![]() 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? 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. NDA - A product marketed under an approved New Drug Application.įDA Application Number What is the FDA Application Number? 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? This field Indicates whether this package is a sample packaging or not. Intravenous - Administration within or into a vein or veins. ![]() Kit - A packaged collection of related material. This data element matches the “Document Type” field of the Structured Product Listing.Īdvanced Accelerator Applications Usa, Inc 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 leading zeros must be added to the appropriate segment to create a 5-4-2 configuration.ĮA - Billing unit of "each" is used when the product is dispensed in discreet units. If the NDC Package code is less than 11 digits the code must be padded with leading zeros. NETSPOT, after radiolabeling with Ga 68, is indicated for use with positron emission tomography (PET) for localization of somatostatin receptor positive neuroendocrine tumors (NETs) in adult and pediatric patients.ġ1-Digit NDC Billing Format NDC Format for Billingįor insurance billing purposes the Centers for Medicare & Medicaid Services (CMS) created an 11 digit NDC derivative identifier. Always ask a health care professional for complete information about this product and your specific health needs. ![]() This information is not individual medical advice and does not substitute for the advice of a health care professional. This information does not assure that this product is safe, effective, or appropriate. The drug use information is a summary and does NOT have all possible information about this product. Usage Information Product Usage Information 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? Field Nameġ KIT in 1 KIT * 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-DOSE The product's dosage form is kit and is administered via intravenous form. The NDC Code 69488-001-40 is assigned to a package of 1 kit in 1 kit * 1 injection, powder, lyophilized, for solution in 1 vial, single-dose of Netspot, a human prescription drug labeled by Advanced Accelerator Applications Usa, Inc.
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