Durapren 0.5%
NDC Package 70529-005-01

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.

Durapren 0.5% 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 It3 Medical Llc, this product is identified by NDC 70529-005 and is authorized under FDA application NDA016964.

Identification & Billing

NDC Package Code
70529-005-01
Package Description
1 VIAL, SINGLE-DOSE in 1 PACKAGE / 30 mL in 1 VIAL, SINGLE-DOSE
Product Code
70529-005
11-Digit Billing Format
70529000501
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Durapren 0.5%
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
It3 Medical Llc
FDA Application #
NDA016964
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
03-01-2017
Listing Expiration
12-31-2023
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 70529-005-01 identifies a specific commercial package of 1 vial, single-dose in 1 package / 30 ml in 1 vial, single-dose of Durapren 0.5%, labeled by It3 Medical Llc. 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 It3 Medical Llc on March 01, 2017. The current certification is valid through December 31, 2023.

How is this It3 Medical Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 70529000501. 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)
70529-005-01
11-Digit CMS (5-4-2)
70529-0005-01

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