Bupivacaine Hydrochloride Injection, Solution
NDC Package 55154-6970-5

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 is indicated 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 Cardinal Health 107, Llc, this product is identified by NDC 55154-6970 and is authorized under FDA application ANDA070583.

Identification & Billing

NDC Package Code
55154-6970-5
Package Description
5 VIAL, SINGLE-DOSE in 1 BAG / 30 mL in 1 VIAL, SINGLE-DOSE
Product Code
55154-6970
11-Digit Billing Format
55154697005
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 is indicated 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. Only the 0.25% and 0.5% concentrations are indicated for obstetrical anesthesia. (See WARNINGS.)Experience with nonobstetrical surgical procedures in pregnant patients is not sufficient to recommend use of 0.75% concentration of Bupivacaine Hydrochloride in these patients.Bupivacaine Hydrochloride is not recommended for intravenous regional anesthesia (Bier Block). (See WARNINGS.) The routes of administration and indicated Bupivacaine Hydrochloride concentrations are:•local infiltration 0.25%•peripheral nerve block 0.25% and 0.5%•retrobulbar block 0.75%•sympathetic block 0.25%•lumbar epidural0.25%, 0.5%, and 0.75% (0.75% not for obstetrical anesthesia)•caudal0.25% and 0.5%•epidural test dose0.5% with epinephrine 1:200,000•dental blocks0.5% with epinephrine 1:200,000(See DOSAGE AND ADMINISTRATION for additional information.)Standard textbooks should be consulted to determine the accepted procedures and techniques for the administration of Bupivacaine Hydrochloride.

Regulatory & Marketing

Labeler Name
Cardinal Health 107, 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
01-06-2010
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 55154-6970-5 identifies a specific commercial package of 5 vial, single-dose in 1 bag / 30 ml in 1 vial, single-dose of Bupivacaine Hydrochloride, a human prescription drug labeled by Cardinal Health 107, 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 Cardinal Health 107, Llc on January 06, 2010. The current certification is valid through December 31, 2027.

How is this Cardinal Health 107, Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 55154697005. 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 (5-4-1)
55154-6970-5
11-Digit CMS (5-4-2)
55154-6970-05

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