Bupivacaine Hydrochloride Injection
NDC Package 71351-022-50

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

Package Information

Bupivacaine Hydrochloride injection is bupivacaine Hydrochloride in Dextrose Injection, USP is indicated for the production of subarachnoid block (spinal anesthesia).Standard textbooks should be consulted to determine the accepted procedures and techniques for the administration of spinal anesthesia. This formulation utilizes a injection delivery system. Marketed by Brookfield Pharmaceuticals, Llc., this product is identified by NDC 71351-022 and is authorized under FDA application ANDA212822.

Identification & Billing

NDC Package Code
71351-022-50
Package Description
50 AMPULE in 1 PACKAGE / 2 mL in 1 AMPULE (71351-022-02)
Product Code
71351-022
11-Digit Billing Format
71351002250
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Bupivacaine Hydrochloride
Non-Proprietary Name
Bupivacaine Hydrochloride
Substance Name
Bupivacaine Hydrochloride
Dosage Form
Injection - A sterile preparation intended for parenteral use; five distinct classes of injections exist as defined by the USP.
Administration Route
Subarachnoid - Administration beneath the arachnoid.
Active Ingredient(s)
BUPIVACAINE HYDROCHLORIDE 7.5 mg/mL
Pharmacologic Class
Usage Information
Bupivacaine Hydrochloride in Dextrose Injection, USP is indicated for the production of subarachnoid block (spinal anesthesia).Standard textbooks should be consulted to determine the accepted procedures and techniques for the administration of spinal anesthesia.

Regulatory & Marketing

Labeler Name
Brookfield Pharmaceuticals, Llc.
Product Type
Human Prescription Drug
FDA Application #
ANDA212822
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
10-31-2022
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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (71351-022). Click a package code to view its specific billing and regulatory data.

71351-022-10
10 AMPULE in 1 PACKAGE / 2 mL in 1 AMPULE (71351-022-02)

* 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 71351-022-50 identifies a specific commercial package of 50 ampule in 1 package / 2 ml in 1 ampule (71351-022-02) of Bupivacaine Hydrochloride, a human prescription drug labeled by Brookfield Pharmaceuticals, Llc.. This injection is formulated for subarachnoid 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 Brookfield Pharmaceuticals, Llc. on October 31, 2022. The current certification is valid through December 31, 2027.

How is this Brookfield Pharmaceuticals, Llc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 71351002250. 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)
71351-022-50
11-Digit CMS (5-4-2)
71351-0022-50

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