NDC 0135-0461 Alli

Orlistat

NDC Product Code 0135-0461

NDC CODE: 0135-0461

Proprietary Name: Alli What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.

Non-Proprietary Name: Orlistat What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.

Drug Use Information

Drug Use Information
The drug use information is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate. This information is not individual medical advice and does not substitute for the advice of a health care professional. Always ask a health care professional for complete information about this product and your specific health needs.

  • 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.

Product Characteristics

Color(s):
TURQUOISE (C48334 - CAPSULE)
BLUE (C48333 - DARK BLUE BAND)
Shape: CAPSULE (C48336)
Size(s):
15 MM
Imprint(s):
ORLISTAT;60
Score: 1

NDC Code Structure

NDC 0135-0461-01

Package Description: 60 CAPSULE in 1 BOTTLE

NDC 0135-0461-02

Package Description: 90 CAPSULE in 1 BOTTLE

NDC 0135-0461-03

Package Description: 120 CAPSULE in 1 BOTTLE

NDC 0135-0461-05

Package Description: 120 CAPSULE in 1 BOTTLE

NDC 0135-0461-06

Package Description: 170 CAPSULE in 1 BOTTLE

NDC 0135-0461-07

Package Description: 21 CAPSULE in 1 BOTTLE

NDC 0135-0461-08

Package Description: 2 BOTTLE in 1 CARTON > 60 CAPSULE in 1 BOTTLE

NDC Product Information

Alli with NDC 0135-0461 is a a human over the counter drug product labeled by Glaxosmithkline Consumer Healthcare Holdings (us) Llc. The generic name of Alli is orlistat. The product's dosage form is capsule and is administered via oral form.

Labeler Name: Glaxosmithkline Consumer Healthcare Holdings (us) 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.

Product Type: Human Otc Drug What kind of product is this?
Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.

Alli Active Ingredient(s)

What is the Active Ingredient(s) List?
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.

  • ORLISTAT 60 mg/1

Inactive Ingredient(s)

About the Inactive Ingredient(s)
The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product.

  • FD&C BLUE NO. 2 (UNII: L06K8R7DQK)
  • GELATIN, UNSPECIFIED (UNII: 2G86QN327L)
  • FERROUS OXIDE (UNII: G7036X8B5H)
  • MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
  • POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)
  • SODIUM LAURYL SULFATE (UNII: 368GB5141J)
  • SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)
  • TALC (UNII: 7SEV7J4R1U)
  • TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Administration Route(s)

What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.

  • Oral - Administration to or by way of the mouth.

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Glaxosmithkline Consumer Healthcare Holdings (us) Llc
Labeler Code: 0135
FDA Application Number: NDA021887 What is the FDA Application Number?
This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.

Marketing Category: NDA - A product marketed under an approved New Drug Application. What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

Start Marketing Date: 02-07-2007 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

Listing Expiration Date: 12-31-2021 What is the Listing Expiration Date?
This is the date when the listing record will expire if not updated or certified by the product labeler.

Exclude Flag: N - NO What is the NDC Exclude Flag?
This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA"s requests for correction to deficient or non-compliant submissions ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".

* Please review the disclaimer below.

Information for Patients

Orlistat

Orlistat is pronounced as (or' li stat)

Why is orlistat medication prescribed?
Orlistat (prescription and nonprescription) is used with an individualized low-calorie, low-fat diet and exercise program to help people lose weight. Prescription orlista...
[Read More]

* Please review the disclaimer below.

Alli Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Labeling Index

Active Ingredient (In Each Sealed Capsule)

Orlistat 60 mg

Purpose

Weight loss aid

Use

  • •for weight loss in overweight adults, 18 years and older, when used along with a reduced-calorie and low-fat diet

Organ Transplant Alert:

  • •do not use if you have had an organ transplant. Orlistat interferes with the medicines used to prevent transplant rejection.

Allergy Alert:

  • •do not use if you are allergic to any of the ingredients in orlistat capsules

Do Not Use

  • •if you are taking cyclosporine •if you have been diagnosed with problems absorbing food •if you are not overweight

Ask A Doctor Before Use If You Have

  • Ever had •gallbladder problems •kidney stones •pancreatitis

Ask A Doctor Or Pharmacist Before Use If You Are

  • •taking any of the following prescription medications. Some prescription doses may need to be adjusted, or some medications may not work as well when used with orlistat. •anticoagulants (blood thinning medicine) •amiodarone (heart medicine) •diabetes medicine •thyroid disease medicine •seizure medicine •antiretrovirals (HIV medicine) •taking any other weight loss products

When Using This Product

  • •take a multivitamin once a day, at bedtime. Orlistat can reduce the absorption of some vitamins. •follow a well-balanced, reduced-calorie, low-fat diet. Try starting this diet before taking orlistat. •orlistat works by preventing the absorption of some of the fat you eat. The fat passes out of your body, so you may have bowel changes. You may get: •gas with oily spotting •loose stools •more frequent stools that may be hard to control •eating a low-fat diet lowers the chance of having these bowel changes •for every 5 pounds you lose from diet alone, orlistat can help you lose 2-3 pounds more. In studies, most people lost 5-10 pounds over 6 months.

Stop Use And Ask A Doctor If

  • •you develop itching, yellow eyes or skin, dark urine or loss of appetite. There have been rare reports of liver injury in people taking orlistat. •severe or continuous abdominal pain occurs. This may be a sign of a serious medical condition. •you are taking medicine for seizures and your seizures happen more often or get worse

Keep Out Of Reach Of Children.

In case of overdose, get medical help or contact a Poison Control Center right away.

Directions

  • •read the enclosed brochure for other important information •diet and exercise are the starting points for any weight loss program. Try these first before adding orlistat. Check with your doctor before starting any exercise program. •to see if orlistat capsules are right for you, find your height on the chart to the right. You may consider starting a weight loss program with orlistat if your weight is the same or more than the weight shown for your height. •for overweight adults 18 years and older: •take 1 capsule with each meal containing fat •do not take more than 3 capsules daily •use with a reduced-calorie, low-fat diet and exercise program until you reach your weight loss goal. Most weight loss occurs in the first 6 months. •if you stop taking orlistat, continue with your diet and exercise program •if you start to regain weight after you stop taking orlistat, you may need to start taking orlistat again along with your diet and exercise program •take a multivitamin once a day, at bedtime, when using orlistatHt. / Wt.4’10”129 lbs.4’11”133 lbs.5’0”138 lbs.5’1”143 lbs.5’2”147 lbs.5’3”152 lbs.5’4”157 lbs.5’5”162 lbs.5’6”167 lbs.5’7”172 lbs.5’8”177 lbs.5’9”182 lbs.5’10”188 lbs.5’11”193 lbs.6’0”199 lbs.6’1”204 lbs.6’2”210 lbs.6’3”216 lbs.6’4”221 lbs.6’5”227 lbs.

Other Information

  • •store at 20 - 25oC (68 - 77oF) •protect drug from excessive light, humidity and temperatures over 30oC (86oF)

Inactive Ingredients

FD&C Blue No. 2, edible ink, gelatin, iron oxide, microcrystalline cellulose, povidone, sodium lauryl sulfate, sodium starch glycolate, talc, titanium dioxide

* Please review the disclaimer below.