FDA.reportPublic FDA data

Byooviz

Product NDC
82667-018
11-digit product format
826670018
Labeler code
82667
Product ID
82667-018_567fe802-cc13-4a6a-bbfe-aa8d3638f5e6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ranibizumab-nuna
Dosage form
INJECTION, SOLUTION
Route
INTRAVITREAL
Labeler
Harrow Eye, LLC
Application
BLA761202
Marketing category
BLA
Marketing start
2026-01-01
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
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

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

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
77b53b2c-da0e-44b2-ade4-b08ff75a7584Available 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
82667-018-05Byooviz0.05 mL in 1 VIAL, SINGLE-DOSEINJECTION, SOLUTION0.051
82667-018-05Byooviz1 in 1 CARTONINJECTION, SOLUTION11

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
82667-018-05ML - Milliliter82667-018f7a35ec0-2c51-4930-b853-d71a76cfca9a12026-02-05

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
ByoovizRANIBIZUMAB-NUNAHarrow Eye, LLC77b53b2c-da0e-44b2-ade4-b08ff75a75842025-11-26Warnings, Adverse reactionsExact identifier
application number: BLA761202
ndc (product): 82667-018

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 InjectionPSN77b53b2c-da0e-44b2-ade4-b08ff75a75841
2602353ranibizumab-nuna 0.5 MG in 0.05 ML InjectionPSN77b53b2c-da0e-44b2-ade4-b08ff75a75841
26023590.05 ML ranibizumab-nuna 10 MG/ML Injection [Byooviz]SBD77b53b2c-da0e-44b2-ade4-b08ff75a75841
26023530.05 ML ranibizumab-nuna 10 MG/ML InjectionSCD77b53b2c-da0e-44b2-ade4-b08ff75a75841
2602359Byooviz 0.5 MG per 0.05 ML InjectionSY77b53b2c-da0e-44b2-ade4-b08ff75a75841
2602359Byooviz 10 MG/ML per 0.05 ML InjectionSY77b53b2c-da0e-44b2-ade4-b08ff75a75841
2602353ranibizumab-nuna 0.5 MG per 0.05 ML InjectionSY77b53b2c-da0e-44b2-ade4-b08ff75a75841
2602353ranibizumab-nuna 10 MG/ML per 0.05 ML InjectionSY77b53b2c-da0e-44b2-ade4-b08ff75a75841

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
82667-018-05826670018051 VIAL, SINGLE-DOSE in 1 CARTON (82667-018-05) / .05 mL in 1 VIAL, SINGLE-DOSE2026-01-01NoNoCurrent