NDC 0003-0371

NULOJIX

Belatacept

NULOJIX is a Intravenous Injection, Powder, Lyophilized, For Solution in the Human Prescription Drug category. It is labeled and distributed by E.r. Squibb & Sons, L.l.c.. The primary component is Belatacept.

• Product ID: 0003-0371_03289654-2e9a-4c95-aa3a-fa5e962032c4
• NDC: 0003-0371
• Product Type: Human Prescription Drug
• Proprietary Name: NULOJIX
• Generic Name: Belatacept
• Dosage Form: Injection, Powder, Lyophilized, For Solution
• Route of Administration: INTRAVENOUS
• Marketing Start Date: 2011-06-15
• Marketing Category: BLA / BLA
• Application Number: BLA125288
• Labeler Name: E.R. Squibb & Sons, L.L.C.
• Substance Name: BELATACEPT
• Active Ingredient Strength: 250 mg/1
• Pharm Classes: Selective T Cell Costimulation Blocker [EPC],CD80-directed Antibody Interactions [MoA],CD86-directed Antibody Interactions [MoA],T Lymphocyte Costimulation Activity Blockade [PE]
• NDC Exclude Flag: N
• Listing Certified Through: 2021-12-31

Packaging

NDC 0003-0371-13

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

• Marketing Start Date: 2011-06-15
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0003-0371-13 [00003037113]

NULOJIX INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION

• Marketing Category: BLA
• Application Number: BLA125288
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2011-06-15

Drug Details

Active Ingredients

Ingredient	Strength
BELATACEPT	250 mg/1

OpenFDA Data

• SPL SET ID: c16ac648-d5d2-9f7d-8637-e2328572754e
• Manufacturer:
  • E.R. Squibb & Sons, L.L.C.
• UNII:
  • E3B2GI648A
• RxNorm Concept Unique ID - RxCUI:
  • 1112976
  • 1112980

Pharmacological Class

• Selective T Cell Costimulation Blocker [EPC]
• CD80-directed Antibody Interactions [MoA]
• CD86-directed Antibody Interactions [MoA]
• T Lymphocyte Costimulation Activity Blockade [PE]