Home NDC 50474-781 Bimzelx
Product NDC 50474-781
11-digit product format 504740781
Labeler code 50474
Product ID 50474-781_37b310bd-f6a0-9d4e-e063-6294a90a889d
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name bimekizumab
Dosage form INJECTION, SOLUTION
Route SUBCUTANEOUS
Labeler UCB, Inc.
Application BLA761151
Marketing category BLA
Marketing start 2023-10-17
Substance BIMEKIZUMAB
Active strength 160 mg/mL
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes Additional Listing Data#
Finished product Yes
Brand name base Bimzelx
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength BIMEKIZUMAB 160 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 09495UIM6V Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 8 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 2668086 Internal RxNorm lookup 2668093 Internal RxNorm lookup 2668099 Internal RxNorm lookup 2668103 Internal RxNorm lookup 2699121 Internal RxNorm lookup 2699122 Internal RxNorm lookup 2699123 Internal RxNorm lookup 2699124 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 50474-781-84 Bimzelx 1 mL in 1 SYRINGE, GLASS INJECTION, SOLUTION 1 14 50474-781-84 Bimzelx 1 in 1 CARTON INJECTION, SOLUTION 1 14 50474-781-85 Bimzelx 2 in 1 CARTON INJECTION, SOLUTION 2 14 50474-781-85 Bimzelx 1 mL in 1 SYRINGE, GLASS INJECTION, SOLUTION 1 14 50474-781-86 Bimzelx 1 in 1 CARTON INJECTION, SOLUTION 1 14 50474-781-86 Bimzelx 1 mL in 1 SYRINGE, GLASS INJECTION, SOLUTION 1 14 50474-781-87 Bimzelx 1 mL in 1 SYRINGE, GLASS INJECTION, SOLUTION 1 14 50474-781-87 Bimzelx 2 in 1 CARTON INJECTION, SOLUTION 2 14
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 50474-781 BIMZELX (BIMEKIZUMAB) INJECTION, SOLUTION [UCB, INC.] 12 Current NDC, 8 package rows 20250519_26b88358-871f-4c80-9d80-b2fb16477f81.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.
Purple Book Biologic Products# BLA, Proprietary name, Proper name table BLA Proprietary name Proper name License type Status Latest source 761151 Bimzelx bimekizumab-bkzx 351(a) Rx 2026-06-01
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Sample Exclude flag Status 50474-781-84 50474078184 1 SYRINGE, GLASS in 1 CARTON (50474-781-84) / 1 mL in 1 SYRINGE, GLASS 2024-10-01 No No Current 50474-781-85 50474078185 2 SYRINGE, GLASS in 1 CARTON (50474-781-85) / 1 mL in 1 SYRINGE, GLASS 2023-10-17 No No Current 50474-781-86 50474078186 1 SYRINGE, GLASS in 1 CARTON (50474-781-86) / 1 mL in 1 SYRINGE, GLASS 2024-10-01 No No Current 50474-781-87 50474078187 2 SYRINGE, GLASS in 1 CARTON (50474-781-87) / 1 mL in 1 SYRINGE, GLASS 2023-10-17 No No Current