FDA.reportPublic FDA data

Dysport

Product NDC
15054-0530
11-digit product format
150540530
Labeler code
15054
Product ID
15054-0530_44512f6b-6a35-4db5-ba17-fe2fe3ec5170
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Botulinum Toxin Type A
Dosage form
INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route
INTRAMUSCULAR
Labeler
Ipsen Biopharmaceuticals, Inc.
Application
BLA125274
Marketing category
BLA
Marketing start
2009-11-02
Substance
BOTULINUM TOXIN TYPE A
Active strength
300 U/1
Pharmacologic classes
Acetylcholine Release Inhibitor [EPC], Acetylcholine Release Inhibitors [MoA], Neuromuscular Blockade [PE], Neuromuscular Blocker [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Dysport
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BOTULINUM TOXIN TYPE A300 U/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
E211KPY694Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1789950Internal RxNorm lookup
1789953Internal RxNorm lookup
1789956Internal RxNorm lookup
1789958Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
97513722-8426-4ce3-b85d-0e08e436a140Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
2a92e090-adb9-48d2-ae5f-5956e4b6ad90Product name120231024
525448fb-6d30-4c07-bb80-9a8499bd8113Product name120230627
0cf2215a-e8b6-4688-9989-d0fcd154e4b8Product name120170725
8c498f95-3b71-4acf-9882-f567b5cc4a2aProduct name120160208
e9681bd0-ddf1-421f-88c4-4337e89d5421Product name120160208
a42a1284-ee26-4b9f-a2b3-1ba05f250710Product name120151202

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
15054-0530-6Dysport1 in 1 CARTONINJECTION, POWDER, LYOPHILIZED,125
15054-0530-6Dysport1 in 1 VIALINJECTION, POWDER, LYOPHILIZED,125

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
15054-0530-6EA - Each15054-053003914895-9b96-4ebd-b178-76b04953554f12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Botulinum Toxin Type AACTIVE INGREDIENTE211KPY694DYSPORT (BOTULINUM TOXIN TYPE A) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [IPSEN BIOPHARMACEUTICALS, INC.]12
Botulinum Toxin Type AACTIVE MOIETYE211KPY694DYSPORT (BOTULINUM TOXIN TYPE A) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [IPSEN BIOPHARMACEUTICALS, INC.]12
albumin humanINACTIVE INGREDIENTZIF514RVZRDYSPORT (BOTULINUM TOXIN TYPE A) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [IPSEN BIOPHARMACEUTICALS, INC.]12
lactose monohydrateINACTIVE INGREDIENTEWQ57Q8I5XDYSPORT (BOTULINUM TOXIN TYPE A) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [IPSEN BIOPHARMACEUTICALS, INC.]12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
15054-0530DYSPORT (BOTULINUM TOXIN TYPE A) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [IPSEN BIOPHARMACEUTICALS, INC.]25Current NDC, Legacy NDC, 2 package rows20230929_97513722-8426-4ce3-b85d-0e08e436a140.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
DysportBOTULINUM TOXIN TYPE AGalderma Laboratories, L.P.71313a04-1349-4c26-b840-a39e4a3ddaed2024-10-24Boxed warning, Warnings, Adverse reactionsExact identifier
application number: BLA125274
DysportBOTULINUM TOXIN TYPE AIpsen Biopharmaceuticals, Inc.97513722-8426-4ce3-b85d-0e08e436a1402023-09-28Boxed warning, Warnings, Adverse reactionsExact identifier
application number: BLA125274
ndc (product): 15054-0530

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
125274DysportabobotulinumtoxinA351(a)Rx2026-06-01

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1789956abobotulinumtoxinA 300 UNT InjectionPSN97513722-8426-4ce3-b85d-0e08e436a14025
1789950abobotulinumtoxinA 500 UNT InjectionPSN97513722-8426-4ce3-b85d-0e08e436a14025
1789958Dysport 300 UNT InjectionPSN97513722-8426-4ce3-b85d-0e08e436a14025
1789953Dysport 500 UNT InjectionPSN97513722-8426-4ce3-b85d-0e08e436a14025
1789958abobotulinumtoxinA 300 UNT Injection [Dysport]SBD97513722-8426-4ce3-b85d-0e08e436a14025
1789953abobotulinumtoxinA 500 UNT Injection [Dysport]SBD97513722-8426-4ce3-b85d-0e08e436a14025
1789956abobotulinumtoxinA 300 UNT InjectionSCD97513722-8426-4ce3-b85d-0e08e436a14025
1789950abobotulinumtoxinA 500 UNT InjectionSCD97513722-8426-4ce3-b85d-0e08e436a14025
1789958Dysport 300 UNT InjectionSY97513722-8426-4ce3-b85d-0e08e436a14025
1789953Dysport 500 UNT InjectionSY97513722-8426-4ce3-b85d-0e08e436a14025

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
15054-0530-6150540530061 VIAL in 1 CARTON (15054-0530-6) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL1 vial2009-11-020000-00-00NoNoCurrent