orencia

Generic: abatacept

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

Drug Facts

Product Profile

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

abatacept 250 mg/15mL

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

Identifiers & Regulatory

Product NDC 0003-2187
Product ID 0003-2187_962695b7-21f5-44bb-80e0-cb3b48c80be6
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category BLA
Application Number BLA125118
Listing Expiration 2026-12-31
Marketing Start 2009-01-01

Pharmacologic Class

Established (EPC)
selective t cell costimulation modulator [epc]
Chemical Structure
recombinant fusion proteins [cs]
Physiologic Effect
decreased cytokine activity [pe]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 00032187
Hyphenated Format 0003-2187

Supplemental Identifiers

RxCUI
616015 616018 1145929 1145932 1799228 1799230 1925254 1925255 1925256 1925257
UNII
7D0YB67S97
NUI
N0000008571 N0000182159 M0018640

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 orencia (source: ndc)
Generic Name abatacept (source: ndc)
Application Number BLA125118 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 250 mg/15mL
source: ndc
Packaging
  • 1 VIAL, SINGLE-USE in 1 CARTON (0003-2187-13) / 15 mL in 1 VIAL, SINGLE-USE
source: ndc

Packages (1)

0003-2187-13 1 VIAL, SINGLE-USE in 1 CARTON (0003-2187-13) / 15 mL in 1 VIAL, SINGLE-USE

Ingredients (1)

abatacept (250 mg/15mL)

Linked Drug Pages (1)

ORENCIA ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "962695b7-21f5-44bb-80e0-cb3b48c80be6", "openfda": {"nui": ["N0000008571", "N0000182159", "M0018640"], "unii": ["7D0YB67S97"], "rxcui": ["616015", "616018", "1145929", "1145932", "1799228", "1799230", "1925254", "1925255", "1925256", "1925257"], "spl_set_id": ["0836c6ac-ee37-5640-2fed-a3185a0b16eb"], "pharm_class_cs": ["Recombinant Fusion Proteins [CS]"], "pharm_class_pe": ["Decreased Cytokine Activity [PE]"], "pharm_class_epc": ["Selective T Cell Costimulation Modulator [EPC]"], "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 (0003-2187-13)  / 15 mL in 1 VIAL, SINGLE-USE", "package_ndc": "0003-2187-13", "marketing_start_date": "20090101"}], "brand_name": "ORENCIA", "product_id": "0003-2187_962695b7-21f5-44bb-80e0-cb3b48c80be6", "dosage_form": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION", "pharm_class": ["Decreased Cytokine Activity [PE]", "Recombinant Fusion Proteins [CS]", "Selective T Cell Costimulation Modulator [EPC]"], "product_ndc": "0003-2187", "generic_name": "abatacept", "labeler_name": "E.R. Squibb & Sons, L.L.C.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "ORENCIA", "active_ingredients": [{"name": "ABATACEPT", "strength": "250 mg/15mL"}], "application_number": "BLA125118", "marketing_category": "BLA", "marketing_start_date": "20090101", "listing_expiration_date": "20261231"}