NDC 65162-811

Quinine Sulfate

Quinine

Quinine Sulfate is a Oral Capsule in the Human Prescription Drug category. It is labeled and distributed by Amneal Pharmaceuticals Of New York, Llc. The primary component is Quinine Sulfate.

Product ID65162-811_08500ecb-d8ef-48f7-b409-8fca0af68edd
NDC65162-811
Product TypeHuman Prescription Drug
Proprietary NameQuinine Sulfate
Generic NameQuinine
Dosage FormCapsule
Route of AdministrationORAL
Marketing Start Date2016-07-29
Marketing CategoryANDA / ANDA
Application NumberANDA203729
Labeler NameAmneal Pharmaceuticals of New York, LLC
Substance NameQUININE SULFATE
Active Ingredient Strength324 mg/1
Pharm ClassesAntimalarial [EPC]
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 65162-811-03

30 CAPSULE in 1 BOTTLE (65162-811-03)
Marketing Start Date2016-07-29
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 65162-811-03 [65162081103]

Quinine Sulfate CAPSULE
Marketing CategoryANDA
Application NumberANDA203729
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2016-07-29

NDC 65162-811-09 [65162081109]

Quinine Sulfate CAPSULE
Marketing CategoryANDA
Application NumberANDA203729
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2016-07-29

NDC 65162-811-50 [65162081150]

Quinine Sulfate CAPSULE
Marketing CategoryANDA
Application NumberANDA203729
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2016-07-29

Drug Details

Active Ingredients

IngredientStrength
QUININE SULFATE324 mg/1

OpenFDA Data

SPL SET ID:f567d5c7-ea5d-49a7-a035-b47208135f73
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 997010
    • UPC Code
  • 0365162811094

    • Pharmacological Class

    • Antimalarial [EPC]

    NDC Crossover Matching brand name "Quinine Sulfate" or generic name "Quinine"

    NDCBrand NameGeneric Name
    0093-3002Quinine SulfateQuinine Sulfate
    50742-238QUININE SULFATEQUININE SULFATE
    53489-700Quinine SulfateQuinine Sulfate
    65162-811Quinine SulfateQuinine
    68084-947Quinine SulfateQuinine Sulfate
    68180-560QUININE SULFATEQUININE SULFATE
    68428-308Chininum purumQUININE
    71919-187Chininum purumQUININE
    0220-1306Chininum sulphuricumQUININE SULFATE
    0220-1307Chininum sulphuricumQUININE SULFATE
    0220-1310Chininum sulphuricumQUININE SULFATE
    0220-1311Chininum sulphuricumQUININE SULFATE
    0220-1314Chininum sulphuricumQUININE SULFATE
    0220-1325Chininum sulphuricumQUININE SULFATE
    62106-5706CHININUM SULPHURICUMQuinine sulfate
    68428-310Chininum sulphuricumQUININE SULFATE
    71919-189Chininum sulphuricumQUININE SULFATE
    13310-153QualaquinQuinine Sulfate
    49708-153QualaquinQuinine Sulfate
    71557-047QualaquinQuinine Sulfate
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