FDA.reportPublic FDA data

VYJUVEK

Product NDC
82194-510
11-digit product format
821940510
Labeler code
82194
Product ID
82194-510_3ff07932-fac8-5b69-e063-6394a90a5cbe
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
VYJUVEK
Dosage form
KIT
Labeler
Krystal Biotech, Inc.
Application
BLA125774
Marketing category
BLA
Marketing start
2023-05-19
NDC exclude flag
No
Listing certified through
2026-12-31
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
VYJUVEK
Listing expiration
2026-12-31

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2637762Internal RxNorm lookup
2637767Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
fe207c8c-04b4-4fdf-87cf-6dbc7eb6e9c2Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
77dc03a4-fbfc-e6a3-fe95-285bbae40d75Product name220250814
4b7700e3-6e0e-45e5-9d22-6f754d61386eProduct name220250304
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
82194-501-01VYJUVEK1 mL in 1 VIALSUSPENSION1 mL5000000000 [PFU] in 1mL6
82194-510-02VYJUVEK1 in 1 CARTONKIT16

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
82194-510-02ML - Milliliter82194-510d5de59ac-c735-4515-a7c3-0be659e546b512023-07-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
82194-510VYJUVEK KIT [KRYSTAL BIOTECH, INC.]4Current NDC, 2 package rows20250112_fe207c8c-04b4-4fdf-87cf-6dbc7eb6e9c2.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
VYJUVEKVYJUVEKKrystal Biotech, Inc.fe207c8c-04b4-4fdf-87cf-6dbc7eb6e9c22025-09-29Warnings, Adverse reactionsExact identifier
application number: BLA125774
ndc (product): 82194-510

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
125774VYJUVEKberemagene geperpavec-svdt351(a)Rx2026-09-01

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2637762beremagene geperpavec-svdt 5,000,000,000 PFU/ML Topical SuspensionPSNfe207c8c-04b4-4fdf-87cf-6dbc7eb6e9c26
2637767Vyjuvek 5,000,000,000 PFU/ML Topical SuspensionPSNfe207c8c-04b4-4fdf-87cf-6dbc7eb6e9c26
2637767beremagene geperpavec-svdt 5000000000 UNT/ML Topical Suspension [Vyjuvek]SBDfe207c8c-04b4-4fdf-87cf-6dbc7eb6e9c26
2637762beremagene geperpavec-svdt 5000000000 UNT/ML Topical SuspensionSCDfe207c8c-04b4-4fdf-87cf-6dbc7eb6e9c26
2637762beremagene geperpavec-svdt 5,000,000,000 UNT/ML Topical SuspensionSYfe207c8c-04b4-4fdf-87cf-6dbc7eb6e9c26
2637767Vyjuvek 5,000,000,000 PFU/ML Topical SuspensionSYfe207c8c-04b4-4fdf-87cf-6dbc7eb6e9c26
2637767Vyjuvek 5,000,000,000 UNT/ML Topical SuspensionSYfe207c8c-04b4-4fdf-87cf-6dbc7eb6e9c26

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
82194-501-01821940501011 mL in 1 VIAL1 mlHistorical
82194-510-02821940510021 KIT in 1 CARTON (82194-510-02) * 1 mL in 1 VIAL (82194-501-01) * 1.5 mL in 1 VIAL (82194-001-01) 1 kit2023-05-19NoNoCurrent