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Drug system identifiers (manufacturer-specific including inactive ingredients): 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
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 ...
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.
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The Unique Ingredient Identifier (UNII) is an alphanumeric identifier linked to a substance's molecular structure or descriptive information and is generated by the Global Substance Registration System (GSRS) of the Food and Drug Administration (FDA).
Lisdexamfetamine is an inactive prodrug that is converted in the body to dextroamphetamine, a pharmacologically active compound that is responsible for the drug's activity. [109] After oral ingestion, lisdexamfetamine is broken down by enzymes in red blood cells to form L-lysine, a naturally occurring essential amino acid, and dextroamphetamine ...
The drug must be combined with inactive ingredients by a method that ensures that the quantity of drug present is consistent in each dosage unit e.g. each tablet. The dosage should have a uniform appearance, with an acceptable taste, tablet hardness, and capsule disintegration.
The dosage form for a pharmaceutical contains the active pharmaceutical ingredient, which is the drug substance itself, and excipients, which are the ingredients of the tablet, or the liquid in which the active agent is suspended, or other material that is pharmaceutically inert. Drugs are chosen primarily for their active ingredients.