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NDC 63323-0286-20 Naropin 5 mg/mL Details
Naropin 5 mg/mL
Naropin is a EPIDURAL; INFILTRATION; PERINEURAL INJECTION, SOLUTION in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Fresenius Kabi USA, LLC. The primary component is ROPIVACAINE HYDROCHLORIDE.
Product Information
| NDC | 63323-0286 |
|---|---|
| Product ID | 63323-286_5e96a969-4311-40c8-a7fc-7859426b9ae2 |
| Associated GPIs | 69100070102020 |
| GCN Sequence Number | 067674 |
| GCN Sequence Number Description | ropivacaine HCl/PF INFUS. BTL 5 MG/ML INJECTION |
| HIC3 | H0A |
| HIC3 Description | LOCAL ANESTHETICS |
| GCN | 30236 |
| HICL Sequence Number | 036674 |
| HICL Sequence Number Description | ROPIVACAINE HCL/PF |
| Brand/Generic | Brand |
| Proprietary Name | Naropin |
| 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 | Fresenius Kabi USA, LLC |
| Pharmaceutical Class | Amide Local Anesthetic [EPC], Amides [CS], Local Anesthesia [PE] |
| DEA Schedule | n/a |
| Marketing Category | NDA |
| Application Number | NDA020533 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 63323-0286-20 (63323028620)
| NDC Package Code | 63323-286-20 |
|---|---|
| Billing NDC | 63323028620 |
| Package | 5 AMPULE in 1 BOX (63323-286-20) / 20 mL in 1 AMPULE (63323-286-01) |
| Marketing Start Date | 2011-05-31 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |