Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. Marketing Category What is the Marketing Category? For unapproved drugs, this field will be null. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. Name of Company corresponding to the labeler code segment of the Product NDC.įDA Application Number What is the FDA Application Number? Product Labeler Information What is the Labeler Name? Intravenous - Administration within or into a vein or veins.Intravascular - Administration within a vessel or vessels.The translation of the route code submitted by the firm, indicating route of administration. Kit - A packaged collection of related material.Īdministration Route(s) What are the Administration Route(s)? This data element matches the “Document Type” field of the Structured Product Listing. Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. Product Type What kind of product is this? The generic name usually includes the active ingredient(s) of the product.
The non-proprietary name is sometimes called the generic name. Non-Proprietary Name What is the Non-Proprietary Name? The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes. Proprietary Name What is the Proprietary Name?
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