NDC 43353-051

Hydroxychloroquine Sulfate

Hydroxychloroquine Sulfate

Hydroxychloroquine Sulfate 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 ID43353-051_185f5714-9f7b-4570-8047-0ba6994a6dc4
NDC43353-051
Product TypeHuman Prescription Drug
Proprietary NameHydroxychloroquine Sulfate
Generic NameHydroxychloroquine Sulfate
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2014-12-12
Marketing CategoryNDA AUTHORIZED GENERIC / NDA AUTHORIZED GENERIC
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 Through2021-12-31

Packaging

NDC 43353-051-09

9000 TABLET in 1 BOTTLE (43353-051-09)
Marketing Start Date2015-09-05
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 43353-051-60 [43353005160]

Hydroxychloroquine Sulfate TABLET
Marketing CategoryNDA AUTHORIZED GENERIC
Application NumberNDA009768
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2015-05-20
Inactivation Date2020-04-13
Reactivation Date2020-04-16

NDC 43353-051-53 [43353005153]

Hydroxychloroquine Sulfate TABLET
Marketing CategoryNDA AUTHORIZED GENERIC
Application NumberNDA009768
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2015-05-19
Inactivation Date2020-04-13
Reactivation Date2020-04-16

NDC 43353-051-09 [43353005109]

Hydroxychloroquine Sulfate TABLET
Marketing CategoryNDA AUTHORIZED GENERIC
Application NumberNDA009768
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2015-09-05
Inactivation Date2020-04-13
Reactivation Date2020-04-16

NDC 43353-051-80 [43353005180]

Hydroxychloroquine Sulfate TABLET
Marketing CategoryNDA AUTHORIZED GENERIC
Application NumberNDA009768
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2015-08-22
Inactivation Date2020-04-13
Reactivation Date2020-04-16

Drug Details

Active Ingredients

IngredientStrength
HYDROXYCHLOROQUINE SULFATE200 mg/1

OpenFDA Data

SPL SET ID:00ab155c-60b7-4527-acc4-316c6b2efa8a
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 979092
  • Pharmacological Class

    • Antirheumatic Agent [EPC]
    • Antimalarial [EPC]

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

    NDCBrand NameGeneric Name
    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
    68071-4648Hydroxychloroquine sulfateHydroxychloroquine sulfate
    68084-269Hydroxychloroquine SulfateHydroxychloroquine Sulfate
    68382-096Hydroxychloroquine sulfateHydroxychloroquine sulfate
    69238-1544Hydroxychloroquine SulfateHydroxychloroquine Sulfate
    71335-0897Hydroxychloroquine sulfateHydroxychloroquine sulfate
    71610-047Hydroxychloroquine SulfateHydroxychloroquine Sulfate
    16714-474Hydroxychloroquine SulfateHydroxychloroquine Sulfate
    16714-753Hydroxychloroquine SulfateHydroxychloroquine Sulfate
    21695-486Hydroxychloroquine SulfateHydroxychloroquine Sulfate
    33261-933Hydroxychloroquine SulfateHydroxychloroquine Sulfate
    42292-011Hydroxychloroquine SulfateHydroxychloroquine Sulfate
    42385-927Hydroxychloroquine SulfateHydroxychloroquine Sulfate
    43353-051Hydroxychloroquine SulfateHydroxychloroquine Sulfate
    43353-794Hydroxychloroquine SulfateHydroxychloroquine Sulfate
    43353-103Hydroxychloroquine SulfateHydroxychloroquine Sulfate
    43353-972Hydroxychloroquine SulfateHydroxychloroquine Sulfate
    43598-721HYDROXYCHLOROQUINE SULFATEHYDROXYCHLOROQUINE SULFATE
    50090-0681Hydroxychloroquine SulfateHydroxychloroquine Sulfate
    50090-2508Hydroxychloroquine SulfateHydroxychloroquine Sulfate
    50090-3432Hydroxychloroquine SulfateHydroxychloroquine Sulfate
    51660-296Hydroxychloroquine SulfateHydroxychloroquine Sulfate
    53002-4850Hydroxychloroquine SulfateHydroxychloroquine Sulfate
    53808-1112Hydroxychloroquine SulfateHydroxychloroquine Sulfate
    55154-2074Hydroxychloroquine sulfateHydroxychloroquine sulfate
    57664-761HYDROXYCHLOROQUINE SULFATEHYDROXYCHLOROQUINE SULFATE
    61919-132HYDROXYCHLOROQUINE SULFATEHYDROXYCHLOROQUINE SULFATE
    63304-296Hydroxychloroquine SulfateHydroxychloroquine Sulfate
    63739-777Hydroxychloroquine sulfateHydroxychloroquine sulfate
    63629-3343Hydroxychloroquine SulfateHydroxychloroquine Sulfate
    65841-633Hydroxychloroquine sulfateHydroxychloroquine sulfate
    66336-555Hydroxychloroquine SulfateHydroxychloroquine Sulfate
    66993-057Hydroxychloroquine SulfateHydroxychloroquine Sulfate
    50090-4659Hydroxychloroquine SulfateHydroxychloroquine Sulfate

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