Home NDC 0003-2814 ORENCIA
Product NDC 0003-2814
11-digit product format 000032814
Labeler code 0003
Product ID 0003-2814_962695b7-21f5-44bb-80e0-cb3b48c80be6
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name abatacept
Dosage form INJECTION, SOLUTION
Route SUBCUTANEOUS
Labeler E.R. Squibb & Sons, L.L.C.
Application BLA125118
Marketing category BLA
Marketing start 2011-07-29
Substance ABATACEPT
Active strength 50 mg/.4mL
Pharmacologic classes Decreased Cytokine Activity [PE], Recombinant Fusion Proteins [CS], Selective T Cell Costimulation Modulator [EPC]
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes Additional Listing Data#
Finished product Yes
Brand name base ORENCIA
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ABATACEPT 50 mg/.4mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 7D0YB67S97 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 10 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 616015 Internal RxNorm lookup 616018 Internal RxNorm lookup 1145929 Internal RxNorm lookup 1145932 Internal RxNorm lookup 1799228 Internal RxNorm lookup 1799230 Internal RxNorm lookup 1925254 Internal RxNorm lookup 1925255 Internal RxNorm lookup 1925256 Internal RxNorm lookup 1925257 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 0003-2814-11 ORENCIA 0.4 mL in 1 SYRINGE, GLASS INJECTION, SOLUTION 0.4 35 0003-2814-11 ORENCIA 4 in 1 CARTON INJECTION, SOLUTION 4 35
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded abatacept ACTIVE INGREDIENT 7D0YB67S97 ORENCIA (ABATACEPT) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION ORENCIA (ABATACEPT) INJECTION, SOLUTION [E.R. SQUIBB & SONS, L.L.C.] 15 abatacept ACTIVE MOIETY 7D0YB67S97 ORENCIA (ABATACEPT) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION ORENCIA (ABATACEPT) INJECTION, SOLUTION [E.R. SQUIBB & SONS, L.L.C.] 15 maltose monohydrate INACTIVE INGREDIENT DM477EE40D ORENCIA (ABATACEPT) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION ORENCIA (ABATACEPT) INJECTION, SOLUTION [E.R. SQUIBB & SONS, L.L.C.] 15 poloxamer 188 INACTIVE INGREDIENT LQA7B6G8JG ORENCIA (ABATACEPT) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION ORENCIA (ABATACEPT) INJECTION, SOLUTION [E.R. SQUIBB & SONS, L.L.C.] 15 sodium chloride INACTIVE INGREDIENT 451W47IQ8X ORENCIA (ABATACEPT) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION ORENCIA (ABATACEPT) INJECTION, SOLUTION [E.R. SQUIBB & SONS, L.L.C.] 15 SODIUM PHOSPHATE, DIBASIC, ANHYDROUS INACTIVE INGREDIENT 22ADO53M6F ORENCIA (ABATACEPT) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION ORENCIA (ABATACEPT) INJECTION, SOLUTION [E.R. SQUIBB & SONS, L.L.C.] 15 sodium phosphate, monobasic INACTIVE INGREDIENT 3980JIH2SW ORENCIA (ABATACEPT) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION ORENCIA (ABATACEPT) INJECTION, SOLUTION [E.R. SQUIBB & SONS, L.L.C.] 15 sodium phosphate, monobasic, monohydrate INACTIVE INGREDIENT 593YOG76RN ORENCIA (ABATACEPT) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION ORENCIA (ABATACEPT) INJECTION, SOLUTION [E.R. SQUIBB & SONS, L.L.C.] 15 sucrose INACTIVE INGREDIENT C151H8M554 ORENCIA (ABATACEPT) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION ORENCIA (ABATACEPT) INJECTION, SOLUTION [E.R. SQUIBB & SONS, L.L.C.] 15 water INACTIVE INGREDIENT 059QF0KO0R ORENCIA (ABATACEPT) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION ORENCIA (ABATACEPT) INJECTION, SOLUTION [E.R. SQUIBB & SONS, L.L.C.] 15
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0003-2814 ORENCIA (ABATACEPT) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION ORENCIA (ABATACEPT) INJECTION, SOLUTION [E.R. SQUIBB & SONS, L.L.C.] 34 Current NDC, Legacy NDC, 2 package rows 20241220_0836c6ac-ee37-5640-2fed-a3185a0b16eb.zip
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 1 of 1 · 1 matching rows.
Purple Book Biologic Products# BLA, Proprietary name, Proper name table BLA Proprietary name Proper name License type Status Latest source 125118 Orencia abatacept 351(a) Rx 2026-07-01
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 0003-2814-11 00003281411 4 SYRINGE, GLASS in 1 CARTON (0003-2814-11) / .4 mL in 1 SYRINGE, GLASS 2017-03-30 0000-00-00 No No Current