Home NDC 51759-708 Selarsdi
Product NDC 51759-708
11-digit product format 517590708
Labeler code 51759
Product ID 51759-708_6faa1c86-d0f8-4260-aeca-8232ab8be678
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name ustekinumab-aekn
Dosage form INJECTION, SOLUTION
Route INTRAVENOUS
Labeler Teva Pharmaceuticals USA, Inc.
Application BLA761343
Marketing category BLA
Marketing start 2025-03-12
Substance USTEKINUMAB-AEKN
Active strength 130 mg/26mL
Pharmacologic classes Interleukin-12 Antagonist [EPC], Interleukin-12 Antagonists [MoA], Interleukin-23 Antagonist [EPC], Interleukin-23 Antagonists [MoA]
NDC exclude flag No
Listing certified through 2027-12-31
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 · 2 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Product NDC Package NDC Code Status Reporting period Archive Snapshot Source SHA-256 2025-03-22 03:12 UTC · source 2025-03-21 excluded product product 51759-708 D Discontinued by firm excluded / ndc_excluded.zip cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 51759-708 51759-708-13 D Discontinued by firm excluded / ndc_excluded.zip cfe11265f3b6…090c488252e2…
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 Selarsdi
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength USTEKINUMAB-AEKN 130 mg/26mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination FU77B4U5Z0 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 8 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 2705382 Internal RxNorm lookup 2705389 Internal RxNorm lookup 2705393 Internal RxNorm lookup 2705398 Internal RxNorm lookup 2705400 Internal RxNorm lookup 2705401 Internal RxNorm lookup 2726116 Internal RxNorm lookup 2726118 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 51759-708-13 Selarsdi 1 in 1 CARTON INJECTION, SOLUTION 1 13 51759-708-13 Selarsdi 26 mL in 1 VIAL, GLASS INJECTION, SOLUTION 26 13
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 51759-708 SELARSDI (USTEKINUMAB-AEKN) INJECTION, SOLUTION [TEVA PHARMACEUTICALS USA, INC.] 7 Current NDC, 2 package rows 20250322_87f75b59-e48b-47c7-a4c0-5fe5965660e7.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 · 4 matching rows.
Purple Book Biologic Products# BLA, Proprietary name, Proper name table BLA Proprietary name Proper name License type Status Latest source 761343 Selarsdi ustekinumab-aekn 351(k) Interchangeable Rx 2026-09-01
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Sample Exclude flag Status 51759-708-13 51759070813 1 VIAL, GLASS in 1 CARTON (51759-708-13) / 26 mL in 1 VIAL, GLASS 2025-03-12 No No Current