FDA.reportPublic FDA data

NDC 64406-019-07 - Byooviz

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC
64406-019
Requested NDC
64406-019-07
Package NDCs from labels
64406-019-07, 64406-019-01, 64406-019-09, 64406-019-08
Manufacturer
BIOGEN INC. | Samsung Bioepis Co., Ltd.
Effective date
2025-12-01
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Byooviz - BIOGEN INC. | Samsung Bioepis Co., Ltd.BIOGEN INC. | Samsung Bioepis Co., Ltd.2025-12-01HUMAN PRESCRIPTION DRUG LABEL

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 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

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

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 3 of 10 · 183 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Quality Choice Eye WashWATERChain Drug Marketing Assoc., Inc.1fb8a109-351b-7039-e063-6394a90a73112025-12-30WarningsExact identifier
unii: 059QF0KO0R
Rite Aid Eye WashPURIFIED WATERRite Aid28a18e04-d735-a511-e063-6394a90af6bb2025-12-30WarningsExact identifier
unii: 059QF0KO0R
OCUFRESHWATEROptics Laboratory Inc.b8e477a9-66b9-496b-92fb-3d4bbd7b36b52025-12-29WarningsExact identifier
unii: 059QF0KO0R
Kollourion Eyesalve EyewashPURIFIED WATER 98.3%Miracle Eye Pharmaceuticalsb56d2ab9-169b-b490-e053-2a95a90a80b32025-12-28WarningsExact identifier
unii: 059QF0KO0R
Sterile WaterWATERProPharma Distribution386a0a2f-4ff7-f128-e063-6294a90a7d4d2025-12-18Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Firstep FirstflushEYEWASHEncon Safety Products, Inc.a44beb26-79ae-98bd-e053-2995a90a9b742025-12-09WarningsExact identifier
unii: 059QF0KO0R
ByoovizRANIBIZUMAB-NUNABIOGEN INC.e46db299-edd1-4457-89b2-c1e2e505f1b02025-12-01Warnings, Adverse reactionsExact identifier
application number: BLA761202
ndc (package): 64406-019-01
ndc (package): 64406-019-08
ndc (package): 64406-019-07
ndc (package): 64406-019-09
ndc (product): 64406-019
ndc11 (package): 64406001907
rxcui: 2602353
rxcui: 2602359
spl id: 44ead429-973b-60cb-e063-6394a90a9a75
spl set id: e46db299-edd1-4457-89b2-c1e2e505f1b0
unii: ZL1R02VT79
ByoovizRANIBIZUMAB-NUNAHarrow Eye, LLC77b53b2c-da0e-44b2-ade4-b08ff75a75842025-11-26Warnings, Adverse reactionsExact identifier
application number: BLA761202
rxcui: 2602353
rxcui: 2602359
unii: ZL1R02VT79
PUR-WASHWATERNiagara Pharmaceuticals Inc.beda35c3-9a8b-47ad-e053-2995a90a7b1b2025-11-24WarningsExact identifier
unii: 059QF0KO0R
Easy Care First Aid EyewashWATERTender Corporationa070aac8-e6d2-ef10-e053-2a95a90aa5b12025-11-24WarningsExact identifier
unii: 059QF0KO0R
PUR-WASHWATERNiagara Pharmaceuticals Inc.e07a064b-f680-405c-bbcd-24fac430951e2025-11-24WarningsExact identifier
unii: 059QF0KO0R
ULINE EyewashEYEWASHNiagara Pharmaceuticals Inc.2d7f22d2-320b-6af1-e063-6294a90addc62025-11-24WarningsExact identifier
unii: 059QF0KO0R
Pur-WashEYEWASHNiagara Pharmaceuticals, Inc.0d43b1c1-2699-37f1-e054-00144ff88e882025-11-24WarningsExact identifier
unii: 059QF0KO0R
PUR-WASHWATERNiagara Pharmaceuticals Inc.777e1559-786f-8d54-e053-2991aa0aa98d2025-11-24WarningsExact identifier
unii: 059QF0KO0R
PUR-WASHWATERNiagara Pharmaceuticals Inc.7289103a-5cbf-42f4-8848-e827149a43ca2025-11-24WarningsExact identifier
unii: 059QF0KO0R
SusvimoRANIBIZUMABGenentech, Inc.9c6d9e2a-9a77-4d11-b692-de87cfde34442025-11-21Boxed warning, Warnings, Adverse reactionsExact identifier
unii: ZL1R02VT79
LUCENTISRANIBIZUMABGenentech, Inc.de4e66cc-ca05-4dc9-8262-e00e9b41c36d2025-11-21Warnings, Adverse reactionsExact identifier
unii: ZL1R02VT79
Eyewash Additive ConcentrateWATER AND PROPYLENE GLYCOLHaws Corporationdd168403-398c-41ff-b1df-d93e4ff39de32025-11-20WarningsExact identifier
unii: 059QF0KO0R
Sterile WaterWATERFresenius Kabi USA, LLCfd823bef-c14c-4708-a18a-8aaa8470412f2025-11-18Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Eyesaline Eyewash ConcentratePURIFIED WATERHoneywell Safety Products USA, Inc.3765c251-eb14-d60f-e063-6294a90a6a4d2025-11-12WarningsExact identifier
unii: 059QF0KO0R

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.