NDC 68071-3375

Spironolactone

Spironolactone

Spironolactone is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Nucare Pharmaceuticals, I. The primary component is Spironolactone.

Product ID68071-3375_7cb4581a-b389-e088-e053-2a91aa0a4d35
NDC68071-3375
Product TypeHuman Prescription Drug
Proprietary NameSpironolactone
Generic NameSpironolactone
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2017-07-11
Marketing CategoryANDA / ANDA
Application NumberANDA203512
Labeler NameNuCare Pharmaceuticals, I
Substance NameSPIRONOLACTONE
Active Ingredient Strength25 mg/1
Pharm ClassesAldosterone Ant
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 68071-3375-6

60 TABLET, FILM COATED in 1 BOTTLE (68071-3375-6)
Marketing Start Date2017-07-11
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 68071-3375-9 [68071337509]

Spironolactone TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA203512
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2017-07-11

NDC 68071-3375-3 [68071337503]

Spironolactone TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA203512
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2017-07-11

NDC 68071-3375-8 [68071337508]

Spironolactone TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA203512
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2017-07-11

NDC 68071-3375-6 [68071337506]

Spironolactone TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA203512
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2017-07-11

NDC 68071-3375-1 [68071337501]

Spironolactone TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA203512
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2017-07-11

Drug Details

Active Ingredients

IngredientStrength
SPIRONOLACTONE25 mg/1

OpenFDA Data

SPL SET ID:540ee876-78fb-1792-e054-00144ff88e88
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 313096
    • UPC Code
  • 0368071337532

    • 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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