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The national drug code (NDC) is a unique product identifier used in the United States for drugs intended for human use. The Drug Listing Act of 1972 [ 1 ] [ 2 ] requires registered drug establishments to provide the Food and Drug Administration (FDA) with a current list of all drugs manufactured, prepared, propagated, compounded, or processed ...
National Drug Code (NDC) — administered by Food and Drug Administration. [1] Drug Identification Number (DIN) — administered by Health Canada under the Food and Drugs Act; Hong Kong Drug Registration — administered by the Pharmaceutical Service of the Department of Health (Hong Kong) National Pharmaceutical Product Index - South Africa
However, the existing epedigree requirements amount to little more than requiring that pharmaceutical supply chain companies be able to provide reports in formats such as pdf, text files or spreadsheets. The basic data elements of an original epedigree are: Lot; Potency; Expiration; National Drug Code and Electronic Product Code; Manufacturer
DailyMed is a website operated by the U.S. National Library of Medicine (NLM) to publish up-to-date and accurate drug labels (also called a "package insert") to health care providers and the general public. The contents of DailyMed is provided and updated daily by the U.S. Food and Drug Administration (FDA). The FDA in turn collects this ...
The Prescribing Information follows one of two formats: "physician labeling rule" format or "old" (non-PLR) format. For "old" format labeling a "product title" may be listed first and may include the proprietary name (if any), the nonproprietary name, dosage form(s), and other information about the product.
The Generic Product Identifier (GPI) is a 14-character hierarchical classification system created by Wolters Kluwer's Medi-Span that identifies drugs from their primary therapeutic use down to the unique interchangeable product regardless of manufacturer or package size. The code consists of seven subsets, each providing increasingly more ...
The National Council for Prescription Drug Programs (NCPDP) is an American nonprofit standards development organization representing most sectors of the U.S. pharmacy services industry. It was founded in 1977 as the extension of a Drug Ad Hoc Committee that made recommendations for the U.S. National Drug Code (NDC).
In order for a generic drug manufacturer to win approval of a drug under the Hatch-Waxman Act, the generic manufacturer must certify that they will not launch their generic until after the expiration of the Orange Book-listed patent, or that the patent is invalid, unenforceable, or that the generic product will not infringe the listed patent.