"80725-810-10" National Drug Code (NDC)

Hydrea 100 CAPSULE in 1 BOTTLE, PLASTIC (80725-810-10)
(Waylis Therapeutics LLC)

NDC Code80725-810-10
Package Description100 CAPSULE in 1 BOTTLE, PLASTIC (80725-810-10)
Product NDC80725-810
Product Type NameHUMAN PRESCRIPTION DRUG
Proprietary NameHydrea
Non-Proprietary NameHydroxyurea
Dosage FormCAPSULE
UsageORAL
Start Marketing Date20250911
Marketing Category NameNDA
Application NumberNDA016295
ManufacturerWaylis Therapeutics LLC
Substance NameHYDROXYUREA
Strength500
Strength Unitmg/1
Pharmacy ClassesAntimetabolite [EPC], Urea [CS]

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