Marcaine With Epinephrine Injection, Solution
NDC Package 0404-9908-30

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

Package Information

Marcaine With Epinephrine (bupivacaine hydrochloride and epinephrine bitartrate) injection is mARCAINE 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 Henry Schein, Inc., this product is identified by NDC 0404-9908 and is authorized under FDA application NDA016964.

Identification & Billing

NDC Package Code
0404-9908-30
Package Description
1 VIAL, SINGLE-DOSE in 1 BAG / 30 mL in 1 VIAL, SINGLE-DOSE
Product Code
0404-9908
11-Digit Billing Format
00404990830
RxNorm Crosswalk
  • RxCUI: 1867596 - BUPivacaine HCl 0.25 % / EPINEPHrine 1:200,000 in 30 ML Injection
  • RxCUI: 1867596 - 30 ML bupivacaine hydrochloride 2.5 MG/ML / epinephrine 0.005 MG/ML Injection
  • RxCUI: 1867596 - bupivacaine HCl 0.25 % / epinephrine 1:200,000 per 30 ML Injection

Clinical Specifications

Proprietary Name
Marcaine With Epinephrine
Non-Proprietary Name
Bupivacaine Hydrochloride And Epinephrine Bitartrate
Substance Name
Bupivacaine Hydrochloride; Epinephrine Bitartrate
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)
Pharmacologic Class
Usage Information
MARCAINE 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 MARCAINE in these patients.MARCAINE is not recommended for intravenous regional anesthesia (Bier Block). See WARNINGS.The routes of administration and indicated MARCAINE 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 MARCAINE.

Regulatory & Marketing

Labeler Name
Henry Schein, Inc.
Product Type
Human Prescription Drug
FDA Application #
NDA016964
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
01-13-2022
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.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 0404-9908-30 identifies a specific commercial package of 1 vial, single-dose in 1 bag / 30 ml in 1 vial, single-dose of Marcaine With Epinephrine, a human prescription drug labeled by Henry Schein, Inc.. This injection, solution is formulated for epidural; infiltration; intracaudal; perineural use and contains bupivacaine hydrochloride; epinephrine bitartrate 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 Henry Schein, Inc. on January 13, 2022. The current certification is valid through December 31, 2027.

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

For medical billing and reimbursement, this package follows the 11-digit CMS format: 00404990830. 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)
0404-9908-30
11-Digit CMS (5-4-2)
00404-9908-30

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