Product NDC: | 63323-690 |
Proprietary Name: | Acetylcysteine |
Non Proprietary Name: | ACETYLCYSTEINE |
Active Ingredient(s): | 200 mg/mL & nbsp; ACETYLCYSTEINE |
Administration Route(s): | ORAL; RESPIRATORY (INHALATION) |
Dosage Form(s): | SOLUTION |
Coding System: | National Drug Codes(NDC) |
Product NDC: | 63323-690 |
Labeler Name: | APP Pharmaceuticals, LLC |
Product Type: | HUMAN PRESCRIPTION DRUG |
FDA Application Number: | ANDA203853 |
Marketing Category: | ANDA |
Start Marketing Date: | 20120901 |
Package NDC: | 63323-690-30 |
Package Description: | 3 VIAL in 1 CARTON (63323-690-30) > 30 mL in 1 VIAL |
NDC Code | 63323-690-30 |
Proprietary Name | Acetylcysteine |
Package Description | 3 VIAL in 1 CARTON (63323-690-30) > 30 mL in 1 VIAL |
Product NDC | 63323-690 |
Product Type Name | HUMAN PRESCRIPTION DRUG |
Non Proprietary Name | ACETYLCYSTEINE |
Dosage Form Name | SOLUTION |
Route Name | ORAL; RESPIRATORY (INHALATION) |
Start Marketing Date | 20120901 |
Marketing Category Name | ANDA |
Labeler Name | APP Pharmaceuticals, LLC |
Substance Name | ACETYLCYSTEINE |
Strength Number | 200 |
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] |