| Product NDC: | 59630-821 | 
| Proprietary Name: | Cedax | 
| Non Proprietary Name: | Ceftibuten dihydrate | 
| Active Ingredient(s): | 18 mg/mL & nbsp; Ceftibuten dihydrate | 
| Administration Route(s): | ORAL | 
| Dosage Form(s): | SUSPENSION | 
| Coding System: | National Drug Codes(NDC) | 
| Product NDC: | 59630-821 | 
| Labeler Name: | Sciele Pharma, Inc. | 
| Product Type: | HUMAN PRESCRIPTION DRUG | 
| FDA Application Number: | NDA050686 | 
| Marketing Category: | NDA | 
| Start Marketing Date: | 19951220 | 
| Package NDC: | 59630-821-12 | 
| Package Description: | 1 BOTTLE in 1 CARTON (59630-821-12) > 120 mL in 1 BOTTLE | 
| NDC Code | 59630-821-12 | 
| Proprietary Name | Cedax | 
| Package Description | 1 BOTTLE in 1 CARTON (59630-821-12) > 120 mL in 1 BOTTLE | 
| Product NDC | 59630-821 | 
| 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 | Sciele Pharma, Inc. | 
| Substance Name | CEFTIBUTEN DIHYDRATE | 
| Strength Number | 18 | 
| Strength Unit | mg/mL | 
| Pharmaceutical Classes | Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] |