FDA.reportPublic FDA data

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
IngredientStrength
BELATACEPT250 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiE3B2GI648A
Rxcui1112976, 1112980

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
726062af-1135-4707-a1d7-57256991bbf9Product name220250226
19c71a3d-ed9c-166b-a7e5-38c250c35631Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0003-0371-13NULOJIX1 in 1 VIAL, SINGLE-USEINJECTION, POWDER, LYOPHILIZED,115
0003-0371-13NULOJIX1 in 1 CARTONINJECTION, POWDER, LYOPHILIZED,115

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0003-0371-13EA - Each0003-037184b070b4-02bd-4850-8a20-cbf76beb6a0712012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
belataceptACTIVE INGREDIENTE3B2GI648ANULOJIX (BELATACEPT) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [E.R. SQUIBB & SONS, L.L.C.]5
belataceptACTIVE MOIETYE3B2GI648ANULOJIX (BELATACEPT) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [E.R. SQUIBB & SONS, L.L.C.]5
sodium chlorideINACTIVE INGREDIENT451W47IQ8XNULOJIX (BELATACEPT) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [E.R. SQUIBB & SONS, L.L.C.]5
sodium phosphate, monobasicINACTIVE INGREDIENT3980JIH2SWNULOJIX (BELATACEPT) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [E.R. SQUIBB & SONS, L.L.C.]5
sucroseINACTIVE INGREDIENTC151H8M554NULOJIX (BELATACEPT) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [E.R. SQUIBB & SONS, L.L.C.]5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0003-0371NULOJIX (BELATACEPT) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [E.R. SQUIBB & SONS, L.L.C.]15Current NDC, Legacy NDC, 2 package rows20230125_c16ac648-d5d2-9f7d-8637-e2328572754e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1112976belatacept 250 MG InjectionPSNc16ac648-d5d2-9f7d-8637-e2328572754e15
1112980Nulojix 250 MG InjectionPSNc16ac648-d5d2-9f7d-8637-e2328572754e15
1112980belatacept 250 MG Injection [Nulojix]SBDc16ac648-d5d2-9f7d-8637-e2328572754e15
1112976belatacept 250 MG InjectionSCDc16ac648-d5d2-9f7d-8637-e2328572754e15
1112980Nulojix 250 MG InjectionSYc16ac648-d5d2-9f7d-8637-e2328572754e15

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0003-0371-13000030371131 VIAL, SINGLE-USE in 1 CARTON (0003-0371-13) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-USE2011-06-150000-00-00NoNoCurrent