Bupivacaine Hydrochloride Injection, Solution
NDC Package 72603-415-10

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

Package Information

Bupivacaine Hydrochloride injection is indicated in adults 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 Northstar Rxllc, this product is identified by NDC 72603-415 and is authorized under FDA application ANDA217821.

Identification & Billing

NDC Package Code
72603-415-10
Package Description
10 VIAL, SINGLE-DOSE in 1 CARTON / 30 mL in 1 VIAL, SINGLE-DOSE (72603-415-01)
Product Code
72603-415
11-Digit Billing Format
72603041510
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Bupivacaine Hydrochloride
Non-Proprietary Name
Bupivacaine Hydrochloride
Substance Name
Bupivacaine Hydrochloride
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)
BUPIVACAINE HYDROCHLORIDE 2.5 mg/mL
Pharmacologic Class
Usage Information
Bupivacaine hydrochloride injection is indicated in adults 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. Specific concentrations and presentations of bupivacaine hydrochloride injection is recommended for each type of block indicated to produce local or regional anesthesia or analgesia [see  Dosage and Administration (2.2)]. Limitations of Use Not all blocks are indicated for use with bupivacaine hydrochloride injection given clinically significant risks associated with use [see  Dosage and Administration (2.2), Contraindications (4), Warnings and Precautions (5.1, 5.5, 5.7, 5.9)].

Regulatory & Marketing

Labeler Name
Northstar Rxllc
Product Type
Human Prescription Drug
FDA Application #
ANDA217821
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
10-01-2024
Listing Expiration
12-31-2026
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.

Billing & HCPCS Mapping

To facilitate insurance claims and reimbursement, this drug package is mapped to specific HCPCS administrative codes. This crosswalk aligns clinical data with the billing standards used in ASP (Average Sales Price), AWP, and OPPS payment systems. Use the cards below to identify the correct billable units for provider claims.

J0665
Source: PDAC
INJECTION, BUPIVACAINE, NOT OTHERWISE SPECIFIED, 0.5 MG
HCPCS Dosage 0.5 MG
Units / Pkg

Note for Medical Coders: These mappings are synthesized from various CMS datasets including OPPS, PrEP, and DAC (Data Analysis and Coding) contractors. Always confirm unit conversions against the current quarter's pricing files before final submission.

* 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 (72603-415). Click a package code to view its specific billing and regulatory data.

72603-415-25
25 VIAL, SINGLE-DOSE in 1 CARTON / 30 mL in 1 VIAL, SINGLE-DOSE (72603-415-01)

* 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 72603-415-10 identifies a specific commercial package of 10 vial, single-dose in 1 carton / 30 ml in 1 vial, single-dose (72603-415-01) of Bupivacaine Hydrochloride, a human prescription drug labeled by Northstar Rxllc. This injection, solution is formulated for epidural; infiltration; intracaudal; perineural use and contains bupivacaine hydrochloride 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 Northstar Rxllc on October 01, 2024. The current certification is valid through December 31, 2026.

How is this Northstar Rxllc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 72603041510. 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 (5-3-2)
72603-415-10
11-Digit CMS (5-4-2)
72603-0415-10

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