NUFYMCO

Product NDC
70710-2173
11-digit product format
707102173
Labeler code
70710
Product ID
70710-2173_0165619b-c985-47a1-8204-2e88bc96ed49
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

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