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NDC 00003-2187-13 ORENCIA 250 mg/15mL Details
ORENCIA 250 mg/15mL
ORENCIA 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 ABATACEPT.
MedlinePlus Drug Summary
Abatacept is used: alone or in combination with other medications to reduce the pain, swelling, difficulty with daily activities, and joint damage caused by rheumatoid arthritis (a condition in which the body attacks its own joints causing pain, swelling, and loss of function) in adults who have not been helped by other medications. alone or in combination with methotrexate (Otrexup, Rasuvo, Reditrex, Trexall, Xatmep) to treat polyarticular juvenile idiopathic arthritis (PJIA; a type of childhood arthritis that affects five or more joints during the first six months of the condition, causing pain, swelling, and loss of function) in children 2 years of age or older. alone or in combination with other medications to treat psoriatic arthritis (condition that causes joint pain and swelling and scales on the skin) in adults. in combination with a calcineurin inhibitor (e.g., cyclosporine [Gengraf, Neoral, Sandimmune], tacrolimus [Astagraf, Prograf]) and methotrexate to prevent graft-versus-host disease (GVHD; a complication of hematopoietic stem-cell transplant [HSCT; a procedure that replaces diseased bone marrow with healthy bone marrow]) in adults and children 2 years of age and older. Abatacept is in a class of medications called selective costimulation modulators (immunomodulators). It works by blocking the activity of T-cells, a type of immune cell in the body that causes swelling and joint damage in people who have arthritis.
Related Packages: 00003-2187-13Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Abatacept Injection
Product Information
NDC | 00003-2187 |
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Product ID | 0003-2187_ca83b90c-3ec0-4803-bf69-18c035bc41f0 |
Associated GPIs | 66400010002120 |
GCN Sequence Number | 060226 |
GCN Sequence Number Description | abatacept/maltose VIAL 250 MG INTRAVEN |
HIC3 | S2Q |
HIC3 Description | ANTINFLAMMATORY, SEL.COSTIM.MOD.,T-CELL INHIBITOR |
GCN | 26306 |
HICL Sequence Number | 033411 |
HICL Sequence Number Description | ABATACEPT/MALTOSE |
Brand/Generic | Brand |
Proprietary Name | ORENCIA |
Proprietary Name Suffix | n/a |
Non-Proprietary Name | abatacept |
Product Type | HUMAN PRESCRIPTION DRUG |
Dosage Form | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION |
Route | INTRAVENOUS |
Active Ingredient Strength | 250 |
Active Ingredient Units | mg/15mL |
Substance Name | ABATACEPT |
Labeler Name | E.R. Squibb & Sons, L.L.C. |
Pharmaceutical Class | Decreased Cytokine Activity [PE], Recombinant Fusion Proteins [CS], Selective T Cell Costimulation Modulator [EPC] |
DEA Schedule | n/a |
Marketing Category | BLA |
Application Number | BLA125118 |
Listing Certified Through | 2024-12-31 |
Package
NDC 00003-2187-13 (00003218713)
NDC Package Code | 0003-2187-13 |
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Billing NDC | 00003218713 |
Package | 1 VIAL, SINGLE-USE in 1 CARTON (0003-2187-13) / 15 mL in 1 VIAL, SINGLE-USE |
Marketing Start Date | 2009-01-01 |
NDC Exclude Flag | N |
Pricing Information | N/A |