NDC 0003-6337

DROXIA

Hydroxyurea

DROXIA is a Oral Capsule in the Human Prescription Drug category. It is labeled and distributed by E.r. Squibb & Sons, L.l.c.. The primary component is Hydroxyurea.

Product ID0003-6337_16f97dab-3e4a-453e-b3b8-f593a15c248e
NDC0003-6337
Product TypeHuman Prescription Drug
Proprietary NameDROXIA
Generic NameHydroxyurea
Dosage FormCapsule
Route of AdministrationORAL
Marketing Start Date2009-06-01
Marketing CategoryNDA / NDA
Application NumberNDA016295
Labeler NameE.R. Squibb & Sons, L.L.C.
Substance NameHYDROXYUREA
Active Ingredient Strength400 mg/1
Pharm ClassesAntimetabolite [EPC],Urea [CS]
NDC Exclude FlagN
Listing Certified Through2021-12-31

Packaging

NDC 0003-6337-17

60 CAPSULE in 1 BOTTLE (0003-6337-17)
Marketing Start Date2015-07-16
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0003-6337-17 [00003633717]

DROXIA CAPSULE
Marketing CategoryNDA
Application NumberNDA016295
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2015-07-16

Drug Details

Active Ingredients

IngredientStrength
HYDROXYUREA400 mg/1

OpenFDA Data

SPL SET ID:740e054b-faac-7c27-f06d-a56efb699355
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 200344
  • 200343
  • 200342
  • 213284
  • 213282
  • 213283
  • Pharmacological Class

    • Antimetabolite [EPC]
    • Urea [CS]

    NDC Crossover Matching brand name "DROXIA" or generic name "Hydroxyurea"

    NDCBrand NameGeneric Name
    0003-6335DROXIAHYDROXYUREA
    0003-6336DROXIAHYDROXYUREA
    0003-6337DROXIAHYDROXYUREA
    0003-0830HYDREAHYDROXYUREA
    0093-0882HYDROXYUREAHydroxyurea
    0555-0882HYDROXYUREAHydroxyurea
    0904-6939HydroxyureaHydroxyurea
    10135-702HydroxyureaHydroxyurea
    24535-0831HydroxyureaHydroxyurea
    42291-321HYDROXYUREAHydroxyurea
    49884-724HydroxyureaHydroxyurea
    55154-3554HydroxyureaHydroxyurea
    55154-7143HydroxyureaHydroxyurea

    Trademark Results [DROXIA]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    DROXIA
    DROXIA
    75318230 2222043 Live/Registered
    BRISTOL-MYERS SQUIBB COMPANY
    1997-07-02

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