Product NDC: | 0574-0805 |
Proprietary Name: | acetylcysteine |
Non Proprietary Name: | Acetylcysteine |
Active Ingredient(s): | 200 mg/mL & nbsp; Acetylcysteine |
Administration Route(s): | INTRAVENOUS |
Dosage Form(s): | INJECTION |
Coding System: | National Drug Codes(NDC) |
Product NDC: | 0574-0805 |
Labeler Name: | Paddock Laboratories, LLC |
Product Type: | HUMAN PRESCRIPTION DRUG |
FDA Application Number: | NDA021539 |
Marketing Category: | NDA |
Start Marketing Date: | 20121220 |
Package NDC: | 0574-0805-30 |
Package Description: | 4 VIAL in 1 CARTON (0574-0805-30) > 30 mL in 1 VIAL |
NDC Code | 0574-0805-30 |
Proprietary Name | acetylcysteine |
Package Description | 4 VIAL in 1 CARTON (0574-0805-30) > 30 mL in 1 VIAL |
Product NDC | 0574-0805 |
Product Type Name | HUMAN PRESCRIPTION DRUG |
Non Proprietary Name | Acetylcysteine |
Dosage Form Name | INJECTION |
Route Name | INTRAVENOUS |
Start Marketing Date | 20121220 |
Marketing Category Name | NDA |
Labeler Name | Paddock Laboratories, 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] |