nulojix

Generic: belatacept

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

Drug Facts

Product Profile

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

belatacept 250 mg/1

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

Identifiers & Regulatory

Product NDC 0003-0371
Product ID 0003-0371_9057087d-7e59-4e5a-8e4a-96a532efb0ab
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category BLA
Application Number BLA125288
Listing Expiration 2026-12-31
Marketing Start 2011-06-15

Pharmacologic Class

Established (EPC)
selective t cell costimulation blocker [epc]
Mechanism of Action
cd80-directed antibody interactions [moa] cd86-directed antibody interactions [moa]
Physiologic Effect
t lymphocyte costimulation activity blockade [pe]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 00030371
Hyphenated Format 0003-0371

Supplemental Identifiers

RxCUI
1112976 1112980
UNII
E3B2GI648A
NUI
N0000182829 N0000182830 N0000182150 N0000182151

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 nulojix (source: ndc)
Generic Name belatacept (source: ndc)
Application Number BLA125288 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 250 mg/1
source: ndc
Packaging
  • 1 VIAL, SINGLE-USE in 1 CARTON (0003-0371-13) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-USE
source: ndc

Packages (1)

0003-0371-13 1 VIAL, SINGLE-USE in 1 CARTON (0003-0371-13) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-USE

Ingredients (1)

belatacept (250 mg/1)

Linked Drug Pages (1)

NULOJIX ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "9057087d-7e59-4e5a-8e4a-96a532efb0ab", "openfda": {"nui": ["N0000182829", "N0000182830", "N0000182150", "N0000182151"], "unii": ["E3B2GI648A"], "rxcui": ["1112976", "1112980"], "spl_set_id": ["c16ac648-d5d2-9f7d-8637-e2328572754e"], "pharm_class_pe": ["T Lymphocyte Costimulation Activity Blockade [PE]"], "pharm_class_epc": ["Selective T Cell Costimulation Blocker [EPC]"], "pharm_class_moa": ["CD80-directed Antibody Interactions [MoA]", "CD86-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 (0003-0371-13)  / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-USE", "package_ndc": "0003-0371-13", "marketing_start_date": "20110615"}], "brand_name": "NULOJIX", "product_id": "0003-0371_9057087d-7e59-4e5a-8e4a-96a532efb0ab", "dosage_form": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION", "pharm_class": ["CD80-directed Antibody Interactions [MoA]", "CD86-directed Antibody Interactions [MoA]", "Selective T Cell Costimulation Blocker [EPC]", "T Lymphocyte Costimulation Activity Blockade [PE]"], "product_ndc": "0003-0371", "generic_name": "BELATACEPT", "labeler_name": "E.R. Squibb & Sons, L.L.C.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "NULOJIX", "active_ingredients": [{"name": "BELATACEPT", "strength": "250 mg/1"}], "application_number": "BLA125288", "marketing_category": "BLA", "marketing_start_date": "20110615", "listing_expiration_date": "20261231"}