"83270-001-04" National Drug Code (NDC)

Acetylcysteine 4 VIAL, SINGLE-DOSE in 1 CARTON (83270-001-04) / 30 mL in 1 VIAL, SINGLE-DOSE (83270-001-01)
(STELIS BIOPHARMA LIMITED)

NDC Code83270-001-04
Package Description4 VIAL, SINGLE-DOSE in 1 CARTON (83270-001-04) / 30 mL in 1 VIAL, SINGLE-DOSE (83270-001-01)
Product NDC83270-001
Product Type NameHUMAN PRESCRIPTION DRUG
Proprietary NameAcetylcysteine
Non-Proprietary NameAcetylcysteine
Dosage FormINJECTION, SOLUTION
UsageINTRAVENOUS
Start Marketing Date20230426
Marketing Category NameANDA
Application NumberANDA217182
ManufacturerSTELIS BIOPHARMA LIMITED
Substance NameACETYLCYSTEINE
Strength200
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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