Source: FDA, National Drug Code (US) | Revision Year: 2021 | Publisher:
The active ingredient of XEOMIN is botulinum toxin type A produced from fermentation of Hall strain Clostridium botulinum serotype A. The botulinum toxin complex is purified from the culture supernatant and then the active ingredient is separated from the proteins (hemagglutinins and non-hemagglutinins) through a series of steps yielding the active neurotoxin with molecular weight of 150 kDa, without accessory proteins. XEOMIN is a sterile white to off-white lyophilized powder intended for intramuscular or intra-salivary gland injection after reconstitution with preservative-free 0.9% Sodium Chloride Injection, USP [see Dosage Forms and Strengths (3)]. One vial of XEOMIN contains 50 Units, 100 Units, or 200 Units of incobotulinumtoxinA, human albumin (1 mg), and sucrose (4.7 mg).
The primary release procedure for XEOMIN uses a cell-based potency assay to determine the potency relative to a reference standard. One Unit corresponds to the median intraperitoneal lethal dose (LD50) in mice. As the method for conducting the assay is specific to XEOMIN, Units of biological activity of XEOMIN cannot be converted into Units of any other botulinum toxin assessed with other specific assays.
For injection: 50 Units, 100 Units, or 200 Units lyophilized powder in a single-dose vial for reconstitution only with preservative-free 0.9% Sodium Chloride Injection, USP.
XEOMIN for injection is a sterile white to off-white lyophilized powder supplied in Type 1 borosilicate glass single-dose vials with tamper-proof aluminum seals and bromobutyl rubber closures that are not made with natural rubber latex in the following pack sizes:
Upper Limb Spasticity and Cervical Dystonia:
| Package | XEOMIN 50 Units | XEOMIN 100 Units | XEOMIN 200 Units |
| Carton with one single-dose vial | NDC 0259-1605-01 | NDC 0259-1610-01 | NDC 0259-1620-01 |
Chronic Sialorrhea and Blepharospasm:
| Package | XEOMIN 50 Units | XEOMIN 100 Units |
| Carton with one single-dose vial | NDC 0259-1605-01 | NDC 0259-1610-01 |
Glabellar Lines:
| Package | XEOMIN 50 Units | XEOMIN 100 Units |
| Carton with one single-dose vial | NDC 46783-161-01 | NDC 46783-160-01 |
Manufactured by: Merz Pharmaceuticals GmbH, Eckenheimer Landstrasse 100, Frankfurt Germany, U.S. License Number 1830
Distributed by:
Merz Pharmaceuticals, LLC, 6501 Six Forks Road, Raleigh, NC 27615
and
Merz North America, Inc., 4133 Courtney Street, Suite 10, Franksville, WI 53126
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