"68083-510-01" National Drug Code (NDC)

Fomepizole 1 VIAL in 1 CARTON (68083-510-01) / 1.5 mL in 1 VIAL
(Gland Pharma Limited)

NDC Code68083-510-01
Package Description1 VIAL in 1 CARTON (68083-510-01) / 1.5 mL in 1 VIAL
Product NDC68083-510
Product Type NameHUMAN PRESCRIPTION DRUG
Proprietary NameFomepizole
Non-Proprietary NameFomepizole
Dosage FormINJECTION
UsageINTRAVENOUS
Start Marketing Date20230706
Marketing Category NameANDA
Application NumberANDA216791
ManufacturerGland Pharma Limited
Substance NameFOMEPIZOLE
Strength1
Strength Unitg/mL
Pharmacy ClassesAntidote [EPC]

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