NDC 70518-0916

Hydroxyurea

Hydroxyurea

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

Product ID70518-0916_60cd209b-49f5-4fd9-e053-2a91aa0a4c7d
NDC70518-0916
Product TypeHuman Prescription Drug
Proprietary NameHydroxyurea
Generic NameHydroxyurea
Dosage FormCapsule
Route of AdministrationORAL
Marketing Start Date2017-12-20
Marketing CategoryANDA / ANDA
Application NumberANDA075340
Labeler NameREMEDYREPACK INC.
Substance NameHYDROXYUREA
Active Ingredient Strength500 mg/1
Pharm ClassesAntimetabolite [EPC],Urea [CS]
NDC Exclude FlagE
Listing Certified Through2018-12-31

Packaging

NDC 70518-0916-0

30 CAPSULE in 1 BLISTER PACK (70518-0916-0)
Marketing Start Date2017-12-20
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 70518-0916-0 [70518091600]

Hydroxyurea CAPSULE
Marketing CategoryANDA
Application NumberANDA075340
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2017-12-20

NDC 70518-0916-2 [70518091602]

Hydroxyurea CAPSULE
Marketing CategoryANDA
Application NumberANDA075340
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-12-22

NDC 70518-0916-1 [70518091601]

Hydroxyurea CAPSULE
Marketing CategoryANDA
Application NumberANDA075340
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-12-18

Drug Details

Active Ingredients

IngredientStrength
HYDROXYUREA500 mg/1

OpenFDA Data

SPL SET ID:af9d68b3-c43e-44e5-bf7d-80dbc2edc53a
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 197797

    • 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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