Bupivacaine Hydrochloride Injection, Solution
NDC Package 76420-018-10

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

Package Information

Bupivacaine Hydrochloride injection is 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. This formulation utilizes a injection, solution delivery system. Marketed by Asclemed Usa, Inc., this product is identified by NDC 76420-018 and is authorized under FDA application ANDA203895.

Identification & Billing

NDC Package Code
76420-018-10
Package Description
10 mL in 1 VIAL, SINGLE-DOSE
Product Code
76420-018
11-Digit Billing Format
76420001810
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
Units Per Package
10 ML
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.
Active Ingredient(s)
BUPIVACAINE HYDROCHLORIDE 2.5 mg/mL
Pharmacologic Class
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.

Regulatory & Marketing

Labeler Name
Asclemed Usa, Inc.
Product Type
Human Prescription Drug
FDA Application #
ANDA203895
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
11-05-2013
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.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 76420-018-10 identifies a specific commercial package of 10 ml in 1 vial, single-dose of Bupivacaine Hydrochloride, a human prescription drug labeled by Asclemed Usa, Inc.. This product is billed per "ML" milliliter and contains an estimated amount of 10 billable units per package. This injection, solution is formulated for epidural; infiltration; intracaudal 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 Asclemed Usa, Inc. on November 05, 2013. The current certification is valid through December 31, 2026.

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

For medical billing and reimbursement, this package follows the 11-digit CMS format: 76420001810. Quantities are measured in per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.. There are 10 total billable units per package. 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)
76420-018-10
11-Digit CMS (5-4-2)
76420-0018-10

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