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NDC 63323-0288-29 Naropin 10 mg/mL Details
Naropin 10 mg/mL
Naropin is a EPIDURAL 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 | 63323-0288 |
|---|---|
| Product ID | 63323-288_5e96a969-4311-40c8-a7fc-7859426b9ae2 |
| Associated GPIs | 69100070102040 |
| GCN Sequence Number | 028223 |
| GCN Sequence Number Description | ropivacaine HCl/PF AMPUL 10 MG/ML INJECTION |
| HIC3 | H0A |
| HIC3 Description | LOCAL ANESTHETICS |
| GCN | 46087 |
| 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 |
| Active Ingredient Strength | 10 |
| 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 63323-0288-29 (63323028829)
| NDC Package Code | 63323-288-29 |
|---|---|
| Billing NDC | 63323028829 |
| Package | 25 VIAL, SINGLE-DOSE in 1 CARTON (63323-288-29) / 20 mL in 1 VIAL, SINGLE-DOSE (63323-288-23) |
| Marketing Start Date | 2009-08-04 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |