Home NDC 68135-100-99 VIMIZIM
Product NDC 68135-100
Requested package NDC 68135-100-99
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 Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 21 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Snapshot, Source SHA-256 table Captured / source date Snapshot Source SHA-256 2025-12-14 21:27 UTC · source 2025-12-05 a6255e0c9aa5…a0211a219f2e…2025-08-26 23:59 UTC · source 2025-08-26 1d862106b807…00c93037cd84…2025-05-15 14:59 UTC · source 2025-05-14 390b4c401c3f…2c692c2daee3…2025-04-01 07:37 UTC · source 2025-03-31 e30019b0c005…a3f0b14938b7…2025-03-01 13:19 UTC · source 2025-02-28 bbbc9f937eca…946b9c97cf81…2025-02-27 05:24 UTC · source 2025-02-26 f268b84574a6…26285f5ac5df…2025-02-01 13:13 UTC · source 2025-01-31 f764e8902f78…92046438deef…2025-01-20 13:05 UTC · source 2025-01-17 68b1e3bced9e…98a755eb8bc6…2024-11-29 20:42 UTC · source 2024-11-29 05c55d027831…ca05dca9dc4c…2024-11-09 02:36 UTC · source 2024-11-08 48b4f40e6753…c7c7a00d2afa…2024-10-09 02:27 UTC · source 2024-10-08 27f29a85d7e4…1372111e901f…2024-07-10 04:00 UTC · source 2024-07-09 8d62ce987f31…9fe9ef23e30d…2024-05-28 21:11 UTC · source 2024-05-28 d1e113ab4d42…063ee3eb0a1d…2024-05-15 03:51 UTC · source 2024-05-14 50b4072663b7…eae3003ed65e…2022-04-09 23:13 UTC · source 2022-04-08 906f6e251498…bf70b80e44f0…2021-12-27 23:28 UTC · source 2021-12-27 6db9cb8d1e19…3449e1ec5b70…2021-02-18 23:40 UTC · source 2021-02-18 8fc7167e32ce…e96bbc724034…2020-12-18 03:04 UTC · source 2020-12-17 4184dd79f89f…545327b3e20f…2020-06-10 20:45 UTC · source 2020-06-10 4bd3596a7b87…5c64c6f6865f…2019-12-08 06:16 UTC · source 2019-12-05 263afe128892…91768de4ddbe…2019-06-01 22:24 UTC · source 2019-05-30 5b2001dcd8f5…54b53d4dc9e4…
Additional Listing Data#
Finished product Yes
Brand name base VIMIZIM
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ELOSULFASE ALFA 5 mg/5mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination ODJ69JZG85 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1490047 Internal RxNorm lookup 1490052 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 68135-100-01 VIMIZIM 5 mL in 1 VIAL INJECTION, SOLUTION, CONCENTRATE 5 38 68135-100-01 VIMIZIM 1 in 1 CARTON INJECTION, SOLUTION, CONCENTRATE 1 38
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded ELOSULFASE ALFA ACTIVE INGREDIENT ODJ69JZG85 VIMIZIM (ELOSULFASE ALFA) INJECTION, SOLUTION, CONCENTRATE [BIOMARIN PHARMACEUTICAL INC.] 8 ELOSULFASE ALFA ACTIVE MOIETY ODJ69JZG85 VIMIZIM (ELOSULFASE ALFA) INJECTION, SOLUTION, CONCENTRATE [BIOMARIN PHARMACEUTICAL INC.] 8 ARGININE HYDROCHLORIDE INACTIVE INGREDIENT F7LTH1E20Y VIMIZIM (ELOSULFASE ALFA) INJECTION, SOLUTION, CONCENTRATE [BIOMARIN PHARMACEUTICAL INC.] 8 POLYSORBATE 20 INACTIVE INGREDIENT 7T1F30V5YH VIMIZIM (ELOSULFASE ALFA) INJECTION, SOLUTION, CONCENTRATE [BIOMARIN PHARMACEUTICAL INC.] 8 SODIUM ACETATE INACTIVE INGREDIENT 4550K0SC9B VIMIZIM (ELOSULFASE ALFA) INJECTION, SOLUTION, CONCENTRATE [BIOMARIN PHARMACEUTICAL INC.] 8 SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE INACTIVE INGREDIENT 593YOG76RN VIMIZIM (ELOSULFASE ALFA) INJECTION, SOLUTION, CONCENTRATE [BIOMARIN PHARMACEUTICAL INC.] 8 SORBITOL INACTIVE INGREDIENT 506T60A25R VIMIZIM (ELOSULFASE ALFA) INJECTION, SOLUTION, CONCENTRATE [BIOMARIN PHARMACEUTICAL INC.] 8 WATER INACTIVE INGREDIENT 059QF0KO0R VIMIZIM (ELOSULFASE ALFA) INJECTION, SOLUTION, CONCENTRATE [BIOMARIN PHARMACEUTICAL INC.] 8
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 68135-100 VIMIZIM (ELOSULFASE ALFA) INJECTION, SOLUTION, CONCENTRATE [BIOMARIN PHARMACEUTICAL INC.] 36 Current NDC, Legacy NDC, 2 package rows 20241213_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 Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join VIMIZIM ELOSULFASE ALFA BioMarin Pharmaceutical Inc. 0caa2565-12b2-0ad0-1f9a-273e81c3d4cc 2025-10-30 Boxed warning, Warnings, Adverse reactions Exact identifier application number: BLA125460 ndc (product): 68135-100
Purple Book Biologic Products# BLA, Proprietary name, Proper name table BLA Proprietary name Proper name License type Status Latest source 125460 Vimizim elosulfase alfa 351(a) Rx 2026-06-01
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Status 68135-100-99 68135010099 20000 mL in 1 BAG (68135-100-99) 20000 ml 14-FEB-14 Current