Prescription drug · BLA
Xeomin (Incobotulinumtoxina) NDC 46783-161
Botulinum toxin type a 50 [USP'U]/1 · Injection, Powder, Lyophilized, For solution · Intramuscular · Merz North America, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 46783-161-01 | 4678301610146783016101 | 1 VIAL, SINGLE-USE in 1 CARTON (46783-161-01) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-USEMarketed from Aug 1, 2011 |
How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules
Product information
- Brand name (proprietary)
- Xeomin
- Generic name (nonproprietary)
- incobotulinumtoxina
- Active ingredients
- Botulinum toxin type a — 50 [USP'U]/1
- Dosage form
- Injection, Powder, Lyophilized, For solution
- Route
- Intramuscular
- Labeler
- Merz North America, Inc.NDC labeler code 46783
- Product type
- Prescription drug
- Marketing category
- BLA — Biologics License ApplicationApplication BLA 125360
- Marketing start
- Listing expires
- Other FDA classes
- Acetylcholine Release Inhibitors (Mechanism)Neuromuscular Blockade (Physiologic effect)
- Identifiers
- Product ID 46783-161_8b2d961a-6bb4-4bef-ac07-7dcc2bbfacc7SPL ID 8b2d961a-6bb4-4bef-ac07-7dcc2bbfacc7SPL set ID 3f35d6e0-3450-4abc-a0da-cc7b277e7c6eRxCUI 1009456, 1009459, 1732157, 1732161UNII E211KPY694UPC 0346783165018, 0346783160013
- Pharmacologic class
- Acetylcholine Release Inhibitor; Neuromuscular Blocker
Billing references
What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.
- HCPCS codeNo match
No drug-specific HCPCS code in Med-Code's directory for this product. The directory is curated and not complete — check the current CMS HCPCS file before billing.
- Administration
Drug administration (CPT 96360–96549)
When a clinician administers the drug, the administration is reported separately. Codes in this range cover hydration, therapeutic injections and infusions, and chemotherapy or other complex drug administration. The right code depends on route, duration and drug type, and self-administered drugs are not billed this way.
- NDC on a medical claim
N446783016101followed by a unit qualifier and the quantityPackage 46783-0161-01. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier
Product label
Current FDA label (SPL), effective . This label includes a boxed warning.
Indications (excerpt from the label)
XEOMIN is an acetylcholine release inhibitor and neuromuscular blocking agent indicated for the treatment or improvement of: Chronic sialorrhea in patients 2 years of age and older ( 1.1 ) Upper limb spasticity in patients 2 years of age and older ( 1.2 ) Cervical dystonia in adults ( 1.3 ) Blepharospasm in adults ( 1.4 ) the appearance of upper facial lines in adults: moderate to severe glabellar lines associated with corrugator and/or procerus muscle activity ( 1.5 ) moderate to severe horizontal forehead lines associated with frontalis muscle activity ( 1.5 ) moderate to severe lateral canthal lines associated with orbicularis oculi muscle activity ( 1.5 ) 1.1 Chronic Sialorrhea XEOMIN is…
Excerpt only. Read the full label for complete information.
About NDC 46783-161
- What is NDC 46783-161?
- 46783-161 is the product NDC for Xeomin (incobotulinumtoxina), Botulinum toxin type a 50 [USP'U]/1 injection, powder, lyophilized, for solution, listed with the FDA by Merz North America, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Xeomin (IncobotulinumtoxinA).
- What is the active ingredient?
- Botulinum toxin type a.
- Who is the labeler?
- Merz North America, Inc., NDC labeler code 46783. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Xeomin?
- 7 other product NDCs are listed under this name. See all Xeomin NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Xeomin products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Xeominincobotulinumtoxina | Botulinum toxin type a 200 [USP'U]/1 | Injection, Powder, Lyophilized, For solutionIntramuscular | Merz Pharmaceuticals, LLC | 0259-1620 | 00259-1620-0100259-1620-10 |
| Xeominincobotulinumtoxina | Botulinum toxin type a 100 [USP'U]/1 | Injection, Powder, Lyophilized, For solutionIntramuscular | Merz North America, Inc. | 46783-160 | 46783-0160-0146783-0160-10 |
| Xeominincobotulinumtoxina | Botulinum toxin type a 50 [USP'U]/1 | Injection, Powder, Lyophilized, For solutionIntramuscular | Merz North America, Inc. | 46783-165 | 46783-0165-01 |
| Xeominincobotulinumtoxina | Botulinum toxin type a 50 [USP'U]/1 | Injection, Powder, Lyophilized, For solutionIntramuscular | Merz Pharmaceuticals, LLC | 0259-1605 | 00259-1605-01 |
| Xeominincobotulinumtoxina | Botulinum toxin type a 100 [USP'U]/1 | Injection, Powder, Lyophilized, For solutionIntramuscular | Merz Pharmaceuticals, LLC | 0259-1610 | 00259-1610-01 |
| Xeominincobotulinumtoxina | Botulinum toxin type a 100 [USP'U]/1 | Injection, Powder, Lyophilized, For solutionIntramuscular | Merz Pharmaceuticals, LLC | 0259-4110 | 00259-4110-01 |
| Xeominincobotulinumtoxina | Botulinum toxin type a 50 [USP'U]/1 | Injection, Powder, Lyophilized, For solutionIntramuscular | Merz Pharmaceuticals, LLC | 0259-4150 | 00259-4150-01 |
Other NDCs under BLA 125360
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Xeominincobotulinumtoxina | Botulinum toxin type a 50 [USP'U]/1 | Injection, Powder, Lyophilized, For solutionIntramuscular | Merz Pharmaceuticals, LLC | 0259-1605 |
| Xeominincobotulinumtoxina | Botulinum toxin type a 100 [USP'U]/1 | Injection, Powder, Lyophilized, For solutionIntramuscular | Merz Pharmaceuticals, LLC | 0259-1610 |
| Xeominincobotulinumtoxina | Botulinum toxin type a 200 [USP'U]/1 | Injection, Powder, Lyophilized, For solutionIntramuscular | Merz Pharmaceuticals, LLC | 0259-1620 |
| Xeominincobotulinumtoxina | Botulinum toxin type a 100 [USP'U]/1 | Injection, Powder, Lyophilized, For solutionIntramuscular | Merz Pharmaceuticals, LLC | 0259-4110 |
| Xeominincobotulinumtoxina | Botulinum toxin type a 50 [USP'U]/1 | Injection, Powder, Lyophilized, For solutionIntramuscular | Merz Pharmaceuticals, LLC | 0259-4150 |
| Xeominincobotulinumtoxina | Botulinum toxin type a 100 [USP'U]/1 | Injection, Powder, Lyophilized, For solutionIntramuscular | Merz North America, Inc. | 46783-160 |
| Xeominincobotulinumtoxina | Botulinum toxin type a 50 [USP'U]/1 | Injection, Powder, Lyophilized, For solutionIntramuscular | Merz North America, Inc. | 46783-165 |