Sumavel Dosepro
NDC Package 43376-104-06
Package Information
Sumavel Dosepro is indicated in adults for (1) the acute treatment of migraine, with or without aura, and (2) the acute treatment of cluster headache. Marketed by Zogenix, Inc., this product is identified by NDC 43376-104 and is authorized under FDA application NDA022239.
Identification & Billing
- RxCUI: 1484927 - Sumavel 4 MG in 0.5 ML Jet Injector
- RxCUI: 1484927 - 0.5 ML sumatriptan 8 MG/ML Jet Injector [Sumavel]
- RxCUI: 1484927 - 0.5 ML Sumavel 8 MG/ML Jet Injector
- RxCUI: 1484927 - Sumavel (as sumatriptan succinate) 4 MG per 0.5 ML Jet Injector
- RxCUI: 1484927 - Sumavel 4 MG per 0.5 ML Jet Injector
Clinical Specifications
Regulatory & Marketing
Hierarchy Structure
- 43376 - Zogenix, Inc.
- 43376-104 - Sumavel Dosepro
- 43376-104-06 - 6 SYRINGE, GLASS in 1 CARTON / .5 mL in 1 SYRINGE, GLASS
- 43376-104 - Sumavel Dosepro
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 (43376-104). Click a package code to view its specific billing and regulatory data.
* 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 43376-104-06 identifies a specific commercial package of 6 syringe, glass in 1 carton / .5 ml in 1 syringe, glass of Sumavel Dosepro, labeled by Zogenix, Inc.. 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 Zogenix, Inc. on December 04, 2013. The current certification is valid through December 31, 2017.
How is this Zogenix, Inc. product billed for insurance claims?
For medical billing and reimbursement, this package follows the 11-digit CMS format: 43376010406. 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:
Note: The zero is added to the Product segment to maintain the 5-4-2 structure.
