NDC 53489-141

Quinidine Gluconate

Quinidine Gluconate

Quinidine Gluconate is a Oral Tablet, Extended Release in the Human Prescription Drug category. It is labeled and distributed by Sun Pharmaceutical Industries, Inc.. The primary component is Quinidine Gluconate.

Product ID53489-141_47cec250-341a-4694-a232-93106833a75e
NDC53489-141
Product TypeHuman Prescription Drug
Proprietary NameQuinidine Gluconate
Generic NameQuinidine Gluconate
Dosage FormTablet, Extended Release
Route of AdministrationORAL
Marketing Start Date1987-02-10
Marketing CategoryANDA / ANDA
Application NumberANDA089338
Labeler NameSun Pharmaceutical Industries, Inc.
Substance NameQUINIDINE GLUCONATE
Active Ingredient Strength324 mg/1
Pharm ClassesAntiarrhythmic [EPC],Cytochrome P450 2D6 Inhibitor [EPC],Cytochrome P450 2D6 Inhibitors [MoA]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 53489-141-01

100 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (53489-141-01)
Marketing Start Date1987-02-10
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 53489-141-06 [53489014106]

Quinidine Gluconate TABLET, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA089338
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date1987-02-10

NDC 53489-141-01 [53489014101]

Quinidine Gluconate TABLET, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA089338
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date1987-02-10

NDC 53489-141-03 [53489014103]

Quinidine Gluconate TABLET, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA089338
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date1987-02-10

NDC 53489-141-07 [53489014107]

Quinidine Gluconate TABLET, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA089338
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date1987-02-10

NDC 53489-141-10 [53489014110]

Quinidine Gluconate TABLET, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA089338
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date1987-02-10

NDC 53489-141-90 [53489014190]

Quinidine Gluconate TABLET, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA089338
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date1987-02-10

NDC 53489-141-05 [53489014105]

Quinidine Gluconate TABLET, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA089338
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date1987-02-10

Drug Details

Active Ingredients

IngredientStrength
QUINIDINE GLUCONATE324 mg/1

OpenFDA Data

SPL SET ID:5023f053-fcc4-4c2c-aa59-9ec198ad185e
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 852920
    • UPC Code
  • 0353489141017

    • Pharmacological Class

    • Antiarrhythmic [EPC]
    • Cytochrome P450 2D6 Inhibitor [EPC]
    • Cytochrome P450 2D6 Inhibitors [MoA]
    • Antiarrhythmic [EPC]
    • Cytochrome P450 2D6 Inhibitor [EPC]
    • Cytochrome P450 2D6 Inhibitors [MoA]

    NDC Crossover Matching brand name "Quinidine Gluconate" or generic name "Quinidine Gluconate"

    NDCBrand NameGeneric Name
    0002-1407Quinidine GluconateQuinidine Gluconate
    51407-288Quinidine GluconateQuinidine Gluconate
    53489-141Quinidine GluconateQuinidine Gluconate
    54738-901Quinidine GluconateQuinidine Gluconate
    68151-2701Quinidine GluconateQuinidine Gluconate
    71930-016Quinidine gluconateQuinidine gluonate
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