"65162-801-51" National Drug Code (NDC)

Temozolomide 1 BOTTLE in 1 CARTON (65162-801-51) / 5 CAPSULE in 1 BOTTLE
(Amneal Pharmaceuticals LLC)

NDC Code65162-801-51
Package Description1 BOTTLE in 1 CARTON (65162-801-51) / 5 CAPSULE in 1 BOTTLE
Product NDC65162-801
Product Type NameHUMAN PRESCRIPTION DRUG
Proprietary NameTemozolomide
Non-Proprietary NameTemozolomide
Dosage FormCAPSULE
UsageORAL
Start Marketing Date20150403
Marketing Category NameANDA
Application NumberANDA203691
ManufacturerAmneal Pharmaceuticals LLC
Substance NameTEMOZOLOMIDE
Strength5
Strength Unitmg/1
Pharmacy ClassesAlkylating Activity [MoA], Alkylating Drug [EPC]

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