Home NDC 73475-1221 VYVGART Hytrulo
Product NDC 73475-1221
11-digit product format 734751221
Labeler code 73475
Product ID 73475-1221_63be80ae-0be8-4da6-9c97-6c5c98ac9043
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name efgartigimod alfa and hyaluronidase (human recombinant)
Dosage form INJECTION, SOLUTION
Route SUBCUTANEOUS
Labeler argenx US
Application BLA761304
Marketing category BLA
Marketing start 2025-04-10
Substance EFGARTIGIMOD ALFA; HYALURONIDASE (HUMAN RECOMBINANT)
Active strength 200; 2000 mg/mL; U/mL
Pharmacologic classes Endoglycosidase [EPC], Glycoside Hydrolases [CS], Neonatal Fc Receptor Blocker [EPC], Neonatal Fc Receptor Blockers [MoA]
NDC exclude flag No
Listing certified through 2027-12-31
Current FDA listing Yes openFDA label cross-check# Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.
Matched openFDA labels page 1 of 1 · 1 matching rows.
Additional Listing Data#
Finished product Yes
Brand name base VYVGART Hytrulo
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength EFGARTIGIMOD ALFA 200 mg/mL HYALURONIDASE (HUMAN RECOMBINANT) 2000 U/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 961YV2O515 Internal UNII lookup 743QUY4VD8 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 4 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 2639951 Internal RxNorm lookup 2639957 Internal RxNorm lookup 2712083 Internal RxNorm lookup 2712088 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 73475-1221-1 VYVGART Hytrulo 1 in 1 CARTON INJECTION, SOLUTION 1 12 73475-1221-1 VYVGART Hytrulo 5 mL in 1 SYRINGE, GLASS INJECTION, SOLUTION 5 12 73475-1221-4 VYVGART Hytrulo 4 in 1 CARTON INJECTION, SOLUTION 4 12 73475-1221-4 VYVGART Hytrulo 5 mL in 1 SYRINGE, GLASS INJECTION, SOLUTION 5 12
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 73475-1221 VYVGART HYTRULO (EFGARTIGIMOD ALFA AND HYALURONIDASE (HUMAN RECOMBINANT)) INJECTION, SOLUTION [ARGENX US] 7 Current NDC, 4 package rows 20250418_7104d9e5-9910-47f5-9a93-741ac50f43b6.zip
Purple Book Biologic Products# BLA, Proprietary name, Proper name table BLA Proprietary name Proper name License type Status Latest source 761304 Vyvgart Hytrulo efgartigimod alfa and hyaluronidase-qvfc 351(a) Rx 2026-06-01
DailyMed RxNorm Mappings# RxCUI, RxNorm string, TTY table RxCUI RxNorm string TTY DailyMed SPL version 2712083 efgartigimod alfa 1,000 MG / hyaluronidase-qvfc 10,000 UNT in 5 ML Prefilled Syringe PSN 7104d9e5-9910-47f5-9a93-741ac50f43b6 12 2639951 efgartigimod alfa-hyaluronidase-qvfc 1008 MG / 11,200 UNT in 5.6 ML Injection PSN 7104d9e5-9910-47f5-9a93-741ac50f43b6 12 2712088 VYVGART Hytrulo 1,000 MG / 10,000 UNT in 5 ML Prefilled Syringe PSN 7104d9e5-9910-47f5-9a93-741ac50f43b6 12 2639957 VYVGART Hytrulo 1008 MG / 11,200 UNT in 5.6 ML Injection PSN 7104d9e5-9910-47f5-9a93-741ac50f43b6 12 2712088 5 ML efgartigimod alfa-qvfc 200 MG/ML / hyaluronidase-qvfc 2000 UNT/ML Prefilled Syringe [Vyvgart Hytrulo] SBD 7104d9e5-9910-47f5-9a93-741ac50f43b6 12 2639957 5.6 ML efgartigimod alfa-qvfc 180 MG/ML / hyaluronidase-qvfc 2000 UNT/ML Injection [Vyvgart Hytrulo] SBD 7104d9e5-9910-47f5-9a93-741ac50f43b6 12 2712083 5 ML efgartigimod alfa-qvfc 200 MG/ML / hyaluronidase-qvfc 2000 UNT/ML Prefilled Syringe SCD 7104d9e5-9910-47f5-9a93-741ac50f43b6 12 2639951 5.6 ML efgartigimod alfa-qvfc 180 MG/ML / hyaluronidase-qvfc 2000 UNT/ML Injection SCD 7104d9e5-9910-47f5-9a93-741ac50f43b6 12 2712083 efgartigimod alfa 1,000 MG / hyaluronidase-qvfc 10,000 UNT per 5 ML Prefilled Syringe SY 7104d9e5-9910-47f5-9a93-741ac50f43b6 12 2639951 efgartigimod alfa-hyaluronidase-qvfc 1008 MG / 11,200 UNT per 5.6 ML Injection SY 7104d9e5-9910-47f5-9a93-741ac50f43b6 12 2639951 efgartigimod alfa-qvfc 1008 MG / hyaluronidase-qvfc 11,200 UNT per 5.6 ML Injection SY 7104d9e5-9910-47f5-9a93-741ac50f43b6 12 2712088 Vyvgart Hytrulo (efgartigimod alfa-hyaluronidase-qvfc 1,000 MG / 10,000 UNT) per 5 ML Prefilled Syringe SY 7104d9e5-9910-47f5-9a93-741ac50f43b6 12 2639957 Vyvgart Hytrulo (efgartigimod alfa-hyaluronidase-qvfc 1008 MG / 11,200 UNT) per 5.6 ML Injection SY 7104d9e5-9910-47f5-9a93-741ac50f43b6 12 2639957 Vyvgart Hytrulo 1008 MG / 11,200 UNT per 5.6 ML Injection SY 7104d9e5-9910-47f5-9a93-741ac50f43b6 12
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Sample Exclude flag Status 73475-1221-1 73475122101 1 SYRINGE, GLASS in 1 CARTON (73475-1221-1) / 5 mL in 1 SYRINGE, GLASS 2025-04-10 No No Current 73475-1221-4 73475122104 4 SYRINGE, GLASS in 1 CARTON (73475-1221-4) / 5 mL in 1 SYRINGE, GLASS 2025-04-10 No No Current