NDC 42291-321

HYDROXYUREA

Hydroxyurea

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

Product ID42291-321_70c0d277-8528-7376-e053-2a91aa0aeda9
NDC42291-321
Product TypeHuman Prescription Drug
Proprietary NameHYDROXYUREA
Generic NameHydroxyurea
Dosage FormCapsule
Route of AdministrationORAL
Marketing Start Date2013-07-23
Marketing CategoryANDA / ANDA
Application NumberANDA075143
Labeler NameAvKARE, Inc.
Substance NameHYDROXYUREA
Active Ingredient Strength500 mg/1
Pharm ClassesAntimetabolite
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 42291-321-01

100 CAPSULE in 1 BOTTLE (42291-321-01)
Marketing Start Date2013-07-23
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 42291-321-01 [42291032101]

HYDROXYUREA CAPSULE
Marketing CategoryANDA
Application NumberANDA075143
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2013-07-23

Drug Details

Active Ingredients

IngredientStrength
HYDROXYUREA500 mg/1

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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