NDC 68084-284

Hydroxyurea

Hydroxyurea

Hydroxyurea is a Oral Capsule in the Human Prescription Drug category. It is labeled and distributed by American Health Packaging. The primary component is Hydroxyurea.

Product ID68084-284_78d3614c-eb17-31e1-e053-2991aa0aecc0
NDC68084-284
Product TypeHuman Prescription Drug
Proprietary NameHydroxyurea
Generic NameHydroxyurea
Dosage FormCapsule
Route of AdministrationORAL
Marketing Start Date2008-08-13
Marketing CategoryANDA / ANDA
Application NumberANDA075340
Labeler NameAmerican Health Packaging
Substance NameHYDROXYUREA
Active Ingredient Strength500 mg/1
Pharm ClassesAntimetabolite [EPC],Urea [CS]
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 68084-284-01

100 BLISTER PACK in 1 BOX, UNIT-DOSE (68084-284-01) > 1 CAPSULE in 1 BLISTER PACK (68084-284-11)
Marketing Start Date2008-08-13
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 68084-284-11 [68084028411]

Hydroxyurea CAPSULE
Marketing CategoryANDA
Application NumberANDA075340
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2008-08-13

NDC 68084-284-01 [68084028401]

Hydroxyurea CAPSULE
Marketing CategoryANDA
Application NumberANDA075340
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2008-08-13

Drug Details

Active Ingredients

IngredientStrength
HYDROXYUREA500 mg/1

OpenFDA Data

SPL SET ID:c84a2241-6c05-480f-8a5b-049e08c27d73
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 197797
  • Pharmacological Class

    • Antimetabolite [EPC]
    • Urea [CS]

    Medicade Reported Pricing

    68084028411 HYDROXYUREA 500 MG CAPSULE

    Pricing Unit: EA | Drug Type:

    68084028401 HYDROXYUREA 500 MG CAPSULE

    Pricing Unit: EA | Drug Type:

    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.