Bupivacaine Hydrochloride Injection, Solution
NDC Package 85766-074-01

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

Package Information

Bupivacaine Hydrochloride injection is /Bupivacaine Hydrochloride and Epinephrine Injection is indicated in adults for the production of local or regional anesthesia or analgesia for surgery, dental and oral surgery procedures, diagnostic and therapeutic procedures, and for obstetrical procedures. This formulation utilizes a injection, solution delivery system. Marketed by Sportpharm Llc, this product is identified by NDC 85766-074 and is authorized under FDA application ANDA070583.

Identification & Billing

NDC Package Code
85766-074-01
Package Description
25 VIAL, SINGLE-DOSE in 1 TRAY / 10 mL in 1 VIAL, SINGLE-DOSE (85766-074-25)
Product Code
85766-074
11-Digit Billing Format
85766007401
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Bupivacaine Hydrochloride
Non-Proprietary Name
Bupivacaine Hydrochloride
Substance Name
Bupivacaine 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.
  • Intracaudal - Administration within the cauda equina.
  • Perineural - Administration surrounding a nerve or nerves.
Active Ingredient(s)
BUPIVACAINE HYDROCHLORIDE 2.5 mg/mL
Pharmacologic Class
Usage Information
Bupivacaine Hydrochloride Injection/Bupivacaine Hydrochloride and Epinephrine Injection is indicated in adults for the production of local or regional anesthesia or analgesia for surgery, dental and oral surgery procedures, diagnostic and therapeutic procedures, and for obstetrical procedures. Specific concentrations and presentations of Bupivacaine Hydrochloride Injection/Bupivacaine Hydrochloride and Epinephrine Injection are recommended for each type of block indicated to produce local or regional anesthesia or analgesia [see Dosage and Administration (2.2)].

Regulatory & Marketing

Labeler Name
Sportpharm Llc
Product Type
Human Prescription Drug
FDA Application #
ANDA070583
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
05-06-2005
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 85766-074-01 identifies a specific commercial package of 25 vial, single-dose in 1 tray / 10 ml in 1 vial, single-dose (85766-074-25) of Bupivacaine Hydrochloride, a human prescription drug labeled by Sportpharm Llc. This injection, solution is formulated for epidural; infiltration; intracaudal; perineural use and contains bupivacaine 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 Sportpharm Llc on May 06, 2005. The current certification is valid through December 31, 2027.

How is this Sportpharm Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 85766007401. 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)
85766-074-01
11-Digit CMS (5-4-2)
85766-0074-01

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