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