Naropin Injection, Solution
NDC Package 63323-285-73

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. NDC HCPCS Crosswalk
    3. Other Packages
    4. Frequently Asked Questions

Package Information

Naropin (ropivacaine hydrochloride) injection is nAROPIN is indicated for the production of local or regional anesthesia for surgery and for acute pain management. This formulation utilizes a injection, solution delivery system. Marketed by Fresenius Kabi Usa, Llc, this product is identified by NDC 63323-285 and is authorized under FDA application NDA020533.

Identification & Billing

NDC Package Code
63323-285-73
Package Description
12 BOTTLE in 1 CASE / 200 mL in 1 BOTTLE (63323-285-59)
Product Code
63323-285
11-Digit Billing Format
63323028573
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Naropin
Non-Proprietary Name
Ropivacaine Hydrochloride
Substance Name
Ropivacaine Hydrochloride
Dosage Form
Injection, Solution - A liquid preparation containing one or more drug substances dissolved in a suitable solvent or mixture of mutually miscible solvents that is suitable for injection.
Administration Route
  • Epidural - Administration upon or over the dura mater.
  • Infiltration - Administration that results in substances passing into tissue spaces or into cells.
  • Epidural - Administration upon or over the dura mater.
  • Infiltration - Administration that results in substances passing into tissue spaces or into cells.
  • Epidural - Administration upon or over the dura mater.
  • Infiltration - Administration that results in substances passing into tissue spaces or into cells.
Active Ingredient(s)
Pharmacologic Class
Usage Information
NAROPIN is indicated for the production of local or regional anesthesia for surgery and for acute pain management. Surgical Anesthesia: epidural block for surgery including cesarean section; major nerve block; local infiltration Acute Pain Management: epidural continuous infusion or intermittent bolus, e.g., postoperative or labor; local infiltration

Regulatory & Marketing

Labeler Name
Fresenius Kabi Usa, Llc
Product Type
Human Prescription Drug
FDA Application #
NDA020533
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
08-04-2009
Listing Expiration
12-31-2026
Exclude Flag
N
Sample Package
No

Hierarchy Structure

Code Lineage

The NDC Directory contains ONLY information on final marketed drugs submitted to FDA electronically by labelers. A labeler might be a manufacturer, re-packager or re-labeler. The product information included in the NDC directory does not indicate that FDA has verified the information provided by the product labeler. Assigned NDC numbers are not in any way an indication of FDA approval of the product.

* Please review the full disclaimer at the bottom of this page.

Billing & HCPCS Mapping

To facilitate insurance claims and reimbursement, this drug package is mapped to specific HCPCS administrative codes. This crosswalk aligns clinical data with the billing standards used in ASP (Average Sales Price), AWP, and OPPS payment systems. Use the cards below to identify the correct billable units for provider claims.

J2795
Source: PDAC
INJECTION, ROPIVACAINE HYDROCHLORIDE, 1 MG
HCPCS Dosage 1 MG
Units / Pkg

Note for Medical Coders: These mappings are synthesized from various CMS datasets including OPPS, PrEP, and DAC (Data Analysis and Coding) contractors. Always confirm unit conversions against the current quarter's pricing files before final submission.

* Please review the full disclaimer at the bottom of this page.

Other Available Packages

The following commercial packages are registered under the same Product NDC (63323-285). Click a package code to view its specific billing and regulatory data.

63323-285-10
5 AMPULE in 1 BOX / 10 mL in 1 AMPULE (63323-285-01)
63323-285-13
25 VIAL, SINGLE-DOSE in 1 CARTON / 10 mL in 1 VIAL, SINGLE-DOSE (63323-285-03)
63323-285-20
5 AMPULE in 1 BOX / 20 mL in 1 AMPULE (63323-285-06)
63323-285-23
25 VIAL, SINGLE-DOSE in 1 CARTON / 20 mL in 1 VIAL, SINGLE-DOSE (63323-285-07)
63323-285-28
25 VIAL, SINGLE-USE in 1 CARTON / 20 mL in 1 VIAL, SINGLE-USE (63323-285-41)
63323-285-61
24 BAG in 1 CASE / 100 mL in 1 BAG (63323-285-02)
63323-285-63
24 BAG in 1 CASE / 200 mL in 1 BAG (63323-285-04)
63323-285-64
12 BOTTLE in 1 CASE / 200 mL in 1 BOTTLE (63323-285-57)
63323-285-65
12 BOTTLE in 1 CASE / 100 mL in 1 BOTTLE (63323-285-51)
63323-285-67
12 BOTTLE in 1 CASE / 100 mL in 1 BOTTLE (63323-285-55)
63323-285-68
12 BOTTLE in 1 CASE / 100 mL in 1 BOTTLE (63323-285-53)

* Please review the full disclaimer at the bottom of this page.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 63323-285-73 identifies a specific commercial package of 12 bottle in 1 case / 200 ml in 1 bottle (63323-285-59) of Naropin, a human prescription drug labeled by Fresenius Kabi Usa, Llc. This injection, solution is formulated for epidural; infiltration use and contains ropivacaine hydrochloride as the active substance.

Is this product currently listed with the FDA?

Yes, this product is active and verified within the NDC Directory. It was introduced to the market by Fresenius Kabi Usa, Llc on August 04, 2009. The current certification is valid through December 31, 2026.

How is this Fresenius Kabi Usa, Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 63323028573. Quantities are measured in per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.. The table below illustrates the segment conversion from the 10-digit labeler code to the 11-digit provider format.

11-Digit Code Conversion

Billing payers usually require a 5-4-2 segment configuration. Below is the conversion from the 10-digit package format to the 11-digit billing format:

10-Digit Format (5-3-2)
63323-285-73
11-Digit CMS (5-4-2)
63323-0285-73

Note: The zero is added to the Product segment to maintain the 5-4-2 structure.