NDC 70771-1028

spironolactone

Spironolactone

spironolactone is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Cadila Healthcare Limited. The primary component is Spironolactone.

Product ID70771-1028_1335c13b-c90f-401c-b30b-582bf687fc74
NDC70771-1028
Product TypeHuman Prescription Drug
Proprietary Namespironolactone
Generic NameSpironolactone
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2018-08-15
Marketing CategoryANDA / ANDA
Application NumberANDA205936
Labeler NameCadila Healthcare Limited
Substance NameSPIRONOLACTONE
Active Ingredient Strength50 mg/1
Pharm ClassesAldosterone Antagonist [EPC],Aldosterone Antagonists [MoA]
NDC Exclude FlagN
Listing Certified Through2022-12-31

Packaging

NDC 70771-1028-0

1000 TABLET in 1 BOTTLE (70771-1028-0)
Marketing Start Date2018-08-15
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 70771-1028-4 [70771102804]

spironolactone TABLET
Marketing CategoryANDA
Application NumberANDA205936
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2018-08-15

NDC 70771-1028-5 [70771102805]

spironolactone TABLET
Marketing CategoryANDA
Application NumberANDA205936
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2018-08-15

NDC 70771-1028-0 [70771102800]

spironolactone TABLET
Marketing CategoryANDA
Application NumberANDA205936
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2018-08-15

NDC 70771-1028-3 [70771102803]

spironolactone TABLET
Marketing CategoryANDA
Application NumberANDA205936
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2018-08-15

NDC 70771-1028-1 [70771102801]

spironolactone TABLET
Marketing CategoryANDA
Application NumberANDA205936
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2018-08-15

NDC 70771-1028-9 [70771102809]

spironolactone TABLET
Marketing CategoryANDA
Application NumberANDA205936
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2018-08-15

Drug Details

Active Ingredients

IngredientStrength
SPIRONOLACTONE50 mg/1

OpenFDA Data

SPL SET ID:963af399-feb7-49d2-a59c-c19edad9c682
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 198222
  • 198223
  • 313096
    • UPC Code
  • 0370771102716
  • 0370771102914

    • 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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