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

NDC Package 46783-160-01 Xeomin

Incobotulinumtoxina Injection, Powder, Lyophilized, For Solution Intramuscular - View Billable Units, 11-Digit Format, RxNorm

Table of Contents

    1. Package Information
    2. NDC HCPCS Crosswalk
    3. Other Packages
    4. Frequently Asked Questions

Package Information

Find all the important details about this NDC Package code, including the 11-Digit NDC Billing number, billing units, wholesale price, RxNorm crosswalk, active ingredients, pharmacologic clasess, etc.

NDC Package Code:
46783-160-01
Package Description:
1 VIAL, SINGLE-USE in 1 CARTON / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-USE
Product Code:
46783-160
Proprietary Name:
Xeomin
Non-Proprietary Name:
Incobotulinumtoxina
Substance Name:
Botulinum Toxin Type A
Usage Information:
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 to RxNorm Crosswalk:
  • RxCUI: 1009456 - incobotulinumtoxinA 100 UNT Injection
  • RxCUI: 1009459 - incobotulinumtoxinA 50 UNT Injection
  • RxCUI: 1732157 - XEOMIN 50 UNT Injection
  • RxCUI: 1732157 - incobotulinumtoxinA 50 UNT Injection [Xeomin]
  • RxCUI: 1732157 - Xeomin 50 UNT Injection
    • Product Type:
    Human Prescription Drug
    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
    • Pharmacologic Class(es):
  • Acetylcholine Release Inhibitor - [EPC] (Established Pharmacologic Class)
  • Acetylcholine Release Inhibitors - [MoA] (Mechanism of Action)
  • Neuromuscular Blockade - [PE] (Physiologic Effect)
  • Neuromuscular Blocker - [EPC] (Established Pharmacologic Class)
    • Sample Package:
    No
    FDA Application Number:
    BLA125360
    Marketing Category:
    BLA - A product marketed under an approved Biologic License Application.
    Start Marketing Date:
    08-01-2011
    Listing Expiration Date:
    12-31-2024
    Exclude Flag:
    N
    Code Structure:

    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 this product:

    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.

    Frequently Asked Questions

    What is NDC 46783-160-01?

    The NDC Packaged 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.

    Is NDC 46783-160 included in the NDC Directory?

    Yes, Xeomin with product code 46783-160 is active and included in the NDC Directory. The product was first marketed by Merz North America, Inc. on August 01, 2011 and its listing in the NDC Directory is set to expire on December 31, 2024 if the product is not updated or renewed by the manufacturer.

    What is the 11-digit format for NDC 46783-160-01?

    The 11-digit format is 46783016001. The 11-digit billing format might be required by the Centers for Medicare & Medicaid Services (CMS) and other payers in billing claim forms.

    This package code is originally configured in a 5-3-2 segment 10-digit format and by adding a zero within the original NDC package code we can obtain the converted 11-digit format in a 5-4-2 segment configuration. The table below shows the 11-digit code conversion:

    10-Digit Format10-Digit Original Code11-Digit Format11-Digit Code
    5-3-246783-160-015-4-246783-0160-01