NDC 0093-0882

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 ID0093-0882_213567c6-cc2e-4936-a18a-bf0034a5d7c8
NDC0093-0882
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 Through2019-12-31

Packaging

NDC 0093-0882-02

100 CAPSULE in 1 BOTTLE (0093-0882-02)
Marketing Start Date1998-10-19
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0093-0882-02 [00093088202]

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

Drug Details

Active Ingredients

IngredientStrength
HYDROXYUREA500 mg/1

OpenFDA Data

SPL SET ID:2703b3d8-dce1-4f37-a109-e2a11e106951
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

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