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?
Oral - Administration to or by way of the mouth. The translation of the route code submitted by the firm, indicating route of administration. Tablet - A solid dosage form containing medicinal substances with or without suitable diluents.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.ĭextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, And Amphetamine Sulfate 
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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