vyvgart hytrulo

Generic: efgartigimod alfa and hyaluronidase (human recombinant)

Labeler: argenx us
NDC Directory HUMAN PRESCRIPTION DRUG BLA Inactive Finished

Drug Facts

Product Profile

Brand Name vyvgart hytrulo
Generic Name efgartigimod alfa and hyaluronidase (human recombinant)
Labeler argenx us
Dosage Form INJECTION, SOLUTION
Routes
SUBCUTANEOUS
Active Ingredients

efgartigimod alfa 180 mg/mL, hyaluronidase (human recombinant) 2000 U/mL

Manufacturer
argenx US

Identifiers & Regulatory

Product NDC 73475-3102
Product ID 73475-3102_45b02fcc-ab21-41b1-8841-340a8bca0388
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category BLA
Application Number BLA761304
Listing Expiration 2027-12-31
Marketing Start 2023-06-20

Pharmacologic Class

Established (EPC)
neonatal fc receptor blocker [epc] endoglycosidase [epc]
Mechanism of Action
neonatal fc receptor blockers [moa]
Chemical Structure
glycoside hydrolases [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 734753102
Hyphenated Format 73475-3102

Supplemental Identifiers

RxCUI
2639951 2639957 2712083 2712088
UNII
961YV2O515 743QUY4VD8
NUI
N0000194004 N0000194005 N0000175531 M0009499

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name vyvgart hytrulo (source: ndc)
Generic Name efgartigimod alfa and hyaluronidase (human recombinant) (source: ndc)
Application Number BLA761304 (source: ndc)
Routes
SUBCUTANEOUS
source: ndc

Resolved Composition

Strengths
  • 180 mg/mL
  • 2000 U/mL
source: ndc
Packaging
  • 1 VIAL, SINGLE-DOSE in 1 CARTON (73475-3102-3) / 5.6 mL in 1 VIAL, SINGLE-DOSE
source: ndc

Packages (1)

73475-3102-3 1 VIAL, SINGLE-DOSE in 1 CARTON (73475-3102-3) / 5.6 mL in 1 VIAL, SINGLE-DOSE

Ingredients (2)

efgartigimod alfa (180 mg/mL) hyaluronidase (human recombinant) (2000 U/mL)

Linked Drug Pages (1)

VYVGART Hytrulo ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["SUBCUTANEOUS"], "spl_id": "45b02fcc-ab21-41b1-8841-340a8bca0388", "openfda": {"nui": ["N0000194004", "N0000194005", "N0000175531", "M0009499"], "unii": ["961YV2O515", "743QUY4VD8"], "rxcui": ["2639951", "2639957", "2712083", "2712088"], "spl_set_id": ["7104d9e5-9910-47f5-9a93-741ac50f43b6"], "pharm_class_cs": ["Glycoside Hydrolases [CS]"], "pharm_class_epc": ["Neonatal Fc Receptor Blocker [EPC]", "Endoglycosidase [EPC]"], "pharm_class_moa": ["Neonatal Fc Receptor Blockers [MoA]"], "manufacturer_name": ["argenx US"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL, SINGLE-DOSE in 1 CARTON (73475-3102-3)  / 5.6 mL in 1 VIAL, SINGLE-DOSE", "package_ndc": "73475-3102-3", "marketing_start_date": "20230620"}], "brand_name": "VYVGART Hytrulo", "product_id": "73475-3102_45b02fcc-ab21-41b1-8841-340a8bca0388", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Endoglycosidase [EPC]", "Glycoside Hydrolases [CS]", "Neonatal Fc Receptor Blocker [EPC]", "Neonatal Fc Receptor Blockers [MoA]"], "product_ndc": "73475-3102", "generic_name": "efgartigimod alfa and hyaluronidase (human recombinant)", "labeler_name": "argenx US", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "VYVGART Hytrulo", "active_ingredients": [{"name": "EFGARTIGIMOD ALFA", "strength": "180 mg/mL"}, {"name": "HYALURONIDASE (HUMAN RECOMBINANT)", "strength": "2000 U/mL"}], "application_number": "BLA761304", "marketing_category": "BLA", "marketing_start_date": "20230620", "listing_expiration_date": "20271231"}