| NDC Code | 65145-109-10 |
| Package Description | 10 VIAL in 1 CARTON (65145-109-10) / 30 mL in 1 VIAL (65145-109-01) |
| Product NDC | 65145-109 |
| Product Type Name | HUMAN PRESCRIPTION DRUG |
| Proprietary Name | Ropivacaine Hydrochloride |
| Non-Proprietary Name | Ropivacaine Hydrochloride |
| Dosage Form | INJECTION |
| Usage | EPIDURAL; INFILTRATION; PERINEURAL |
| Start Marketing Date | 20250624 |
| Marketing Category Name | ANDA |
| Application Number | ANDA212808 |
| Manufacturer | Caplin Steriles Limited |
| Substance Name | ROPIVACAINE HYDROCHLORIDE |
| Strength | 5 |
| Strength Unit | mg/mL |
| Pharmacy Classes | Amide Local Anesthetic [EPC], Amides [CS], Local Anesthesia [PE] |