| NDC Code | 0143-9297-01 |
| Package Description | 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL (0143-9297-01) |
| Product NDC | 0143-9297 |
| Product Type Name | HUMAN PRESCRIPTION DRUG |
| Proprietary Name | Dantrolene |
| Non-Proprietary Name | Dantrolene |
| Dosage Form | INJECTION, POWDER, FOR SOLUTION |
| Usage | INTRAVENOUS |
| Start Marketing Date | 20170619 |
| Marketing Category Name | ANDA |
| Application Number | ANDA204762 |
| Manufacturer | Hikma Pharmaceuticals USA Inc. |
| Substance Name | DANTROLENE SODIUM |
| Strength | 20 |
| Strength Unit | mg/1 |
| Pharmacy Classes | Decreased Striated Muscle Contraction [PE], Decreased Striated Muscle Tone [PE], Skeletal Muscle Relaxant [EPC] |