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  5. NDC Package Code: 83854-015-25 Ropivacaine Hydrochloride

NDC Package 83854-015-25 Ropivacaine Hydrochloride

Injection, Solution Epidural; Infiltration; Perineural - View Billable Units, 11-Digit Format, RxNorm

Table of Contents

    1. Package Information
    2. Frequently Asked Questions

Package Information

Find all the important details about this NDC Package code, including the 11-Digit NDC Billing number, billing units, wholesale price, RxNorm crosswalk, active ingredients, pharmacologic clasess, etc.

NDC Package Code:
83854-015-25
Package Description:
25 VIAL in 1 CARTON / 20 mL in 1 VIAL (83854-015-01)
Product Code:
83854-015
Proprietary Name:
Ropivacaine Hydrochloride
Non-Proprietary Name:
Ropivacaine Hydrochloride
Substance Name:
Ropivacaine Hydrochloride
Usage Information:
Ropivacaine Hydrochloride Injection 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
11-Digit NDC Billing Format:
83854001525
NDC to RxNorm Crosswalk:
Product Type:
Human Prescription Drug
Labeler Name:
Anthea Pharma Private Limited
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(s):
  • 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 10 mg/mL
Pharmacologic Class(es):
Sample Package:
No
FDA Application Number:
ANDA219883
Marketing Category:
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date:
03-21-2025
Listing Expiration Date:
12-31-2026
Exclude Flag:
N
Code Structure:

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 disclaimer below.

Frequently Asked Questions

What is NDC 83854-015-25?

The NDC Packaged Code 83854-015-25 is assigned to a package of 25 vial in 1 carton / 20 ml in 1 vial (83854-015-01) of Ropivacaine Hydrochloride, a human prescription drug labeled by Anthea Pharma Private Limited. The product's dosage form is injection, solution and is administered via epidural; infiltration; perineural form.

Is NDC 83854-015 included in the NDC Directory?

Yes, Ropivacaine Hydrochloride with product code 83854-015 is active and included in the NDC Directory. The product was first marketed by Anthea Pharma Private Limited on March 21, 2025 and its listing in the NDC Directory is set to expire on December 31, 2026 if the product is not updated or renewed by the manufacturer.

What is the 11-digit format for NDC 83854-015-25?

The 11-digit format is 83854001525. The 11-digit billing format might be required by the Centers for Medicare & Medicaid Services (CMS) and other payers in billing claim forms.

This package code is originally configured in a 5-3-2 segment 10-digit format and by adding a zero within the original NDC package code we can obtain the converted 11-digit format in a 5-4-2 segment configuration. The table below shows the 11-digit code conversion:

10-Digit Format10-Digit Original Code11-Digit Format11-Digit Code
5-3-283854-015-255-4-283854-0015-25