| NDC Code | 68083-596-10 |
|---|
| Package Description | 10 VIAL, SINGLE-DOSE in 1 CARTON (68083-596-10) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-DOSE (68083-596-01) |
|---|
| Product NDC | 68083-596 |
|---|
| Product Type Name | HUMAN PRESCRIPTION DRUG |
|---|
| Proprietary Name | Vancomycin Hydrochloride |
|---|
| Non-Proprietary Name | Vancomycin Hydrochloride |
|---|
| Dosage Form | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION |
|---|
| Usage | INTRAVENOUS |
|---|
| Start Marketing Date | 20250321 |
|---|
| Marketing Category Name | ANDA |
|---|
| Application Number | ANDA218140 |
|---|
| Manufacturer | Gland Pharma Limited |
|---|
| Substance Name | VANCOMYCIN HYDROCHLORIDE |
|---|
| Strength | 1.25 |
|---|
| Strength Unit | g/1 |
|---|
| Pharmacy Classes | Glycopeptide Antibacterial [EPC], Glycopeptides [CS] |
|---|