Bupivacaine Hydrochloride Injection, Solution
NDC Package 83854-005-10

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. 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 Anthea Pharma Private Limited, this product is identified by NDC 83854-005 and is authorized under FDA application ANDA220493.

Identification & Billing

NDC Package Code
83854-005-10
Package Description
10 VIAL in 1 CARTON / 30 mL in 1 VIAL (83854-005-01)
Product Code
83854-005
11-Digit Billing Format
83854000510
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.
  • Retrobulbar - Administration behind the pons or behind the eyeball.
Active Ingredient(s)
BUPIVACAINE HYDROCHLORIDE 7.5 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 UseNot 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, 5.4, 5.5, 5.7, 5.9) ].

Regulatory & Marketing

Labeler Name
Anthea Pharma Private Limited
Product Type
Human Prescription Drug
FDA Application #
ANDA220493
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
04-22-2026
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.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 83854-005-10 identifies a specific commercial package of 10 vial in 1 carton / 30 ml in 1 vial (83854-005-01) of Bupivacaine Hydrochloride, a human prescription drug labeled by Anthea Pharma Private Limited. This injection, solution is formulated for epidural; retrobulbar 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 Anthea Pharma Private Limited on April 22, 2026. The current certification is valid through December 31, 2027.

How is this Anthea Pharma Private Limited product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 83854000510. 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)
83854-005-10
11-Digit CMS (5-4-2)
83854-0005-10

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