FDA.reportPublic FDA data

VIMIZIM

Product NDC
68135-100
Requested package NDC
68135-100-01
11-digit product format
681350100
Labeler code
68135
Product ID
68135-100_d3f50b07-ab7c-4922-83b5-6441be0c3c11
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
elosulfase alfa
Dosage form
INJECTION, SOLUTION, CONCENTRATE
Route
INTRAVENOUS
Labeler
BioMarin Pharmaceutical Inc.
Application
BLA125460
Marketing category
BLA
Marketing start
2014-02-14
Substance
ELOSULFASE ALFA
Active strength
5 mg/5mL
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

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ELOSULFASE ALFA5 mg/5mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
ODJ69JZG85Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1490047Internal RxNorm lookup
1490052Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
0caa2565-12b2-0ad0-1f9a-273e81c3d4ccAvailable on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68135-100-01VIMIZIM5 mL in 1 VIALINJECTION, SOLUTION, CONCENTRATE538
68135-100-01VIMIZIM1 in 1 CARTONINJECTION, SOLUTION, CONCENTRATE138

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ELOSULFASE ALFAACTIVE INGREDIENTODJ69JZG85VIMIZIM (ELOSULFASE ALFA) INJECTION, SOLUTION, CONCENTRATE [BIOMARIN PHARMACEUTICAL INC.]8
ELOSULFASE ALFAACTIVE MOIETYODJ69JZG85VIMIZIM (ELOSULFASE ALFA) INJECTION, SOLUTION, CONCENTRATE [BIOMARIN PHARMACEUTICAL INC.]8
ARGININE HYDROCHLORIDEINACTIVE INGREDIENTF7LTH1E20YVIMIZIM (ELOSULFASE ALFA) INJECTION, SOLUTION, CONCENTRATE [BIOMARIN PHARMACEUTICAL INC.]8
POLYSORBATE 20INACTIVE INGREDIENT7T1F30V5YHVIMIZIM (ELOSULFASE ALFA) INJECTION, SOLUTION, CONCENTRATE [BIOMARIN PHARMACEUTICAL INC.]8
SODIUM ACETATEINACTIVE INGREDIENT4550K0SC9BVIMIZIM (ELOSULFASE ALFA) INJECTION, SOLUTION, CONCENTRATE [BIOMARIN PHARMACEUTICAL INC.]8
SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATEINACTIVE INGREDIENT593YOG76RNVIMIZIM (ELOSULFASE ALFA) INJECTION, SOLUTION, CONCENTRATE [BIOMARIN PHARMACEUTICAL INC.]8
SORBITOLINACTIVE INGREDIENT506T60A25RVIMIZIM (ELOSULFASE ALFA) INJECTION, SOLUTION, CONCENTRATE [BIOMARIN PHARMACEUTICAL INC.]8
WATERINACTIVE INGREDIENT059QF0KO0RVIMIZIM (ELOSULFASE ALFA) INJECTION, SOLUTION, CONCENTRATE [BIOMARIN PHARMACEUTICAL INC.]8

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68135-100VIMIZIM (ELOSULFASE ALFA) INJECTION, SOLUTION, CONCENTRATE [BIOMARIN PHARMACEUTICAL INC.]36Current NDC, Legacy NDC, 2 package rows20241213_0caa2565-12b2-0ad0-1f9a-273e81c3d4cc.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
VIMIZIMELOSULFASE ALFABioMarin Pharmaceutical Inc.0caa2565-12b2-0ad0-1f9a-273e81c3d4cc2025-10-30Boxed warning, Warnings, Adverse reactionsExact identifier
application number: BLA125460
ndc (package): 68135-100-01
ndc (product): 68135-100
ndc11 (package): 68135010001

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
125460Vimizimelosulfase alfa351(a)Rx2026-09-01

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1490047elosulfase alfa 5 MG in 5 ML InjectionPSN0caa2565-12b2-0ad0-1f9a-273e81c3d4cc38
1490052Vimizim 5 MG in 5 ML InjectionPSN0caa2565-12b2-0ad0-1f9a-273e81c3d4cc38
14900525 ML elosulfase alfa 1 MG/ML Injection [Vimizim]SBD0caa2565-12b2-0ad0-1f9a-273e81c3d4cc38
14900475 ML elosulfase alfa 1 MG/ML InjectionSCD0caa2565-12b2-0ad0-1f9a-273e81c3d4cc38
14900525 ML Vimizim 1 MG/ML InjectionSY0caa2565-12b2-0ad0-1f9a-273e81c3d4cc38
1490047elosulfase alfa 5 MG per 5 ML InjectionSY0caa2565-12b2-0ad0-1f9a-273e81c3d4cc38
1490052Vimizim 5 MG per 5 ML InjectionSY0caa2565-12b2-0ad0-1f9a-273e81c3d4cc38

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68135-100-01681350100011 VIAL in 1 CARTON (68135-100-01) / 5 mL in 1 VIAL1 vial2014-02-140000-00-00NoNoCurrent