NDC 46783-160-01 Xeomin

Incobotulinumtoxina

  1. Labeler Index
  2. Merz North America, Inc.
  3. 46783-160
  4. NDC Package Code: 46783-160-01 Xeomin

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.
Drug Uses There are different types of botulinum toxin products (toxin A and B) with different uses (eye problems, muscle stiffness/spasms, migraines, cosmetic, overactive bladder). Different brands of this medication deliver different amounts of medication. Your doctor will choose the correct product for you. Botulinum toxin is used to treat certain eye disorders such as crossed eyes (strabismus) and uncontrolled blinking (blepharospasm), to treat muscle stiffness/spasms or movement disorders (such as cervical dystonia, torticollis), and to reduce the cosmetic appearance of wrinkles. It is also used to prevent headaches in people with very frequent migraines. Botulinum toxin relaxes muscle by blocking the release of a chemical called acetylcholine. Botulinum toxin is also used to treat overactive bladder by patients who do not respond to or who cannot tolerate the side effects of other medications. It helps to reduce leaking of urine, feeling of needing to urinate right away, and frequent trips to the bathroom. It is also used to treat severe underarm sweating and drooling/excess saliva. Botulinum toxin works by blocking the chemicals that turn on the sweat and salivary glands. Botulinum toxin is not a cure, and your symptoms will gradually return as the medication wears off.
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.
RxNorm Crosswalk1009456, 1009459, 1732157 and 1732161 - RxCUI 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.
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 12-31-2022 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.
Exclude Flag 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

  • 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.

* Please review the disclaimer below.

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 CodeHCPCS CodeHCPCS Code Desc.DosagePackage SizePackage QuantityBillable UnitsBillable Units / Pkg
46783016001J0588Incobotulinumtoxin a1 UNIT11100100

* Please review the disclaimer below.

Other Product Packages

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

NDC Package CodePackage Description
46783-160-101 VIAL, SINGLE-USE in 1 CARTON > 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-USE

* Please review the disclaimer below.