![]() This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA"s requests for correction to deficient or non-compliant submissions ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). This is the date when the listing record will expire if not updated or certified by the product labeler.Įxclude Flag What is the NDC Exclude Flag? Listing Expiration Date What is the Listing Expiration Date? This is the date that the labeler indicates was the start of its marketing of the drug product. Start Marketing Date What is the Start Marketing Date? ![]() OTC MONOGRAPH NOT FINAL - A product marketed pursuant to an Over-the-Counter (OTC) Drug Monograph that is not final. The complete list of codes and translations can be found at under Structured Product Labeling Resources. ![]() Currently, only final marketed product categories are included. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. 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? The E2B term TRANSMAMMARY is a subset of the term TOPICAL. Topical - Administration to a particular spot on the outer surface of the body.The translation of the route code submitted by the firm, indicating route of administration. This dosage form is generally for external application to the skin or mucous membranes.Īdministration Route(s) What are the Administration Route(s)? ![]() This data element matches the “Document Type” field of the Structured Product Listing.ĪCTIVE PRODUCT and included in NDC DirectoryĬream - An emulsion, semisolid3 dosage form, usually containing > 20% water and volatiles5 and/or < 50% hydrocarbons, waxes, or polyols as the vehicle. Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. Product Type What kind of product is this? Each active ingredient name is the preferred term of the UNII code submitted. Substance Name What is the Substance Name?Īn active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. 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? Loreal Paris Age Perfect Radiant Serum Foundation Spf 50 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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