empliciti

Generic: elotuzumab

Labeler: e.r. squibb & sons, l.l.c.
NDC Directory HUMAN PRESCRIPTION DRUG BLA Inactive Finished

Drug Facts

Product Profile

Brand Name empliciti
Generic Name elotuzumab
Labeler e.r. squibb & sons, l.l.c.
Dosage Form INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Routes
INTRAVENOUS
Active Ingredients

elotuzumab 300 mg/1

Manufacturer
E.R. Squibb & Sons, L.L.C.

Identifiers & Regulatory

Product NDC 0003-2291
Product ID 0003-2291_8441efc2-338a-4d1d-8fa1-9b9863a49ffd
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category BLA
Application Number BLA761035
Listing Expiration 2026-12-31
Marketing Start 2015-11-30

Pharmacologic Class

Established (EPC)
slamf7-directed immunostimulatory antibody [epc]
Mechanism of Action
slamf7-directed antibody interactions [moa]
Chemical Structure
antibodies, monoclonal [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 00032291
Hyphenated Format 0003-2291

Supplemental Identifiers

RxCUI
1726110 1726115 1726117 1726119
UPC
0300032291118
UNII
1351PE5UGS
NUI
N0000192338 N0000192337 M0001357

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name empliciti (source: ndc)
Generic Name elotuzumab (source: ndc)
Application Number BLA761035 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 300 mg/1
source: ndc
Packaging
  • 1 VIAL, SINGLE-USE in 1 CARTON (0003-2291-11) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-USE
source: ndc

Packages (1)

0003-2291-11 1 VIAL, SINGLE-USE in 1 CARTON (0003-2291-11) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-USE

Ingredients (1)

elotuzumab (300 mg/1)

Linked Drug Pages (1)

EMPLICITI ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "8441efc2-338a-4d1d-8fa1-9b9863a49ffd", "openfda": {"nui": ["N0000192338", "N0000192337", "M0001357"], "upc": ["0300032291118"], "unii": ["1351PE5UGS"], "rxcui": ["1726110", "1726115", "1726117", "1726119"], "spl_set_id": ["80686b7e-f6f4-4154-b5c0-c846425e2d91"], "pharm_class_cs": ["Antibodies, Monoclonal [CS]"], "pharm_class_epc": ["SLAMF7-directed Immunostimulatory Antibody [EPC]"], "pharm_class_moa": ["SLAMF7-directed Antibody Interactions [MoA]"], "manufacturer_name": ["E.R. Squibb & Sons, L.L.C."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL, SINGLE-USE in 1 CARTON (0003-2291-11)  / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-USE", "package_ndc": "0003-2291-11", "marketing_start_date": "20151130"}], "brand_name": "EMPLICITI", "product_id": "0003-2291_8441efc2-338a-4d1d-8fa1-9b9863a49ffd", "dosage_form": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION", "pharm_class": ["Antibodies", "Monoclonal [CS]", "SLAMF7-directed Antibody Interactions [MoA]", "SLAMF7-directed Immunostimulatory Antibody [EPC]"], "product_ndc": "0003-2291", "generic_name": "elotuzumab", "labeler_name": "E.R. Squibb & Sons, L.L.C.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "EMPLICITI", "active_ingredients": [{"name": "ELOTUZUMAB", "strength": "300 mg/1"}], "application_number": "BLA761035", "marketing_category": "BLA", "marketing_start_date": "20151130", "listing_expiration_date": "20261231"}