Product NDC: | 65224-802 |
Proprietary Name: | CEDAX |
Non Proprietary Name: | ceftibuten dihydrate |
Active Ingredient(s): | 90 mg/5mL & nbsp; ceftibuten dihydrate |
Administration Route(s): | ORAL |
Dosage Form(s): | SUSPENSION |
Coding System: | National Drug Codes(NDC) |
Product NDC: | 65224-802 |
Labeler Name: | Pernix Therapeutics, LLC |
Product Type: | HUMAN PRESCRIPTION DRUG |
FDA Application Number: | NDA050686 |
Marketing Category: | NDA |
Start Marketing Date: | 19951220 |
Package NDC: | 65224-802-04 |
Package Description: | 1 BOTTLE in 1 CARTON (65224-802-04) > 120 mL in 1 BOTTLE |
NDC Code | 65224-802-04 |
Proprietary Name | CEDAX |
Package Description | 1 BOTTLE in 1 CARTON (65224-802-04) > 120 mL in 1 BOTTLE |
Product NDC | 65224-802 |
Product Type Name | HUMAN PRESCRIPTION DRUG |
Non Proprietary Name | ceftibuten dihydrate |
Dosage Form Name | SUSPENSION |
Route Name | ORAL |
Start Marketing Date | 19951220 |
Marketing Category Name | NDA |
Labeler Name | Pernix Therapeutics, LLC |
Substance Name | CEFTIBUTEN DIHYDRATE |
Strength Number | 90 |
Strength Unit | mg/5mL |
Pharmaceutical Classes | Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] |