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  5. NDC Package Code: 70529-008-01 Burapren 0.75%

NDC Package 70529-008-01 Burapren 0.75%

View Billable Units, 11-Digit Format, RxNorm

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.

Find all the important details about this NDC Package code, including the 11-Digit NDC Billing number, billing units, wholesale price, RxNorm crosswalk, active ingredients, pharmacologic clasess, etc.

NDC Package Code:
70529-008-01
Package Description:
1 VIAL, SINGLE-DOSE in 1 PACKAGE / 30 mL in 1 VIAL, SINGLE-DOSE
Product Code:
70529-008
Proprietary Name:
Burapren 0.75%
Usage Information:
Bupivacaine hydrochloride injection, USP is indicated for the production of local or regional anesthesia or analgesia for surgery, 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 injection, USP in these patients.Bupivacaine hydrochloride injection, USP is not recommended for intravenous regional anesthesia (Bier Block). See WARNINGS.The routes of administration and indicated bupivacaine hydrochloride injection, USP 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                      (see PRECAUTIONS)(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 injection, USP.
11-Digit NDC Billing Format:
70529000801
NDC to RxNorm Crosswalk:
  • RxCUI: 1724786 - BUPivacaine HCl 0.75 % in 30 ML Injection
  • RxCUI: 1724786 - 30 ML bupivacaine hydrochloride 7.5 MG/ML Injection
  • RxCUI: 1724786 - bupivacaine HCl 0.75 % in 30 ML Injection
  • RxCUI: 1724786 - bupivacaine HCl 225 MG per 30 ML Injection
    • Labeler Name:
    It3 Medical Llc
    Sample Package:
    No
    Start Marketing Date:
    03-01-2017
    Listing Expiration Date:
    12-31-2023
    Exclude Flag:
    I
    Code Structure:

    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 disclaimer below.

    Frequently Asked Questions

    What is NDC 70529-008-01?

    The NDC Packaged Code 70529-008-01 is assigned to a package of 1 vial, single-dose in 1 package / 30 ml in 1 vial, single-dose of Burapren 0.75%, labeled by It3 Medical Llc. The product's dosage form is and is administered via form.

    Is NDC 70529-008 included in the NDC Directory?

    No, Burapren 0.75% with product code 70529-008 is excluded from the NDC Directory because it's listing has been INACTIVATED by FDA. The product was first marketed by It3 Medical Llc on March 01, 2017 and its listing in the NDC Directory is set to expire on December 31, 2023 if the product is not updated or renewed by the manufacturer.

    What is the 11-digit format for NDC 70529-008-01?

    The 11-digit format is 70529000801. The 11-digit billing format might be required by the Centers for Medicare & Medicaid Services (CMS) and other payers in billing claim forms.

    This package code is originally configured in a 5-3-2 segment 10-digit format and by adding a zero within the original NDC package code we can obtain the converted 11-digit format in a 5-4-2 segment configuration. The table below shows the 11-digit code conversion:

    10-Digit Format10-Digit Original Code11-Digit Format11-Digit Code
    5-3-270529-008-015-4-270529-0008-01