Topiramate
NDC Package 70771-1675-2

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

This product is EXCLUDED from the official NDC directory because the listing expired due to lack of listing certification.

Topiramate is used alone or with other medications to prevent and control seizures (epilepsy). Marketed by Zydus Lifesciences Limited, this product is identified by NDC 70771-1675 and is authorized under FDA application ANDA216167.

Identification & Billing

NDC Package Code
70771-1675-2
Package Description
10 CAPSULE, EXTENDED RELEASE in 1 BLISTER PACK
Product Code
70771-1675
11-Digit Billing Format
70771167502

Clinical Specifications

Proprietary Name
Topiramate
Dosage Form
-
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
FDA Application #
ANDA216167
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
08-09-2026
Listing Expiration
12-31-2024
Exclude Flag
U
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 (70771-1675). Click a package code to view its specific billing and regulatory data.

70771-1675-1
100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE
70771-1675-3
30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE
70771-1675-5
500 CAPSULE, EXTENDED RELEASE in 1 BOTTLE
70771-1675-7
30 CAPSULE, EXTENDED RELEASE in 1 CARTON

* 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 70771-1675-2 identifies a specific commercial package of 10 capsule, extended release in 1 blister pack of Topiramate, labeled by Zydus Lifesciences Limited. This is formulated for use and contains as the active substance.

Is this product currently listed with the FDA?

This product code is currently listed as inactive or excluded from the primary directory. It was introduced to the market by Zydus Lifesciences Limited on August 09, 2026. The current certification is valid through December 31, 2024.

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: 70771167502. 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 (5-4-1)
70771-1675-2
11-Digit CMS (5-4-2)
70771-1675-02

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