FDA.reportPublic FDA data

VIMIZIM

Product NDC
68135-100
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

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 Identifiers#

Field, Values table
FieldValues
UniiODJ69JZG85
Rxcui1490047, 1490052

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

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