Naropin Injection, Solution
Product Images NDC 0404-9924

14 FDA label images from Henry Schein, Inc. · Packaging, Regulatory Labels, and Product Appearance

Product Visual Gallery

This gallery contains 14 technical images submitted to the FDA as part of the official labeling for Naropin (NDC 0404-9924). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Henry Schein, Inc., these visuals offer a comprehensive scientific overview of the product's physical and chemical identity, aiding pharmacists and researchers in product verification and study.

FDA Label Image

Formula.jpg (Formula1)

Formula.jpg (Formula1)
Chemical structure diagram of ropivacaine hydrochloride, showing its molecular formula C17H26N2O·HCl·H2O and molecular weight of 328.89.*
FDA Label Image

Image1.jpg (Image1)

Image1.jpg (Image1)
A pharmacokinetic data table comparing ropivacaine hydrochloride dosing and parameters for NAROPIN 5 mg/mL injection by various administration routes. Columns show routes including epidural infusion, epidural block, plexus block, and IV infusion. Rows list dose (mg), sample size (N), maximum concentration (Cmax mg/L), time to max concentration (Tmax min), area under curve (AUC mg·h/L), clearance (CL L/h), and half-life (t1/2 hours) with associated values and variability for each route.*
FDA Label Image

Image10.jpg (Image10)

Image10.jpg (Image10)
A dosage recommendations table titled 'Table 7' for NAROPIN (ropivacaine hydrochloride) injection solution. The table provides detailed dosing guidelines for surgical anesthesia, labor pain management, and postoperative pain management. It lists concentrations, volumes, doses, onset times, and durations for various administration routes including lumbar epidural, thoracic epidural, major nerve block, field block, continuous infusion, and infiltration. Footnotes clarify dose adjustments and infusion details.*
FDA Label Image

Image11.jpg (Image11)

Image11.jpg (Image11)
A data table listing multiple product codes, units of sale, strengths, and vial sizes for various concentrations of a drug, including 0.2%, 0.5%, 0.75%, and 1%. The table specifies NDC numbers, packaging configurations such as units of 5 or 25, and vial volumes ranging from 10 mL to 30 mL single dose vials.*
FDA Label Image

Image12.jpg (Image12)

Image12.jpg (Image12)
A table presenting product codes, unit of sale, strength, and package details for infusion bottles of an unidentified drug. It lists NDC codes, quantities sold, strengths in percentages and mg/mL, and package types including 100 mL and 200 mL single dose infusion bottles.*
FDA Label Image

Image2.jpg (Image2)

Image2.jpg (Image2)
A table titled 'Labor and Delivery Meta-Analysis: Mode of Delivery' comparing delivery modes between Naropin and Bupivacaine groups. It details counts and percentages for spontaneous vertex, vacuum extractor, forceps, and cesarean section deliveries in each group, with sample sizes of 199 for Naropin and 188 for Bupivacaine. A note indicates a statistical significance (p=0.004) versus Bupivacaine.*
FDA Label Image

Image3.jpg (Image3)

Image3.jpg (Image3)
A table summarizing uses of ropivacaine hydrochloride injection for surgical anesthesia and acute pain management. It lists indications such as epidural block for surgery including cesarean section, major nerve block, local infiltration, and epidural continuous infusion or intermittent bolus for postoperative or labor pain management.*
FDA Label Image

Image4.jpg (Image4)

Image4.jpg (Image4)
A data table listing drug classes and examples. Classes include Nitrates/Nitrites, Local anesthetics, Antineoplastic agents, Antibiotics, Antimalarials, Anticonvulsants, and Other drugs, with examples such as ropivacaine under Local anesthetics.*
FDA Label Image

Image5.jpg (Image5)

Image5.jpg (Image5)
A data table comparing adverse reactions between Naropin and Bupivacaine. The table lists reactions such as hypotension, nausea, vomiting, bradycardia, headache, and others, with columns showing the number and percentage of patients experiencing each reaction for Naropin (N=1661) and Bupivacaine (N=1433).*
FDA Label Image

Image6.jpg (Image6)

Image6.jpg (Image6)
A data table comparing adverse reactions between Naropin and Bupivacaine based on total cases (Naropin N=639, Bupivacaine N=573). It lists various neonatal and fetal conditions such as fetal bradycardia, neonatal jaundice, and neonatal hypoglycemia, with the number of occurrences and percentages for each drug group.*
FDA Label Image

Image7.jpg (Image7)

Image7.jpg (Image7)
This table presents adverse reaction data for Naropin (ropivacaine hydrochloride) at strengths 5 mg/mL, 7.5 mg/mL, and 10 mg/mL, compared with Bupivacaine at 5 mg/mL and 7.5 mg/mL. It lists reactions such as hypotension, nausea, bradycardia, and back pain, showing the number and percentage of occurrences in each group.*
FDA Label Image

Image8.jpg (Image8)

Image8.jpg (Image8)
A data table comparing Naropin (ropivacaine hydrochloride) and Bupivacaine at various concentrations (5 mg/mL, 7.5 mg/mL, 10 mg/mL). The table presents the number and percentage of patients by age groups (<65 and ≥65) for each drug and concentration.*
FDA Label Image

Image9.jpg (Image9)

Image9.jpg (Image9)
A table presenting adverse reactions by gender for Naropin (ropivacaine hydrochloride) injection. It lists several adverse reactions with corresponding counts (N) and percentages for females and males, showing hypotension, nausea, bradycardia, vomiting, back pain, headache, chills, fever, pruritus, pain, urinary retention, dizziness, hypoesthesia, and paresthesia.*
FDA Label Image

Label1.jpg (Label1)

Label1.jpg (Label1)
NAROPIN 0.5% (ropivacaine hydrochloride) injection, USP, 5 mg/mL, 30 mL single dose vial label. Indicated for infiltration, nerve block, and epidural administration only. Contains no preservatives. Packaged by Henry Schein, Inc., Bastian, VA. Includes storage instruction at 20 to 25°C and barcodes with lot and expiration placeholders.*

* About these descriptions: Image descriptions on this page are generated by automated AI analysis of the product label images from the manufacturer's FDA label submission (SPL). They are provided for reference only and may contain errors or omissions. Always rely on the printed label itself and the official FDA labeling, and consult a pharmacist or healthcare professional with any questions about this product.