NDC 0378-1030

Eplerenone

Eplerenone

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

Product ID0378-1030_c5bb2ccf-435b-4111-a2fc-da914844788c
NDC0378-1030
Product TypeHuman Prescription Drug
Proprietary NameEplerenone
Generic NameEplerenone
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2017-10-03
Marketing CategoryANDA / ANDA
Application NumberANDA203896
Labeler NameMylan Pharmaceuticals Inc.
Substance NameEPLERENONE
Active Ingredient Strength25 mg/1
Pharm ClassesAldosterone Antagonist [EPC],Aldosterone Antagonists [MoA]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 0378-1030-77

90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-1030-77)
Marketing Start Date2017-10-03
Marketing End Date2022-07-31
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0378-1030-93 [00378103093]

Eplerenone TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA203896
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2017-10-03

NDC 0378-1030-77 [00378103077]

Eplerenone TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA203896
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2017-10-03

Drug Details

Active Ingredients

IngredientStrength
EPLERENONE25 mg/1

OpenFDA Data

SPL SET ID:a3f4afdc-0620-4899-ab4f-168fbfa446a8
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 351256
  • 351257
  • UPC Code
  • 0303781030939
  • Pharmacological Class

    • 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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