FDA.reportPublic FDA data

Byooviz

Product NDC
64406-019
11-digit product format
644060019
Labeler code
64406
Product ID
64406-019_44ead429-973b-60cb-e063-6394a90a9a75
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ranibizumab-nuna
Dosage form
INJECTION, SOLUTION
Route
INTRAVITREAL
Labeler
BIOGEN INC.
Application
BLA761202
Marketing category
BLA
Marketing start
2022-06-01
Marketing end
2028-07-19
Substance
RANIBIZUMAB
Active strength
10 mg/mL
Pharmacologic classes
Vascular Endothelial Growth Factor Inhibitor [EPC], Vascular Endothelial Growth Factor Inhibitors [MoA]
NDC exclude flag
No
Current FDA listing
Yes

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 3 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopeProduct NDCPackage NDCCodeStatusReporting periodArchiveSnapshotSource SHA-256
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct64406-019UExcluded because listing certification expiredexcluded / ndc_excluded.zip0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage64406-01964406-019-08UExcluded because listing certification expiredexcluded / ndc_excluded.zip0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage64406-01964406-019-01UExcluded because listing certification expiredexcluded / ndc_excluded.zip0efc9e666f02…f202fb6c5f17…

Additional Listing Data#

Finished product
Yes
Brand name base
Byooviz

Active Ingredients#

Ingredient, Strength table
IngredientStrength
RANIBIZUMAB10 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
2602353Internal RxNorm lookup
2602359Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
e46db299-edd1-4457-89b2-c1e2e505f1b0Available 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
64406-019-01Byooviz1 in 1 CARTONINJECTION, SOLUTION114
64406-019-07Byooviz0.05 mL in 1 VIAL, SINGLE-DOSEINJECTION, SOLUTION0.0514
64406-019-08Byooviz1 in 1 CARTONINJECTION, SOLUTION114
64406-019-09Byooviz0.05 mL in 1 VIAL, SINGLE-DOSEINJECTION, SOLUTION0.0514

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
64406-019-01ML - Milliliter64406-0199849b676-581c-4900-ac9e-c83711db637012022-06-06
64406-019-07ML - Milliliter64406-0196d74303c-4b7b-47dd-b294-c8ae2517c02612022-06-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
64406-019BYOOVIZ (RANIBIZUMAB-NUNA) INJECTION, SOLUTION [BIOGEN INC.]11Current NDC, Legacy NDC, 4 package rows20250117_e46db299-edd1-4457-89b2-c1e2e505f1b0.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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ByoovizRANIBIZUMAB-NUNABIOGEN INC.e46db299-edd1-4457-89b2-c1e2e505f1b02025-12-01Warnings, Adverse reactionsExact identifier
application number: BLA761202
ndc (product): 64406-019
ByoovizRANIBIZUMAB-NUNAHarrow Eye, LLC77b53b2c-da0e-44b2-ade4-b08ff75a75842025-11-26Warnings, Adverse reactionsExact identifier
application number: BLA761202

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
761202Byoovizranibizumab-nuna351(k) InterchangeableRx2026-08-01

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2602359Byooviz 0.5 MG in 0.05 ML InjectionPSNe46db299-edd1-4457-89b2-c1e2e505f1b014
2602353ranibizumab-nuna 0.5 MG in 0.05 ML InjectionPSNe46db299-edd1-4457-89b2-c1e2e505f1b014
26023590.05 ML ranibizumab-nuna 10 MG/ML Injection [Byooviz]SBDe46db299-edd1-4457-89b2-c1e2e505f1b014
26023530.05 ML ranibizumab-nuna 10 MG/ML InjectionSCDe46db299-edd1-4457-89b2-c1e2e505f1b014
2602359Byooviz 0.5 MG per 0.05 ML InjectionSYe46db299-edd1-4457-89b2-c1e2e505f1b014
2602359Byooviz 10 MG/ML per 0.05 ML InjectionSYe46db299-edd1-4457-89b2-c1e2e505f1b014
2602353ranibizumab-nuna 0.5 MG per 0.05 ML InjectionSYe46db299-edd1-4457-89b2-c1e2e505f1b014
2602353ranibizumab-nuna 10 MG/ML per 0.05 ML InjectionSYe46db299-edd1-4457-89b2-c1e2e505f1b014

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
64406-019-01644060019011 VIAL, SINGLE-DOSE in 1 CARTON (64406-019-01) / .05 mL in 1 VIAL, SINGLE-DOSE (64406-019-07) 2022-06-012028-07-19NoNoCurrent
64406-019-07644060019070.05 mL in 1 VIAL, SINGLE-DOSE0.05 mlHistorical
64406-019-08644060019081 VIAL, SINGLE-DOSE in 1 CARTON (64406-019-08) / .05 mL in 1 VIAL, SINGLE-DOSE (64406-019-09) 2022-10-032028-07-19NoNoCurrent
64406-019-09644060019090.05 mL in 1 VIAL, SINGLE-DOSE0.05 mlHistorical