"0054-3027-02" National Drug Code (NDC)

Acetylcysteine 3 VIAL in 1 BOX (0054-3027-02) > 10 mL in 1 VIAL
(Roxane Laboratories, Inc.)

NDC Code0054-3027-02
Package Description3 VIAL in 1 BOX (0054-3027-02) > 10 mL in 1 VIAL
Product NDC0054-3027
Product Type NameHUMAN PRESCRIPTION DRUG
Proprietary NameAcetylcysteine
Non-Proprietary NameAcetylcysteine
Dosage FormSOLUTION
UsageORAL; RESPIRATORY (INHALATION)
Start Marketing Date19960501
Marketing Category NameANDA
Application NumberANDA072323
ManufacturerRoxane Laboratories, Inc.
Substance NameACETYLCYSTEINE
Strength100
Strength Unitmg/mL
Pharmacy ClassesAntidote [EPC],Antidote for Acetaminophen Overdose [EPC],Decreased Respiratory Secretion Viscosity [PE],Increased Glutathione Concentration [PE],Mucolytic [EPC],Reduction Activity [MoA]

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