NDC Package 10370-368-05 Topiramate

Capsule, Extended Release 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:
10370-368-05
Package Description:
500 CAPSULE, EXTENDED RELEASE in 1 BOTTLE
Product Code:
Proprietary Name:
Topiramate
Non-Proprietary Name:
Topiramate
Substance Name:
Topiramate
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.
11-Digit NDC Billing Format:
10370036805
NDC to RxNorm Crosswalk:
  • RxCUI: 1437288 - topiramate 200 MG 24HR Extended Release Oral Capsule
  • RxCUI: 1437288 - 24 HR topiramate 200 MG Extended Release Oral Capsule
  • RxCUI: 1437288 - topiramate 200 MG 24 HR Extended Release Oral Capsule
  • Product Type:
    Human Prescription Drug
    Labeler Name:
    Par Pharmaceutical, Inc.
    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):
  • Oral - Administration to or by way of the mouth.
  • Active Ingredient(s):
    Sample Package:
    No
    FDA Application Number:
    ANDA205976
    Marketing Category:
    ANDA - A product marketed under an approved Abbreviated New Drug Application.
    Start Marketing Date:
    03-24-2023
    Listing Expiration Date:
    12-31-2024
    Exclude Flag:
    N
    Code Structure:

    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.

    Other Product Packages

    The following packages are also available for this product:

    NDC Package CodePackage Description
    10370-368-01100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE
    10370-368-1130 CAPSULE, EXTENDED RELEASE in 1 BOTTLE

    * Please review the disclaimer below.

    Frequently Asked Questions

    What is NDC 10370-368-05?

    The NDC Packaged Code 10370-368-05 is assigned to a package of 500 capsule, extended release in 1 bottle of Topiramate, a human prescription drug labeled by Par Pharmaceutical, Inc.. The product's dosage form is capsule, extended release and is administered via oral form.

    Is NDC 10370-368 included in the NDC Directory?

    Yes, Topiramate with product code 10370-368 is active and included in the NDC Directory. The product was first marketed by Par Pharmaceutical, Inc. on March 24, 2023 and its listing in the NDC Directory is set to expire on December 31, 2024 if the product is not updated or renewed by the manufacturer.

    What is the 11-digit format for NDC 10370-368-05?

    The 11-digit format is 10370036805. 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
    5-3-210370-368-055-4-210370-0368-05