NDC 69315-164

HYDROXYUREA

Hydroxyurea

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

Product ID69315-164_7dc4ea47-6ad7-48c9-942c-b2aeb7e13c62
NDC69315-164
Product TypeHuman Prescription Drug
Proprietary NameHYDROXYUREA
Generic NameHydroxyurea
Dosage FormCapsule
Route of AdministrationORAL
Marketing Start Date2020-07-09
Marketing CategoryANDA / ANDA
Application NumberANDA213438
Labeler NameLeading Pharma, LLC
Substance NameHYDROXYUREA
Active Ingredient Strength500 mg/1
Pharm ClassesAntimetabolite [EPC], Urea [CS]
NDC Exclude FlagN
Listing Certified Through2023-12-31

Packaging

NDC 69315-164-01

100 CAPSULE in 1 BOTTLE, PLASTIC (69315-164-01)
Marketing Start Date2020-07-09
NDC Exclude FlagN
Sample Package?N

Drug Details

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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