"70301-2007-1" National Drug Code (NDC)

Temozolomide 5 PACKET in 1 CARTON (70301-2007-1) / 1 CAPSULE in 1 PACKET
(OPKO Pharmaceuticals, LLC)

NDC Code70301-2007-1
Package Description5 PACKET in 1 CARTON (70301-2007-1) / 1 CAPSULE in 1 PACKET
Product NDC70301-2007
Product Type NameHUMAN PRESCRIPTION DRUG
Proprietary NameTemozolomide
Non-Proprietary NameTemozolomide
Dosage FormCAPSULE
UsageORAL
Start Marketing Date20260511
Marketing Category NameANDA
Application NumberANDA203898
ManufacturerOPKO Pharmaceuticals, LLC
Substance NameTEMOZOLOMIDE
Strength140
Strength Unitmg/1
Pharmacy ClassesAlkylating Activity [MoA], Alkylating Drug [EPC]

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