NDC 0378-0403

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 Mylan Pharmaceuticals Inc.. The primary component is Spironolactone; Hydrochlorothiazide.

Product ID0378-0403_17e0af93-9e24-4796-853f-e5a5892c6c85
NDC0378-0403
Product TypeHuman Prescription Drug
Proprietary NameSpironolactone and Hydrochlorothiazide
Generic NameSpironolactone And Hydrochlorothiazide
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date1979-08-03
Marketing End Date2030-01-01
Marketing CategoryANDA / ANDA
Application NumberANDA086513
Labeler NameMylan Pharmaceuticals 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

Packaging

NDC 0378-0403-01

100 TABLET in 1 BOTTLE, PLASTIC (0378-0403-01)
Marketing Start Date1979-08-03
Marketing End Date2030-01-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0378-0403-01 [00378040301]

Spironolactone and Hydrochlorothiazide TABLET
Marketing CategoryANDA
Application NumberANDA086513
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date1979-08-03

NDC 0378-0403-05 [00378040305]

Spironolactone and Hydrochlorothiazide TABLET
Marketing CategoryANDA
Application NumberANDA086513
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date1979-08-03

Drug Details

Active Ingredients

IngredientStrength
SPIRONOLACTONE25 mg/1

OpenFDA Data

SPL SET ID:0c8c973f-13a2-4883-8316-4006398e2931
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 198224
  • Pharmacological Class

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

    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

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