The NDC Code 0054-0468-23 is assigned to a package of 112 tablet in 1 bottle of Tetrabenazine, a human prescription drug labeled by Hikma Pharmaceuticals Usa Inc.. The product's dosage form is tablet and is administered via oral form.
||112 TABLET in 1 BOTTLE
||Tetrabenazine 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.
||Tetrabenazine 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.
||Tetrabenazine is used to decrease the uncontrollable movements (chorea) caused by Huntington's disease. However, it is not a cure for the disease. Reducing the chorea will help you take part in more of your normal daily activities. This medication is thought to work by decreasing the amount of certain natural substances in the brain (monoamines such as dopamine, serotonin, and norepinephrine), which are involved with nerve and muscle function. Tetrabenazine belongs to a class of drugs called monoamine depletors.
|11-Digit NDC Billing Format
||00054046823 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.
||EA - Billing unit of "each" is used when the product is dispensed in discreet units.
||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.
Hikma Pharmaceuticals Usa Inc.
||Tablet - A solid dosage form containing medicinal substances with or without suitable diluents.
- Oral - Administration to or by way of the mouth.
- Vesicular Monoamine Transporter 2 Inhibitor - [EPC] (Established Pharmacologic Class)
- Vesicular Monoamine Transporter 2 Inhibitors - [MoA] (Mechanism of Action)
||No Sample Package?
This field Indicates whether this package is a sample packaging or not.
||ANDA - A product marketed under an approved Abbreviated 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
||ANDA209739 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
||09-19-2019 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
||12-31-2021 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".
NDC Code Structure
- 0054 - Hikma Pharmaceuticals Usa Inc.
- 0054-0468 - Tetrabenazine
0054-0468-23 - 112 TABLET in 1 BOTTLE
The NDC Directory contains ONLY information on final marketed drugs submitted to FDA electronically by labelers. A labeler might be a manufacturer, re-packager or re-labeler. The product information included in the NDC directory does not indicate that FDA has verified the information provided by the product labeler. Assigned NDC numbers are not in any way an indication of FDA approval of the product.
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