Home NDC 82705-002 EPKINLY
Product NDC 82705-002
11-digit product format 827050002
Labeler code 82705
Product ID 82705-002_e2f39a72-c677-4ded-a10c-da739f457180
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name epcoritamab-bysp
Dosage form INJECTION, SOLUTION
Route SUBCUTANEOUS
Labeler Genmab US, Inc.
Application BLA761324
Marketing category BLA
Marketing start 2023-05-19
Substance EPCORITAMAB
Active strength 4 mg/.8mL
Pharmacologic classes Bispecific CD20-directed CD3 T Cell Engager [EPC], CD20-directed Antibody Interactions [MoA], CD3 Receptor Agonists [MoA], CD3-directed Antibody Interactions [MoA], Cytochrome P450 Inhibitors [MoA], Increased Cytokine Activity [PE]
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 EPKINLY
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength EPCORITAMAB 4 mg/.8mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination D6OMY2L0WA Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 4 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 2637399 Internal RxNorm lookup 2637405 Internal RxNorm lookup 2637408 Internal RxNorm lookup 2637411 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 82705-002-01 EPKINLY 0.8 mL in 1 VIAL, GLASS INJECTION, SOLUTION 0.8 10 82705-002-01 EPKINLY 1 in 1 CARTON INJECTION, SOLUTION 1 10
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 82705-002 EPKINLY (EPCORITAMAB-BYSP) INJECTION, SOLUTION [GENMAB US, INC.] 6 Current NDC, 2 package rows 20240809_d7836711-b677-412d-bf2d-0f7c8444103a.zip
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.
Purple Book Biologic Products# BLA, Proprietary name, Proper name table BLA Proprietary name Proper name License type Status Latest source 761324 Epkinly epcoritamab-bysp 351(a) Rx 2026-09-01
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Sample Exclude flag Status 82705-002-01 82705000201 1 VIAL, GLASS in 1 CARTON (82705-002-01) / .8 mL in 1 VIAL, GLASS 2023-05-19 No No Current