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NDC 55150-0198-30 Ropivacaine Hydrochloride 5 mg/mL Details
Ropivacaine Hydrochloride 5 mg/mL
Ropivacaine Hydrochloride is a EPIDURAL; INFILTRATION; PERINEURAL INJECTION, SOLUTION in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Eugia US LLC. The primary component is ROPIVACAINE HYDROCHLORIDE.
Product Information
| NDC | 55150-0198 |
|---|---|
| Product ID | 55150-198_5c702449-8911-42f1-8057-139cef400fb8 |
| Associated GPIs | 69100070102020 |
| GCN Sequence Number | 028220 |
| GCN Sequence Number Description | ropivacaine HCl/PF VIAL 5 MG/ML INJECTION |
| HIC3 | H0A |
| HIC3 Description | LOCAL ANESTHETICS |
| GCN | 46084 |
| HICL Sequence Number | 036674 |
| HICL Sequence Number Description | ROPIVACAINE HCL/PF |
| Brand/Generic | Generic |
| Proprietary Name | Ropivacaine Hydrochloride |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | Ropivacaine Hydrochloride |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | INJECTION, SOLUTION |
| Route | EPIDURAL; INFILTRATION; PERINEURAL |
| Active Ingredient Strength | 5 |
| Active Ingredient Units | mg/mL |
| Substance Name | ROPIVACAINE HYDROCHLORIDE |
| Labeler Name | Eugia US LLC |
| Pharmaceutical Class | Amide Local Anesthetic [EPC], Amides [CS], Local Anesthesia [PE] |
| DEA Schedule | n/a |
| Marketing Category | ANDA |
| Application Number | ANDA205612 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 55150-0198-30 (55150019830)
| NDC Package Code | 55150-198-30 |
|---|---|
| Billing NDC | 55150019830 |
| Package | 25 VIAL, SINGLE-DOSE in 1 CARTON (55150-198-30) / 30 mL in 1 VIAL, SINGLE-DOSE |
| Marketing Start Date | 2016-09-15 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |