xeomin

Generic: incobotulinumtoxina

Labeler: merz north america, inc.
NDC Directory HUMAN PRESCRIPTION DRUG BLA Inactive Finished

Drug Facts

Product Profile

Brand Name xeomin
Generic Name incobotulinumtoxina
Labeler merz north america, inc.
Dosage Form INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Routes
INTRAMUSCULAR
Active Ingredients

botulinum toxin type a 50 [USP'U]/1

Manufacturer
Merz North America, Inc.

Identifiers & Regulatory

Product NDC 46783-165
Product ID 46783-165_cc302fc7-e87f-41ff-b716-388abdbf957a
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category BLA
Application Number BLA125360
Listing Expiration 2027-12-31
Marketing Start 2011-08-01

Pharmacologic Class

Established (EPC)
acetylcholine release inhibitor [epc] neuromuscular blocker [epc]
Mechanism of Action
acetylcholine release inhibitors [moa]
Physiologic Effect
neuromuscular blockade [pe]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 46783165
Hyphenated Format 46783-165

Supplemental Identifiers

UPC
0346783165018 0346783160013
UNII
E211KPY694
NUI
N0000175771 N0000193962 N0000175731 N0000175770

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name xeomin (source: ndc)
Generic Name incobotulinumtoxina (source: ndc)
Application Number BLA125360 (source: ndc)
Routes
INTRAMUSCULAR
source: ndc

Resolved Composition

Strengths
  • 50 [USP'U]/1
source: ndc
Packaging
  • 1 VIAL, SINGLE-USE in 1 CARTON (46783-165-01) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-USE
source: ndc

Packages (1)

46783-165-01 1 VIAL, SINGLE-USE in 1 CARTON (46783-165-01) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-USE

Ingredients (1)

botulinum toxin type a (50 [USP'U]/1)

Linked Drug Pages (1)

Xeomin ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAMUSCULAR"], "spl_id": "cc302fc7-e87f-41ff-b716-388abdbf957a", "openfda": {"nui": ["N0000175771", "N0000193962", "N0000175731", "N0000175770"], "upc": ["0346783165018", "0346783160013"], "unii": ["E211KPY694"], "spl_set_id": ["3f35d6e0-3450-4abc-a0da-cc7b277e7c6e"], "pharm_class_pe": ["Neuromuscular Blockade [PE]"], "pharm_class_epc": ["Acetylcholine Release Inhibitor [EPC]", "Neuromuscular Blocker [EPC]"], "pharm_class_moa": ["Acetylcholine Release Inhibitors [MoA]"], "manufacturer_name": ["Merz North America, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL, SINGLE-USE in 1 CARTON (46783-165-01)  / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-USE", "package_ndc": "46783-165-01", "marketing_start_date": "20110801"}], "brand_name": "Xeomin", "product_id": "46783-165_cc302fc7-e87f-41ff-b716-388abdbf957a", "dosage_form": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION", "pharm_class": ["Acetylcholine Release Inhibitor [EPC]", "Acetylcholine Release Inhibitors [MoA]", "Neuromuscular Blockade [PE]", "Neuromuscular Blocker [EPC]"], "product_ndc": "46783-165", "generic_name": "incobotulinumtoxinA", "labeler_name": "Merz North America, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Xeomin", "active_ingredients": [{"name": "BOTULINUM TOXIN TYPE A", "strength": "50 [USP'U]/1"}], "application_number": "BLA125360", "marketing_category": "BLA", "marketing_start_date": "20110801", "listing_expiration_date": "20271231"}