FDA.reportPublic FDA data

VABYSMO

Product NDC
50242-096
11-digit product format
502420096
Labeler code
50242
Product ID
50242-096_d03c8813-cfdd-498f-9085-44e3d8436620
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Faricimab
Dosage form
INJECTION, SOLUTION
Route
INTRAVITREAL
Labeler
Genentech, Inc.
Application
BLA761235
Marketing category
BLA
Marketing start
2022-01-28
Substance
FARICIMAB
Active strength
6 mg/.05mL
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
FARICIMAB6 mg/.05mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
QC4F7FKK7IInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2591588Internal RxNorm lookup
2591594Internal RxNorm lookup
2692684Internal RxNorm lookup
2692688Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
04cc9ef7-c02a-4e92-a655-0062674e8487Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
4f6d5f88-d592-4cb1-b3c1-6d2e58bf8ed1Product name120221110
f1e0dc7e-7d61-4625-b6d9-4894927679d7Product name220211025
3c386306-c48a-413e-bb69-70cb268496f3Product name120210727
e4870509-7e28-6f92-f0be-dd3dd889a9cfProduct name520200810
6e9d4a47-c464-b93e-aebc-ad7bffc9c4cdProduct name220190619
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
48747306-602a-42cc-957b-5b0c69158eeeProduct name120180604
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
5668b646-cd56-c3c7-bdea-3f6b1a8840dbProduct name120140508
684ea482-2e8b-14af-5664-b98f1e402036Product name120140508
810ab97e-f109-f41c-7c83-6a652a9cbf43Product name120140508
87711080-88eb-65c5-b2dd-bf99e700a372Product name120140508
8dbefedf-0a0d-a224-5a3c-66dc9e11c2ddProduct name120140508
b060cc1a-fe47-856b-0b77-4448b5963de8Product name120140508
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508
db5ebcdb-b6ae-21cd-4dc5-76cd84b5578bProduct name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50242-096-01VABYSMO1 in 1 CARTONINJECTION, SOLUTION111
50242-096-03VABYSMO0.05 mL in 1 VIALINJECTION, SOLUTION0.0511
50242-096-06VABYSMO1 in 1 CARTONINJECTION, SOLUTION111
50242-096-06VABYSMO0.05 mL in 1 SYRINGEINJECTION, SOLUTION0.0511
50242-096-45VABYSMO1 in 1 CARTONINJECTION, SOLUTION111
50242-096-45VABYSMO0.05 mL in 1 SYRINGEINJECTION, SOLUTION0.0511
50242-096-77VABYSMO0.05 mL in 1 VIALINJECTION, SOLUTION0.0511
50242-096-86VABYSMO1 in 1 CARTONINJECTION, SOLUTION111

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50242-096-01ML - Milliliter50242-0960fd61f54-60a0-4496-a03e-e2dcd36ed93e12022-03-09
50242-096-06ML - Milliliter50242-096908be41d-f918-4a20-80ef-b96096d6fd4612024-09-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50242-096VABYSMO (FARICIMAB) INJECTION, SOLUTION [GENENTECH, INC.]8Current NDC, Legacy NDC, 8 package rows20241206_04cc9ef7-c02a-4e92-a655-0062674e8487.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
VABYSMOFARICIMABGenentech, Inc.04cc9ef7-c02a-4e92-a655-0062674e84872026-04-15Warnings, Adverse reactionsExact identifier
application number: BLA761235
ndc (product): 50242-096

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
761235Vabysmofaricimab-svoa351(a)Rx2026-06-01

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2591588faricimab-svoa 6 MG in 0.05 ML InjectionPSN04cc9ef7-c02a-4e92-a655-0062674e848711
2692684faricimab-svoa 6 MG in 0.05 ML Prefilled SyringePSN04cc9ef7-c02a-4e92-a655-0062674e848711
2591594Vabysmo 6 MG in 0.05 ML InjectionPSN04cc9ef7-c02a-4e92-a655-0062674e848711
2692688Vabysmo 6 MG in 0.05 ML Prefilled SyringePSN04cc9ef7-c02a-4e92-a655-0062674e848711
25915940.05 ML faricimab-svoa 120 MG/ML Injection [Vabysmo]SBD04cc9ef7-c02a-4e92-a655-0062674e848711
26926880.05 ML faricimab-svoa 120 MG/ML Prefilled Syringe [Vabysmo]SBD04cc9ef7-c02a-4e92-a655-0062674e848711
25915880.05 ML faricimab-svoa 120 MG/ML InjectionSCD04cc9ef7-c02a-4e92-a655-0062674e848711
26926840.05 ML faricimab-svoa 120 MG/ML Prefilled SyringeSCD04cc9ef7-c02a-4e92-a655-0062674e848711
25915940.05 ML Vabysmo 120 MG/ML InjectionSY04cc9ef7-c02a-4e92-a655-0062674e848711
26926880.05 ML Vabysmo 120 MG/ML Prefilled SyringeSY04cc9ef7-c02a-4e92-a655-0062674e848711
2591588faricimab-svoa 6 MG per 0.05 ML InjectionSY04cc9ef7-c02a-4e92-a655-0062674e848711
2692684faricimab-svoa 6 MG per 0.05 ML Prefilled SyringeSY04cc9ef7-c02a-4e92-a655-0062674e848711
2591594Vabysmo 6 MG per 0.05 ML InjectionSY04cc9ef7-c02a-4e92-a655-0062674e848711
2692688Vabysmo 6 MG per 0.05 ML Prefilled SyringeSY04cc9ef7-c02a-4e92-a655-0062674e848711

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50242-096-01502420096011 VIAL in 1 CARTON (50242-096-01) / .05 mL in 1 VIAL (50242-096-03) 1 vial2022-01-280000-00-00NoNoCurrent
50242-096-03502420096030.05 mL in 1 VIAL0.05 mlHistorical
50242-096-06502420096061 SYRINGE in 1 CARTON (50242-096-06) / .05 mL in 1 SYRINGE1 syringe2024-07-03NoNoCurrent
50242-096-45502420096451 SYRINGE in 1 CARTON (50242-096-45) / .05 mL in 1 SYRINGE1 syringe2024-07-03YesNoCurrent
50242-096-77502420096770.05 mL in 1 VIAL0.05 mlHistorical
50242-096-86502420096861 VIAL in 1 CARTON (50242-096-86) / .05 mL in 1 VIAL (50242-096-77) 1 vial2022-01-280000-00-00YesNoCurrent