NDC 53489-144

Spironolactone and Hydrochlorothiazide

Spironolactone And Hydrochlorothiazide

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

Product ID53489-144_1d728eb7-c0a6-4706-9671-92c8099c815f
NDC53489-144
Product TypeHuman Prescription Drug
Proprietary NameSpironolactone and Hydrochlorothiazide
Generic NameSpironolactone And Hydrochlorothiazide
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date1987-07-02
Marketing CategoryANDA / ANDA
Application NumberANDA089534
Labeler NameSun Pharmaceutical Industries, Inc.
Substance NameSPIRONOLACTONE; HYDROCHLOROTHIAZIDE
Active Ingredient Strength25 mg/1; mg/1
Pharm ClassesAldosterone Antagonist [EPC],Aldosterone Antagonists [MoA],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [CS]
NDC Exclude FlagN
Listing Certified Through2021-12-31

Packaging

NDC 53489-144-01

100 TABLET in 1 BOTTLE, PLASTIC (53489-144-01)
Marketing Start Date1987-07-02
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 53489-144-01 [53489014401]

Spironolactone and Hydrochlorothiazide TABLET
Marketing CategoryANDA
Application NumberANDA089534
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date1987-07-02

NDC 53489-144-10 [53489014410]

Spironolactone and Hydrochlorothiazide TABLET
Marketing CategoryANDA
Application NumberANDA089534
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date1987-07-02

NDC 53489-144-05 [53489014405]

Spironolactone and Hydrochlorothiazide TABLET
Marketing CategoryANDA
Application NumberANDA089534
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date1987-07-02

Drug Details

Active Ingredients

IngredientStrength
SPIRONOLACTONE25 mg/1

OpenFDA Data

SPL SET ID:d7fa3c79-9f26-415b-8039-eb2acabcf66b
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 198224

    • Pharmacological Class

    • Aldosterone Antagonist [EPC]
    • Aldosterone Antagonists [MoA]
    • Increased Diuresis [PE]
    • Thiazide Diuretic [EPC]
    • Thiazides [CS]
    • Aldosterone Antagonist [EPC]
    • Aldosterone Antagonists [MoA]
    • Increased Diuresis [PE]
    • Thiazide Diuretic [EPC]
    • Thiazides [CS]

    Medicade Reported Pricing

    53489014410 SPIRONOLACTONE-HYDROCHLOROTHIAZIDE 25-25 TAB

    Pricing Unit: EA | Drug Type:

    53489014405 SPIRONOLACTONE-HYDROCHLOROTHIAZIDE 25-25 TAB

    Pricing Unit: EA | Drug Type:

    53489014401 SPIRONOLACTONE-HYDROCHLOROTHIAZIDE 25-25 TAB

    Pricing Unit: EA | Drug Type:

    NDC Crossover Matching brand name "Spironolactone and Hydrochlorothiazide" or generic name "Spironolactone And Hydrochlorothiazide"

    NDCBrand NameGeneric Name
    0378-0141Spironolactone and Hydrochlorothiazidespironolactone and hydrochlorothiazide
    0378-0403Spironolactone and Hydrochlorothiazidespironolactone and hydrochlorothiazide
    42292-017Spironolactone and Hydrochlorothiazidespironolactone and hydrochlorothiazide
    53489-144Spironolactone and HydrochlorothiazideSpironolactone and Hydrochlorothiazide
    59762-5014Spironolactone and Hydrochlorothiazidespironolactone and hydrochlorothiazide
    63629-1068Spironolactone and HydrochlorothiazideSpironolactone and Hydrochlorothiazide
    63629-1069Spironolactone and HydrochlorothiazideSpironolactone and Hydrochlorothiazide
    63629-1071Spironolactone and HydrochlorothiazideSpironolactone and Hydrochlorothiazide
    66993-188Spironolactone and Hydrochlorothiazidespironolactone and hydrochlorothiazide
    0025-1011ALDACTAZIDEspironolactone and hydrochlorothiazide
    0025-1021ALDACTAZIDEspironolactone and hydrochlorothiazide
    © 2024 FDA.report
    This site is not affiliated with or endorsed by the FDA.