FDA.reportPublic FDA data

NUFYMCO

Product NDC
70710-2173
Requested package NDC
70710-2173-1
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]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Reported adverse events (FAERS/openFDA)#

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

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

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 · 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 (package): 70710-2173-1
ndc (product): 70710-2173
ndc11 (package): 70710217301

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
761473Nufymcoranibizumab-leyk351(k) InterchangeableRx2026-09-01

Packages#

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