Marcaine With Epinephrine
NDC Package 54868-3439-0

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
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 inactivated by the FDA.

Marcaine With Epinephrine 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. Marketed by Physicians Total Care, Inc., this product is identified by NDC 54868-3439 and is authorized under FDA application NDA016964.

Identification & Billing

NDC Package Code
54868-3439-0
Package Description
1 VIAL, MULTI-DOSE in 1 CARTON / 50 mL in 1 VIAL, MULTI-DOSE
Product Code
54868-3439
11-Digit Billing Format
54868343900
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
RxNorm Crosswalk
  • RxCUI: 1012377 - BUPivacaine HCl 0.25 % / EPINEPHrine 1:200,000 Injectable Solution
  • RxCUI: 1012377 - bupivacaine hydrochloride 2.5 MG/ML / epinephrine 0.005 MG/ML Injectable Solution
  • RxCUI: 1012377 - bupivacaine hydrochloride 0.25 % / epinephrine (as epinephrine bitartrate) 1:200,000 Injectable Solution
  • RxCUI: 1012381 - Marcaine 0.25 % / EPINEPHrine 1:200,000 Injectable Solution
  • RxCUI: 1012381 - bupivacaine hydrochloride 2.5 MG/ML / epinephrine 0.005 MG/ML Injectable Solution [Marcaine with Epinephrine]

Clinical Specifications

Proprietary Name
Marcaine With Epinephrine
Dosage Form
-
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:∙ local infiltration                                                                                 0.25%∙ peripheral nerve block                                                                      0.25% and 0.5%∙ retrobulbar block                                                                              0.75%∙ sympathetic block                                                                             0.25%∙ lumbar epidural                                                                                 0.25%, 0.5%, and 0.75%                                                                                                          (0.75% not for obstetrical anesthesia)∙ caudal                                                                                               0.25% and 0.5%∙ epidural test dose                                                                              0.5% with epinephrine 1:200,000∙ dental blocks                                                                                     0.5% 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 MARCAINE.

Regulatory & Marketing

Labeler Name
Physicians Total Care, Inc.
FDA Application #
NDA016964
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
05-10-2010
Listing Expiration
12-31-2017
Exclude Flag
I
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 54868-3439-0 identifies a specific commercial package of 1 vial, multi-dose in 1 carton / 50 ml in 1 vial, multi-dose of Marcaine With Epinephrine, labeled by Physicians Total Care, 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 Physicians Total Care, Inc. on May 10, 2010. The current certification is valid through December 31, 2017.

How is this Physicians Total Care, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 54868343900. Quantities are measured in per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.. 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)
54868-3439-0
11-Digit CMS (5-4-2)
54868-3439-00

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