| NDC Code | 54868-4191-1 |
|---|
| Package Description | 1 BLISTER PACK in 1 BOTTLE, DISPENSING (54868-4191-1) > 14 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK |
|---|
| Product NDC | 54868-4191 |
|---|
| Product Type Name | HUMAN PRESCRIPTION DRUG |
|---|
| Proprietary Name | Biaxin |
|---|
| Non-Proprietary Name | Clarithromycin |
|---|
| Dosage Form | TABLET, FILM COATED, EXTENDED RELEASE |
|---|
| Usage | ORAL |
|---|
| Start Marketing Date | 20001103 |
|---|
| Marketing Category Name | NDA |
|---|
| Application Number | NDA050775 |
|---|
| Manufacturer | Physicians Total Care, Inc. |
|---|
| Substance Name | CLARITHROMYCIN |
|---|
| Strength | 500 |
|---|
| Strength Unit | mg/1 |
|---|
| Pharmacy Classes | Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 3A Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] |
|---|