Qsymia Capsule, Extended Release
NDC 62541-201

View dosage, usage, ingredients, routes, and UNII mappings.
Table of Contents
  1. Product Information
  2. Product Packages
  3. Product Characteristics
  4. What is NDC 62541-201?
  5. Qsymia Uses
  6. Active Ingredients
  7. Active Ingredients UNII Codes
  8. Inactive Ingredients UNII Codes
  9. NDC to RxNorm Crosswalk
  10. Pharmacologic Classes
  11. Patient Education

Product Information

Qsymia (phentermine and topiramate) is a NDA-approved product labeled by Vivus Llc. This medication is used with a doctor-approved exercise, behavior change, and reduced-calorie diet program to help you lose weight. It is supplied as a purple capsule, extended release for oral administration. This product entry covers the primary NDC 62541-201 and 2 associated package configurations. This profile includes active and inactive ingredient UNII references and FDA labeling data.

Primary Identification

NDC Product Code:
62541-201
Proprietary Name:
Qsymia
Non-Proprietary Name: [1]
Phentermine And Topiramate
Substance Name: [2]
Phentermine Hydrochloride; Topiramate
NDC Directory Status:
Human Prescription Drug
Product Type: [3]
ACTIVE PRODUCT INCLUDED in the NDC Directory
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Clinical Specifications

Dosage Form:
Capsule, Extended Release - A solid dosage form in which the drug is enclosed within either a hard or soft soluble container made from a suitable form of gelatin, and which releases a drug (or drugs) in such a manner to allow a reduction in dosing frequency as compared to that drug (or drugs) presented as a conventional dosage form.
Administration Route(s): [4]
Oral - Administration to or by way of the mouth.

Labeler & Regulatory Data

Labeler Name: [5]
Vivus Llc
Labeler Code:
62541
Product Label ID:
40dd5602-53da-45ac-bb4b-15789aba40f9
FDA Application Number: [6]
NDA022580
DEA Schedule: [7]
Schedule IV (CIV) Substances
Marketing Category: [8]
NDA - A product marketed under an approved New Drug Application.

Marketing Timeline

Start Marketing Date: [9]
09-17-2012
Listing Expiration Date: [11]
12-31-2027
Exclude Flag: [12]
N

Product Characteristics

Color(s):
PURPLE (C48327)
Shape:
CAPSULE (C48336)
Size(s):
12 MM
Imprint(s):
VIVUS;375;23
Score:
1

Code Structure Chart

Product Details

What is NDC 62541-201?

The NDC code 62541-201 is assigned by the FDA to the product Qsymia. It is commonly known by its generic name, phentermine and topiramate. This pharmaceutical product is labeled by Vivus Llc and is currently categorized as listed product. The medication is a capsule, extended release administered via oral route. In terms of distribution, this product is available in 2 different package configurations. The associated package NDC(s) include: 62541-201-14, 62541-201-30. Beyond standard identification, this entry provides technical data including pharmacologic classes, UNII ingredient references, and RxNorm cross-referencing for healthcare systems.

What are the uses of this product?

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. 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. It is not known how this medication helps people to lose weight. It may work by decreasing your appetite, by increasing the amount of energy used by your body, or by affecting certain parts of the brain. This medication is a combination of phentermine and topiramate. Phentermine is an appetite suppressant and belongs to a class of drugs called sympathomimetic amines. Topiramate is known as an anticonvulsant or antiepileptic drug.

What are Active Ingredients of this product?

An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.
  • PHENTERMINE HYDROCHLORIDE 3.75 mg/1 - A central nervous system stimulant and sympathomimetic with actions and uses similar to those of DEXTROAMPHETAMINE. It has been used most frequently in the treatment of obesity.
  • TOPIRAMATE 23 mg/1 - A sulfamate-substituted fructose analog that was originally identified as a hypoglycemic agent. It is used for the treatment of EPILEPSY and MIGRAINE DISORDERS, and may also promote weight loss.

Which are the associated UNII Codes?

The UNII codes for the active ingredients in this product are:

Which are the Inactive Ingredients associated UNII Codes?

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. The UNII codes for the inactive ingredients in this product are:

What is the NDC to RxNorm Crosswalk for this product?

RxNorm is a normalized naming system for generic and branded drugs that assigns unique concept identifier(s) known as RxCUIs to NDC products.The NDC to RxNorm Crosswalk for this produdct indicates multiple concept unique identifiers (RXCUIs) are associated with this product:
  • RxCUI: 1302827 - phentermine 7.5 MG / topiramate 46 MG 24HR Extended Release Oral Capsule
  • RxCUI: 1302827 - 24 HR phentermine 7.5 MG / topiramate 46 MG Extended Release Oral Capsule
  • RxCUI: 1302827 - phentermine 7.5 MG / topiramate 46 MG 24 HR Extended Release Oral Capsule
  • RxCUI: 1302833 - Qsymia 7.5 MG / 46 MG 24HR Extended Release Oral Capsule
  • RxCUI: 1302833 - 24 HR phentermine 7.5 MG / topiramate 46 MG Extended Release Oral Capsule [Qsymia]

Which are the Pharmacologic Classes of this product?

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Patient Education

Phentermine and Topiramate


Phentermine and topiramate extended-release (long-acting) capsules are used to help adults who are obese or who are overweight and have weight-related medical problems to lose weight and to keep from gaining back that weight. Phentermine and topiramate extended-release (long-acting) capsules are also used to help children aged 12 years or older who have a body mass index (BMI) in the 95th percentile or greater based on age and sex standards. Phentermine and topiramate extended-release capsules must be used along with a reduced calorie diet and exercise plan. Phentermine is in a class of medications called anorectics. It works by decreasing appetite. Topiramate is in a class of medications called anticonvulsants. It works by decreasing appetite and by causing feelings of fullness to last longer after eating.
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Product & Regulatory Definitions
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.
What is the Substance Name? An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.
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.
What are the Administration Routes? The translation of the route code submitted by the firm, indicating route of administration.
What is the Labeler Name? Name of Company corresponding to the labeler code segment of the Product NDC.
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.
What is the DEA Schedule? This is the assigned DEA Schedule number as reported by the labeler. Values are CI, CII, CIII, CIV, and CV.
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.
What is the Start Marketing Date? This is the date that the labeler indicates was the start of its marketing of the drug product.
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.
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, or because the listing certification is expired, or because the listing data was inactivated by FDA, or because it was discontinued by the labeler. Possible values in this field are: "D", "E", "I", "N", "U".