FDA.reportPublic FDA data

NUFYMCO

Product NDC
70710-2173
11-digit product format
707102173
Labeler code
70710
Product ID
70710-2173_4a45dd5a-c8d9-4e98-9586-ab6c069c2ffe
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ranibizumab-leyk
Dosage form
INJECTION, SOLUTION
Route
INTRAVITREAL
Labeler
Zydus Pharmaceuticals USA Inc.
Application
BLA761473
Marketing category
BLA
Marketing start
2026-06-11
Substance
RANIBIZUMAB
Active strength
.5 mg/.05mL
Pharmacologic classes
Vascular Endothelial Growth Factor Inhibitor [EPC]; Vascular Endothelial Growth Factor Inhibitors [MoA]
Listing certified through
2027-12-31
Current FDA listing
Yes

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
NUFYMCORANIBIZUMAB-LEYKZydus Pharmaceuticals USA Inc.05ed75bc-ae21-480b-9be4-cbc51689dd8a2026-06-04Warnings, Adverse reactionsExact identifier
application number: BLA761473
ndc (product): 70710-2173

Additional Listing Data#

Finished product
Yes
Brand name base
NUFYMCO
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
RANIBIZUMAB.5 mg/.05mL

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 · 4 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2744887Internal RxNorm lookup
2744894Internal RxNorm lookup
2744897Internal RxNorm lookup
2744900Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
05ed75bc-ae21-480b-9be4-cbc51689dd8aAvailable on FDA.report

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
761473Nufymcoranibizumab-leyk351(k) InterchangeableRx2026-06-01

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleStatus
70710-2173-1707102173011 VIAL, GLASS in 1 CARTON (70710-2173-1) / .05 mL in 1 VIAL, GLASS2026-06-110Current