"81927-105-01" National Drug Code (NDC)

Tepylute 1 VIAL, SINGLE-DOSE in 1 CARTON (81927-105-01) / 1.5 mL in 1 VIAL, SINGLE-DOSE
(Shorla Oncology Inc.)

NDC Code81927-105-01
Package Description1 VIAL, SINGLE-DOSE in 1 CARTON (81927-105-01) / 1.5 mL in 1 VIAL, SINGLE-DOSE
Product NDC81927-105
Product Type NameHUMAN PRESCRIPTION DRUG
Proprietary NameTepylute
Non-Proprietary NameThiotepa
Dosage FormINJECTION
UsageINTRAVENOUS
Start Marketing Date20250101
Marketing Category NameNDA
Application NumberNDA216984
ManufacturerShorla Oncology Inc.
Substance NameTHIOTEPA
Strength10
Strength Unitmg/mL
Pharmacy ClassesAlkylating Activity [MoA], Alkylating Drug [EPC]

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