NDC 71770-105

Siklos

Hydroxyurea

Siklos is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Medunik. The primary component is Hydroxyurea.

Product ID71770-105_84d4d009-ae2f-4b64-8c54-4589f1f40ef0
NDC71770-105
Product TypeHuman Prescription Drug
Proprietary NameSiklos
Generic NameHydroxyurea
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2020-10-15
Marketing CategoryNDA /
Application NumberNDA208843
Labeler NameMedunik
Substance NameHYDROXYUREA
Active Ingredient Strength100 mg/1
Pharm ClassesAntimetabolite [EPC],Urea [CS]
NDC Exclude FlagN
Listing Certified Through2021-12-31

Packaging

NDC 71770-105-60

1 BOTTLE in 1 CARTON (71770-105-60) > 60 TABLET, FILM COATED in 1 BOTTLE
Marketing Start Date2020-10-15
NDC Exclude FlagN
Sample Package?N

Drug Details

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

NDCBrand NameGeneric Name
71770-100Sikloshydroxyurea
71770-105Sikloshydroxyurea
71770-120Sikloshydroxyurea
0003-6335DROXIAHYDROXYUREA
0003-6336DROXIAHYDROXYUREA
0003-6337DROXIAHYDROXYUREA
0003-0830HYDREAHYDROXYUREA
0093-0882HYDROXYUREAHydroxyurea
0555-0882HYDROXYUREAHydroxyurea
0904-6939HydroxyureaHydroxyurea
24535-0831HydroxyureaHydroxyurea
42291-321HYDROXYUREAHydroxyurea
49884-724HydroxyureaHydroxyurea
55154-7143HydroxyureaHydroxyurea
60429-265HydroxyureaHydroxyurea
68084-284HydroxyureaHydroxyurea
69315-164HYDROXYUREAHYDROXYUREA
70518-0916HydroxyureaHydroxyurea

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