Habitrol Nicotine Polacrilex Gum 2 Mg Coated Mint Gum, Chewing
NDC Package 75907-302-80

11-digit billing NDC: 75907030280
Table of Contents
    1. Package Information
    2. Other Packages
    3. Frequently Asked Questions

Package Information

Habitrol Nicotine Polacrilex Gum 2 Mg Coated Mint (nicotine polacrilex) gums is if you are under 18 years of age, ask a doctor before usebefore using this product, read the enclosed User's Guide for complete directions and other important information begin using the gum on your quit day if you smoke your first cigarette within 30 minutes of waking up, use 4 mg nicotine gum if you smoke your first cigarette more than 30 minutes after waking up, use 2 mg nicotine gum according to the following 12 week schedule: Weeks 1 to 6 Weeks 7 to 9 Weeks 10 to 12 1 piece every 1 to 2 hours1 piece every 2 to 4 hours1 piece every 4 to 8 hoursnicotine gum is a medicine and must be used a certain way to get the best results chew the gum slowly until it tingles. This formulation utilizes a gum, chewing delivery system. Marketed by Dr. Reddy's Laboratories Inc., this product is identified by NDC 75907-302 and is authorized under FDA application ANDA078699.

Identification & Billing

NDC Package Code
75907-302-80
Package Description
8 BLISTER PACK in 1 CARTON / 10 GUM, CHEWING in 1 BLISTER PACK
Product Code
75907-302
11-Digit Billing Format
75907030280
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Habitrol Nicotine Polacrilex Gum 2 Mg Coated Mint
Non-Proprietary Name
Nicotine Polacrilex
Substance Name
Nicotine
Dosage Form
Gum, Chewing - A sweetened and flavored insoluble plastic material of various shapes which when chewed, releases a drug substance into the oral cavity.
Administration Route
Buccal - Administration directed toward the cheek, generally from within the mouth.
Active Ingredient(s)
NICOTINE 2 mg/1
Pharmacologic Class
Usage Information
If you are under 18 years of age, ask a doctor before usebefore using this product, read the enclosed User's Guide for complete directions and other important information begin using the gum on your quit day if you smoke your first cigarette within 30 minutes of waking up, use 4 mg nicotine gum if you smoke your first cigarette more than 30 minutes after waking up, use 2 mg nicotine gum according to the following 12 week schedule: Weeks 1 to 6 Weeks 7 to 9 Weeks 10 to 12 1 piece every 1 to 2 hours1 piece every 2 to 4 hours1 piece every 4 to 8 hoursnicotine gum is a medicine and must be used a certain way to get the best results chew the gum slowly until it tingles. Then park it between your cheek and gum. When the tingle is gone, begin chewing again, until the tingle returns. repeat this process until most of the tingle is gone (about 30 minutes) do not eat or drink for 15 minutes before chewing the nicotine gum, or while chewing a piece to improve your chances of quitting, use at least 9 pieces per day for the first 6 weeks if you experience strong or frequent cravings, you may use a second piece within the hour. However, do not continuously use one piece after another since this may cause you hiccups, heartburn, nausea or other side effects. do not use more than 24 pieces a day it is important to complete treatment. If you feel you need to use the gum for a longer period to keep from smoking, talk to your health care provider

Regulatory & Marketing

Labeler Name
Dr. Reddy's Laboratories Inc.
Product Type
Human Otc Drug
FDA Application #
ANDA078699
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
06-12-2025
Listing Expiration
12-31-2027
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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (75907-302). Click a package code to view its specific billing and regulatory data.

75907-302-10
10 GUM, CHEWING in 1 BLISTER PACK
75907-302-15
15 BLISTER PACK in 1 CARTON / 10 GUM, CHEWING in 1 BLISTER PACK

* 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 75907-302-80 identifies a specific commercial package of 8 blister pack in 1 carton / 10 gum, chewing in 1 blister pack of Habitrol Nicotine Polacrilex Gum 2 Mg Coated Mint, a human over the counter drug labeled by Dr. Reddy's Laboratories Inc.. This gum, chewing is formulated for buccal 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 Dr. Reddy's Laboratories Inc. on June 12, 2025. The current certification is valid through December 31, 2027.

How is this Dr. Reddy's Laboratories Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 75907030280. 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)
75907-302-80
11-Digit CMS (5-4-2)
75907-0302-80

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