FDA.reportPublic FDA data

Susvimo

Product NDC
50242-078
11-digit product format
502420078
Labeler code
50242
Product ID
50242-078_2850382e-4e4f-4005-a047-33fc758bafef
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ranibizumab
Dosage form
INJECTION, SOLUTION
Route
INTRAVITREAL
Labeler
Genentech, Inc.
Application
BLA761197
Marketing category
BLA
Marketing start
2021-10-22
Substance
RANIBIZUMAB
Active strength
100 mg/mL
Pharmacologic classes
Vascular Endothelial Growth Factor Inhibitor [EPC], Vascular Endothelial Growth Factor Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
RANIBIZUMAB100 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiZL1R02VT79
Rxcui2584857, 2584863

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
02a7bcab-2730-41aa-8529-7c6226e65babProduct name120220516
d6b571bf-7bed-4e31-93c1-5553936e1c45Product name120220315
da4394b8-eff9-4932-92e2-14d8feb38640Product name120161208
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50242-078-12Susvimo1 in 1 CARTONINJECTION, SOLUTION114
50242-078-12Susvimo1 mL in 1 VIALINJECTION, SOLUTION114
50242-078-55Susvimo1 mL in 1 VIALINJECTION, SOLUTION114
50242-078-55Susvimo1 in 1 CARTONINJECTION, SOLUTION114

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50242-078-12ML - Milliliter50242-0780ac96957-b6f7-41f5-83c3-49702c7a437a12021-11-09
50242-078-55ML - Milliliter50242-07850af3932-d9f6-4f3f-8824-e18a9636ee4212021-11-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50242-078SUSVIMO (RANIBIZUMAB) INJECTION, SOLUTION [GENENTECH, INC.]10Current NDC, Legacy NDC, 4 package rows20250215_9c6d9e2a-9a77-4d11-b692-de87cfde3444.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2584857ranibizumab 10 MG in 0.1 ML InjectionPSN9c6d9e2a-9a77-4d11-b692-de87cfde344414
2584863Susvimo 10 MG in 0.1 ML InjectionPSN9c6d9e2a-9a77-4d11-b692-de87cfde344414
25848630.1 ML ranibizumab 100 MG/ML Injection [Susvimo]SBD9c6d9e2a-9a77-4d11-b692-de87cfde344414
25848570.1 ML ranibizumab 100 MG/ML InjectionSCD9c6d9e2a-9a77-4d11-b692-de87cfde344414
25848630.1 ML Susvimo 100 MG/ML InjectionSY9c6d9e2a-9a77-4d11-b692-de87cfde344414
2584857ranibizumab 10 MG per 0.1 ML InjectionSY9c6d9e2a-9a77-4d11-b692-de87cfde344414
2584863Susvimo 10 MG per 0.1 ML InjectionSY9c6d9e2a-9a77-4d11-b692-de87cfde344414

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50242-078-12502420078121 VIAL in 1 CARTON (50242-078-12) / 1 mL in 1 VIAL1 vial2021-10-220000-00-00NoNoCurrent
50242-078-55502420078551 VIAL in 1 CARTON (50242-078-55) / 1 mL in 1 VIAL1 vial2021-10-222027-09-30NoNoCurrent