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Acetylcysteine - 0054-3025-02 - (Acetylcysteine)

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Drug Information of Acetylcysteine

Product NDC: 0054-3025
Proprietary Name: Acetylcysteine
Non Proprietary Name: Acetylcysteine
Active Ingredient(s): 100    mg/mL & nbsp;   Acetylcysteine
Administration Route(s): ORAL; RESPIRATORY (INHALATION)
Dosage Form(s): SOLUTION
Coding System: National Drug Codes(NDC)

Labeler Information of Acetylcysteine

Product NDC: 0054-3025
Labeler Name: Roxane Laboratories, Inc.
Product Type: HUMAN PRESCRIPTION DRUG
FDA Application Number: ANDA072323
Marketing Category: ANDA
Start Marketing Date: 19960501

Package Information of Acetylcysteine

Package NDC: 0054-3025-02
Package Description: 3 VIAL in 1 BOX (0054-3025-02) > 30 mL in 1 VIAL

NDC Information of Acetylcysteine

NDC Code 0054-3025-02
Proprietary Name Acetylcysteine
Package Description 3 VIAL in 1 BOX (0054-3025-02) > 30 mL in 1 VIAL
Product NDC 0054-3025
Product Type Name HUMAN PRESCRIPTION DRUG
Non Proprietary Name Acetylcysteine
Dosage Form Name SOLUTION
Route Name ORAL; RESPIRATORY (INHALATION)
Start Marketing Date 19960501
Marketing Category Name ANDA
Labeler Name Roxane Laboratories, Inc.
Substance Name ACETYLCYSTEINE
Strength Number 100
Strength Unit mg/mL
Pharmaceutical Classes Antidote [EPC],Antidote for Acetaminophen Overdose [EPC],Decreased Respiratory Secretion Viscosity [PE],Increased Glutathione Concentration [PE],Mucolytic [EPC],Reduction Activity [MoA]

Complete Information of Acetylcysteine


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