| Product NDC: | 54868-5621 |
| Proprietary Name: | PULMICORT RESPULES |
| Non Proprietary Name: | Budesonide |
| Active Ingredient(s): | .5 mg/2mL & nbsp; Budesonide |
| Administration Route(s): | RESPIRATORY (INHALATION) |
| Dosage Form(s): | SUSPENSION |
| Coding System: | National Drug Codes(NDC) |
| Product NDC: | 54868-5621 |
| Labeler Name: | Physicians Total Care, Inc. |
| Product Type: | HUMAN PRESCRIPTION DRUG |
| FDA Application Number: | NDA020929 |
| Marketing Category: | NDA |
| Start Marketing Date: | 20060629 |
| Package NDC: | 54868-5621-0 |
| Package Description: | 6 POUCH in 1 CARTON (54868-5621-0) > 5 AMPULE in 1 POUCH > 2 mL in 1 AMPULE |
| NDC Code | 54868-5621-0 |
| Proprietary Name | PULMICORT RESPULES |
| Package Description | 6 POUCH in 1 CARTON (54868-5621-0) > 5 AMPULE in 1 POUCH > 2 mL in 1 AMPULE |
| Product NDC | 54868-5621 |
| Product Type Name | HUMAN PRESCRIPTION DRUG |
| Non Proprietary Name | Budesonide |
| Dosage Form Name | SUSPENSION |
| Route Name | RESPIRATORY (INHALATION) |
| Start Marketing Date | 20060629 |
| Marketing Category Name | NDA |
| Labeler Name | Physicians Total Care, Inc. |
| Substance Name | BUDESONIDE |
| Strength Number | .5 |
| Strength Unit | mg/2mL |
| Pharmaceutical Classes | Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] |