NDC Package 0409-1159-01 Bupivacaine Hydrochloride

Injection, Solution Epidural; Infiltration; Intracaudal; Perineural - View Billable Units, 11-Digit Format, RxNorm

Package Information

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:
0409-1159-01
Package Description:
25 VIAL, SINGLE-DOSE in 1 TRAY / 10 mL in 1 VIAL, SINGLE-DOSE (0409-1159-18)
Product Code:
Proprietary Name:
Bupivacaine Hydrochloride
Non-Proprietary Name:
Bupivacaine Hydrochloride
Substance Name:
Bupivacaine Hydrochloride
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:•local infiltration 0.25%•peripheral nerve block 0.25% and 0.5%•retrobulbar block 0.75%•sympathetic block 0.25%•lumbar epidural0.25%, 0.5%, and 0.75% (0.75% not for obstetrical anesthesia)•caudal0.25% and 0.5%•epidural test dose0.5% with epinephrine 1:200,000•dental blocks0.5% 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 Bupivacaine Hydrochloride.
11-Digit NDC Billing Format:
00409115901
Billing Unit:
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
Product Type:
Human Prescription Drug
Labeler Name:
Hospira, Inc.
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(s):
  • 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.
  • 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.
  • Sample Package:
    No
    FDA Application Number:
    ANDA070583
    Marketing Category:
    ANDA - A product marketed under an approved Abbreviated New Drug Application.
    Start Marketing Date:
    08-11-2015
    Listing Expiration Date:
    12-31-2024
    Exclude Flag:
    N
    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.

    Other Product Packages

    The following packages are also available for this product:

    NDC Package CodePackage Description
    0409-1159-0225 VIAL, SINGLE-DOSE in 1 TRAY / 30 mL in 1 VIAL, SINGLE-DOSE (0409-1159-19)
    0409-1159-1025 VIAL, SINGLE-DOSE in 1 TRAY / 30 mL in 1 VIAL, SINGLE-DOSE (0409-1159-09)

    * Please review the disclaimer below.

    Frequently Asked Questions

    What is NDC 0409-1159-01?

    The NDC Packaged Code 0409-1159-01 is assigned to a package of 25 vial, single-dose in 1 tray / 10 ml in 1 vial, single-dose (0409-1159-18) of Bupivacaine Hydrochloride, a human prescription drug labeled by Hospira, Inc.. The product's dosage form is injection, solution and is administered via epidural; infiltration; intracaudal; perineural form.

    Is NDC 0409-1159 included in the NDC Directory?

    Yes, Bupivacaine Hydrochloride with product code 0409-1159 is active and included in the NDC Directory. The product was first marketed by Hospira, Inc. on August 11, 2015 and its listing in the NDC Directory is set to expire on December 31, 2024 if the product is not updated or renewed by the manufacturer.

    What is the NDC billing unit for package 0409-1159-01?

    The contents of this package are billed per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.

    What is the 11-digit format for NDC 0409-1159-01?

    The 11-digit format is 00409115901. 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 4-4-2 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
    4-4-20409-1159-015-4-200409-1159-01