Topiramate Capsule, Coated Pellets
NDC Package 65841-652-10

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

Package Information

Topiramate capsules is topiramate is used alone or with other medications to prevent and control seizures (epilepsy). This formulation utilizes a capsule, coated pellets delivery system. Marketed by Zydus Lifesciences Limited, this product is identified by NDC 65841-652 and is authorized under FDA application ANDA078877.

Identification & Billing

NDC Package Code
65841-652-10
Package Description
1000 CAPSULE, COATED PELLETS in 1 BOTTLE
Product Code
65841-652
11-Digit Billing Format
65841065210
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Topiramate
Non-Proprietary Name
Topiramate
Substance Name
Topiramate
Dosage Form
Capsule, Coated Pellets - A solid dosage form in which the drug is enclosed within either a hard or soft soluble container or "shell" made from a suitable form of gelatin; the drug itself is in the form of granules to which varying amounts of coating have been applied.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
TOPIRAMATE 25 mg/1
Pharmacologic Class
Usage Information
Topiramate is used alone or with other medications to prevent and control seizures (epilepsy). This medication is also used to prevent migraine headaches and decrease how often you get them. Topiramate will not treat a migraine headache once it occurs. If you get a migraine headache, treat it as directed by your doctor (such as by taking pain medication, lying down in a dark room). Topiramate is known as an anticonvulsant or antiepileptic drug.

Regulatory & Marketing

Labeler Name
Zydus Lifesciences Limited
Product Type
Human Prescription Drug
FDA Application #
ANDA078877
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
10-14-2009
Listing Expiration
12-31-2026
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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (65841-652). Click a package code to view its specific billing and regulatory data.

65841-652-01
100 CAPSULE, COATED PELLETS in 1 BOTTLE
65841-652-05
500 CAPSULE, COATED PELLETS in 1 BOTTLE
65841-652-14
60 CAPSULE, COATED PELLETS in 1 BOTTLE
65841-652-16
90 CAPSULE, COATED PELLETS in 1 BOTTLE
65841-652-17
28 CAPSULE, COATED PELLETS in 1 BOTTLE

* 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 65841-652-10 identifies a specific commercial package of 1000 capsule, coated pellets in 1 bottle of Topiramate, a human prescription drug labeled by Zydus Lifesciences Limited. This capsule, coated pellets is formulated for oral use and contains 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 Zydus Lifesciences Limited on October 14, 2009. The current certification is valid through December 31, 2026.

What are the primary indications for this medication?

Topiramate is used alone or with other medications to prevent and control seizures (epilepsy). This medication is also used to prevent migraine headaches and decrease how often you get them. Topiramate will not treat a migraine headache once it occurs. If you get a migraine headache, treat it as directed by your doctor (such as by taking pain medication, lying down in a dark room). Topiramate is known as an anticonvulsant or antiepileptic drug.

How is this Zydus Lifesciences Limited product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 65841065210. 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)
65841-652-10
11-Digit CMS (5-4-2)
65841-0652-10

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