FDA.reportPublic FDA data

ADSTILADRIN

Product NDC
55566-1050
11-digit product format
555661050
Labeler code
55566
Product ID
55566-1050_dac17f96-6c26-41e4-bd42-92aff75d339e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
nadofaragene firadenovec-vncg
Dosage form
SUSPENSION
Route
INTRAVESICAL
Labeler
Ferring Pharmaceuticals Inc.
Application
BLA125700
Marketing category
BLA
Marketing start
2023-09-05
Substance
NADOFARAGENE FIRADENOVEC
Active strength
300000000000 {VP}/mL
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
ADSTILADRIN
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
NADOFARAGENE FIRADENOVEC300000000000 {VP}/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii0OOS09O1FH
Rxcui2644440, 2644445

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
77dc03a4-fbfc-e6a3-fe95-285bbae40d75Product name220250814
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55566-1050-0ADSTILADRIN20 mL in 1 VIALSUSPENSION2015
55566-1050-1ADSTILADRIN4 in 1 CARTONSUSPENSION415
55566-1050-2ADSTILADRIN20 mL in 1 VIALSUSPENSION2015

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
55566-1050-0EA - Each55566-10504203df5f-1d5b-4b8b-8e7c-7af8a15a546d12024-03-12
55566-1050-1EA - Each55566-1050049aef06-041b-45bb-89e4-9ee749788cf012023-10-16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55566-1050ADSTILADRIN (NADOFARAGENE FIRADENOVEC-VNCG) SUSPENSION [FERRING PHARMACEUTICALS]9Current NDC, 3 package rows20241101_5ca20ed4-da4f-463c-ac2a-ccd6ab3774fa.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2644445ADSTILADRIN 300000000000 VIRAL-PARTICLES in 20 ML Intravesical SuspensionPSN5ca20ed4-da4f-463c-ac2a-ccd6ab3774fa15
2644440nadofaragene firadenovec-vncg 300000000000 VIRAL-PARTICLES in 20 ML Intravesical SuspensionPSN5ca20ed4-da4f-463c-ac2a-ccd6ab3774fa15
2644445nadofaragene firadenovec-vncg 15000000000 VIRAL-PARTICLES/ML Intravesical Suspension [Adstiladrin]SBD5ca20ed4-da4f-463c-ac2a-ccd6ab3774fa15
2644440nadofaragene firadenovec-vncg 15000000000 VIRAL-PARTICLES/ML Intravesical SuspensionSCD5ca20ed4-da4f-463c-ac2a-ccd6ab3774fa15
2644445Adstiladrin 15000000000 VIRAL-PARTICLES/ML Intravesical SuspensionSY5ca20ed4-da4f-463c-ac2a-ccd6ab3774fa15
2644445Adstiladrin 300000000000 VIRAL-PARTICLES per 20 ML Intravesical SuspensionSY5ca20ed4-da4f-463c-ac2a-ccd6ab3774fa15
2644440nadofaragene firadenovec-vncg 300000000000 VIRAL-PARTICLES per 20 ML Intravesical SuspensionSY5ca20ed4-da4f-463c-ac2a-ccd6ab3774fa15

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
55566-1050-05556610500020 mL in 1 VIAL20 mlHistorical
55566-1050-1555661050014 VIAL in 1 CARTON (55566-1050-1) / 20 mL in 1 VIAL (55566-1050-0) 4 vial2023-09-05NoNoHistorical
55566-1050-25556610500220 mL in 1 VIAL (55566-1050-2) 20 ml2025-10-13NoNoHistorical