NDC 16729-294

Eplerenone

Eplerenone

Eplerenone is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Accord Healthcare, Inc.. The primary component is Eplerenone.

Product ID16729-294_81d7a84b-29fe-36c8-e053-2a91aa0a549f
NDC16729-294
Product TypeHuman Prescription Drug
Proprietary NameEplerenone
Generic NameEplerenone
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2018-10-09
Marketing CategoryANDA / ANDA
Application NumberANDA206922
Labeler NameAccord Healthcare, Inc.
Substance NameEPLERENONE
Active Ingredient Strength50 mg/1
Pharm ClassesAldosterone Antagonist [EPC],Aldosterone Antagonists [MoA]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 16729-294-10

30 TABLET, FILM COATED in 1 BOTTLE (16729-294-10)
Marketing Start Date2018-10-09
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 16729-294-10 [16729029410]

Eplerenone TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA206922
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2018-10-09

NDC 16729-294-15 [16729029415]

Eplerenone TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA206922
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2018-10-09

Drug Details

Active Ingredients

IngredientStrength
EPLERENONE50 mg/1

OpenFDA Data

SPL SET ID:b0886e4e-5710-4053-9270-4d7de34068e7
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 351256
  • 351257
    • UPC Code
  • 0316729294102

    • Pharmacological Class

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

    Medicade Reported Pricing

    16729029415 EPLERENONE 50 MG TABLET

    Pricing Unit: EA | Drug Type:

    16729029410 EPLERENONE 50 MG TABLET

    Pricing Unit: EA | Drug Type:

    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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