"35573-459-60" National Drug Code (NDC)

Carglumic Acid 60 TABLET, FOR SUSPENSION in 1 BOTTLE (35573-459-60)
(Burel Pharmaceuticals, LLC)

NDC Code35573-459-60
Package Description60 TABLET, FOR SUSPENSION in 1 BOTTLE (35573-459-60)
Product NDC35573-459
Product Type NameHUMAN PRESCRIPTION DRUG
Proprietary NameCarglumic Acid
Non-Proprietary NameCarglumic Acid
Dosage FormTABLET, FOR SUSPENSION
UsageORAL
Start Marketing Date20221219
Marketing Category NameANDA
Application NumberANDA213395
ManufacturerBurel Pharmaceuticals, LLC
Substance NameCARGLUMIC ACID
Strength200
Strength Unitmg/1
Pharmacy ClassesCarbamoyl Phosphate Synthetase 1 Activator [EPC], Carbamoyl Phosphate Synthetase 1 Activators [MoA]

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