Eletriptan Hydrobromide Tablet, Film Coated
NDC Package 68382-923-77

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

Eletriptan Hydrobromide tablets is eletriptan is used to treat migraines. This formulation utilizes a tablet, film coated delivery system. Marketed by Zydus Pharmaceuticals Usa Inc., this product is identified by NDC 68382-923 and is authorized under FDA application ANDA206409.

Identification & Billing

NDC Package Code
68382-923-77
Package Description
10 BLISTER PACK in 1 CARTON / 10 TABLET, FILM COATED in 1 BLISTER PACK (68382-923-30)
Product Code
68382-923
11-Digit Billing Format
68382092377
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Eletriptan Hydrobromide
Non-Proprietary Name
Eletriptan Hydrobromide
Substance Name
Eletriptan Hydrobromide
Dosage Form
Tablet, Film Coated - A solid dosage form that contains medicinal substances with or without suitable diluents and is coated with a thin layer of a water-insoluble or water-soluble polymer.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
ELETRIPTAN HYDROBROMIDE 40 mg/1
Pharmacologic Class
Usage Information
Eletriptan is used to treat migraines. It helps to relieve headache, pain, and other migraine symptoms (including nausea, vomiting, sensitivity to light/sound). Prompt treatment helps you return to your normal routine and may decrease your need for other pain medications. Eletriptan belongs to a class of drugs known as triptans. It affects a certain natural substance (serotonin) that causes narrowing of blood vessels in the brain. It may also relieve pain by affecting certain nerves in the brain. Eletriptan does not prevent future migraines or lessen how often you get migraine attacks.

Regulatory & Marketing

Labeler Name
Zydus Pharmaceuticals Usa Inc.
Product Type
Human Prescription Drug
FDA Application #
ANDA206409
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
07-12-2017
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 (68382-923). Click a package code to view its specific billing and regulatory data.

68382-923-05
500 TABLET, FILM COATED in 1 BOTTLE
68382-923-06
30 TABLET, FILM COATED in 1 BOTTLE
68382-923-86
1 BLISTER PACK in 1 CARTON / 6 TABLET, FILM COATED in 1 BLISTER PACK

* 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 68382-923-77 identifies a specific commercial package of 10 blister pack in 1 carton / 10 tablet, film coated in 1 blister pack (68382-923-30) of Eletriptan Hydrobromide, a human prescription drug labeled by Zydus Pharmaceuticals Usa Inc.. This tablet, film coated is formulated for oral use and contains eletriptan hydrobromide 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 Pharmaceuticals Usa Inc. on July 12, 2017. The current certification is valid through December 31, 2026.

What are the primary indications for this medication?

Eletriptan is used to treat migraines. It helps to relieve headache, pain, and other migraine symptoms (including nausea, vomiting, sensitivity to light/sound). Prompt treatment helps you return to your normal routine and may decrease your need for other pain medications. Eletriptan belongs to a class of drugs known as triptans. It affects a certain natural substance (serotonin) that causes narrowing of blood vessels in the brain. It may also relieve pain by affecting certain nerves in the brain. Eletriptan does not prevent future migraines or lessen how often you get migraine attacks.

How is this Zydus Pharmaceuticals Usa Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 68382092377. 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)
68382-923-77
11-Digit CMS (5-4-2)
68382-0923-77

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