| Product NDC: | 65224-800 |
| Proprietary Name: | CEDAX |
| Non Proprietary Name: | ceftibuten dihydrate |
| Active Ingredient(s): | 400 mg/1 & nbsp; ceftibuten dihydrate |
| Administration Route(s): | ORAL |
| Dosage Form(s): | CAPSULE |
| Coding System: | National Drug Codes(NDC) |
| Product NDC: | 65224-800 |
| Labeler Name: | Pernix Therapeutics, LLC |
| Product Type: | HUMAN PRESCRIPTION DRUG |
| FDA Application Number: | NDA050685 |
| Marketing Category: | NDA |
| Start Marketing Date: | 19951220 |
| Package NDC: | 65224-800-99 |
| Package Description: | 1 CAPSULE in 1 POUCH (65224-800-99) |
| NDC Code | 65224-800-99 |
| Proprietary Name | CEDAX |
| Package Description | 1 CAPSULE in 1 POUCH (65224-800-99) |
| Product NDC | 65224-800 |
| Product Type Name | HUMAN PRESCRIPTION DRUG |
| Non Proprietary Name | ceftibuten dihydrate |
| Dosage Form Name | CAPSULE |
| Route Name | ORAL |
| Start Marketing Date | 19951220 |
| Marketing Category Name | NDA |
| Labeler Name | Pernix Therapeutics, LLC |
| Substance Name | CEFTIBUTEN DIHYDRATE |
| Strength Number | 400 |
| Strength Unit | mg/1 |
| Pharmaceutical Classes | Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] |