FDA.reportPublic FDA data

NDC 15054-0500-02 - 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
15054-0500-02
Package NDCs from labels
15054-0500-1, 15054-0500-2, 15054-0500-9, 15054-0500-02
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 1 of 2 · 21 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
XeominINCOBOTULINUMTOXINAMerz Pharmaceuticals, LLCccdc3aae-6e2d-4cd0-a51c-8375bfee94582026-07-10Boxed warning, Warnings, Adverse reactionsExact identifier
unii: E211KPY694
XeominINCOBOTULINUMTOXINAMerz North America, Inc.3f35d6e0-3450-4abc-a0da-cc7b277e7c6e2026-07-10Boxed warning, Warnings, Adverse reactionsExact identifier
unii: E211KPY694
B-ForceECHINACEA ANGUSTIFOLIA, LOMATIUM DISSECTUM, MYRRHA, NASTURTIUM AQUATICUM, TABEBUIA IMPETIGINOSA, HYDRASTIS CANADENSIS, PROPOLIS, GLANDULA SUPRARENALIS SUIS, LYMPH NODE (SUIS), SPLEEN (SUIS), THYMUS (SUIS), THYROIDINUM (SUIS), ARSENICUM ALBUM, BELLADONNA, HYPERICUM PERFORATUM, PHOSPHORUS, BOTULINUM, COLIBACILLINUM CUM NATRUM MURIATICUM, PROTEUS (VULGARIS), PSEUDOMONAS AERUGINOSA, PROTEUS (MORGANI), SALMONELLA TYPHI NOSODE, CLOSTRIDIUM PERFRINGENSBioActive Nutritional, Inc.0ccc9d9a-58d4-4957-91a3-4e8c04d1c86d2026-03-11WarningsExact identifier
unii: E211KPY694
BOTOXONABOTULINUMTOXINASportpharm LLCa6f42753-d31e-4b23-8da0-4b990fee4b382026-02-02Boxed warning, Warnings, Adverse reactionsExact identifier
unii: E211KPY694
Proteinuria Drops 2053PROTEINURIA DROPSProfessional Complementary Health Formulas1bf80282-8283-4835-acd4-fbdb47788c672026-01-08WarningsExact identifier
unii: ZIF514RVZR
DAXXIFYBOTULINUM TOXIN TYPE ARevance Therapeutics, Inc.3aaa6e14-a3f7-4fb2-b9f9-d3a9c3ae1f742026-01-07Boxed warning, Warnings, Adverse reactionsExact identifier
unii: E211KPY694
NeurotoxAGARICUS MUSCARIUS, COCCUS CACTI, CONIUM MACULATUM, LYCOPODIUM CLAVATUM, PHOSPHORUS, ALUMINIUM METALLICUM, ANTIMONIUM CRUDUM, ARGENTUM METALLICUM, ARSENICUM ALBUM, AURUM METALLICUM, BARYTA CARBONICA, BERYLLIUM METALLICUM, BISMUTHUM METALLICUM, BORON, BROMIUM, CADMIUM METALLICUM, CERIUM METALLICUM, CESIUM CHLORIDE, CHROMIUM, COBALTUM METALLICUM, CUPRUM METALLICUM, DYSPROSIUM METALLICUM, ERBIUM METALLICUM, EUROPIUM METALLICUM, FERRUM METALLICUM, GADOLINIUM METALLICUM, GERMANIUM SESQUIOXIDE,BioActive Nutritional, Inc.07a457c0-df0d-468a-b0d8-84c739c17b702025-05-19WarningsExact identifier
unii: E211KPY694
