NDC 71335-0966

Spironolactone

Spironolactone

Spironolactone is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Bryant Ranch Prepack. The primary component is Spironolactone.

Product ID71335-0966_31aeab13-8f71-49f1-b101-8b0abb21b0dc
NDC71335-0966
Product TypeHuman Prescription Drug
Proprietary NameSpironolactone
Generic NameSpironolactone
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2010-08-02
Marketing CategoryANDA / ANDA
Application NumberANDA091426
Labeler NameBryant Ranch Prepack
Substance NameSPIRONOLACTONE
Active Ingredient Strength100 mg/1
Pharm ClassesAldosterone Antagonist [EPC], Aldosterone Antagonists [MoA]
NDC Exclude FlagN
Listing Certified Through2023-12-31

Packaging

NDC 71335-0966-1

100 TABLET in 1 BOTTLE (71335-0966-1)
Marketing Start Date2021-12-28
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 71335-0966-3 [71335096603]

Spironolactone TABLET
Marketing CategoryANDA
Application NumberANDA091426
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2018-10-12

NDC 71335-0966-5 [71335096605]

Spironolactone TABLET
Marketing CategoryANDA
Application NumberANDA091426
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2018-10-12

NDC 71335-0966-4 [71335096604]

Spironolactone TABLET
Marketing CategoryANDA
Application NumberANDA091426
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2018-10-12

NDC 71335-0966-1 [71335096601]

Spironolactone TABLET
Marketing CategoryANDA
Application NumberANDA091426
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2018-10-12

NDC 71335-0966-2 [71335096602]

Spironolactone TABLET
Marketing CategoryANDA
Application NumberANDA091426
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2018-10-12

Drug Details

Active Ingredients

IngredientStrength
SPIRONOLACTONE100 mg/1

OpenFDA Data

SPL SET ID:31aeab13-8f71-49f1-b101-8b0abb21b0dc
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 198222

    • 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
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