Bupivacaine Hydrochloride Injection, Solution
NDC Package 51662-1638-3

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, Solution injection is bupivacaine hydrochloride injection is indicated in adults 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 Hf Acquisition Co Llc, Dba Healthfirst, this product is identified by NDC 51662-1638 and is authorized under FDA application ANDA207183.

Identification & Billing

NDC Package Code
51662-1638-3
Package Description
25 POUCH in 1 CASE / 1 VIAL, MULTI-DOSE in 1 POUCH (51662-1638-2) / 50 mL in 1 VIAL, MULTI-DOSE
Product Code
51662-1638
11-Digit Billing Format
51662163803
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Bupivacaine Hydrochloride Injection, Solution
Non-Proprietary Name
Bupivacaine Hydrochloride Injection, Solution
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
Perineural - Administration surrounding a nerve or nerves.
Active Ingredient(s)
BUPIVACAINE HYDROCHLORIDE 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, oral surgery procedures, diagnostic and therapeutic procedures, and for obstetrical procedures. Specific concentrations and presentations of bupivacaine hydrochloride injection are recommended for each type of block indicated to produce local or regional anesthesia or analgesia [see DOSAGE AND ADMINISTRATION]. 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, CONTRAINDICATIONS, WARNINGS AND PRECAUTIONS].

Regulatory & Marketing

Labeler Name
Hf Acquisition Co Llc, Dba Healthfirst
Product Type
Human Prescription Drug
FDA Application #
ANDA207183
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
05-13-2016
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.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 51662-1638-3 identifies a specific commercial package of 25 pouch in 1 case / 1 vial, multi-dose in 1 pouch (51662-1638-2) / 50 ml in 1 vial, multi-dose of Bupivacaine Hydrochloride Injection, Solution, a human prescription drug labeled by Hf Acquisition Co Llc, Dba Healthfirst. This injection, solution is formulated for 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 Hf Acquisition Co Llc, Dba Healthfirst on May 13, 2016. The current certification is valid through December 31, 2026.

How is this Hf Acquisition Co Llc, Dba Healthfirst product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 51662163803. 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 (5-4-1)
51662-1638-3
11-Digit CMS (5-4-2)
51662-1638-03

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