NDC 43353-997

Plaquenil

Hydroxychloroquine Sulfate

Plaquenil is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Aphena Pharma Solutions - Tennessee, Llc. The primary component is Hydroxychloroquine Sulfate.

Product ID43353-997_7fda39a8-57ef-42fa-8eda-03f88eb0c7ce
NDC43353-997
Product TypeHuman Prescription Drug
Proprietary NamePlaquenil
Generic NameHydroxychloroquine Sulfate
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2013-06-28
Marketing CategoryNDA / NDA
Application NumberNDA009768
Labeler NameAphena Pharma Solutions - Tennessee, LLC
Substance NameHYDROXYCHLOROQUINE SULFATE
Active Ingredient Strength200 mg/1
Pharm ClassesAntirheumatic Agent [EPC],Antimalarial [EPC]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 43353-997-53

60 TABLET in 1 BOTTLE (43353-997-53)
Marketing Start Date2015-02-18
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 43353-997-53 [43353099753]

Plaquenil TABLET
Marketing CategoryNDA
Application NumberNDA009768
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2015-02-18
Inactivation Date2020-04-02

NDC 43353-997-60 [43353099760]

Plaquenil TABLET
Marketing CategoryNDA
Application NumberNDA009768
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2015-02-19
Inactivation Date2020-04-02

NDC 43353-997-09 [43353099709]

Plaquenil TABLET
Marketing CategoryNDA
Application NumberNDA009768
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2015-02-14
Inactivation Date2020-04-02

Drug Details

Active Ingredients

IngredientStrength
HYDROXYCHLOROQUINE SULFATE200 mg/1

OpenFDA Data

SPL SET ID:53355f8f-e3bb-4db1-8e11-e721c5b62067
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 979092
  • 979094

    • Pharmacological Class

    • Antirheumatic Agent [EPC]
    • Antimalarial [EPC]

    NDC Crossover Matching brand name "Plaquenil" or generic name "Hydroxychloroquine Sulfate"

    NDCBrand NameGeneric Name
    68151-0511PlaquenilPlaquenil
    43353-997PlaquenilPlaquenil
    59212-562PlaquenilPlaquenil
    67296-1781PlaquenilPlaquenil
    71205-448PlaquenilPlaquenil
    71610-473PlaquenilPlaquenil
    0093-2401Hydroxychloroquine SulfateHydroxychloroquine Sulfate
    0143-2128Hydroxychloroquine SulfateHydroxychloroquine Sulfate
    0378-0373Hydroxychloroquine SulfateHydroxychloroquine Sulfate
    0591-3041Hydroxychloroquine SulfateHydroxychloroquine Sulfate
    0615-8218Hydroxychloroquine SulfateHydroxychloroquine Sulfate
    0615-8325Hydroxychloroquine SulfateHydroxychloroquine Sulfate
    0615-8374Hydroxychloroquine SulfateHydroxychloroquine Sulfate
    0615-8401Hydroxychloroquine SulfateHydroxychloroquine Sulfate
    0781-1407Hydroxychloroquine SulfateHydroxychloroquine Sulfate
    0781-5994Hydroxychloroquine SulfateHydroxychloroquine Sulfate
    0904-6508Hydroxychloroquine SulfateHydroxychloroquine Sulfate
    0904-6884Hydroxychloroquine SulfateHydroxychloroquine Sulfate
    0904-7046HYDROXYCHLOROQUINE SULFATEHYDROXYCHLOROQUINE SULFATE
    10544-578Hydroxychloroquine SulfateHydroxychloroquine Sulfate
    16571-687Hydroxychloroquine SulfateHydroxychloroquine Sulfate
    16714-110Hydroxychloroquine sulfateHydroxychloroquine sulfate

    Trademark Results [Plaquenil]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    PLAQUENIL
    PLAQUENIL
    73662985 1470405 Live/Registered
    STERLING DRUG INC.
    1987-05-26
    PLAQUENIL
    PLAQUENIL
    72102433 0712043 Live/Registered
    Sterling Drug Inc.
    1960-08-10
    PLAQUENIL
    PLAQUENIL
    71618068 0562377 Live/Registered
    WINTHROP-STEARNS INC.
    1951-08-24
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