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 UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
ZL1R02VT79Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2584857Internal RxNorm lookup
2584863Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
9c6d9e2a-9a77-4d11-b692-de87cfde3444Available on FDA.report

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

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
SusvimoRANIBIZUMABGenentech, Inc.9c6d9e2a-9a77-4d11-b692-de87cfde34442025-11-21Boxed warning, Warnings, Adverse reactionsExact identifier
application number: BLA761197
ndc (product): 50242-078

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
761197Susvimoranibizumab351(a)Rx2026-08-01

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