Arestin Powder
NDC Package 65976-100-01

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

Arestin (minocycline hydrochloride) powders is a medication used to treat adult gum disease (periodontitis). This formulation utilizes a powder delivery system. Marketed by Orapharma, Inc., this product is identified by NDC 65976-100 and is authorized under FDA application NDA050781.

Identification & Billing

NDC Package Code
65976-100-01
Package Description
1 POWDER in 1 POUCH
Product Code
65976-100
11-Digit Billing Format
65976010001
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
1 EA
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Arestin
Non-Proprietary Name
Minocycline Hydrochloride
Substance Name
Minocycline Hydrochloride
Dosage Form
Powder - An intimate mixture of dry, finely divided drugs and/or chemicals that may be intended for internal or external use.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
MINOCYCLINE HYDROCHLORIDE 1 mg/1
Pharmacologic Class
Usage Information
This medication is used to treat adult gum disease (periodontitis). Minocycline belongs to a class of drugs known as tetracycline antibiotics. It works by preventing the growth of bacteria. This medication is a powder that your dental professional places into infected tooth pockets. Minocycline is then slowly released over the next several weeks.

Regulatory & Marketing

Labeler Name
Orapharma, Inc.
Product Type
Human Prescription Drug
FDA Application #
NDA050781
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
03-21-2011
Listing Expiration
12-31-2026
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 (65976-100). Click a package code to view its specific billing and regulatory data.

65976-100-12
1 POUCH in 1 BOX / 1 TRAY in 1 POUCH / 12 POWDER in 1 TRAY
65976-100-24
2 POUCH in 1 BOX / 1 TRAY in 1 POUCH / 12 POWDER in 1 TRAY

* 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 65976-100-01 identifies a specific commercial package of 1 powder in 1 pouch of Arestin, a human prescription drug labeled by Orapharma, Inc.. This product is billed for "EA" each discreet unit and contains an estimated amount of 1 billable units per package. This powder is formulated for oral use and contains minocycline hydrochloride 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 Orapharma, Inc. on March 21, 2011. The current certification is valid through December 31, 2026.

What are the primary indications for this medication?

This medication is used to treat adult gum disease (periodontitis). Minocycline belongs to a class of drugs known as tetracycline antibiotics. It works by preventing the growth of bacteria. This medication is a powder that your dental professional places into infected tooth pockets. Minocycline is then slowly released over the next several weeks.

How is this Orapharma, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 65976010001. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 1 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)
65976-100-01
11-Digit CMS (5-4-2)
65976-0100-01

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