Home NDC 0003-0371 NULOJIX
Product NDC 0003-0371
11-digit product format 000030371
Labeler code 0003
Product ID 0003-0371_9057087d-7e59-4e5a-8e4a-96a532efb0ab
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name BELATACEPT
Dosage form INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route INTRAVENOUS
Labeler E.R. Squibb & Sons, L.L.C.
Application BLA125288
Marketing category BLA
Marketing start 2011-06-15
Substance BELATACEPT
Active strength 250 mg/1
Pharmacologic classes CD80-directed Antibody Interactions [MoA], CD86-directed Antibody Interactions [MoA], Selective T Cell Costimulation Blocker [EPC], T Lymphocyte Costimulation Activity Blockade [PE]
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes Additional Listing Data#
Finished product Yes
Brand name base NULOJIX
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength BELATACEPT 250 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination E3B2GI648A Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1112976 Internal RxNorm lookup 1112980 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 0003-0371-13 NULOJIX 1 in 1 VIAL, SINGLE-USE INJECTION, POWDER, LYOPHILIZED, 1 15 0003-0371-13 NULOJIX 1 in 1 CARTON INJECTION, POWDER, LYOPHILIZED, 1 15
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded belatacept ACTIVE INGREDIENT E3B2GI648A NULOJIX (BELATACEPT) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [E.R. SQUIBB & SONS, L.L.C.] 5 belatacept ACTIVE MOIETY E3B2GI648A NULOJIX (BELATACEPT) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [E.R. SQUIBB & SONS, L.L.C.] 5 sodium chloride INACTIVE INGREDIENT 451W47IQ8X NULOJIX (BELATACEPT) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [E.R. SQUIBB & SONS, L.L.C.] 5 sodium phosphate, monobasic INACTIVE INGREDIENT 3980JIH2SW NULOJIX (BELATACEPT) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [E.R. SQUIBB & SONS, L.L.C.] 5 sucrose INACTIVE INGREDIENT C151H8M554 NULOJIX (BELATACEPT) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [E.R. SQUIBB & SONS, L.L.C.] 5
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0003-0371 NULOJIX (BELATACEPT) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [E.R. SQUIBB & SONS, L.L.C.] 15 Current NDC, Legacy NDC, 2 package rows 20230125_c16ac648-d5d2-9f7d-8637-e2328572754e.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 Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join NULOJIX BELATACEPT E.R. Squibb & Sons, L.L.C. c16ac648-d5d2-9f7d-8637-e2328572754e 2021-07-28 Boxed warning, Warnings, Adverse reactions Exact identifier application number: BLA125288 ndc (product): 0003-0371
Purple Book Biologic Products# BLA, Proprietary name, Proper name table BLA Proprietary name Proper name License type Status Latest source 125288 Nulojix belatacept 351(a) Rx 2026-07-01
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 0003-0371-13 00003037113 1 VIAL, SINGLE-USE in 1 CARTON (0003-0371-13) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-USE 2011-06-15 0000-00-00 No No Current