NDC Package 85766-097-30 Ropivacaine Hydrochloride

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

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:
85766-097-30
Package Description:
1 VIAL in 1 CARTON / 30 mL in 1 VIAL
Product Code:
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:
85766009730
NDC to RxNorm Crosswalk:
Product Type:
Human Prescription Drug
Labeler Name:
Sportpharm, Inc. Dba Sportpharm
Dosage Form:
Injection - A sterile preparation intended for parenteral use; five distinct classes of injections exist as defined by the USP.
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.
Sample Package:
No
FDA Application Number:
ANDA207636
Marketing Category:
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date:
06-15-2018
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.

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Frequently Asked Questions

What is NDC 85766-097-30?

The NDC Packaged Code 85766-097-30 is assigned to a package of 1 vial in 1 carton / 30 ml in 1 vial of Ropivacaine Hydrochloride, a human prescription drug labeled by Sportpharm, Inc. Dba Sportpharm. The product's dosage form is injection and is administered via epidural; infiltration; perineural form.

Is NDC 85766-097 included in the NDC Directory?

Yes, Ropivacaine Hydrochloride with product code 85766-097 is active and included in the NDC Directory. The product was first marketed by Sportpharm, Inc. Dba Sportpharm on June 15, 2018 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 85766-097-30?

The 11-digit format is 85766009730. 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
5-3-285766-097-305-4-285766-0097-30