VYVGART

Product NDC
73475-3041
11-digit product format
734753041
Labeler code
73475
Product ID
73475-3041_3bce287a-2242-4c56-ba66-c06cc0eec56c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
EFGARTIGIMOD ALFA
Dosage form
INJECTION
Route
INTRAVENOUS
Labeler
argenx US
Application
BLA761195
Marketing category
BLA
Marketing start
2021-12-17
Substance
EFGARTIGIMOD ALFA
Active strength
20 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

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
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
EFGARTIGIMOD ALFA20 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
961YV2O515Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2587723Internal RxNorm lookup
2587729Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
8aefc8e3-26d6-4ff6-aab9-a7542927e084Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
00bb4496-246c-4f2c-910a-2b2783035958Product name120231025
e0c39752-98ba-4b96-a1e0-1fe4c0365ed0Product name120220720
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
1681bc73-b05f-12c3-1075-382ae39f449cProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
73475-3041-5VYVGART20 mL in 1 VIAL, SINGLE-DOSEINJECTION2015
73475-3041-5VYVGART1 in 1 CARTONINJECTION115

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
73475-3041-5ML - Milliliter73475-3041c30ee184-ae24-44e7-bb75-01e6e39d5e4212022-02-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
73475-3041VYVGART (EFGARTIGIMOD ALFA) INJECTION [ARGENX US]11Current NDC, Legacy NDC, 2 package rows20250413_8aefc8e3-26d6-4ff6-aab9-a7542927e084.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.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
VYVGARTEFGARTIGIMOD ALFAargenx US8aefc8e3-26d6-4ff6-aab9-a7542927e0842026-05-13Warnings, Adverse reactionsExact identifier
application number: BLA761195
ndc (product): 73475-3041

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
761195Vyvgartefgartigimod alfa-fcab351(a)Rx2026-09-01

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2587723efgartigimod alfa-fcab 400 MG in 20 ML InjectionPSN8aefc8e3-26d6-4ff6-aab9-a7542927e08415
2587729VYVGART 400 MG in 20 ML InjectionPSN8aefc8e3-26d6-4ff6-aab9-a7542927e08415
258772920 ML efgartigimod alfa-fcab 20 MG/ML Injection [Vyvgart]SBD8aefc8e3-26d6-4ff6-aab9-a7542927e08415
258772320 ML efgartigimod alfa-fcab 20 MG/ML InjectionSCD8aefc8e3-26d6-4ff6-aab9-a7542927e08415
2587723efgartigimod alfa-fcab 20 MG/ML per 20 ML InjectionSY8aefc8e3-26d6-4ff6-aab9-a7542927e08415
2587723efgartigimod alfa-fcab 400 MG per 20 ML InjectionSY8aefc8e3-26d6-4ff6-aab9-a7542927e08415
2587729Vyvgart 20 MG/ML per 20 ML InjectionSY8aefc8e3-26d6-4ff6-aab9-a7542927e08415
2587729Vyvgart 400 MG per 20 ML InjectionSY8aefc8e3-26d6-4ff6-aab9-a7542927e08415

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
73475-3041-5734753041051 VIAL, SINGLE-DOSE in 1 CARTON (73475-3041-5) / 20 mL in 1 VIAL, SINGLE-DOSE2021-12-170000-00-00NoNoCurrent