NDC 68788-9124

Spironolactone

Spironolactone

Spironolactone is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Preferred Pharmaceuticals, Inc. The primary component is Spironolactone.

Product ID68788-9124_260b560d-94c7-42f7-bedd-5f42972f2b12
NDC68788-9124
Product TypeHuman Prescription Drug
Proprietary NameSpironolactone
Generic NameSpironolactone
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date1994-03-25
Marketing CategoryANDA / ANDA
Application NumberANDA040353
Labeler NamePreferred Pharmaceuticals, Inc
Substance NameSPIRONOLACTONE
Active Ingredient Strength25 mg/1
Pharm ClassesAldosterone Antagonist [EPC],Aldosterone Antagonists [MoA]
NDC Exclude FlagE
Listing Certified Through2017-12-31

Packaging

NDC 68788-9124-3

30 TABLET in 1 BLISTER PACK (68788-9124-3)
Marketing Start Date1994-03-25
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 68788-9124-3 [68788912403]

Spironolactone TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA040353
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date1994-03-25
Marketing End Date2019-11-15

NDC 68788-9124-9 [68788912409]

Spironolactone TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA040353
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date1994-03-25
Marketing End Date2019-11-15

NDC 68788-9124-6 [68788912406]

Spironolactone TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA040353
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date1994-03-25
Marketing End Date2019-11-15

Drug Details

Active Ingredients

IngredientStrength
SPIRONOLACTONE25 mg/1

OpenFDA Data

SPL SET ID:7a0bba98-8f39-4020-b2a5-c487278a057a
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 313096
  • Pharmacological Class

    • 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.