Phentermine And Topiramate Capsule, Extended Release
NDC Package 66993-780-30

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. Frequently Asked Questions

Package Information

Phentermine And Topiramate capsules is 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. This formulation utilizes a capsule, extended release delivery system. Marketed by Prasco Laboratories, this product is identified by NDC 66993-780 and is authorized under FDA application NDA022580.

Identification & Billing

NDC Package Code
66993-780-30
Package Description
30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, UNIT-DOSE
Product Code
66993-780
11-Digit Billing Format
66993078030
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
30 EA
RxNorm Crosswalk
  • 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

Clinical Specifications

Proprietary Name
Phentermine And Topiramate
Non-Proprietary Name
Phentermine And Topiramate
Substance Name
Phentermine Hydrochloride; Topiramate
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
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
Pharmacologic Class
Usage Information
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.
DEA Schedule
Schedule IV (CIV) Substances

Regulatory & Marketing

Labeler Name
Prasco Laboratories
Product Type
Human Prescription Drug
FDA Application #
NDA022580
Marketing Category
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
06-01-2025
Listing Expiration
12-31-2027
Exclude Flag
N
Sample Package
No

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.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 66993-780-30 identifies a specific commercial package of 30 capsule, extended release in 1 bottle, unit-dose of Phentermine And Topiramate, a human prescription drug labeled by Prasco Laboratories. This capsule, extended release is formulated for oral use and contains phentermine hydrochloride; topiramate 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 Prasco Laboratories on June 01, 2025. The current certification is valid through December 31, 2027.

How is this Prasco Laboratories product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 66993078030. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 30 total billable units per package. 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 (5-3-2)
66993-780-30
11-Digit CMS (5-4-2)
66993-0780-30

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