Lidocaine Ointment
NDC Package 83008-044-50

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. Frequently Asked Questions

Package Information

Lidocaine ointment is a medication used to help reduce itching and pain from certain skin conditions (such as scrapes, minor skin irritations, insect bites). This formulation utilizes a ointment delivery system. Marketed by Quality Care Products, Llc, this product is identified by NDC 83008-044 and is authorized under FDA application ANDA086724.

Identification & Billing

NDC Package Code
83008-044-50
Package Description
1 JAR in 1 CARTON / 50 g in 1 JAR
Product Code
83008-044
11-Digit Billing Format
83008004450
Billing Unit
GM - Billing unit of "gram" is used when a product is measured by its weight.
Units Per Package
50 GM
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Lidocaine
Non-Proprietary Name
Lidocaine
Substance Name
Lidocaine
Dosage Form
Ointment - A semisolid3 dosage form, usually containing <20% water and volatiles5 and >50% hydrocarbons, waxes, or polyols as the vehicle. This dosage form is generally for external application to the skin or mucous membranes.
Administration Route
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 50 mg/g
Pharmacologic Class
Usage Information
This product is used to help reduce itching and pain from certain skin conditions (such as scrapes, minor skin irritations, insect bites). It may also be used to help relieve nerve pain after shingles (infection with herpes zoster virus). Lidocaine belongs to a class of drugs known as local anesthetics. It works by causing a temporary loss of feeling in the area where you apply the patch.

Regulatory & Marketing

Labeler Name
Quality Care Products, Llc
Product Type
Human Prescription Drug
FDA Application #
ANDA086724
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
06-26-2024
End Marketing Date
02-28-2027
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 83008-044-50 identifies a specific commercial package of 1 jar in 1 carton / 50 g in 1 jar of Lidocaine, a human prescription drug labeled by Quality Care Products, Llc. This product is billed per "GM" gram and contains an estimated amount of 50 billable units per package. This ointment is formulated for topical use and contains lidocaine 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 Quality Care Products, Llc on June 26, 2024.

What are the primary indications for this medication?

This product is used to help reduce itching and pain from certain skin conditions (such as scrapes, minor skin irritations, insect bites). It may also be used to help relieve nerve pain after shingles (infection with herpes zoster virus). Lidocaine belongs to a class of drugs known as local anesthetics. It works by causing a temporary loss of feeling in the area where you apply the patch.

How is this Quality Care Products, Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 83008004450. Quantities are measured in per "gm or gram", products billed per gram are products measured by weight.. There are 50 total billable units per package. 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)
83008-044-50
11-Digit CMS (5-4-2)
83008-0044-50

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