Xeomin Injection, Powder, Lyophilized, For Solution
NDC Package 46783-160-01

11-digit billing NDC: 46783016001 · Billing unit: EA · 1 EA per package
Table of Contents
    1. Package Information
    2. NDC HCPCS Crosswalk
    3. Other Packages
    4. Frequently Asked Questions

Package Information

Xeomin (incobotulinumtoxina) injection is xEOMIN is contraindicated in patients with:Known hypersensitivity to any botulinum toxin product or to any of the components in the formulation [see Warnings and Precautions (5.3) and Description (11)].Infection at the proposed injection site(s) because it could lead to severe local or disseminated infection. This formulation utilizes a injection, powder, lyophilized, for solution delivery system. Marketed by Merz North America, Inc., this product is identified by NDC 46783-160 and is authorized under FDA application BLA125360.

Identification & Billing

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
11-Digit Billing Format
46783016001
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
1 EA
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Xeomin
Non-Proprietary Name
Incobotulinumtoxina
Substance Name
Botulinum Toxin Type A
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
Intramuscular - Administration within a muscle.
Active Ingredient(s)
BOTULINUM TOXIN TYPE A 100 [USP'U]/1
Pharmacologic Class
Usage Information
XEOMIN is contraindicated in patients with:Known hypersensitivity to any botulinum toxin product or to any of the components in the formulation [see Warnings and Precautions (5.3) and Description (11)].Infection at the proposed injection site(s) because it could lead to severe local or disseminated infection.

Regulatory & Marketing

Labeler Name
Merz North America, Inc.
Product Type
Human Prescription Drug
FDA Application #
BLA125360
Marketing Category
BLA - A product marketed under an approved Biologic License Application.
Start Marketing Date
08-01-2011
Listing Expiration
12-31-2027
Exclude Flag
N
Sample Package
No

Hierarchy Structure

Code Lineage

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 full disclaimer at the bottom of this page.

Billing & HCPCS Mapping

To facilitate insurance claims and reimbursement, this drug package is mapped to specific HCPCS administrative codes. This crosswalk aligns clinical data with the billing standards used in ASP (Average Sales Price), AWP, and OPPS payment systems. Use the cards below to identify the correct billable units for provider claims.

J0588
Source: ASP
Incobotulinumtoxin a
HCPCS Dosage 1 UNIT
Units / Pkg 100

Note for Medical Coders: These mappings are synthesized from various CMS datasets including OPPS, PrEP, and DAC (Data Analysis and Coding) contractors. Always confirm unit conversions against the current quarter's pricing files before final submission.

* Please review the full disclaimer at the bottom of this page.

Other Available Packages

The following commercial packages are registered under the same Product NDC (46783-160). Click a package code to view its specific billing and regulatory data.

46783-160-10
1 VIAL, SINGLE-USE in 1 CARTON / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-USE

* Please review the full disclaimer at the bottom of this page.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 46783-160-01 identifies a specific commercial 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.. This product is billed for "EA" each discreet unit and contains an estimated amount of 1 billable units per package. This injection, powder, lyophilized, for solution is formulated for intramuscular use and contains botulinum toxin type a as the active substance.

Is this product currently listed with the FDA?

Yes, this product is active and verified within the NDC Directory. It was introduced to the market by Merz North America, Inc. on August 01, 2011. The current certification is valid through December 31, 2027.

How is this Merz North America, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 46783016001. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 1 total billable units per package. The table below illustrates the segment conversion from the 10-digit labeler code to the 11-digit provider format.

11-Digit Code Conversion

Billing payers usually require a 5-4-2 segment configuration. Below is the conversion from the 10-digit package format to the 11-digit billing format:

10-Digit Format (5-3-2)
46783-160-01
11-Digit CMS (5-4-2)
46783-0160-01

Note: The zero is added to the Product segment to maintain the 5-4-2 structure.