FDA.reportPublic FDA data

NDC 15054-0500-01 - Dysport

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC
15054-0500
Requested NDC
15054-0500-01
Package NDCs from labels
15054-0500-1, 15054-0500-2, 15054-0500-9, 15054-0500-01
Manufacturer
Ipsen Biopharmaceuticals, Inc. | IPSEN BIOPHARM LTD
Effective date
2023-09-28
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Dysport - Ipsen Biopharmaceuticals, Inc. | IPSEN BIOPHARM LTDIpsen Biopharmaceuticals, Inc. | IPSEN BIOPHARM LTD2023-09-28HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
15054-0500-1Dysport1 in 1 CARTONINJECTION, POWDER, LYOPHILIZED,125
15054-0500-1Dysport1 in 1 VIALINJECTION, POWDER, LYOPHILIZED,125
15054-0500-2Dysport2 in 1 CARTONINJECTION, POWDER, LYOPHILIZED,225
15054-0500-2Dysport1 in 1 VIALINJECTION, POWDER, LYOPHILIZED,125
15054-0500-9Dysport1 in 1 CARTONINJECTION, POWDER, LYOPHILIZED,125
15054-0500-9Dysport1 in 1 VIALINJECTION, POWDER, LYOPHILIZED,125

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
15054-0500DYSPORT (BOTULINUM TOXIN TYPE A) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [IPSEN BIOPHARMACEUTICALS, INC.]25Current NDC, Legacy NDC, 6 package rows20230929_97513722-8426-4ce3-b85d-0e08e436a140.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
15054-0500-1EA - Each15054-05001f4c5f05-865b-4e26-8ae3-2e9c3f7c504512012-07-24

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

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 2 of 2 · 21 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Biological Complex IIIANTHRACINUM, ARSENICUM ALBUM, BOTULINUM, CALCAREA HYPOPHOSPHOROSA, COXIELLA BURNETII, DYSENTERY BACILLUS, FRANCISELLA TULARENSIS, GAERTNER BACILLUS, KALI SULPHURICUM, LAC CANINUM, MALARIA OFFICINALIS, MUTABILE BACILLUS, PERTUSSINUM, PESTINUM, PYROGENIUM, TYPHOID FEVER,Deseret Biologicals, Inc.903c680c-c7fc-4671-b809-1b81bd4c6be42018-10-24WarningsExact identifier
unii: E211KPY694

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.