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

Additional Listing Data#

Finished product
Yes
Brand name base
Byooviz

Active Ingredients#

Ingredient, Strength table
IngredientStrength
RANIBIZUMAB10 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiZL1R02VT79
Rxcui2602353, 2602359

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

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