"58181-4331-4" National Drug Code (NDC)

Temozolomide 14 POUCH in 1 CARTON (58181-4331-4) / 1 CAPSULE in 1 POUCH
(NextSource Biotechnology LLC)

NDC Code58181-4331-4
Package Description14 POUCH in 1 CARTON (58181-4331-4) / 1 CAPSULE in 1 POUCH
Product NDC58181-4331
Product Type NameHUMAN PRESCRIPTION DRUG
Proprietary NameTemozolomide
Non-Proprietary NameTemozolomide
Dosage FormCAPSULE
UsageORAL
Start Marketing Date20250401
Marketing Category NameANDA
Application NumberANDA203898
ManufacturerNextSource Biotechnology LLC
Substance NameTEMOZOLOMIDE
Strength140
Strength Unitmg/1
Pharmacy ClassesAlkylating Activity [MoA], Alkylating Drug [EPC]

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