NDC 24535-0831

Hydroxyurea

Hydroxyurea

Hydroxyurea is a Oral Capsule in the Human Prescription Drug category. It is labeled and distributed by Arab Pharmaceutical Manufacturing Co. Psc Ltd. The primary component is Hydroxyurea.

Product ID24535-0831_8ff7b994-411f-481b-9923-311a1e3505c6
NDC24535-0831
Product TypeHuman Prescription Drug
Proprietary NameHydroxyurea
Generic NameHydroxyurea
Dosage FormCapsule
Route of AdministrationORAL
Marketing Start Date2017-08-20
Marketing CategoryANDA / ANDA
Application NumberANDA204998
Labeler NameArab Pharmaceutical Manufacturing Co. PSC Ltd
Substance NameHYDROXYUREA
Active Ingredient Strength500 mg/1
Pharm ClassesAntimetabolite [EPC],Urea [CS]
NDC Exclude FlagE
Listing Certified Through2017-12-31

Packaging

NDC 24535-0831-1

100 CAPSULE in 1 BOTTLE (24535-0831-1)
Marketing Start Date2017-08-20
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 24535-0831-1 [24535083101]

Hydroxyurea CAPSULE
Marketing CategoryANDA
Application NumberANDA204998
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2017-08-20
Inactivation Date2019-11-27

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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