dysport

Generic: botulinum toxin type a

Labeler: ipsen biopharmaceuticals, inc.
NDC Directory HUMAN PRESCRIPTION DRUG BLA Inactive Finished

Drug Facts

Product Profile

Brand Name dysport
Generic Name botulinum toxin type a
Labeler ipsen biopharmaceuticals, inc.
Dosage Form INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Routes
INTRAMUSCULAR
Active Ingredients

botulinum toxin type a 500 U/1

Manufacturer
Ipsen Biopharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 15054-0500
Product ID 15054-0500_44512f6b-6a35-4db5-ba17-fe2fe3ec5170
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category BLA
Application Number BLA125274
Listing Expiration 2026-12-31
Marketing Start 2009-11-02

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 150540500
Hyphenated Format 15054-0500

Supplemental Identifiers

RxCUI
1789950 1789953 1789956 1789958
UPC
0315054050018
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 dysport (source: ndc)
Generic Name botulinum toxin type a (source: ndc)
Application Number BLA125274 (source: ndc)
Routes
INTRAMUSCULAR
source: ndc

Resolved Composition

Strengths
  • 500 U/1
source: ndc
Packaging
  • 1 VIAL in 1 CARTON (15054-0500-1) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL
  • 2 VIAL in 1 CARTON (15054-0500-2) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL
  • 1 VIAL in 1 CARTON (15054-0500-9) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL
source: ndc

Packages (3)

15054-0500-1 1 VIAL in 1 CARTON (15054-0500-1) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL 15054-0500-2 2 VIAL in 1 CARTON (15054-0500-2) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL 15054-0500-9 1 VIAL in 1 CARTON (15054-0500-9) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL

Ingredients (1)

botulinum toxin type a (500 U/1)

Linked Drug Pages (1)

Dysport ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAMUSCULAR"], "spl_id": "44512f6b-6a35-4db5-ba17-fe2fe3ec5170", "openfda": {"nui": ["N0000175771", "N0000193962", "N0000175731", "N0000175770"], "upc": ["0315054050018"], "unii": ["E211KPY694"], "rxcui": ["1789950", "1789953", "1789956", "1789958"], "spl_set_id": ["97513722-8426-4ce3-b85d-0e08e436a140"], "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": ["Ipsen Biopharmaceuticals, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL in 1 CARTON (15054-0500-1)  / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL", "package_ndc": "15054-0500-1", "marketing_start_date": "20091102"}, {"sample": false, "description": "2 VIAL in 1 CARTON (15054-0500-2)  / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL", "package_ndc": "15054-0500-2", "marketing_start_date": "20091102"}, {"sample": true, "description": "1 VIAL in 1 CARTON (15054-0500-9)  / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL", "package_ndc": "15054-0500-9", "marketing_start_date": "20091102"}], "brand_name": "Dysport", "product_id": "15054-0500_44512f6b-6a35-4db5-ba17-fe2fe3ec5170", "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": "15054-0500", "generic_name": "Botulinum Toxin Type A", "labeler_name": "Ipsen Biopharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Dysport", "active_ingredients": [{"name": "BOTULINUM TOXIN TYPE A", "strength": "500 U/1"}], "application_number": "BLA125274", "marketing_category": "BLA", "marketing_start_date": "20091102", "listing_expiration_date": "20261231"}