||1 BLISTER PACK in 1 CARTON > 1 TABLET, FILM COATED in 1 BLISTER PACK
||Xofluza What is the 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.
||Baloxavir Marboxil What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
||Baloxavir marboxil is an antiviral medication used to treat the flu (influenza) if your symptoms started less than 48 hours ago. It helps make the symptoms (such as stuffy nose, cough, sore throat, fever/chills, aches, tiredness) less severe and may shorten the recovery time by 1 to 2 days. Baloxavir marboxil works by stopping the flu virus from growing. It will not treat other kinds of infection besides the flu virus. Baloxavir marboxil is not a substitute for the flu vaccine. (See also Notes section.)
|11-Digit NDC Billing Format
||50242087701 NDC Format for Billing
For insurance billing purposes the Centers for Medicare & Medicaid Services (CMS) created an 11 digit NDC derivative identifier. If the NDC Package code is less than 11 digits the code must be padded with leading zeros. The leading zeros must be added to the appropriate segment to create a 5-4-2 configuration.
|RxNorm Crosswalk||2100000, 2100006, 2100008, 2100010, 2100024, 2100026, 2100099, 2100100, 2467537, 2467539, 2536740 and 2536742 - RxCUIs What is RxNorm?|
The RxNorm crosswalk provides a normalized naming system for generic and branded drugs by assigning unique concept identifiers (RxCUI) to each NDC.
||Human Prescription Drug What kind of product is this?
Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.
||Tablet, Film Coated - A solid dosage form that contains medicinal substances with or without suitable diluents and is coated with a thin layer of a water-insoluble or water-soluble polymer.
- Oral - Administration to or by way of the mouth.
- BALOXAVIR MARBOXIL 80 mg/1
- Polymerase Acidic Endonuclease Inhibitor - [EPC] (Established Pharmacologic Class)
- Polymerase Acidic Endonuclease Inhibitors - [MoA] (Mechanism of Action)
- Chelating Activity - [MoA] (Mechanism of Action)
||No Sample Package?
This field Indicates whether this package is a sample packaging or not.
||NDA - A product marketed under an approved New Drug Application. What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.
|FDA Application Number
||NDA210854 What is the FDA Application Number?
This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. 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. “part 341”). For unapproved drugs, this field will be null.
|Start Marketing Date
||10-24-2018 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.
|Listing Expiration Date
||12-31-2022 What is the Listing Expiration Date?
This is the date when the listing record will expire if not updated or certified by the product labeler.
||N What is the NDC Exclude Flag?
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"). Values = "Y", "N", "E", or "I".