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  5. NDC Package Code: 59651-943-01 Lidocaine Hydrochloride

NDC Package 59651-943-01 Lidocaine Hydrochloride

Solution Oral; Topical - 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:
59651-943-01
Package Description:
100 mL in 1 BOTTLE
Product Code:
59651-943
Proprietary Name:
Lidocaine Hydrochloride
Non-Proprietary Name:
Lidocaine Hydrochloride
Substance Name:
Lidocaine Hydrochloride
Usage Information:
Lidocaine Hydrochloride Oral Topical Solution, USP 2% (Viscous) is indicated for the production of topical anesthesia of irritated or inflamed mucous membranes of the mouth and pharynx. It is also useful for reducing gagging during the taking of X-ray pictures and dental impressions.
11-Digit NDC Billing Format:
59651094301
Product Type:
Human Prescription Drug
Labeler Name:
Aurobindo Pharma Limited
Dosage Form:
Solution - A clear, homogeneous liquid1 dosage form that contains one or more chemical substances dissolved in a solvent or mixture of mutually miscible solvents.
Administration Route(s):
  • Oral - Administration to or by way of the mouth.
  • Topical - Administration to a particular spot on the outer surface of the body. The E2B term TRANSMAMMARY is a subset of the term TOPICAL.
Active Ingredient(s):
LIDOCAINE HYDROCHLORIDE 20 mg/mL
Pharmacologic Class(es):
Sample Package:
No
FDA Application Number:
ANDA219759
Marketing Category:
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date:
07-29-2025
Listing Expiration Date:
12-31-2026
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 59651-943-01?

The NDC Packaged Code 59651-943-01 is assigned to a package of 100 ml in 1 bottle of Lidocaine Hydrochloride, a human prescription drug labeled by Aurobindo Pharma Limited. The product's dosage form is solution and is administered via oral; topical form.

Is NDC 59651-943 included in the NDC Directory?

Yes, Lidocaine Hydrochloride with product code 59651-943 is active and included in the NDC Directory. The product was first marketed by Aurobindo Pharma Limited on July 29, 2025 and its listing in the NDC Directory is set to expire on December 31, 2026 if the product is not updated or renewed by the manufacturer.

What is the 11-digit format for NDC 59651-943-01?

The 11-digit format is 59651094301. 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 5-3-2 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
5-3-259651-943-015-4-259651-0943-01