Zembrace Symtouch Injection, Solution
NDC Package 0245-0809-38

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

Package Information

This product is approaching its end of marketing date. An upcoming end of marketing date means the product has been delisted but will remain in the NDC database until the end of marketing date is reached. In most cases, the FDA advises firms to use the expiration date of the last lot produced as the end marketing date, reflecting the possibility that the product may still be available even after manufacturing has stopped.

Zembrace Symtouch (sumatriptan succinate) injection is sumatriptan is used to treat migraines and cluster headaches. This formulation utilizes a injection, solution delivery system. Marketed by Upsher-smith Laboratories, Llc, this product is identified by NDC 0245-0809 and is authorized under FDA application NDA208223.

Identification & Billing

NDC Package Code
0245-0809-38
Package Description
4 SYRINGE in 1 CARTON / 1 INJECTION, SOLUTION in 1 SYRINGE (0245-0809-89)
Product Code
0245-0809
11-Digit Billing Format
00245080938
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Zembrace Symtouch
Non-Proprietary Name
Sumatriptan Succinate
Substance Name
Sumatriptan Succinate
Dosage Form
Injection, Solution - A liquid preparation containing one or more drug substances dissolved in a suitable solvent or mixture of mutually miscible solvents that is suitable for injection.
Administration Route
Subcutaneous - Administration beneath the skin; hypodermic. Synonymous with the term SUBDERMAL.
Active Ingredient(s)
SUMATRIPTAN SUCCINATE 3 mg/1
Pharmacologic Class
Usage Information
Sumatriptan is used to treat migraines and cluster headaches. It helps to relieve pain and other symptoms of migraines/headaches including sensitivity to light or sound, nausea, and vomiting. Prompt treatment allows you to get back to your normal routine and may decrease your need for other pain medications. It does not prevent future migraines/headaches or reduce how often you may get a headache. Sumatriptan belongs to a group of drugs called triptans. It affects a certain natural chemical (serotonin) that constricts blood vessels in the brain. It may also block other pain pathways in the brain.

Regulatory & Marketing

Labeler Name
Upsher-smith Laboratories, Llc
Product Type
Human Prescription Drug
FDA Application #
NDA208223
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
02-22-2016
End Marketing Date
08-31-2026
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.

Billing & HCPCS Mapping

To facilitate insurance claims and reimbursement, this drug package is mapped to specific HCPCS administrative codes. This crosswalk aligns clinical data with the billing standards used in ASP (Average Sales Price), AWP, and OPPS payment systems. Use the cards below to identify the correct billable units for provider claims.

J3030
Source: PDAC
INJECTION, SUMATRIPTAN SUCCINATE, 6 MG (CODE MAY BE USED FOR MEDICARE WHEN DRUG ADMINISTERED UNDER THE DIRECT SUPERVISION OF A PHYSICIAN, NOT FOR USE WHEN DRUG IS SELF ADMINISTERED)
HCPCS Dosage 6 MG
Units / Pkg

Note for Medical Coders: These mappings are synthesized from various CMS datasets including OPPS, PrEP, and DAC (Data Analysis and Coding) contractors. Always confirm unit conversions against the current quarter's pricing files before final submission.

* 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 0245-0809-38 identifies a specific commercial package of 4 syringe in 1 carton / 1 injection, solution in 1 syringe (0245-0809-89) of Zembrace Symtouch, a human prescription drug labeled by Upsher-smith Laboratories, Llc. This injection, solution is formulated for subcutaneous 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 Upsher-smith Laboratories, Llc on February 22, 2016.

What are the primary indications for this medication?

Sumatriptan is used to treat migraines and cluster headaches. It helps to relieve pain and other symptoms of migraines/headaches including sensitivity to light or sound, nausea, and vomiting. Prompt treatment allows you to get back to your normal routine and may decrease your need for other pain medications. It does not prevent future migraines/headaches or reduce how often you may get a headache. Sumatriptan belongs to a group of drugs called triptans. It affects a certain natural chemical (serotonin) that constricts blood vessels in the brain. It may also block other pain pathways in the brain.

How is this Upsher-smith Laboratories, Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 00245080938. Quantities are measured in per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.. 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 (4-4-2)
0245-0809-38
11-Digit CMS (5-4-2)
00245-0809-38

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