xeomin

Generic: incobotulinumtoxina

Labeler: merz pharmaceuticals, llc
NDC Directory HUMAN PRESCRIPTION DRUG BLA Inactive Finished

Drug Facts

Product Profile

Brand Name xeomin
Generic Name incobotulinumtoxina
Labeler merz pharmaceuticals, llc
Dosage Form INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Routes
INTRAMUSCULAR
Active Ingredients

botulinum toxin type a 200 [USP'U]/1

Manufacturer
Merz Pharmaceuticals, LLC

Identifiers & Regulatory

Product NDC 0259-1620
Product ID 0259-1620_f8c62d22-d9d7-4559-b9a3-f5c94447fb14
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category BLA
Application Number BLA125360
Listing Expiration 2027-12-31
Marketing Start 2015-11-20

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 02591620
Hyphenated Format 0259-1620

Supplemental Identifiers

RxCUI
1000107 1009456 1009459 1732157 1732161 1732165
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
  • 200 [USP'U]/1
source: ndc
Packaging
  • 1 VIAL, SINGLE-USE in 1 CARTON (0259-1620-01) / 200 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-USE
  • 1 VIAL, SINGLE-USE in 1 CARTON (0259-1620-10) / 200 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-USE
source: ndc

Packages (2)

Ingredients (1)

botulinum toxin type a (200 [USP'U]/1)

Linked Drug Pages (1)

Raw FDA Data

View complete raw FDA NDC JSON payload
{"route": ["INTRAMUSCULAR"], "spl_id": "f8c62d22-d9d7-4559-b9a3-f5c94447fb14", "openfda": {"nui": ["N0000175771", "N0000193962", "N0000175731", "N0000175770"], "unii": ["E211KPY694"], "rxcui": ["1000107", "1009456", "1009459", "1732157", "1732161", "1732165"], "spl_set_id": ["ccdc3aae-6e2d-4cd0-a51c-8375bfee9458"], "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 Pharmaceuticals, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL, SINGLE-USE in 1 CARTON (0259-1620-01)  / 200 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-USE", "package_ndc": "0259-1620-01", "marketing_start_date": "20151120"}, {"sample": false, "description": "1 VIAL, SINGLE-USE in 1 CARTON (0259-1620-10)  / 200 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-USE", "package_ndc": "0259-1620-10", "marketing_start_date": "20151120"}], "brand_name": "Xeomin", "product_id": "0259-1620_f8c62d22-d9d7-4559-b9a3-f5c94447fb14", "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": "0259-1620", "generic_name": "incobotulinumtoxinA", "labeler_name": "Merz Pharmaceuticals, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Xeomin", "active_ingredients": [{"name": "BOTULINUM TOXIN TYPE A", "strength": "200 [USP'U]/1"}], "application_number": "BLA125360", "marketing_category": "BLA", "marketing_start_date": "20151120", "listing_expiration_date": "20271231"}