RenotoxTRITICUM AESTIVUM, ASPARAGUS OFFICINALIS, BERBERIS VULGARIS, ECHINACEA (ANGUSTIFOLIA), KALI MURIATICUM, PETROSELINUM SATIVUM, SABAL SERRULATA, SOLIDAGO VIRGAUREA, TARAXACUM OFFICINALE, UVA-URSI, BAROSMA (BETULINA), EUPATORIUM PURPUREUM, KIDNEY (SUIS), BRYONIA (ALBA), MERCURIUS CORROSIVUS, ALUMINUM METALLICUM, ANTIMONIUM CRUDUM, ARGENTUM METALLICUM, ARSENICUM ALBUM, AURUM METALLICUM, BARYTA CARBONICA, BERYLLIUM METALLICUM, BISMUTHUM METALLICUM, BORON, BROMIUM, CADMIUM METALLICUM, CERIUM METALLICUM,BioActive Nutritional, Inc.f2b9cc0d-e146-47f7-b1b8-3e4d1cf6d0e92025-03-20WarningsExact identifier
unii: E211KPY694
RenotoxTRITICUM AESTIVUM, ASPARAGUS OFFICINALIS, BERBERIS VULGARIS, ECHINACEA (ANGUSTIFOLIA), KALI MURIATICUM, PETROSELINUM SATIVUM, SABAL SERRULATA, SOLIDAGO VIRGAUREA, TARAXACUM OFFICINALE, UVA-URSI, BAROSMA (BETULINA), EUPATORIUM PURPUREUM, KIDNEY (SUIS), BRYONIA (ALBA), MERCURIUS CORROSIVUS, ALUMINUM METALLICUM, ANTIMONIUM CRUDUM, ARGENTUM METALLICUM, ARSENICUM ALBUM, AURUM METALLICUM, BARYTA CARBONICA, BERYLLIUM METALLICUM, BISMUTHUM METALLICUM, BORON, BROMIUM, CADMIUM METALLICUM, CERIUM METALLICUM,BioActive Nutritional, Inc.2b691b17-296b-49d2-924e-c62522d4b9a72025-03-20WarningsExact identifier
unii: E211KPY694
ALBUMINEXALBUMIN HUMANBPL8428d373-f4b1-4e3b-bb19-ea89048f7c792024-12-31Warnings, Adverse reactionsExact identifier
unii: ZIF514RVZR
ALBUMINEXALBUMIN HUMANBPL167f48d0-8ae5-4f7e-b050-9673dad78acc2024-12-31Warnings, Adverse reactionsExact identifier
unii: ZIF514RVZR
DysportBOTULINUM TOXIN TYPE AGalderma Laboratories, L.P.71313a04-1349-4c26-b840-a39e4a3ddaed2024-10-24Boxed warning, Warnings, Adverse reactionsExact identifier
application number: BLA125274
rxcui: 1789958
rxcui: 1789956
unii: E211KPY694
BOTOX CosmeticONABOTULINUMTOXINAAllergan, Inc.485d9b71-6881-42c5-a620-a4360c7192ab2024-10-18Boxed warning, Warnings, Adverse reactionsExact identifier
unii: E211KPY694
B ForceECHINACEA ANGUSTIFOLIA, LOMATIUM DISSECTUM, MYRRHA, NASTURTIUM AQUATICUM, TABEBUIA IMPETIGINOSA, HYDRASTIS CANADENSIS, PROPOLIS, GLANDULA SUPRARENALIS SUIS, LYMPH NODE (SUIS), SPLEEN (SUIS), THYMUS (SUIS), THYROIDINUM (SUIS), ARSENICUM ALBUM, BELLADONNA, HYPERICUM PERFORATUM, PHOSPHORUS, BOTULINUM, COLIBACILLINUM CUM NATRUM MURIATICUM, PROTEUS (VULGARIS), PSEUDOMONAS AERUGINOSA, PROTEUS (MORGANI), SALMONELLA TYPHI NOSODE, CLOSTRIDIUM PERFRINGENSBioActive Nutritional, Inc.2eb4e898-4019-425a-9ef9-536f112b88f02024-03-05WarningsExact identifier
unii: E211KPY694
BOTOXONABOTULINUMTOXINAAllergan, Inc.33d066a9-34ff-4a1a-b38b-d10983df33002023-11-18Boxed warning, Warnings, Adverse reactionsExact identifier
unii: E211KPY694
