NDC 0832-0480

Eplerenone

Eplerenone

Eplerenone is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Upsher-smith Laboratories, Llc. The primary component is Eplerenone.

Product ID0832-0480_3e83bc5f-8d57-4af9-b7a0-58d11cb412de
NDC0832-0480
Product TypeHuman Prescription Drug
Proprietary NameEplerenone
Generic NameEplerenone
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2015-03-16
Marketing End Date2021-10-31
Marketing CategoryANDA / ANDA
Application NumberANDA078510
Labeler NameUpsher-Smith Laboratories, LLC
Substance NameEPLERENONE
Active Ingredient Strength25 mg/1
Pharm ClassesAldosterone Antagonist [EPC],Aldosterone Antagonists [MoA]
NDC Exclude FlagN

Packaging

NDC 0832-0480-30

30 TABLET in 1 BOTTLE (0832-0480-30)
Marketing Start Date2015-03-16
Marketing End Date2021-10-31
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0832-0480-30 [00832048030]

Eplerenone TABLET
Marketing CategoryANDA
Application NumberANDA078510
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2015-03-16

NDC 0832-0480-90 [00832048090]

Eplerenone TABLET
Marketing CategoryANDA
Application NumberANDA078510
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2015-03-16

Drug Details

Active Ingredients

IngredientStrength
EPLERENONE25 mg/1

OpenFDA Data

SPL SET ID:84babd0d-cb0e-4292-bf45-8883a5ab5500
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 351256
  • 351257
  • Pharmacological Class

    • Aldosterone Antagonist [EPC]
    • Aldosterone Antagonists [MoA]
    • Aldosterone Antagonist [EPC]
    • Aldosterone Antagonists [MoA]

    NDC Crossover Matching brand name "Eplerenone" or generic name "Eplerenone"

    NDCBrand NameGeneric Name
    0185-5368EplerenoneEplerenone
    0185-5369EplerenoneEplerenone
    0378-1030Eplerenoneeplerenone
    0378-1031Eplerenoneeplerenone
    0832-0480EplerenoneEplerenone
    0832-0481EplerenoneEplerenone
    16729-293EplerenoneEplerenone
    16729-294EplerenoneEplerenone
    42254-011EplerenoneEplerenone
    42291-454EplerenoneEplerenone
    42291-455EplerenoneEplerenone
    51991-877EPLERENONEEPLERENONE
    51991-878EPLERENONEEPLERENONE
    59762-1710Eplerenoneeplerenone
    68084-948EplerenoneEplerenone
    59762-1720EplerenoneEplerenone
    60505-2652EplerenoneEplerenone
    60505-2651EplerenoneEplerenone
    60687-451EPLERENONEEPLERENONE
    70436-098eplerenoneeplerenone
    70436-099eplerenoneeplerenone
    0025-1710Inspraeplerenone
    0025-1720Inspraeplerenone
    21695-797Inspraeplerenone

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