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

Additional Listing Data#

Finished product
Yes
Brand name base
VYJUVEK
Listing expiration
2026-12-31

Harmonized Identifiers#

Field, Values table
FieldValues
Rxcui2637762, 2637767

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

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 kit2023-05-19NoNoHistorical