NDC 0378-0243

Spironolactone

Spironolactone

Spironolactone 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 Spironolactone.

Product ID0378-0243_0149c25d-6194-47be-8410-df7ae443b72d
NDC0378-0243
Product TypeHuman Prescription Drug
Proprietary NameSpironolactone
Generic NameSpironolactone
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2002-01-22
Marketing CategoryANDA / ANDA
Application NumberANDA040424
Labeler NameMylan Pharmaceuticals Inc.
Substance NameSPIRONOLACTONE
Active Ingredient Strength50 mg/1
Pharm ClassesAldosterone Antagonist [EPC],Aldosterone Antagonists [MoA]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 0378-0243-01

100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-0243-01)
Marketing Start Date2002-01-22
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0378-0243-93 [00378024393]

Spironolactone TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA040424
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2002-01-22
Marketing End Date2014-03-31

NDC 0378-0243-01 [00378024301]

Spironolactone TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA040424
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2002-01-22

NDC 0378-0243-05 [00378024305]

Spironolactone TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA040424
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2002-01-22

Drug Details

Active Ingredients

IngredientStrength
SPIRONOLACTONE50 mg/1

OpenFDA Data

SPL SET ID:beaf74db-4159-3b59-ef99-575c3ac99aa1
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 198222
  • 198223
  • 313096

    • Pharmacological Class

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

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

    NDCBrand NameGeneric Name
    0228-2672SpironolactoneSpironolactone
    0228-2673SpironolactoneSpironolactone
    0228-2803SpironolactoneSpironolactone
    0378-0243Spironolactonespironolactone
    0378-0437Spironolactonespironolactone
    0378-2146Spironolactonespironolactone
    0603-5763Spironolactonespironolactone
    0603-5764Spironolactonespironolactone
    0603-5765Spironolactonespironolactone
    0615-1535Spironolactonespironolactone
    0615-5592Spironolactonespironolactone
    0615-6591Spironolactonespironolactone
    0615-8031Spironolactonespironolactone
    0615-8178Spironolactonespironolactone
    0615-8221Spironolactonespironolactone
    0781-1599SpironolactoneSpironolactone
    68071-1992SpironolactoneSpironolactone
    68071-3112SpironolactoneSpironolactone
    68071-3375SpironolactoneSpironolactone
    68071-4073SpironolactoneSpironolactone
    68071-4374SpironolactoneSpironolactone
    68084-207SpironolactoneSpironolactone
    68084-208SpironolactoneSpironolactone
    68084-206SpironolactoneSpironolactone
    68151-2776SpironolactoneSpironolactone
    68382-661spironolactonespironolactone
    68382-662spironolactonespironolactone
    68382-660spironolactonespironolactone
    68788-7051SpironolactoneSpironolactone
    68788-6332SpironolactoneSpironolactone
    68788-6895SpironolactoneSpironolactone
    68788-6900SpironolactoneSpironolactone
    68788-9227SpironolactoneSpironolactone
    68788-7019SpironolactoneSpironolactone
    68788-7258SpironolactoneSpironolactone
    68788-7297SpironolactoneSpironolactone
    68788-9124SpironolactoneSpironolactone
    68788-9729SpironolactoneSpironolactone
    70518-0455SpironolactoneSpironolactone
    70518-0563SpironolactoneSpironolactone
    70518-0603SpironolactoneSpironolactone
    70518-0630SpironolactoneSpironolactone
    70518-1334SpironolactoneSpironolactone
    70518-0665SpironolactoneSpironolactone
    70518-1314SpironolactoneSpironolactone
    70518-1746SpironolactoneSpironolactone
    70518-1742SpironolactoneSpironolactone
    70771-1029spironolactonespironolactone
    70771-1028spironolactonespironolactone
    70771-1027spironolactonespironolactone
    © 2024 FDA.report
    This site is not affiliated with or endorsed by the FDA.