Product NDC: | 68788-0013 |
Proprietary Name: | Budesonide |
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: | 68788-0013 |
Labeler Name: | Preferred Pharmaceuticals, Inc |
Product Type: | HUMAN PRESCRIPTION DRUG |
FDA Application Number: | ANDA077519 |
Marketing Category: | ANDA |
Start Marketing Date: | 20090204 |
Package NDC: | 68788-0013-1 |
Package Description: | 6 POUCH in 1 CARTON (68788-0013-1) > 5 VIAL in 1 POUCH > 2 mL in 1 VIAL |
NDC Code | 68788-0013-1 |
Proprietary Name | Budesonide |
Package Description | 6 POUCH in 1 CARTON (68788-0013-1) > 5 VIAL in 1 POUCH > 2 mL in 1 VIAL |
Product NDC | 68788-0013 |
Product Type Name | HUMAN PRESCRIPTION DRUG |
Non Proprietary Name | Budesonide |
Dosage Form Name | SUSPENSION |
Route Name | RESPIRATORY (INHALATION) |
Start Marketing Date | 20090204 |
Marketing Category Name | ANDA |
Labeler Name | Preferred Pharmaceuticals, Inc |
Substance Name | BUDESONIDE |
Strength Number | .5 |
Strength Unit | mg/2mL |
Pharmaceutical Classes | Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] |