Orlistat Capsule
NDC Package 11014-0674-2

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.

Orlistat capsules is a medication used with a doctor-approved exercise, behavior change, and reduced-calorie diet program to help you lose weight. This formulation utilizes a capsule delivery system. Marketed by Catalent Pharma Solutions, Llc, this product is identified by NDC 11014-0674.

Identification & Billing

NDC Package Code
11014-0674-2
Package Description
105 BOTTLE in 1 BOX / 120 CAPSULE in 1 BOTTLE
Product Code
11014-0674
11-Digit Billing Format
11014067402

Clinical Specifications

Proprietary Name
Orlistat
Non-Proprietary Name
Orlistat
Substance Name
Orlistat
Dosage Form
Capsule - A solid oral dosage form consisting of a shell and a filling. The shell is composed of a single sealed enclosure, or two halves that fit together and which are sometimes sealed with a band. Capsule shells may be made from gelatin, starch, or cellulose, or other suitable materials, may be soft or hard, and are filled with solid or liquid ingredients that can be poured or squeezed.
Active Ingredient(s)
ORLISTAT 60 mg/1
Usage Information
This medication is used with a doctor-approved exercise, behavior change, and reduced-calorie diet program to help you lose weight. It is used by certain overweight people, such as those who are obese or have weight-related medical problems. Taking orlistat can also help keep you from gaining back weight you have lost. Losing weight and keeping it off can lessen the many health risks that come with obesity, including heart disease, diabetes, high blood pressure, and a shorter life. Dietary fats need to be broken down into smaller pieces before the body can absorb them. Orlistat works by blocking the enzyme that breaks down fats in your diet. This undigested fat then passes out of your body in your bowel movement. Orlistat does not block the absorption of calories from sugar and other non-fat foods, so you still need to restrict your total intake of calories.

Regulatory & Marketing

Labeler Name
Catalent Pharma Solutions, Llc
Product Type
Drug For Further Processing
Marketing Category
DRUG FOR FURTHER PROCESSING - A drug (other than the bulk ingredient API) that is in an interim stage of manufacture, processing, preparation, or packaging, and not ready for human or animal use.
Start Marketing Date
04-23-2023
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 (11014-0674). Click a package code to view its specific billing and regulatory data.

11014-0674-1
120 BOTTLE in 1 BOX / 84 CAPSULE in 1 BOTTLE
11014-0674-4
1 BAG in 1 DRUM / 44000 CAPSULE in 1 BAG
11014-0674-5
6 BOTTLE in 1 BOX / 84 CAPSULE in 1 BOTTLE

* 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 11014-0674-2 identifies a specific commercial package of 105 bottle in 1 box / 120 capsule in 1 bottle of Orlistat (UNFINISHED drug), drug for further processing labeled by Catalent Pharma Solutions, Llc. This capsule is formulated for use and contains orlistat 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 Catalent Pharma Solutions, Llc on April 23, 2023. The current certification is valid through December 31, 2026.

What are the primary indications for this medication?

This medication is used with a doctor-approved exercise, behavior change, and reduced-calorie diet program to help you lose weight. It is used by certain overweight people, such as those who are obese or have weight-related medical problems. Taking orlistat can also help keep you from gaining back weight you have lost. Losing weight and keeping it off can lessen the many health risks that come with obesity, including heart disease, diabetes, high blood pressure, and a shorter life. Dietary fats need to be broken down into smaller pieces before the body can absorb them. Orlistat works by blocking the enzyme that breaks down fats in your diet. This undigested fat then passes out of your body in your bowel movement. Orlistat does not block the absorption of calories from sugar and other non-fat foods, so you still need to restrict your total intake of calories.

How is this Catalent Pharma Solutions, Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 11014067402. 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)
11014-0674-2
11-Digit CMS (5-4-2)
11014-0674-02

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