NDC 53489-328

SPIRONOLACTONE

Spironolactone

SPIRONOLACTONE is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Sun Pharmaceutical Industries, Inc.. The primary component is Spironolactone.

Product ID53489-328_238e1b9f-7ff3-436e-bdc8-9a7453a1ff13
NDC53489-328
Product TypeHuman Prescription Drug
Proprietary NameSPIRONOLACTONE
Generic NameSpironolactone
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date1986-07-23
Marketing CategoryANDA / ANDA
Application NumberANDA089424
Labeler NameSun Pharmaceutical Industries, Inc.
Substance NameSPIRONOLACTONE
Active Ingredient Strength50 mg/1
Pharm ClassesAldosterone Antagonist [EPC],Aldosterone Antagonists [MoA]
NDC Exclude FlagN
Listing Certified Through2021-12-31

Packaging

NDC 53489-328-01

100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (53489-328-01)
Marketing Start Date1986-07-23
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 53489-328-02 [53489032802]

SPIRONOLACTONE TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA089424
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date1986-07-23

NDC 53489-328-03 [53489032803]

SPIRONOLACTONE TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA089424
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date1986-07-23

NDC 53489-328-06 [53489032806]

SPIRONOLACTONE TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA089424
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date1986-07-23

NDC 53489-328-01 [53489032801]

SPIRONOLACTONE TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA089424
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date1986-07-23

NDC 53489-328-07 [53489032807]

SPIRONOLACTONE TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA089424
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date1986-07-23

NDC 53489-328-05 [53489032805]

SPIRONOLACTONE TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA089424
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date1986-07-23

NDC 53489-328-10 [53489032810]

SPIRONOLACTONE TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA089424
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date1986-07-23

Drug Details

Active Ingredients

IngredientStrength
SPIRONOLACTONE50 mg/1

OpenFDA Data

SPL SET ID:c23b6b9b-aec3-48a8-a518-76e4097f6479
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 198222
  • 198223
  • 313096
    • UPC Code
  • 0353489143011
  • 0353489329019

    • Pharmacological Class

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

    Medicade Reported Pricing

    53489032807 SPIRONOLACTONE 50 MG TABLET

    Pricing Unit: EA | Drug Type:

    53489032806 SPIRONOLACTONE 50 MG TABLET

    Pricing Unit: EA | Drug Type:

    53489032805 SPIRONOLACTONE 50 MG TABLET

    Pricing Unit: EA | Drug Type:

    53489032801 SPIRONOLACTONE 50 MG TABLET

    Pricing Unit: EA | Drug Type:

    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
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