Nicotine Polacrilex Powder
NDC Package 61252-3003-4

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

Package Information

This product is an UNFINISHED DRUG part of the official NDC directory. Unfinished drugs include products like active ingredients some of which are used in bulk for further processing or compounding. The FDA requires a list of these drugs manufactured in a U.S. commercial distribution facility.

Nicotine Polacrilex powders is this medication can help you quit smoking by replacing the nicotine in cigarettes. This formulation utilizes a powder delivery system. Marketed by Nicobrand Ltd, this product is identified by NDC 61252-3003.

Identification & Billing

NDC Package Code
61252-3003-4
Package Description
25 kg in 1 DRUM
Product Code
61252-3003
11-Digit Billing Format
61252300304

Clinical Specifications

Proprietary Name
Nicotine Polacrilex
Non-Proprietary Name
Nicotine Polacrilex
Substance Name
Nicotine
Dosage Form
Powder - An intimate mixture of dry, finely divided drugs and/or chemicals that may be intended for internal or external use.
Active Ingredient(s)
NICOTINE 1 kg/kg
Usage Information
This medication can help you quit smoking by replacing the nicotine in cigarettes. The nicotine in tobacco is an important part of cigarette addiction. When you stop smoking, your nicotine levels drop quickly. This drop can cause withdrawal symptoms such as craving tobacco, nervousness, irritability, headache, weight gain, and difficulty concentrating. Stopping smoking is hard and your chance of success is best when you are ready and have made a commitment to quit. Nicotine replacement products are part of a total stop-smoking program that includes behavior change, counseling, and support. Smoking causes lung disease, cancer, and heart disease. Stopping smoking is one of the most important things you can do to improve your health and live longer.

Regulatory & Marketing

Labeler Name
Nicobrand Ltd
Product Type
Bulk Ingredient
Marketing Category
BULK INGREDIENT - A category specifying that a product is marketed as a bulk ingredient.
Start Marketing Date
02-01-1994
Listing Expiration
12-31-2026
Exclude Flag
N
Unfinished Product
Yes
Sample Package
N/A

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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (61252-3003). Click a package code to view its specific billing and regulatory data.

61252-3003-1
5 kg in 1 DRUM
61252-3003-2
10 kg in 1 DRUM
61252-3003-3
20 kg in 1 DRUM
61252-3003-5
5 kg in 1 BOX
61252-3003-6
10 kg in 1 BOX

* 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 61252-3003-4 identifies a specific commercial package of 25 kg in 1 drum of Nicotine Polacrilex (UNFINISHED drug), a bulk ingredient labeled by Nicobrand Ltd. This powder is formulated for use and contains nicotine 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 Nicobrand Ltd on February 01, 1994. The current certification is valid through December 31, 2026.

What are the primary indications for this medication?

This medication can help you quit smoking by replacing the nicotine in cigarettes. The nicotine in tobacco is an important part of cigarette addiction. When you stop smoking, your nicotine levels drop quickly. This drop can cause withdrawal symptoms such as craving tobacco, nervousness, irritability, headache, weight gain, and difficulty concentrating. Stopping smoking is hard and your chance of success is best when you are ready and have made a commitment to quit. Nicotine replacement products are part of a total stop-smoking program that includes behavior change, counseling, and support. Smoking causes lung disease, cancer, and heart disease. Stopping smoking is one of the most important things you can do to improve your health and live longer.

How is this Nicobrand Ltd product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 61252300304. 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)
61252-3003-4
11-Digit CMS (5-4-2)
61252-3003-04

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