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NDC and CVX Mitra Rocca. NDC  NDC is produced by the Federal Drug Administration (FDA) and serves as a universal product identifier for human drugs.

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Presentation on theme: "NDC and CVX Mitra Rocca. NDC  NDC is produced by the Federal Drug Administration (FDA) and serves as a universal product identifier for human drugs."— Presentation transcript:

1 NDC and CVX Mitra Rocca

2 NDC  NDC is produced by the Federal Drug Administration (FDA) and serves as a universal product identifier for human drugs. These codes indicate the product, the manufacturer or packager, and the packaging (e.g. 5 dose vial).  FDA assigns the first portion of the NDC, which is the labeler code. The firm then assigns the second and third portions of the NDC, which are the product code and package code, respectively. The firm reports the NDC to FDA when it eLists.  FDA knows how many NDCs have been eListed, but if a firm assigns an NDC and chooses not to eList (e.g., non-compliance with the eListing regs, or being exempt from the eListing regs), then FDA would have no knowledge of those assigned NDCs.  FDA has not allowed the reuse of an NDC since the 1990s. Therefore, reuse of NDCs should not be an issue anymore.  FDA maintains the NDC Directory: (http://www.fda.gov/Drugs/InformationOnDrugs/ucm142438.htm )http://www.fda.gov/Drugs/InformationOnDrugs/ucm142438.htm

3 CVX In 1999, the CDC published an implementation guide for messaging immunization histories. Two value sets were defined that allowed specification of the vaccine used at the vaccine administration level. 1. The CVX code is a numeric string, which identifies the type of vaccine product used. For example, a CVX code of 43 represents Hepatitis B, adult formulation. 2. The MVX code is an alphabetic string that identifies the manufacturer of that vaccine. Taken together, the immunization can be resolved to a trade name. Ex: A CVX code of 43 represents Hepatitis B, adult formulation. There are 2 manufacturers of this vaccine, GlaxoSmithKline (MVX = SKB) and Merck (MVX = MSD). An immunization using Recombivax, a Hepatitis B vaccine manufactured by Merck, would have a CVX of 43 and an MVX of MSD.

4 CVX  CDC maintains the CVX and MVX codes, which are updated weekly.  CVX codes are intended to identify vaccines that are currently or recently in use in the US.

5 NDC and CVX  NDC codes will become important ways of identifying recently administered vaccines.  They are used in ordering vaccines from manufacturer and are part of the GTIN 2-D barcode  NDC codes are found on :  the outer packaging (carton)  on the unit of use(syringe) for many vaccines.  CDC maintains a table of both unit of use and unit of sale NDC for vaccines.  CDC provides a mapping table for linking unit of use and unit of sale and CVX codes.  (http://www.cdc.gov/vaccines/programs/iis/code-sets.html)http://www.cdc.gov/vaccines/programs/iis/code-sets.html  CDC does NOT favor using NDC-like codes for the historic doses where exact formulation are not known.  CVX and MVX should be required for all administered doses  Systems should support NDC for administered doses.  CVX is the code of choice for historical doses


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