NDC Package 43598-624-30 Phentermine And Topiramate Extended-release

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

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:
43598-624-30
Package Description:
30 CAPSULE in 1 BOTTLE
Product Code:
Proprietary Name:
Phentermine And Topiramate Extended-release
Non-Proprietary Name:
Phentermine And Topiramate Extended-release
Substance Name:
Phentermine Hydrochloride; Topiramate
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:Adult patients with obesityAdults with overweight in the presence of at least one weight-related comorbid conditionLimitations of Use• The 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.Pediatric use information is approved for Vivus LLC's Qsymia® (phentermine and topiramate) extended-release capsules. However, due to Vivus LLC's marketing exclusivity rights, this drug product is not labeled with that information.
11-Digit NDC Billing Format:
43598062430
Billing Unit:
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
NDC to RxNorm Crosswalk:
30 EA
NDC to 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
Product Type:
Human Prescription Drug
Labeler Name:
Dr.reddys Laboratories Inc
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.
DEA Schedule:
Schedule IV (CIV) Substances
Sample Package:
No
FDA Application Number:
ANDA208175
Marketing Category:
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date:
06-01-2025
Listing Expiration Date:
12-31-2026
Exclude Flag:
N

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.

Frequently Asked Questions

What is NDC 43598-624-30?

The NDC Packaged Code 43598-624-30 is assigned to a package of 30 capsule in 1 bottle of Phentermine And Topiramate Extended-release, a human prescription drug labeled by Dr.reddys Laboratories Inc. The product's dosage form is capsule and is administered via oral form.

Is NDC 43598-624 included in the NDC Directory?

Yes, Phentermine And Topiramate Extended-release with product code 43598-624 is active and included in the NDC Directory. The product was first marketed by Dr.reddys Laboratories Inc on June 01, 2025 and its listing in the NDC Directory is set to expire on December 31, 2026 if the product is not updated or renewed by the manufacturer.

What is the NDC billing unit for package 43598-624-30?

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 30.

What is the 11-digit format for NDC 43598-624-30?

The 11-digit format is 43598062430. 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 5-3-2 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
5-3-243598-624-305-4-243598-0624-30