Home NDC 73475-3102 VYVGART Hytrulo
Product NDC 73475-3102
11-digit product format 734753102
Labeler code 73475
Product ID 73475-3102_a2607d4b-76e8-4004-94c2-190fdc8593fb
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 2023-06-20
Substance EFGARTIGIMOD ALFA; HYALURONIDASE (HUMAN RECOMBINANT)
Active strength 180; 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 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 VYVGART Hytrulo
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength EFGARTIGIMOD ALFA 180 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# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 73475-3102-3 VYVGART Hytrulo 1 in 1 CARTON INJECTION, SOLUTION 1 12 73475-3102-3 VYVGART Hytrulo 5.6 mL in 1 VIAL, SINGLE-DOSE INJECTION, SOLUTION 5.6 12
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 73475-3102 VYVGART HYTRULO (EFGARTIGIMOD ALFA AND HYALURONIDASE (HUMAN RECOMBINANT)) INJECTION, SOLUTION [ARGENX US] 7 Current NDC, 2 package rows 20250418_7104d9e5-9910-47f5-9a93-741ac50f43b6.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 761304 Vyvgart Hytrulo efgartigimod alfa and hyaluronidase-qvfc 351(a) Rx 2026-09-01
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 73475-3102-3 73475310203 1 VIAL, SINGLE-DOSE in 1 CARTON (73475-3102-3) / 5.6 mL in 1 VIAL, SINGLE-DOSE 2023-06-20 No No Current