| Product NDC: | 0517-7630 |
| Proprietary Name: | Acetylcysteine |
| Non Proprietary Name: | acetylcysteine |
| Active Ingredient(s): | 200 mg/mL & nbsp; acetylcysteine |
| Administration Route(s): | RESPIRATORY (INHALATION) |
| Dosage Form(s): | INHALANT |
| Coding System: | National Drug Codes(NDC) |
| Product NDC: | 0517-7630 |
| Labeler Name: | American Regent, Inc. |
| Product Type: | HUMAN PRESCRIPTION DRUG |
| FDA Application Number: | ANDA072547 |
| Marketing Category: | ANDA |
| Start Marketing Date: | 19951001 |
| Package NDC: | 0517-7630-03 |
| Package Description: | 3 VIAL, GLASS in 1 BOX (0517-7630-03) > 30 mL in 1 VIAL, GLASS |
| NDC Code | 0517-7630-03 |
| Proprietary Name | Acetylcysteine |
| Package Description | 3 VIAL, GLASS in 1 BOX (0517-7630-03) > 30 mL in 1 VIAL, GLASS |
| Product NDC | 0517-7630 |
| Product Type Name | HUMAN PRESCRIPTION DRUG |
| Non Proprietary Name | acetylcysteine |
| Dosage Form Name | INHALANT |
| Route Name | RESPIRATORY (INHALATION) |
| Start Marketing Date | 19951001 |
| Marketing Category Name | ANDA |
| Labeler Name | American Regent, Inc. |
| 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] |