NDC 0185-1047

Quinidine Sulfate

Quinidine Sulfate

Quinidine Sulfate is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Eon Labs, Inc.. The primary component is Quinidine Sulfate.

Product ID0185-1047_b39cc973-0fe2-4b68-85c3-a29a0c54bb76
NDC0185-1047
Product TypeHuman Prescription Drug
Proprietary NameQuinidine Sulfate
Generic NameQuinidine Sulfate
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date1983-09-26
Marketing CategoryANDA / ANDA
Application NumberANDA088072
Labeler NameEon Labs, Inc.
Substance NameQUINIDINE SULFATE
Active Ingredient Strength300 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 0185-1047-01

100 TABLET in 1 BOTTLE (0185-1047-01)
Marketing Start Date1983-09-26
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0185-1047-01 [00185104701]

Quinidine Sulfate TABLET
Marketing CategoryANDA
Application NumberANDA088072
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date1983-09-26

NDC 0185-1047-10 [00185104710]

Quinidine Sulfate TABLET
Marketing CategoryANDA
Application NumberANDA088072
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date1983-09-26
Marketing End Date2017-12-31

Drug Details

Active Ingredients

IngredientStrength
QUINIDINE SULFATE300 mg/1

OpenFDA Data

SPL SET ID:a10b6ded-4fe0-4059-bd77-c45acc3c876d
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 852913
  • 852877
  • 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 Sulfate" or generic name "Quinidine Sulfate"

    NDCBrand NameGeneric Name
    0185-1047Quinidine SulfateQuinidine Sulfate
    0185-4346Quinidine SulfateQuinidine Sulfate
    42806-512QUINIDINE SULFATEquinidine sulfate tablet
    42806-513QUINIDINE SULFATEquinidine sulfate tablet
    68151-1991Quinidine SulfateQuinidine Sulfate

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