FDA.reportPublic FDA data

EMPLICITI

Product NDC
0003-2291
11-digit product format
000032291
Labeler code
0003
Product ID
0003-2291_8441efc2-338a-4d1d-8fa1-9b9863a49ffd
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
elotuzumab
Dosage form
INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route
INTRAVENOUS
Labeler
E.R. Squibb & Sons, L.L.C.
Application
BLA761035
Marketing category
BLA
Marketing start
2015-11-30
Substance
ELOTUZUMAB
Active strength
300 mg/1
Pharmacologic classes
Antibodies, Monoclonal [CS], SLAMF7-directed Antibody Interactions [MoA], SLAMF7-directed Immunostimulatory Antibody [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
EMPLICITI
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ELOTUZUMAB300 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1351PE5UGSInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1726110Internal RxNorm lookup
1726115Internal RxNorm lookup
1726117Internal RxNorm lookup
1726119Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
80686b7e-f6f4-4154-b5c0-c846425e2d91Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c94a0353-f44d-461e-b70d-9389ff5e5602Product name120151215

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0003-2291-11EMPLICITI1 in 1 CARTONINJECTION, POWDER, LYOPHILIZED,113
0003-2291-11EMPLICITI1 in 1 VIAL, SINGLE-USEINJECTION, POWDER, LYOPHILIZED,113

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0003-2291-11EA - Each0003-22915e1e7a04-10f5-4e46-8f2f-835bd6cc119412016-01-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0003-2291EMPLICITI (ELOTUZUMAB) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [E.R. SQUIBB & SONS, L.L.C.]13Current NDC, Legacy NDC, 2 package rows20240628_80686b7e-f6f4-4154-b5c0-c846425e2d91.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.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
EMPLICITIELOTUZUMABE.R. Squibb & Sons, L.L.C.80686b7e-f6f4-4154-b5c0-c846425e2d912022-03-22Warnings, Adverse reactionsExact identifier
application number: BLA761035
ndc (product): 0003-2291

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
761035Emplicitielotuzumab351(a)Rx2026-07-01

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1726110elotuzumab 300 MG InjectionPSN80686b7e-f6f4-4154-b5c0-c846425e2d9113
1726117elotuzumab 400 MG InjectionPSN80686b7e-f6f4-4154-b5c0-c846425e2d9113
1726115Empliciti 300 MG InjectionPSN80686b7e-f6f4-4154-b5c0-c846425e2d9113
1726119Empliciti 400 MG InjectionPSN80686b7e-f6f4-4154-b5c0-c846425e2d9113
1726115elotuzumab 300 MG Injection [Empliciti]SBD80686b7e-f6f4-4154-b5c0-c846425e2d9113
1726119elotuzumab 400 MG Injection [Empliciti]SBD80686b7e-f6f4-4154-b5c0-c846425e2d9113
1726110elotuzumab 300 MG InjectionSCD80686b7e-f6f4-4154-b5c0-c846425e2d9113
1726117elotuzumab 400 MG InjectionSCD80686b7e-f6f4-4154-b5c0-c846425e2d9113
1726115Empliciti 300 MG InjectionSY80686b7e-f6f4-4154-b5c0-c846425e2d9113
1726119Empliciti 400 MG InjectionSY80686b7e-f6f4-4154-b5c0-c846425e2d9113

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0003-2291-11000032291111 VIAL, SINGLE-USE in 1 CARTON (0003-2291-11) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-USE2015-11-300000-00-00NoNoCurrent