Bupivacaine Hydrochloride And Epinephrine
NDC Package 0404-9828-30

11-digit billing NDC: 00404982830
Table of Contents
    1. Package Information
    2. Frequently Asked Questions

Package Information

This product is EXCLUDED from the official NDC directory because the listing data was discontinued by the firm.

Bupivacaine Hydrochloride And Epinephrine 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. Marketed by Henry Schein, Inc., this product is identified by NDC 0404-9828 and is authorized under FDA application ANDA071165.

Identification & Billing

NDC Package Code
0404-9828-30
Package Description
1 VIAL, SINGLE-DOSE in 1 BAG / 30 mL in 1 VIAL, SINGLE-DOSE
Product Code
0404-9828
11-Digit Billing Format
00404982830

Clinical Specifications

Proprietary Name
Bupivacaine Hydrochloride And Epinephrine
Dosage Form
-
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:(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
Henry Schein, Inc.
FDA Application #
ANDA071165
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
01-09-2022
End Marketing Date
10-05-2026
Listing Expiration
10-05-2026
Exclude Flag
D
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 0404-9828-30 identifies a specific commercial package of 1 vial, single-dose in 1 bag / 30 ml in 1 vial, single-dose of Bupivacaine Hydrochloride And Epinephrine, labeled by Henry Schein, Inc.. This is formulated for use and contains as the active substance.

Is this product currently listed with the FDA?

This product code is currently listed as inactive or excluded from the primary directory. It was introduced to the market by Henry Schein, Inc. on January 09, 2022. The current certification is valid through October 05, 2026.

How is this Henry Schein, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 00404982830. 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)
0404-9828-30
11-Digit CMS (5-4-2)
00404-9828-30

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