NDC 70518-1396

Aldactone

Spironolactone

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

Product ID70518-1396_752988e7-a1d4-3d43-e053-2991aa0a5ea7
NDC70518-1396
Product TypeHuman Prescription Drug
Proprietary NameAldactone
Generic NameSpironolactone
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2018-08-31
Marketing CategoryNDA / NDA
Application NumberNDA012151
Labeler NameREMEDYREPACK INC.
Substance NameSPIRONOLACTONE
Active Ingredient Strength25 mg/1
Pharm ClassesAldosterone Antagonist [EPC],Aldosterone Antagonists [MoA]
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 70518-1396-0

30 TABLET, FILM COATED in 1 BLISTER PACK (70518-1396-0)
Marketing Start Date2018-08-31
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 70518-1396-0 [70518139600]

Aldactone TABLET, FILM COATED
Marketing CategoryNDA
Application NumberNDA012151
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2018-08-31
Marketing End Date2020-05-20

Drug Details

Active Ingredients

IngredientStrength
SPIRONOLACTONE25 mg/1

OpenFDA Data

SPL SET ID:db1e617e-3245-46bb-a8c2-776451db7e19
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 313096
  • 200820

    • Pharmacological Class

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

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

    NDCBrand NameGeneric Name
    0025-1001Aldactonespironolactone
    0025-1031Aldactonespironolactone
    0025-1041Aldactonespironolactone
    70518-1396AldactoneAldactone
    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

    Trademark Results [Aldactone]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    ALDACTONE
    ALDACTONE
    76376168 2720832 Live/Registered
    PHARMACIA & UPJOHN COMPANY LLC
    2002-02-27
    ALDACTONE
    ALDACTONE
    72075208 0695542 Dead/Cancelled
    G. D. SEARLE & CO.
    1959-06-05
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