Ropivacaine Hydrochloride Injection
NDC Package 72485-519-10

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. Frequently Asked Questions

Package Information

Ropivacaine Hydrochloride injection is ropivacaine Hydrochloride 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 infiltrationAcute Pain Management: epidural continuous infusion or intermittent bolus, e.g., postoperative or labor; local infiltration. This formulation utilizes a injection delivery system. Marketed by Armas Pharmaceuticals Inc., this product is identified by NDC 72485-519 and is authorized under FDA application ANDA212808.

Identification & Billing

NDC Package Code
72485-519-10
Package Description
10 VIAL, SINGLE-DOSE in 1 CARTON / 30 mL in 1 VIAL, SINGLE-DOSE (72485-519-01)
Product Code
72485-519
11-Digit Billing Format
72485051910
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Ropivacaine Hydrochloride
Non-Proprietary Name
Ropivacaine Hydrochloride
Substance Name
Ropivacaine Hydrochloride
Dosage Form
Injection - A sterile preparation intended for parenteral use; five distinct classes of injections exist as defined by the USP.
Administration Route
  • Epidural - Administration upon or over the dura mater.
  • Infiltration - Administration that results in substances passing into tissue spaces or into cells.
  • Perineural - Administration surrounding a nerve or nerves.
Active Ingredient(s)
ROPIVACAINE HYDROCHLORIDE 150 mg/30mL
Pharmacologic Class
Usage Information
Ropivacaine Hydrochloride 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 infiltrationAcute Pain Management: epidural continuous infusion or intermittent bolus, e.g., postoperative or labor; local infiltration

Regulatory & Marketing

Labeler Name
Armas Pharmaceuticals Inc.
Product Type
Human Prescription Drug
FDA Application #
ANDA212808
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
06-01-2026
Listing Expiration
12-31-2027
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.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 72485-519-10 identifies a specific commercial package of 10 vial, single-dose in 1 carton / 30 ml in 1 vial, single-dose (72485-519-01) of Ropivacaine Hydrochloride, a human prescription drug labeled by Armas Pharmaceuticals Inc.. This injection is formulated for epidural; infiltration; perineural 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 Armas Pharmaceuticals Inc. on June 01, 2026. The current certification is valid through December 31, 2027.

How is this Armas Pharmaceuticals Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 72485051910. 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)
72485-519-10
11-Digit CMS (5-4-2)
72485-0519-10

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