FDA.reportPublic FDA data

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

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.

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

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

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
761195Vyvgartefgartigimod alfa-fcab351(a)Rx2026-06-01

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