| Product NDC: | 49502-693 |
| Proprietary Name: | AccuNeb |
| Non Proprietary Name: | albuterol sulfate |
| Active Ingredient(s): | 1.25 mg/3mL & nbsp; albuterol sulfate |
| Administration Route(s): | RESPIRATORY (INHALATION) |
| Dosage Form(s): | SOLUTION |
| Coding System: | National Drug Codes(NDC) |
| Product NDC: | 49502-693 |
| Labeler Name: | Dey Pharma, LP |
| Product Type: | HUMAN PRESCRIPTION DRUG |
| FDA Application Number: | NDA020949 |
| Marketing Category: | NDA |
| Start Marketing Date: | 20110210 |
| Package NDC: | 49502-693-03 |
| Package Description: | 5 POUCH in 1 CARTON (49502-693-03) > 5 VIAL in 1 POUCH > 3 mL in 1 VIAL |
| NDC Code | 49502-693-03 |
| Proprietary Name | AccuNeb |
| Package Description | 5 POUCH in 1 CARTON (49502-693-03) > 5 VIAL in 1 POUCH > 3 mL in 1 VIAL |
| Product NDC | 49502-693 |
| Product Type Name | HUMAN PRESCRIPTION DRUG |
| Non Proprietary Name | albuterol sulfate |
| Dosage Form Name | SOLUTION |
| Route Name | RESPIRATORY (INHALATION) |
| Start Marketing Date | 20110210 |
| Marketing Category Name | NDA |
| Labeler Name | Dey Pharma, LP |
| Substance Name | ALBUTEROL SULFATE |
| Strength Number | 1.25 |
| Strength Unit | mg/3mL |
| Pharmaceutical Classes | Adrenergic beta2-Agonists [MoA],beta2-Adrenergic Agonist [EPC] |