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The national drug code is a unique 10 or 11 digit, 3-segment numeric identifier assigned to each medication listed under Section 510 of the US Federal Food, Drug, and Cosmetic Act. The segments identify the labeler or vendor, product (within the scope of the labeler), and trade package (of this product). The first segment, the labeler code, is ...
The Universal Product Code ( UPC or UPC code) is a barcode symbology that is used worldwide for tracking trade items in stores. The chosen symbology has bars (or spaces) of exactly 1, 2, 3, or 4 units wide each; each decimal digit to be encoded consists of two bars and two spaces chosen to have a total width of 7 units, in both an "even" and an ...
Global Medical Device Nomenclature. Global Medical Device Nomenclature ( GMDN) is a system of internationally agreed generic descriptors used to identify all medical device products. This nomenclature is a naming system for products which include those used for the diagnosis, prevention, monitoring, treatment or alleviation of disease or injury ...
Structured Product Labeling ( SPL) is a Health Level Seven International (HL7) standard which defines the content of human prescription drug labeling in an XML format. [ 1] The "drug labeling" includes all published material accompanying a drug, such as the Prescribing Information which contains a great deal of detailed information about the ...
The Center for Biologics Evaluation and Research ( CBER) is one of six main centers for the U.S. Food and Drug Administration (FDA), which is a part of the U.S. Department of Health and Human Services. The current Director of CBER is Peter Marks, M.D., PhD. CBER is responsible for assuring the safety, purity, potency, and effectiveness of ...
This list of pharmaceutical compound number prefixes provides codes used by individual pharmaceutical companies when naming their pharmaceutical drug candidates. . Pharmaceutical companies generally produce large numbers of compounds in the research phase for which it is impractical to use often long and cumbersome systematic chemical names, and for which the effort to generate nonproprietary ...
Form FDA 483. The U.S. Food and Drug Administration (FDA) is authorized to perform inspections under the Federal Food, Drug, and Cosmetic Act, Sec. 704 (21 USC ยง374) "Factory Inspection". [ 1] Form FDA 483, [ 2] "Inspectional Observations", is a form used by the FDA to document and communicate concerns discovered during these inspections.
Pharmaceutical code. Pharmaceutical codes are used in medical classification to uniquely identify medication. They may uniquely identify an active ingredient, drug system (including inactive ingredients and time-release agents) in general, or a specific pharmaceutical product from a specific manufacturer.