| Product NDC: | 54868-5709 |
| Proprietary Name: | Albuterol Sulfate |
| Non Proprietary Name: | Albuterol Sulfate |
| Active Ingredient(s): | 1.5 mg/3mL & nbsp; Albuterol Sulfate |
| Administration Route(s): | RESPIRATORY (INHALATION) |
| Dosage Form(s): | SOLUTION |
| Coding System: | National Drug Codes(NDC) |
| Product NDC: | 54868-5709 |
| Labeler Name: | Physicians Total Care, Inc. |
| Product Type: | HUMAN PRESCRIPTION DRUG |
| FDA Application Number: | ANDA076355 |
| Marketing Category: | ANDA |
| Start Marketing Date: | 20070426 |
| Package NDC: | 54868-5709-0 |
| Package Description: | 30 POUCH in 1 CARTON (54868-5709-0) > 1 VIAL, SINGLE-DOSE in 1 POUCH > 3 mL in 1 VIAL, SINGLE-DOSE |
| NDC Code | 54868-5709-0 |
| Proprietary Name | Albuterol Sulfate |
| Package Description | 30 POUCH in 1 CARTON (54868-5709-0) > 1 VIAL, SINGLE-DOSE in 1 POUCH > 3 mL in 1 VIAL, SINGLE-DOSE |
| Product NDC | 54868-5709 |
| Product Type Name | HUMAN PRESCRIPTION DRUG |
| Non Proprietary Name | Albuterol Sulfate |
| Dosage Form Name | SOLUTION |
| Route Name | RESPIRATORY (INHALATION) |
| Start Marketing Date | 20070426 |
| Marketing Category Name | ANDA |
| Labeler Name | Physicians Total Care, Inc. |
| Substance Name | ALBUTEROL SULFATE |
| Strength Number | 1.5 |
| Strength Unit | mg/3mL |
| Pharmaceutical Classes | Adrenergic beta2-Agonists [MoA],beta2-Adrenergic Agonist [EPC] |