NDC 0555-0882

HYDROXYUREA

Hydroxyurea

HYDROXYUREA is a Oral Capsule in the Human Prescription Drug category. It is labeled and distributed by Teva Pharmaceuticals Usa, Inc.. The primary component is Hydroxyurea.

Product ID0555-0882_28568498-1bd4-4312-9faf-3bcf89824189
NDC0555-0882
Product TypeHuman Prescription Drug
Proprietary NameHYDROXYUREA
Generic NameHydroxyurea
Dosage FormCapsule
Route of AdministrationORAL
Marketing Start Date1998-10-19
Marketing CategoryANDA / ANDA
Application NumberANDA075143
Labeler NameTeva Pharmaceuticals USA, Inc.
Substance NameHYDROXYUREA
Active Ingredient Strength500 mg/1
Pharm ClassesAntimetabolite [EPC], Urea [CS]
NDC Exclude FlagN
Listing Certified Through2023-12-31

Packaging

NDC 0555-0882-02

100 CAPSULE in 1 BOTTLE (0555-0882-02)
Marketing Start Date1998-10-19
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0555-0882-02 [00555088202]

HYDROXYUREA CAPSULE
Marketing CategoryANDA
Application NumberANDA075143
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date1998-10-19

Drug Details

Active Ingredients

IngredientStrength
HYDROXYUREA500 mg/1

OpenFDA Data

SPL SET ID:b9514ae5-79ae-4cc2-9d7f-c8f7806d1694
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 197797
  • UPC Code
  • 0305550882022
  • Pharmacological Class

    • Antimetabolite [EPC]
    • Urea [CS]

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

    NDCBrand NameGeneric Name
    0093-0882HYDROXYUREAHydroxyurea
    0555-0882HYDROXYUREAHydroxyurea
    0904-6939HydroxyureaHydroxyurea
    10135-702HydroxyureaHydroxyurea
    24535-0831HydroxyureaHydroxyurea
    42291-321HYDROXYUREAHydroxyurea
    49884-724HydroxyureaHydroxyurea
    55154-3554HydroxyureaHydroxyurea
    55154-7143HydroxyureaHydroxyurea
    68084-284HydroxyureaHydroxyurea
    70518-0916HydroxyureaHydroxyurea
    60429-265HydroxyureaHydroxyurea
    69315-164HYDROXYUREAHYDROXYUREA
    0003-6335DROXIAHYDROXYUREA
    0003-6336DROXIAHYDROXYUREA
    0003-6337DROXIAHYDROXYUREA
    0003-0830HYDREAHYDROXYUREA

    © 2024 FDA.report
    This site is not affiliated with or endorsed by the FDA.