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 Identifiers#

Field, Values table
FieldValues
Unii5W8JGG2651
Rxcui644104, 647118

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

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