RenotoxTRITICUM AESTIVUM, ASPARAGUS OFFICINALIS, BERBERIS VULGARIS, ECHINACEA (ANGUSTIFOLIA), KALI MURIATICUM, PETROSELINUM SATIVUM, SABAL SERRULATA, SOLIDAGO VIRGAUREA, TARAXACUM OFFICINALE, UVA-URSI, BAROSMA (BETULINA), EUPATORIUM PURPUREUM, KIDNEY (SUIS), BRYONIA (ALBA), MERCURIUS CORROSIVUS, ALUMINUM METALLICUM, ANTIMONIUM CRUDUM, ARGENTUM METALLICUM, ARSENICUM ALBUM, AURUM METALLICUM, BARYTA CARBONICA, BERYLLIUM METALLICUM, BISMUTHUM METALLICUM, BORON, BROMIUM, CADMIUM METALLICUM, CERIUM METALLICUM,BioActive Nutritional, Inc.b501f7bc-fa3a-494e-bf95-6779a3169a492023-11-17WarningsExact identifier
unii: E211KPY694
DysportBOTULINUM TOXIN TYPE AIpsen Biopharmaceuticals, Inc.97513722-8426-4ce3-b85d-0e08e436a1402023-09-28Boxed warning, Warnings, Adverse reactionsExact identifier
application number: BLA125274
ndc (package): 15054-0500-2
ndc (package): 15054-0500-1
ndc (package): 15054-0500-9
ndc (package): 15054-0530-6
ndc (product): 15054-0500
ndc (product): 15054-0530
ndc11 (package): 15054050002
rxcui: 1789953
rxcui: 1789950
rxcui: 1789958
rxcui: 1789956
spl id: 44512f6b-6a35-4db5-ba17-fe2fe3ec5170
spl set id: 97513722-8426-4ce3-b85d-0e08e436a140
unii: E211KPY694
AndrotoxECHINACEA (ANGUSTIFOLIA), HYDROCOTYLE ASIATICA, SABAL SERRULATA, TABEBUIA IMPETIGINOSA, THUJA OCCIDENTALIS, ASTRAGALUS MEMBRANACEUS, GLANDULA SUPRARENALIS SUIS, LYMPH NODE (SUIS), ZINCUM GLUCONICUM, JUNIPERUS VIRGINIANA, MERCURIUS SOLUBILIS, NATRUM SULPHURICUM, ORCHITINUM (SUIS), PROSTATE (SUIS), PULSATILLA (PRATENSIS), RHODODENDRON CHRYSANTHUM, SPONGIA TOSTA, CALCAREA SULPHURICA, LYCOPODIUM CLAVATUM, PHOSPHORUS, BOTULINUM, ESCHERICHIA COLI, PROTEUS (VULGARIS), PSEUDOMONAS AERUGINOSA, SALMONELLA TYPHINOSODEBioActive Nutritional, Inc.d3f89e4d-c3a0-4481-bf0e-0413993a8bc52023-08-03WarningsExact identifier
unii: E211KPY694
JeuveauPRABOTULINUM TOXIN TYPE AEvolus, Inc.17a914c1-e54b-4b50-965d-b0fd9111bba42023-04-28Boxed warning, Warnings, Adverse reactionsExact identifier
unii: E211KPY694
DysBio PlusECHINACEA (ANGUSTIFOLIA), ALOE, COLCHICUM AUTUMNALE, COLOCYNTHIS, MERCURIUS CORROSIVUS, NUX VOMICA, ARSENICUM ALBUM, ACETICUM ACIDUM, CHININUM SULPHURICUM, CHOLERA NOSODE, PROTEUS (VULGARIS), COLIBACILLINUM CUM NATRUM MURIATICUM, HELICOBACTER PYLORI, BOTULINUM, SALMONELLA TYPHI NOSODE, MORGAN GAERTNER, CLOSTRIDIUM DIFFICILE, BRUGIA MALAYIDeseret Biologicals, Inc.4dcb84ac-48a4-4e09-a6ff-9748218149002023-04-20WarningsExact identifier
unii: E211KPY694

Reported adverse events (FAERS/openFDA)#

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