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  5. NDC Package Code: 0135-0461-01 Alli

NDC Package 0135-0461-01 Alli

Orlistat Capsule Oral - View Billable Units, 11-Digit Format, RxNorm

Table of Contents

    1. Package Information
    2. Other Packages
    3. Frequently Asked Questions

Package Information

Find all the important details about this NDC Package code, including the 11-Digit NDC Billing number, billing units, wholesale price, RxNorm crosswalk, active ingredients, pharmacologic clasess, etc.

NDC Package Code:
0135-0461-01
Package Description:
60 CAPSULE in 1 BOTTLE
Product Code:
0135-0461
Proprietary Name:
Alli
Non-Proprietary Name:
Orlistat
Substance Name:
Orlistat
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.
11-Digit NDC Billing Format:
00135046101
Billing Unit:
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
NDC to RxNorm Crosswalk:
60 EA
NDC to RxNorm Crosswalk:
  • RxCUI: 692876 - orlistat 60 MG Oral Capsule
  • RxCUI: 723846 - Alli 60 MG Oral Capsule
  • RxCUI: 723846 - orlistat 60 MG Oral Capsule [Alli]
    • Product Type:
    Human Otc Drug
    Labeler Name:
    Haleon Us Holdings Llc
    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.
    Administration Route(s):
  • Oral - Administration to or by way of the mouth.
    • Active Ingredient(s):
  • ORLISTAT 60 mg/1
    • Pharmacologic Class(es):
  • Intestinal Lipase Inhibitor - [EPC] (Established Pharmacologic Class)
  • Lipase Inhibitors - [MoA] (Mechanism of Action)
    • Sample Package:
    No
    FDA Application Number:
    NDA021887
    Marketing Category:
    NDA - A product marketed under an approved New Drug Application.
    Start Marketing Date:
    02-07-2007
    Listing Expiration Date:
    12-31-2025
    Exclude Flag:
    N
    Code Structure:

    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 disclaimer below.

    Other Product Packages

    The following packages are also available for this product:

    NDC Package CodePackage Description
    0135-0461-0290 CAPSULE in 1 BOTTLE
    0135-0461-03120 CAPSULE in 1 BOTTLE
    0135-0461-05120 CAPSULE in 1 BOTTLE
    0135-0461-06170 CAPSULE in 1 BOTTLE
    0135-0461-0721 CAPSULE in 1 BOTTLE
    0135-0461-082 BOTTLE in 1 CARTON / 60 CAPSULE in 1 BOTTLE

    * Please review the disclaimer below.

    Frequently Asked Questions

    What is NDC 0135-0461-01?

    The NDC Packaged Code 0135-0461-01 is assigned to a package of 60 capsule in 1 bottle of Alli, a human over the counter drug labeled by Haleon Us Holdings Llc. The product's dosage form is capsule and is administered via oral form.

    Is NDC 0135-0461 included in the NDC Directory?

    Yes, Alli with product code 0135-0461 is active and included in the NDC Directory. The product was first marketed by Haleon Us Holdings Llc on February 07, 2007 and its listing in the NDC Directory is set to expire on December 31, 2025 if the product is not updated or renewed by the manufacturer.

    What is the NDC billing unit for package 0135-0461-01?

    The contents of this package are billed per "each", products billed on a per each basis are usually products dispensed in discreet units. The calculated billable units for this package is 60.

    What is the 11-digit format for NDC 0135-0461-01?

    The 11-digit format is 00135046101. The 11-digit billing format might be required by the Centers for Medicare & Medicaid Services (CMS) and other payers in billing claim forms.

    This package code is originally configured in a 4-4-2 segment 10-digit format and by adding a zero within the original NDC package code we can obtain the converted 11-digit format in a 5-4-2 segment configuration. The table below shows the 11-digit code conversion:

    10-Digit Format10-Digit Original Code11-Digit Format11-Digit Code
    4-4-20135-0461-015-4-200135-0461-01