"69315-164-01" National Drug Code (NDC)

Hydroxyurea 100 CAPSULE in 1 BOTTLE, PLASTIC (69315-164-01)
(Leading Pharma, LLC)

NDC Code69315-164-01
Package Description100 CAPSULE in 1 BOTTLE, PLASTIC (69315-164-01)
Product NDC69315-164
Product Type NameHUMAN PRESCRIPTION DRUG
Proprietary NameHydroxyurea
Non-Proprietary NameHydroxyurea
Dosage FormCAPSULE
UsageORAL
Start Marketing Date20200709
Marketing Category NameANDA
Application NumberANDA213438
ManufacturerLeading Pharma, LLC
Substance NameHYDROXYUREA
Strength500
Strength Unitmg/1
Pharmacy ClassesAntimetabolite [EPC], Urea [CS]

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