Bupivacaine Hydrochloride And Epinephrine Injection, Solution
NDC Package 0409-9042-01

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

Package Information

Bupivacaine Hydrochloride And Epinephrine injection is 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. This formulation utilizes a injection, solution delivery system. Marketed by Hospira, Inc., this product is identified by NDC 0409-9042 and is authorized under FDA application ANDA071165.

Identification & Billing

NDC Package Code
0409-9042-01
Package Description
10 VIAL, SINGLE-DOSE in 1 CARTON / 10 mL in 1 VIAL, SINGLE-DOSE (0409-9042-11)
Product Code
0409-9042
11-Digit Billing Format
00409904201
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: 1012384 - BUPivacaine HCl 0.5 % / EPINEPHrine 1:200,000 Injectable Solution
  • RxCUI: 1012384 - bupivacaine hydrochloride 5 MG/ML / epinephrine 0.005 MG/ML Injectable Solution

Clinical Specifications

Proprietary Name
Bupivacaine Hydrochloride And Epinephrine
Non-Proprietary Name
Bupivacaine Hydrochloride And Epinephrine
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
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.

Regulatory & Marketing

Labeler Name
Hospira, Inc.
Product Type
Human Prescription Drug
FDA Application #
ANDA071165
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
06-15-2005
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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (0409-9042). Click a package code to view its specific billing and regulatory data.

0409-9042-10
25 VIAL, SINGLE-DOSE in 1 TRAY / 30 mL in 1 VIAL, SINGLE-DOSE (0409-9042-09)
0409-9042-17
25 VIAL, SINGLE-DOSE in 1 TRAY / 30 mL in 1 VIAL, SINGLE-DOSE (0409-9042-16)

* 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 0409-9042-01 identifies a specific commercial package of 10 vial, single-dose in 1 carton / 10 ml in 1 vial, single-dose (0409-9042-11) of Bupivacaine Hydrochloride And Epinephrine, a human prescription drug labeled by Hospira, 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 Hospira, Inc. on June 15, 2005. The current certification is valid through December 31, 2027.

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

For medical billing and reimbursement, this package follows the 11-digit CMS format: 00409904201. 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 (4-4-2)
0409-9042-01
11-Digit CMS (5-4-2)
00409-9042-01

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