"0378-5263-14" National Drug Code (NDC)

Temozolomide 14 CAPSULE in 1 BOTTLE, PLASTIC (0378-5263-14)
(Mylan Pharmaceuticals Inc.)

NDC Code0378-5263-14
Package Description14 CAPSULE in 1 BOTTLE, PLASTIC (0378-5263-14)
Product NDC0378-5263
Product Type NameHUMAN PRESCRIPTION DRUG
Proprietary NameTemozolomide
Non-Proprietary NameTemozolomide
Dosage FormCAPSULE
UsageORAL
Start Marketing Date20160629
Marketing Category NameANDA
Application NumberANDA205227
ManufacturerMylan Pharmaceuticals Inc.
Substance NameTEMOZOLOMIDE
Strength140
Strength Unitmg/1
Pharmacy ClassesAlkylating Activity [MoA],Alkylating Drug [EPC]

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