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  5. NDC Package Code: 51662-1638-3 Bupivacaine Hydrochloride Injection, Solution

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

Injection, Solution Perineural - View Billable Units, 11-Digit Format, RxNorm

Table of Contents

    1. Package Information
    2. Frequently Asked Questions

Package Information

Find all the important details about this NDC Package code, including the 11-Digit NDC Billing number, billing units, wholesale price, RxNorm crosswalk, active ingredients, pharmacologic clasess, etc.

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
Proprietary Name:
Bupivacaine Hydrochloride Injection, Solution
Non-Proprietary Name:
Bupivacaine Hydrochloride Injection, Solution
Substance Name:
Bupivacaine Hydrochloride
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].
11-Digit NDC Billing Format:
51662163803
NDC to RxNorm Crosswalk:
  • RxCUI: 1012404 - BUPivacaine HCl 0.5 % Injectable Solution
  • RxCUI: 1012404 - bupivacaine hydrochloride 5 MG/ML Injectable Solution
  • RxCUI: 1012404 - bupivacaine hydrochloride 0.5 % Injectable Solution
    • Product Type:
    Human Prescription Drug
    Labeler Name:
    Hf Acquisition Co Llc, Dba Healthfirst
    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(s):
  • Perineural - Administration surrounding a nerve or nerves.
    • Active Ingredient(s):
  • BUPIVACAINE HYDROCHLORIDE 5 mg/mL
    • Pharmacologic Class(es):
  • Amide Local Anesthetic - [EPC] (Established Pharmacologic Class)
  • Amides - [CS]
  • Local Anesthesia - [PE] (Physiologic Effect)
    • Sample Package:
    No
    FDA Application Number:
    ANDA207183
    Marketing Category:
    ANDA - A product marketed under an approved Abbreviated New Drug Application.
    Start Marketing Date:
    05-13-2016
    Listing Expiration Date:
    12-31-2025
    Exclude Flag:
    N
    Code Structure:

    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 disclaimer below.

    Frequently Asked Questions

    What is NDC 51662-1638-3?

    The NDC Packaged Code 51662-1638-3 is assigned to a 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. The product's dosage form is injection, solution and is administered via perineural form.

    Is NDC 51662-1638 included in the NDC Directory?

    Yes, Bupivacaine Hydrochloride Injection, Solution with product code 51662-1638 is active and included in the NDC Directory. The product was first marketed by Hf Acquisition Co Llc, Dba Healthfirst on May 13, 2016 and its listing in the NDC Directory is set to expire on December 31, 2025 if the product is not updated or renewed by the manufacturer.

    What is the 11-digit format for NDC 51662-1638-3?

    The 11-digit format is 51662163803. The 11-digit billing format might be required by the Centers for Medicare & Medicaid Services (CMS) and other payers in billing claim forms.

    This package code is originally configured in a 5-4-1 segment 10-digit format and by adding a zero within the original NDC package code we can obtain the converted 11-digit format in a 5-4-2 segment configuration. The table below shows the 11-digit code conversion:

    10-Digit Format10-Digit Original Code11-Digit Format11-Digit Code
    5-4-151662-1638-35-4-251662-1638-03