NDC 43376-106 Sumavel Dosepro

View Dosage, Usage, Ingredients, Routes, UNII

Product Information

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.
NDC Product Code:
43376-106
Proprietary Name:
Sumavel Dosepro
Product Type: [3]
INACTIVATED PRODUCT and EXCLUDED the from NDC Directory
Labeler Name: [5]
Zogenix, Inc.
Labeler Code:
43376
Start Marketing Date: [9]
07-15-2009
Listing Expiration Date: [11]
12-31-2017
Exclude Flag: [12]
I
Code Structure:
Code Navigator:

Product Packages

NDC Code 43376-106-01

Package Description: 1 SYRINGE, GLASS in 1 CARTON / .5 mL in 1 SYRINGE, GLASS

NDC Code 43376-106-06

Package Description: 6 SYRINGE, GLASS in 1 CARTON / .5 mL in 1 SYRINGE, GLASS

Price per Unit: $323.33079 per ML

NDC Code 43376-106-51

Package Description: 1 SYRINGE, GLASS in 1 CARTON / .5 mL in 1 SYRINGE, GLASS

NDC Code 43376-106-54

Package Description: 4 SYRINGE, GLASS in 1 CARTON / .5 mL in 1 SYRINGE, GLASS

Product Details

What is NDC 43376-106?

The NDC code 43376-106 is assigned by the FDA to the product Sumavel Dosepro which is product labeled by Zogenix, Inc.. The product's dosage form is . The product is distributed in 4 packages with assigned NDC codes 43376-106-01 1 syringe, glass in 1 carton / .5 ml in 1 syringe, glass, 43376-106-06 6 syringe, glass in 1 carton / .5 ml in 1 syringe, glass, 43376-106-51 1 syringe, glass in 1 carton / .5 ml in 1 syringe, glass, 43376-106-54 4 syringe, glass in 1 carton / .5 ml in 1 syringe, glass. This page includes all the important details about this product, including active and inactive ingredients, pharmagologic classes, product uses and characteristics, UNII information and RxNorm crosswalk.

What are the uses for Sumavel Dosepro?

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. Limitations of Use: Use only if a clear diagnosis of migraine or cluster headache has been established. If a patient has no response to the first migraine attack treated with Sumavel DosePro, reconsider the diagnosis of migraine before Sumavel DosePro is administered to treat any subsequent attacks. Sumavel DosePro is not indicated for the prevention of migraine attacks.

Which are Sumavel Dosepro UNII Codes?

The UNII codes for the active ingredients in this product are:

Which are Sumavel Dosepro Inactive Ingredients UNII Codes?

The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product. The UNII codes for the inactive ingredients in this product are:

What is the NDC to RxNorm Crosswalk for Sumavel Dosepro?

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:

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Product Footnotes

[5] What is the Labeler Name? - Name of Company corresponding to the labeler code segment of the Product NDC.

[9] What is the Start Marketing Date? - This is the date that the labeler indicates was the start of its marketing of the drug product.

[11] 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.

[12] 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 ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".