| Product NDC: | 44009-802 |
| Proprietary Name: | Cefditoren Pivoxil |
| Non Proprietary Name: | cefditoren pivoxil |
| Active Ingredient(s): | 400 mg/1 & nbsp; cefditoren pivoxil |
| Administration Route(s): | ORAL |
| Dosage Form(s): | TABLET, FILM COATED |
| Coding System: | National Drug Codes(NDC) |
| Product NDC: | 44009-802 |
| Labeler Name: | Pharma RomLev Inc. |
| Product Type: | HUMAN PRESCRIPTION DRUG |
| FDA Application Number: | NDA021222 |
| Marketing Category: | NDA |
| Start Marketing Date: | 20100101 |
| Package NDC: | 44009-802-28 |
| Package Description: | 28 TABLET, FILM COATED in 1 BLISTER PACK (44009-802-28) |
| NDC Code | 44009-802-28 |
| Proprietary Name | Cefditoren Pivoxil |
| Package Description | 28 TABLET, FILM COATED in 1 BLISTER PACK (44009-802-28) |
| Product NDC | 44009-802 |
| Product Type Name | HUMAN PRESCRIPTION DRUG |
| Non Proprietary Name | cefditoren pivoxil |
| Dosage Form Name | TABLET, FILM COATED |
| Route Name | ORAL |
| Start Marketing Date | 20100101 |
| Marketing Category Name | NDA |
| Labeler Name | Pharma RomLev Inc. |
| Substance Name | CEFDITOREN PIVOXIL |
| Strength Number | 400 |
| Strength Unit | mg/1 |
| Pharmaceutical Classes | Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] |