FDA.reportPublic FDA data

EPKINLY

Product NDC
82705-002
11-digit product format
827050002
Labeler code
82705
Product ID
82705-002_13fee518-576f-45f0-885a-b6b537128dde
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

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
EPCORITAMAB4 mg/.8mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiD6OMY2L0WA
Rxcui2637399, 2637405, 2637408, 2637411

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
2b78a333-30d8-4278-b3cd-5e6f0b5a4adfProduct name120240515
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
48747306-602a-42cc-957b-5b0c69158eeeProduct name120180604
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508
db5ebcdb-b6ae-21cd-4dc5-76cd84b5578bProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
82705-002-01EPKINLY0.8 mL in 1 VIAL, GLASSINJECTION, SOLUTION0.810
82705-002-01EPKINLY1 in 1 CARTONINJECTION, SOLUTION110

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
82705-002-01ML - Milliliter82705-0023f1042f3-fdff-46d1-889b-50b8e2fea46512023-06-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
82705-002EPKINLY (EPCORITAMAB-BYSP) INJECTION, SOLUTION [GENMAB US, INC.]6Current NDC, 2 package rows20240809_d7836711-b677-412d-bf2d-0f7c8444103a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2637408epcoritamab-bysp 4 MG in 0.8 ML InjectionPSNd7836711-b677-412d-bf2d-0f7c8444103a10
2637399epcoritamab-bysp 48 MG in 0.8 ML InjectionPSNd7836711-b677-412d-bf2d-0f7c8444103a10
2637411epkinly 4 MG in 0.8 ML InjectionPSNd7836711-b677-412d-bf2d-0f7c8444103a10
2637405epkinly 48 MG in 0.8 ML InjectionPSNd7836711-b677-412d-bf2d-0f7c8444103a10
26374110.8 ML epcoritamab-bysp 5 MG/ML Injection [Epkinly]SBDd7836711-b677-412d-bf2d-0f7c8444103a10
26374050.8 ML epcoritamab-bysp 60 MG/ML Injection [Epkinly]SBDd7836711-b677-412d-bf2d-0f7c8444103a10
26374080.8 ML epcoritamab-bysp 5 MG/ML InjectionSCDd7836711-b677-412d-bf2d-0f7c8444103a10
26373990.8 ML epcoritamab-bysp 60 MG/ML InjectionSCDd7836711-b677-412d-bf2d-0f7c8444103a10
26374110.8 ML Epkinly 5 MG/ML InjectionSYd7836711-b677-412d-bf2d-0f7c8444103a10
26374050.8 ML Epkinly 60 MG/ML InjectionSYd7836711-b677-412d-bf2d-0f7c8444103a10
2637408epcoritamab-bysp 4 MG per 0.8 ML InjectionSYd7836711-b677-412d-bf2d-0f7c8444103a10
2637399epcoritamab-bysp 48 MG per 0.8 ML InjectionSYd7836711-b677-412d-bf2d-0f7c8444103a10
2637411Epkinly 4 MG per 0.8 ML InjectionSYd7836711-b677-412d-bf2d-0f7c8444103a10
2637405Epkinly 48 MG per 0.8 ML InjectionSYd7836711-b677-412d-bf2d-0f7c8444103a10

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
82705-002-01827050002011 VIAL, GLASS in 1 CARTON (82705-002-01) / .8 mL in 1 VIAL, GLASS2023-05-19NoNoHistorical