6
402106Inspra 25 MG Oral TabletSY1a52bedc-8e2c-4116-a296-a87770676b4a6
402105Inspra 50 MG Oral TabletSY1a52bedc-8e2c-4116-a296-a87770676b4a6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
58151-142-935815101429330 TABLET, FILM COATED in 1 BOTTLE (58151-142-93) 2024-04-192027-01-31NoNoHistorical