FDA.reportPublic FDA data

ELAPRASE

Product NDC
54092-700
11-digit product format
540920700
Labeler code
54092
Product ID
54092-700_25f45811-e646-4342-9954-d8220cadf886
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
idursulfase
Dosage form
SOLUTION, CONCENTRATE
Route
INTRAVENOUS
Labeler
Takeda Pharmaceuticals America, Inc.
Application
BLA125151
Marketing category
BLA
Marketing start
2006-07-24
Substance
IDURSULFASE
Active strength
6 mg/3mL
Pharmacologic classes
Hydrolytic Lysosomal Glycosaminoglycan-specific Enzyme [EPC], alpha-Glucosidases [CS]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
IDURSULFASE6 mg/3mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
5W8JGG2651Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
644104Internal RxNorm lookup
647118Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
60cba843-5aab-4dd7-96dc-66648d413be3Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
726062af-1135-4707-a1d7-57256991bbf9Product name220250226
19c71a3d-ed9c-166b-a7e5-38c250c35631Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
54092-700-012020-08-21C16284748780-1ab0e2407-27b5-f274-e053-dbdaa90a6471These highlights do not include all the information needed to use ELAPRASE safely and effectively. See full prescribing information for ELAPRASE. ELAPRASE ® (idursulfase) injection, for intravenous use Initial U.S. Approval: 2006
54092-700-012020-07-22C16284748780-1ab0e2407-27b5-f274-e053-dbdaa90a6471These highlights do not include all the information needed to use ELAPRASE safely and effectively. See full prescribing information for ELAPRASE. ELAPRASE ® (idursulfase) injection, for intravenous use Initial U.S. Approval: 2006

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
54092-700-01ELAPRASE1 in 1 BOXSOLUTION, CONCENTRATE125
54092-700-01ELAPRASE3 mL in 1 VIAL, GLASSSOLUTION, CONCENTRATE325

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
54092-700-01ML - Milliliter54092-700a96cb4a5-13f7-422e-a7b4-5248c49f3b7f12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
idursulfaseACTIVE INGREDIENT5W8JGG2651ELAPRASE (IDURSULFASE) SOLUTION, CONCENTRATE [SHIRE US MANUFACTURING INC.]15
idursulfaseACTIVE MOIETY5W8JGG2651ELAPRASE (IDURSULFASE) SOLUTION, CONCENTRATE [SHIRE US MANUFACTURING INC.]15
polysorbate 20INACTIVE INGREDIENT7T1F30V5YHELAPRASE (IDURSULFASE) SOLUTION, CONCENTRATE [SHIRE US MANUFACTURING INC.]15
sodium chlorideINACTIVE INGREDIENT451W47IQ8XELAPRASE (IDURSULFASE) SOLUTION, CONCENTRATE [SHIRE US MANUFACTURING INC.]15
sodium phosphate, dibasic, heptahydrateINACTIVE INGREDIENT70WT22SF4BELAPRASE (IDURSULFASE) SOLUTION, CONCENTRATE [SHIRE US MANUFACTURING INC.]15
sodium phosphate, monobasic, monohydrateINACTIVE INGREDIENT593YOG76RNELAPRASE (IDURSULFASE) SOLUTION, CONCENTRATE [SHIRE US MANUFACTURING INC.]15

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
54092-700ELAPRASE (IDURSULFASE) SOLUTION, CONCENTRATE [TAKEDA PHARMACEUTICALS AMERICA, INC.]25Current NDC, Legacy NDC, 2 package rows20250418_60cba843-5aab-4dd7-96dc-66648d413be3.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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ELAPRASEIDURSULFASETakeda Pharmaceuticals America, Inc.60cba843-5aab-4dd7-96dc-66648d413be32025-04-15Boxed warning, Warnings, Adverse reactionsExact identifier
application number: BLA125151
ndc (product): 54092-700

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
125151Elapraseidursulfase351(a)Rx2026-07-01

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
647118elaprase 6 MG in 3 ML InjectionPSN60cba843-5aab-4dd7-96dc-66648d413be325
644104idursulfase 6 MG in 3 ML InjectionPSN60cba843-5aab-4dd7-96dc-66648d413be325
6471183 ML idursulfase 2 MG/ML Injection [Elaprase]SBD60cba843-5aab-4dd7-96dc-66648d413be325
6441043 ML idursulfase 2 MG/ML InjectionSCD60cba843-5aab-4dd7-96dc-66648d413be325
6471183 ML Elaprase 2 MG/ML InjectionSY60cba843-5aab-4dd7-96dc-66648d413be325
647118Elaprase 6 MG per 3 ML InjectionSY60cba843-5aab-4dd7-96dc-66648d413be325
644104idursulfase 6 MG per 3 ML InjectionSY60cba843-5aab-4dd7-96dc-66648d413be325

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
54092-700-01540920700011 VIAL, GLASS in 1 BOX (54092-700-01) / 3 mL in 1 VIAL, GLASS2006-07-240000-00-00NoNoCurrent