| Product NDC: | 63323-963 |
| Proprietary Name: | Acetylcysteine |
| Non Proprietary Name: | Acetylcysteine |
| Active Ingredient(s): | 200 mg/mL & nbsp; Acetylcysteine |
| Administration Route(s): | INTRAVENOUS |
| Dosage Form(s): | INJECTION, SOLUTION |
| Coding System: | National Drug Codes(NDC) |
| Product NDC: | 63323-963 |
| Labeler Name: | APP Pharmaceuticals, LLC |
| Product Type: | HUMAN PRESCRIPTION DRUG |
| FDA Application Number: | ANDA200644 |
| Marketing Category: | ANDA |
| Start Marketing Date: | 20121109 |
| Package NDC: | 63323-963-30 |
| Package Description: | 4 VIAL, SINGLE-DOSE in 1 CARTON (63323-963-30) > 30 mL in 1 VIAL, SINGLE-DOSE |
| NDC Code | 63323-963-30 |
| Proprietary Name | Acetylcysteine |
| Package Description | 4 VIAL, SINGLE-DOSE in 1 CARTON (63323-963-30) > 30 mL in 1 VIAL, SINGLE-DOSE |
| Product NDC | 63323-963 |
| Product Type Name | HUMAN PRESCRIPTION DRUG |
| Non Proprietary Name | Acetylcysteine |
| Dosage Form Name | INJECTION, SOLUTION |
| Route Name | INTRAVENOUS |
| Start Marketing Date | 20121109 |
| 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] |