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 UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
0OOS09O1FHInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2644440Internal RxNorm lookup
2644445Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
5ca20ed4-da4f-463c-ac2a-ccd6ab3774faAvailable on FDA.report

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

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
ADSTILADRINNADOFARAGENE FIRADENOVEC-VNCGFerring Pharmaceuticals Inc.5ca20ed4-da4f-463c-ac2a-ccd6ab3774fa2026-03-24Warnings, Adverse reactionsExact identifier
application number: BLA125700
ndc (product): 55566-1050

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
125700Adstiladrinnadofaragene firadenovec-vncg351(a)Rx2026-07-01

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 vial2023-09-05NoNoCurrent
55566-1050-25556610500220 mL in 1 VIAL (55566-1050-2) 20 ml2025-10-13NoNoCurrent