Home NDC 50474-981 RYSTIGGO
Product NDC 50474-981
11-digit product format 504740981
Labeler code 50474
Product ID 50474-981_48d5f5c1-c45c-cb63-e063-6394a90a31c8
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name ROZANOLIXIZUMAB
Dosage form INJECTION, SOLUTION
Route SUBCUTANEOUS
Labeler UCB, Inc.
Application BLA761286
Marketing category BLA
Marketing start 2024-06-14
Substance ROZANOLIXIZUMAB
Active strength 140 mg/mL
Pharmacologic classes Neonatal Fc Receptor Blocker [EPC], Neonatal Fc Receptor Blockers [MoA]
NDC exclude flag No
Listing certified through 2027-12-31
Current FDA listing Yes Additional Listing Data#
Finished product Yes
Brand name base RYSTIGGO
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ROZANOLIXIZUMAB 140 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination P7186074QC Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 8 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 2642288 Internal RxNorm lookup 2642294 Internal RxNorm lookup 2685614 Internal RxNorm lookup 2685615 Internal RxNorm lookup 2685616 Internal RxNorm lookup 2685617 Internal RxNorm lookup 2685618 Internal RxNorm lookup 2685619 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 50474-981-83 RYSTIGGO 3 mL in 1 VIAL, GLASS INJECTION, SOLUTION 3 10 50474-981-83 RYSTIGGO 1 in 1 CARTON INJECTION, SOLUTION 1 10
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 50474-981 RYSTIGGO (ROZANOLIXIZUMAB) INJECTION, SOLUTION [UCB, INC.] 5 Current NDC, 2 package rows 20250508_3c0eb8c2-c042-4954-b451-3baa77f5e6d1.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 761286 Rystiggo rozanolixizumab-noli 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 50474-981-83 50474098183 1 VIAL, GLASS in 1 CARTON (50474-981-83) / 3 mL in 1 VIAL, GLASS 2024-07-15 No No Current