Brief introduction for application of the USA national drug code

doi:10.5246/jcps.2019.03.020

Journal of Chinese Pharmaceutical Sciences ›› 2019, Vol. 28 ›› Issue (3): 203-208.DOI: 10.5246/jcps.2019.03.020

• Drug administration and clinical pharmacy column • Previous Articles Next Articles

Brief introduction for application of the USA national drug code

Dongsheng Yang, Lingyun Ma, Jianzhao Niu, Mingdi Xu^*

National Institutes for Food and Drug Control, Beijing 100050, China

Received:2019-01-15 Revised:2019-02-27 Online:2019-03-30 Published:2019-02-28
Contact: Tel.: +86-13521033996, E-mail: yangdongsheng@nifdc.org.cn
Supported by:
National Science and Technology Major Projects for ‘Major New Drugs Innovation and Development’ (Grant No. 2017ZX09101001, Beijing, China).

Abstract

Abstract:

The reference listed drug (RLD) adopted in the USA orange book is the important source of the Chinese comparator product directories of generic medicinal products. Therefore, its availability has the vital significance for pharmaceutical enterprise to carry out the re-evaluation of generic medicinal products and study of generic medicinal products. The national drug code (NDC) is the unique, 3-segment number for each drug product in USA, and it serves as a universal product identifier for drugs. While the NDC directory adopts the information of drug products in the current commercial distribution, including all of the prescription drug and over the counter (OTC) drug products. The composition and configuration of the NDC number are systemically elaborated in this paper, as well as the data source, development history and supporting measures of the NDC directory. At the same time, by taking drugs, which are adopted in the Chinese comparator product directory of generic medicinal product (first batch) and sourced from USA orange book, as example, it introduces the application of the NDC directory in the availability aspect of the Chinese comparator products to facilitate the Chinese or foreign pharmaceutical manufacturers to search, identify and purchase the suitable RLD sourced from USA orange book. Moreover, it can provide reference for Chinese drug regulatory to prepare the Chinese comparator product directories of generic medicinal products.

Key words: National drug code, Comparator product, Re-evaluation of generic medicinal product, Orange book

CLC Number:

R951

Supporting:

Dongsheng Yang, Lingyun Ma, Jianzhao Niu, Mingdi Xu. Brief introduction for application of the USA national drug code[J]. Journal of Chinese Pharmaceutical Sciences, 2019, 28(3): 203-208.

References

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Brief introduction for application of the USA national drug code

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