"43975-257-05" National Drug Code (NDC)

Temozolomide 5 CAPSULE in 1 BOTTLE, GLASS (43975-257-05)
(ANI Pharmaceuticals, Inc.)

NDC Code43975-257-05
Package Description5 CAPSULE in 1 BOTTLE, GLASS (43975-257-05)
Product NDC43975-257
Product Type NameHUMAN PRESCRIPTION DRUG
Proprietary NameTemozolomide
Non-Proprietary NameTemozolomide
Dosage FormCAPSULE
UsageORAL
Start Marketing Date20160713
Marketing Category NameANDA
Application NumberANDA203490
ManufacturerANI Pharmaceuticals, Inc.
Substance NameTEMOZOLOMIDE
Strength250
Strength Unitmg/1
Pharmacy ClassesAlkylating Activity [MoA],Alkylating Drug [EPC]

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