Bupivacaine Hydrochloride With Dextrose Injection
NDC Package 0264-9379-88

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

Package Information

Bupivacaine Hydrochloride With Dextrose 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 B. Braun Medical Inc., this product is identified by NDC 0264-9379 and is authorized under FDA application ANDA209087.

Identification & Billing

NDC Package Code
0264-9379-88
Package Description
10 AMPULE in 1 CARTON / 2 mL in 1 AMPULE
Product Code
0264-9379
11-Digit Billing Format
00264937988
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Bupivacaine Hydrochloride With Dextrose
Non-Proprietary Name
Bupivacaine Hydrochloride With Dextrose
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
B. Braun Medical Inc.
Product Type
Human Prescription Drug
FDA Application #
ANDA209087
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
04-02-2019
Listing Expiration
12-31-2026
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 0264-9379-88 identifies a specific commercial package of 10 ampule in 1 carton / 2 ml in 1 ampule of Bupivacaine Hydrochloride With Dextrose, a human prescription drug labeled by B. Braun Medical Inc.. 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 B. Braun Medical Inc. on April 02, 2019. The current certification is valid through December 31, 2026.

How is this B. Braun Medical Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 00264937988. 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 (4-4-2)
0264-9379-88
11-Digit CMS (5-4-2)
00264-9379-88

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