dysport

Generic: botulinum toxin type a

Labeler: galderma laboratories, l.p.
NDC Directory HUMAN PRESCRIPTION DRUG BLA Inactive Finished

Drug Facts

Product Profile

Brand Name dysport
Generic Name botulinum toxin type a
Labeler galderma laboratories, l.p.
Dosage Form INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Routes
INTRAMUSCULAR
Active Ingredients

botulinum toxin type a 300 U/1

Manufacturer
Galderma Laboratories, L.P.

Identifiers & Regulatory

Product NDC 0299-5962
Product ID 0299-5962_253b9c91-ded3-b0b3-e063-6294a90a669a
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 02995962
Hyphenated Format 0299-5962

Supplemental Identifiers

RxCUI
1789956 1789958
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
  • 300 U/1
source: ndc
Packaging
  • 1 VIAL in 1 CARTON (0299-5962-01) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL
  • 1 VIAL in 1 CARTON (0299-5962-30) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL
source: ndc

Packages (2)

Ingredients (1)

botulinum toxin type a (300 U/1)

Linked Drug Pages (1)

Raw FDA Data

View complete raw FDA NDC JSON payload
{"route": ["INTRAMUSCULAR"], "spl_id": "253b9c91-ded3-b0b3-e063-6294a90a669a", "openfda": {"nui": ["N0000175771", "N0000193962", "N0000175731", "N0000175770"], "unii": ["E211KPY694"], "rxcui": ["1789956", "1789958"], "spl_set_id": ["71313a04-1349-4c26-b840-a39e4a3ddaed"], "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": ["Galderma Laboratories, L.P."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": true, "description": "1 VIAL in 1 CARTON (0299-5962-01)  / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL", "package_ndc": "0299-5962-01", "marketing_start_date": "20091102"}, {"sample": false, "description": "1 VIAL in 1 CARTON (0299-5962-30)  / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL", "package_ndc": "0299-5962-30", "marketing_start_date": "20091102"}], "brand_name": "Dysport", "product_id": "0299-5962_253b9c91-ded3-b0b3-e063-6294a90a669a", "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": "0299-5962", "generic_name": "Botulinum Toxin Type A", "labeler_name": "Galderma Laboratories, L.P.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Dysport", "active_ingredients": [{"name": "BOTULINUM TOXIN TYPE A", "strength": "300 U/1"}], "application_number": "BLA125274", "marketing_category": "BLA", "marketing_start_date": "20091102", "listing_expiration_date": "20261231"}