byooviz

Generic: ranibizumab-nuna

Labeler: biogen inc.
NDC Directory HUMAN PRESCRIPTION DRUG BLA Inactive Finished

Drug Facts

Product Profile

Brand Name byooviz
Generic Name ranibizumab-nuna
Labeler biogen inc.
Dosage Form INJECTION, SOLUTION
Routes
INTRAVITREAL
Active Ingredients

ranibizumab 10 mg/mL

Manufacturer
BIOGEN INC.

Identifiers & Regulatory

Product NDC 64406-019
Product ID 64406-019_44ead429-973b-60cb-e063-6394a90a9a75
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category BLA
Application Number BLA761202
Marketing Start 2022-06-01
Marketing End 2028-07-19

Pharmacologic Class

Established (EPC)
vascular endothelial growth factor inhibitor [epc]
Mechanism of Action
vascular endothelial growth factor inhibitors [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 64406019
Hyphenated Format 64406-019

Supplemental Identifiers

RxCUI
2602353 2602359
UNII
ZL1R02VT79
NUI
N0000193542 N0000193543

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name byooviz (source: ndc)
Generic Name ranibizumab-nuna (source: ndc)
Application Number BLA761202 (source: ndc)
Routes
INTRAVITREAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/mL
source: ndc
Packaging
  • 1 VIAL, SINGLE-DOSE in 1 CARTON (64406-019-01) / .05 mL in 1 VIAL, SINGLE-DOSE (64406-019-07)
  • 1 VIAL, SINGLE-DOSE in 1 CARTON (64406-019-08) / .05 mL in 1 VIAL, SINGLE-DOSE (64406-019-09)
source: ndc

Packages (2)

64406-019-01 1 VIAL, SINGLE-DOSE in 1 CARTON (64406-019-01) / .05 mL in 1 VIAL, SINGLE-DOSE (64406-019-07) 64406-019-08 1 VIAL, SINGLE-DOSE in 1 CARTON (64406-019-08) / .05 mL in 1 VIAL, SINGLE-DOSE (64406-019-09)

Ingredients (1)

ranibizumab (10 mg/mL)

Linked Drug Pages (1)

Byooviz ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVITREAL"], "spl_id": "44ead429-973b-60cb-e063-6394a90a9a75", "openfda": {"nui": ["N0000193542", "N0000193543"], "unii": ["ZL1R02VT79"], "rxcui": ["2602353", "2602359"], "spl_set_id": ["e46db299-edd1-4457-89b2-c1e2e505f1b0"], "pharm_class_epc": ["Vascular Endothelial Growth Factor Inhibitor [EPC]"], "pharm_class_moa": ["Vascular Endothelial Growth Factor Inhibitors [MoA]"], "manufacturer_name": ["BIOGEN INC."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL, SINGLE-DOSE in 1 CARTON (64406-019-01)  / .05 mL in 1 VIAL, SINGLE-DOSE (64406-019-07)", "package_ndc": "64406-019-01", "marketing_end_date": "20280719", "marketing_start_date": "20220601"}, {"sample": false, "description": "1 VIAL, SINGLE-DOSE in 1 CARTON (64406-019-08)  / .05 mL in 1 VIAL, SINGLE-DOSE (64406-019-09)", "package_ndc": "64406-019-08", "marketing_end_date": "20280719", "marketing_start_date": "20221003"}], "brand_name": "Byooviz", "product_id": "64406-019_44ead429-973b-60cb-e063-6394a90a9a75", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Vascular Endothelial Growth Factor Inhibitor [EPC]", "Vascular Endothelial Growth Factor Inhibitors [MoA]"], "product_ndc": "64406-019", "generic_name": "ranibizumab-nuna", "labeler_name": "BIOGEN INC.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Byooviz", "active_ingredients": [{"name": "RANIBIZUMAB", "strength": "10 mg/mL"}], "application_number": "BLA761202", "marketing_category": "BLA", "marketing_end_date": "20280719", "marketing_start_date": "20220601"}