NDC 70504-0282 Ixinity

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:
70504-0282
Proprietary Name:
Ixinity
Product Type: [3]
INACTIVATED PRODUCT and EXCLUDED the from NDC Directory
Labeler Name: [5]
Aptevo Biotherapeutics Llc
Labeler Code:
70504
Start Marketing Date: [9]
05-12-2017
Listing Expiration Date: [11]
12-31-2022
Exclude Flag: [12]
I
Code Structure:
Code Navigator:

Product Packages

NDC Code 70504-0282-5

Package Description: 1 KIT in 1 CARTON * 5 mL in 1 VIAL (70504-0270-1) * 5 mL in 1 SYRINGE (70504-0280-1)

Product Details

What is NDC 70504-0282?

The NDC code 70504-0282 is assigned by the FDA to the product Ixinity which is product labeled by Aptevo Biotherapeutics Llc. The product's dosage form is . The product is distributed in a single package with assigned NDC code 70504-0282-5 1 kit in 1 carton * 5 ml in 1 vial (70504-0270-1) * 5 ml in 1 syringe (70504-0280-1). 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 Ixinity?

This medication is used to prevent or control bleeding in people with little or no factor IX (due to hemophilia B, Christmas disease). Factor IX is a protein (clotting factor) in the blood that works with other clotting factors to help the blood clot and therefore stop bleeding. People with little or no factor IX are at risk for bleeding longer after an injury/surgery or bleeding suddenly (often in the joints/muscle) without an obvious cause. This medication should not be used to treat other types of factor deficiencies (e.g., factors II, VII, VIII, X) or factor problems (e.g., inhibitor to factor XIII), to reverse the effects of "blood thinners" (e.g., warfarin), or to treat bleeding from low levels of liver-dependent clotting factors (due to liver problems).

Which are Ixinity UNII Codes?

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

  • COAGULATION FACTOR IX RECOMBINANT HUMAN (UNII: 382L14738L)
  • COAGULATION FACTOR IX RECOMBINANT HUMAN (UNII: 382L14738L) (Active Moiety)

Which are Ixinity 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 Ixinity?

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".