NDC 0003-0830

HYDREA

Hydroxyurea

HYDREA 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 ID0003-0830_1fbe7104-4379-41be-bdc6-bf79d108a77b
NDC0003-0830
Product TypeHuman Prescription Drug
Proprietary NameHYDREA
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 Strength500 mg/1
Pharm ClassesAntimetabolite [EPC],Urea [CS]
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 0003-0830-50

100 CAPSULE in 1 BOTTLE (0003-0830-50)
Marketing Start Date2009-06-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0003-0830-50 [00003083050]

HYDREA CAPSULE
Marketing CategoryNDA
Application NumberNDA016295
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2009-06-01

Drug Details

Active Ingredients

IngredientStrength
HYDROXYUREA500 mg/1

OpenFDA Data

SPL SET ID:050bd2a2-a125-721a-e366-255c5466f018
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 197797
  • 105602
  • Pharmacological Class

    • Antimetabolite [EPC]
    • Urea [CS]

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

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

    Trademark Results [HYDREA]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    HYDREA
    HYDREA
    72153976 0753215 Live/Registered
    Olin Mathieson Chemical Corporation
    1962-09-26

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