Zembrace Symtouch
NDC 67857-809
View dosage, usage, ingredients, routes, and UNII mappings.
Product Information
This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.
Zembrace Symtouch is a NDA-approved product labeled by Promius Pharma, Llc. Sumatriptan is used to treat migraines and cluster headaches. It is supplied as a product. This product entry covers the primary NDC 67857-809 and its associated package configuration. This profile includes active and inactive ingredient UNII references and FDA labeling data.
Primary Identification
NDC Product Code:
67857-809
Proprietary Name:
Zembrace Symtouch
Product Type: [3]
INACTIVATED PRODUCT and EXCLUDED the from NDC Directory
Code Navigator:
Labeler & Regulatory Data
Labeler Name: [5]
Labeler Code:
67857
Product Label ID:
HCPCS Code:
J3030
- 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)
FDA Application Number: [6]
NDA208223
Marketing Category: [8]
NDA - A product marketed under an approved New Drug Application.
Marketing Timeline
Start Marketing Date: [9]
02-22-2016
Listing Expiration Date: [11]
12-31-2022
Exclude Flag: [12]
I
Code Structure Chart
Product Details
What is NDC 67857-809?
The NDC code 67857-809 is assigned by the FDA to the product Zembrace Symtouch. This pharmaceutical product is labeled by Promius Pharma, Llc and is currently categorized as listed product. In terms of distribution, this product is available in a single package configuration. The associated package NDC(s) include: 67857-809-38. Beyond standard identification, this entry provides technical data including pharmacologic classes, UNII ingredient references, and RxNorm cross-referencing for healthcare systems.
What are the uses of this product?
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.
Which are the associated UNII Codes?
The UNII codes for the active ingredients in this product are:
- SUMATRIPTAN SUCCINATE (UNII: J8BDZ68989)
- SUMATRIPTAN (UNII: 8R78F6L9VO) (Active Moiety)
What is the NDC to RxNorm Crosswalk for this product?
RxNorm is a normalized naming system for generic and branded drugs that assigns unique concept identifier(s) known as RxCUIs to NDC products.The NDC to RxNorm Crosswalk for this produdct indicates multiple concept unique identifiers (RXCUIs) are associated with this product:
- RxCUI: 1738576 - SUMAtriptan 3 MG in 0.5 ML Auto-Injector
- RxCUI: 1738576 - 0.5 ML sumatriptan 6 MG/ML Auto-Injector
- RxCUI: 1738576 - sumatriptan (as succinate) 3 MG per 0.5 ML Auto-Injector
- RxCUI: 1738576 - sumatriptan 3 MG per 0.5 ML Auto-Injector
- RxCUI: 1738581 - Zembrace 3 MG in 0.5 ML Auto-Injector
* Please review the full disclaimer at the bottom of this page.
Patient Education
Sumatriptan Injection
Sumatriptan injection is used to treat the symptoms of migraine headaches (severe, throbbing headaches that sometimes are accompanied by nausea and sensitivity to sound and light). Sumatriptan injection is also used to treat the symptoms of cluster headaches (severe headaches usually on one side of the head or around one eye). Sumatriptan is in a class of medications called selective serotonin receptor agonists. It works by narrowing blood vessels in the brain, stopping pain signals from being sent to the brain, and blocking the release of certain natural substances that cause pain, nausea, and other symptoms of migraine or cluster headaches. Sumatriptan does not prevent migraine attacks or reduce the number of headaches you have.
[Learn More]
* Please review the full disclaimer at the bottom of this page.
Product & Regulatory Definitions
What is the Labeler Name? Name of Company corresponding to the labeler code segment of the Product NDC.
What is the FDA Application Number? This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.
What is the Marketing Category? Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.
What is the Start Marketing Date? This is the date that the labeler indicates was the start of its marketing of the drug product.
What is the Listing Expiration Date? This is the date when the listing record will expire if not updated or certified by the product labeler.
What is the NDC Exclude Flag? This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA"s requests for correction to deficient or non-compliant submissions, or because the listing certification is expired, or because the listing data was inactivated by FDA, or because it was discontinued by the labeler. Possible values in this field are: "D", "E", "I", "N", "U".
