NDC 54348-340

Spironolactone

Spironolactone

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

Product ID54348-340_8f76596c-8f69-7660-e053-2995a90aff34
NDC54348-340
Product TypeHuman Prescription Drug
Proprietary NameSpironolactone
Generic NameSpironolactone
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2019-07-09
Marketing CategoryANDA / ANDA
Application NumberANDA091426
Labeler NamePharmPak, 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 54348-340-90

1 BOTTLE in 1 BOX (54348-340-90) > 90 TABLET in 1 BOTTLE
Marketing Start Date2019-07-09
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 54348-340-90 [54348034090]

Spironolactone TABLET
Marketing CategoryANDA
Application NumberANDA091426
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-07-09

Drug Details

Active Ingredients

IngredientStrength
SPIRONOLACTONE50 mg/1

OpenFDA Data

SPL SET ID:c450e66a-0f05-445e-b1df-df2b17a2f064
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 198223

    • 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.