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  2. National drug code - Wikipedia

    en.wikipedia.org/wiki/National_Drug_Code

    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 by it ...

  3. DailyMed - Wikipedia

    en.wikipedia.org/wiki/DailyMed

    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 ...

  4. First Databank - Wikipedia

    en.wikipedia.org/wiki/First_Databank

    First Databank (FDB) is a major provider of drug and medical device databases that help inform healthcare professionals to make decisions. [1] FDB partners with information system developers to deliver useful medication- and medical device-related information to clinicians, business associates, and patients.

  5. Approved drug - Wikipedia

    en.wikipedia.org/wiki/Approved_drug

    Before a drug can be prescribed, it must undergo the FDA's approval process. While a drug can feasibly be used off-label (for non-approved indications), it still is required to be approved for a specific disease or medical condition. [2] Drug companies seeking to sell a drug in the United States must first test it.

  6. Generic Product Identifier - Wikipedia

    en.wikipedia.org/wiki/Generic_Product_Identifier

    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 ...

  7. List of drugs granted breakthrough therapy designation

    en.wikipedia.org/wiki/List_of_drugs_granted...

    In combination with palbociclib and fulvestrant for the treatment of adults with endocrine-resistant, PIK3CA-mutated, hormone receptor (HR)-positive, human epidermal growth-factor receptor 2 (HER2)-negative, locally advanced or metastatic breast cancer, as detected by an FDA-approved test, following recurrence on or after completing adjuvant ...

  8. Approved Drug Products with Therapeutic Equivalence ...

    en.wikipedia.org/wiki/Approved_Drug_Products...

    inducing pioneering research and development of new drugs and; enabling competitors to bring low-cost, generic copies of those drugs to market'". [1] The Orange Book identifies drug products approved on the basis of safety and effectiveness by the Food and Drug Administration (FDA) under the Federal Food, Drug, and Cosmetic Act.

  9. RxList - Wikipedia

    en.wikipedia.org/wiki/RxList

    RxList is an online medical resource of US prescription medications providing full prescribing information and patient education. It was founded in 1995 by Neil Sandow, Pharm.D. [1] [2]