Onzetra Xsail Capsule
NDC Package 42847-311-08

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

Package Information

Onzetra Xsail (sumatriptan succinate) capsules is sumatriptan is used to treat migraines. This formulation utilizes a capsule delivery system. Marketed by Currax Pharmaceuticals Llc, this product is identified by NDC 42847-311 and is authorized under FDA application NDA206099.

Identification & Billing

NDC Package Code
42847-311-08
Package Description
8 POUCH in 1 CARTON / 2 CAPSULE in 1 POUCH
Product Code
42847-311
11-Digit Billing Format
42847031108
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
8 EA
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Onzetra Xsail
Non-Proprietary Name
Sumatriptan Succinate
Substance Name
Sumatriptan Succinate
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
Nasal - Administration to the nose; administered by way of the nose.
Active Ingredient(s)
SUMATRIPTAN SUCCINATE 11 mg/1
Pharmacologic Class
Usage Information
Sumatriptan is used to treat migraines. It helps to relieve headache, pain, and other migraine symptoms (such as nausea, vomiting, sensitivity to light/sound). Prompt treatment helps you return to your normal routine and may decrease your need for other pain medications. Sumatriptan belongs to a class of drugs known as triptans. It affects a certain natural substance (serotonin) that narrows blood vessels in the brain. It may also relieve pain by affecting certain nerves in the brain. Sumatriptan does not prevent future migraines or lessen how often you get migraine attacks.

Regulatory & Marketing

Labeler Name
Currax Pharmaceuticals Llc
Product Type
Human Prescription Drug
FDA Application #
NDA206099
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
10-01-2015
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.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 42847-311-08 identifies a specific commercial package of 8 pouch in 1 carton / 2 capsule in 1 pouch of Onzetra Xsail, a human prescription drug labeled by Currax Pharmaceuticals Llc. This product is billed for "EA" each discreet unit and contains an estimated amount of 8 billable units per package. This capsule is formulated for nasal use and contains sumatriptan succinate 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 Currax Pharmaceuticals Llc on October 01, 2015. The current certification is valid through December 31, 2026.

What are the primary indications for this medication?

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

How is this Currax Pharmaceuticals Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 42847031108. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 8 total billable units per package. 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)
42847-311-08
11-Digit CMS (5-4-2)
42847-0311-08

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