NDC Package 0143-9335-10 Bupivacaine Hydrochloride

Injection, Solution Epidural; Retrobulbar - View Billable Units, 11-Digit Format, RxNorm

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:
0143-9335-10
Package Description:
10 VIAL, SINGLE-DOSE in 1 CARTON / 30 mL in 1 VIAL, SINGLE-DOSE (0143-9335-01)
Product Code:
Proprietary Name:
Bupivacaine Hydrochloride
Non-Proprietary Name:
Bupivacaine Hydrochloride
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, dental and 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 (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, 5.5, 5.7, 5.9)].
11-Digit NDC Billing Format:
00143933510
Billing Unit:
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
NDC to RxNorm Crosswalk:
  • RxCUI: 1724786 - BUPivacaine HCl 0.75 % in 30 ML Injection
  • RxCUI: 1724786 - 30 ML bupivacaine hydrochloride 7.5 MG/ML Injection
  • RxCUI: 1724786 - bupivacaine HCl 0.75 % in 30 ML Injection
  • RxCUI: 1724786 - bupivacaine HCl 225 MG per 30 ML Injection
  • RxCUI: 1724787 - BUPivacaine HCl 0.75 % in 10 ML Injection
  • Product Type:
    Human Prescription Drug
    Labeler Name:
    Hikma Pharmaceuticals Usa Inc.
    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):
  • Epidural - Administration upon or over the dura mater.
  • Retrobulbar - Administration behind the pons or behind the eyeball.
  • Sample Package:
    No
    FDA Application Number:
    ANDA204842
    Marketing Category:
    ANDA - A product marketed under an approved Abbreviated New Drug Application.
    Start Marketing Date:
    02-11-2021
    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 0143-9335-10?

    The NDC Packaged Code 0143-9335-10 is assigned to a package of 10 vial, single-dose in 1 carton / 30 ml in 1 vial, single-dose (0143-9335-01) of Bupivacaine Hydrochloride, a human prescription drug labeled by Hikma Pharmaceuticals Usa Inc.. The product's dosage form is injection, solution and is administered via epidural; retrobulbar form.

    Is NDC 0143-9335 included in the NDC Directory?

    Yes, Bupivacaine Hydrochloride with product code 0143-9335 is active and included in the NDC Directory. The product was first marketed by Hikma Pharmaceuticals Usa Inc. on February 11, 2021 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 NDC billing unit for package 0143-9335-10?

    The contents of this package are billed per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.

    What is the 11-digit format for NDC 0143-9335-10?

    The 11-digit format is 00143933510. 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 4-4-2 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
    4-4-20143-9335-105-4-200143-9335-10