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NDC 66993-782 Phentermine And Topiramate

Capsule, Extended Release Oral - View Dosage, Usage, Ingredients, Routes, UNII

Table of Contents

  1. Product Information
  2. Product Packages
  3. Product Characteristics
  4. What is NDC 66993-782?
  5. Phentermine And Topiramate Uses
  6. Active Ingredients
  7. Active Ingredients UNII Codes
  8. Inactive Ingredients UNII Codes
  9. NDC to RxNorm Crosswalk
  10. Pharmacologic Classes

Product Information

Get all the details for National Drug Code (NDC) 66993-782 in one place. This page breaks down everything you need to know about the NDC, including proprietary name, active and inactive substances, package configurations, billing units, labeler information, and routes of administration. It also includes enhanced data such as HCPCS codes, FDA product labels with images, UNIIs, and RxNorm cross-references. Whether you're a healthcare professional verifying drug data or a consumer researching medication, this NDC page helps you make informed, accurate decisions.

NDC Product Code:
66993-782
Proprietary Name:
Phentermine And Topiramate
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
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 Name: [5]
Prasco Laboratories
Labeler Code:
66993
Product Label ID:
876bd763-13fa-481e-b579-c2fc44dbf3c2
FDA Application Number: [6]
NDA022580
DEA Schedule: [7]
Schedule IV (CIV) Substances
Marketing Category: [8]
NDA AUTHORIZED GENERIC - A product marketed as a "generic" drug under an approved New Drug Application (NDA), rather than an Abbreviated New Drug Application (ANDA),.
Start Marketing Date: [9]
06-01-2025
Listing Expiration Date: [11]
12-31-2026
Exclude Flag: [12]
N
Code Navigator:

Product Characteristics

Color(s):
PURPLE (C48327)
YELLOW (C48330)
Shape:
CAPSULE (C48336)
Size(s):
12 MM
Imprint(s):
VIVUS;375;23
VIVUS;75;46
VIVUS;1125;69
Score:
1

Code Structure Chart

Product Details

What is NDC 66993-782?

The NDC code 66993-782 is assigned by the FDA to the product Phentermine And Topiramate which is a human prescription drug product labeled by Prasco Laboratories. The product's dosage form is capsule, extended release and is administered via oral form. The product is distributed in a single package with assigned NDC code 66993-782-30 30 capsule, extended release in 1 bottle . This page includes all the important details about this product, including active and inactive ingredients, pharmagologic classes, product uses and characteristics, UNII information and RxNorm crosswalk.

What are the uses for Phentermine And Topiramate?

Phentermine and topiramate extended-release capsules are indicated in combination with a reduced-calorie diet and increased physical activity to reduce excess body weight and maintain weight reduction long term in:Adults and pediatric patients aged 12 years and older with obesityAdults with overweight in the presence of at least one weight-related comorbid conditionLimitations of UseThe effect of phentermine and topiramate extended-release capsules on cardiovascular morbidity and mortality has not been established.The safety and effectiveness of phentermine and topiramate extended-release capsules in combination with other products intended for weight loss, including prescription drugs, over-the-counter drugs, and herbal preparations, have not been established.

What are Phentermine And Topiramate Active Ingredients?

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 11.25 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 69 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 Phentermine And Topiramate UNII Codes?

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

Which are Phentermine And Topiramate Inactive Ingredients 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 Phentermine And Topiramate?

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: 1302839 - phentermine 3.75 MG / topiramate 23 MG 24HR Extended Release Oral Capsule
  • RxCUI: 1302839 - 24 HR phentermine 3.75 MG / topiramate 23 MG Extended Release Oral Capsule

Which are the Pharmacologic Classes for Phentermine And Topiramate?

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Product Footnotes

[1] 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.

[2] 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.

[3] 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.

[4] What are the Administration Routes? - The translation of the route code submitted by the firm, indicating route of administration.

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

[6] 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.

[7] What is the Drug Enforcement Administration (DEA) CIV Schedule? - This is the assigned DEA Schedule number as reported by the labeler. Values are CI, CII, CIII, CIV, and CV.

[8] 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.

[9] What is the Start Marketing Date? - This is the date that the labeler indicates was the start of its marketing of the drug product.

[11] 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.

[12] 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".