| 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: | 59630-821-60 |
| Package Description: | 1 BOTTLE in 1 CARTON (59630-821-60) > 60 mL in 1 BOTTLE |
| NDC Code | 59630-821-60 |
| Proprietary Name | Cedax |
| Package Description | 1 BOTTLE in 1 CARTON (59630-821-60) > 60 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] |