NDC 46783-160-01 Xeomin

Incobotulinumtoxina

NDC Package Code 46783-160-01

The NDC Code 46783-160-01 is assigned to a package of 1 vial, single-use in 1 carton > 1 injection, powder, lyophilized, for solution in 1 vial, single-use of Xeomin, a human prescription drug labeled by Merz North America, Inc.. The product's dosage form is injection, powder, lyophilized, for solution and is administered via intramuscular form.

Field Name	Field Value
NDC Code	46783-160-01
Package Description	1 VIAL, SINGLE-USE in 1 CARTON > 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-USE
Proprietary Name	Xeomin 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.
Non-Proprietary Name	Incobotulinumtoxina 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.
11-Digit NDC Billing Format	46783016001 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.
Product Type	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.
Labeler Name	Merz North America, Inc.
Dosage Form	Injection, Powder, Lyophilized, For Solution - A dosage form intended for the solution prepared by lyophilization ("freeze drying"), a process which involves the removal of water from products in the frozen state at extremely low pressures; this is intended for subsequent addition of liquid to create a solution that conforms in all respects to the requirements for Injections.
Administration Route(s)	Intramuscular - Administration within a muscle.
Active Ingredient(s)	BOTULINUM TOXIN TYPE A 100 [USP'U]/1
Pharmacological Class(es)	Acetylcholine Release Inhibitor - [EPC] (Established Pharmacologic Class) Acetylcholine Release Inhibitors - [MoA] (Mechanism of Action)
Sample Package	No Sample Package? This field Indicates whether this package is a sample packaging or not.
Marketing Category	BLA - A product marketed under an approved Biologic License 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	BLA125360 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	08-01-2011 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	12-31-2020 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.

NDC Code Structure

46783 - Merz North America, Inc.
- 46783-160 - Xeomin
  - 46783-160-01 - 1 VIAL, SINGLE-USE in 1 CARTON

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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NDC HCPCS Crosswalk

This crosswalk is intended to help the public understand which drug products (identified by NDCs) are assigned to which HCPCS billing codes.

NDC 46783-160-01 HCPCS crosswalk information with package details and bill units information.

NDC Billing Code	HCPCS Code	HCPCS Code Desc.	Dosage	Package Size	Package Quantity	Billable Units	Billable Units / Pkg
46783016001	J0588	Incobotulinumtoxin a	1 UNIT	1	1	100	100

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Other Product Packages

The following packages are also available for Xeomin with product NDC 46783-160.

NDC Package Code	Package Description
46783-160-10	1 VIAL, SINGLE-USE in 1 CARTON > 100 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-USE

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