| NDC Code | 0054-0064-47 |
| Package Description | 1 BOTTLE, GLASS in 1 CARTON (0054-0064-47) / 50 mL in 1 BOTTLE, GLASS |
| Product NDC | 0054-0064 |
| Product Type Name | HUMAN PRESCRIPTION DRUG |
| Proprietary Name | Ondansetron Hydrochloride |
| Non-Proprietary Name | Ondansetron Hydrochloride |
| Dosage Form | SOLUTION |
| Usage | ORAL |
| Start Marketing Date | 20061226 |
| Marketing Category Name | ANDA |
| Application Number | ANDA076960 |
| Manufacturer | Hikma Pharmaceuticals USA Inc. |
| Substance Name | ONDANSETRON HYDROCHLORIDE |
| Strength | 4 |
| Strength Unit | mg/5mL |
| Pharmacy Classes | Serotonin 3 Receptor Antagonists [MoA], Serotonin-3 Receptor Antagonist [EPC] |