NDC 0003-2188-31 - ORENCIA

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC
0003-2188
Requested NDC
0003-2188-31
Package NDCs from labels
0003-2188-11, 0003-2188-21, 0003-2188-91, 0003-2188-51, 0003-2188-50, 0003-2188-90, 0003-2188-31
Manufacturer
E.R. Squibb & Sons, L.L.C. | Patheon Italia S.p.A.
Effective date
2025-11-13
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
ORENCIA - E.R. Squibb & Sons, L.L.C. | Patheon Italia S.p.A.E.R. Squibb & Sons, L.L.C. | Patheon Italia S.p.A.2025-11-13HUMAN PRESCRIPTION DRUG LABEL
National Council for Prescription Drug Programs indexing - billing unitNational Council for Prescription Drug Programs2012-07-24Indexing - Billing Unit

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0003-2188-11ORENCIA1 mL in 1 SYRINGE, GLASSINJECTION, SOLUTION135
0003-2188-11ORENCIA4 in 1 CARTONINJECTION, SOLUTION435
0003-2188-21ORENCIA1 mL in 1 SYRINGE, GLASSINJECTION, SOLUTION135
0003-2188-21ORENCIA1 in 1 CARTONINJECTION, SOLUTION135
0003-2188-50ORENCIA1 in 1 CARTONINJECTION, SOLUTION135
0003-2188-50ORENCIA1 mL in 1 SYRINGE, GLASSINJECTION, SOLUTION135
0003-2188-51ORENCIA1 mL in 1 SYRINGE, GLASSINJECTION, SOLUTION135
0003-2188-51ORENCIA4 in 1 CARTONINJECTION, SOLUTION435
0003-2188-90ORENCIA1 in 1 CARTONINJECTION, SOLUTION135
0003-2188-90ORENCIA1 mL in 1 SYRINGE, GLASSINJECTION, SOLUTION135
0003-2188-91ORENCIA1 in 1 CARTONINJECTION, SOLUTION135
0003-2188-91ORENCIA1 mL in 1 SYRINGE, GLASSINJECTION, SOLUTION135

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0003-2188ORENCIA (ABATACEPT) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION ORENCIA (ABATACEPT) INJECTION, SOLUTION [E.R. SQUIBB & SONS, L.L.C.]34Current NDC, Legacy NDC, 12 package rows20241220_0836c6ac-ee37-5640-2fed-a3185a0b16eb.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0003-2188-11ML - Milliliter0003-21883fe641af-15b9-41a0-8a4f-c12cb1c7b82512013-12-02
0003-2188-31ML - Milliliter0003-2188482bab0d-4f60-4ea7-8acf-95f384c2aaa812012-07-24
0003-2188-51ML - Milliliter0003-2188985da64f-d6ff-4d68-9837-8ff2143aea8812016-07-19

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
abataceptACTIVE INGREDIENT7D0YB67S97ORENCIA (ABATACEPT) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION ORENCIA (ABATACEPT) INJECTION, SOLUTION [E.R. SQUIBB & SONS, L.L.C.]15
abataceptACTIVE MOIETY7D0YB67S97ORENCIA (ABATACEPT) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION ORENCIA (ABATACEPT) INJECTION, SOLUTION [E.R. SQUIBB & SONS, L.L.C.]15
maltose monohydrateINACTIVE INGREDIENTDM477EE40DORENCIA (ABATACEPT) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION ORENCIA (ABATACEPT) INJECTION, SOLUTION [E.R. SQUIBB & SONS, L.L.C.]15
poloxamer 188INACTIVE INGREDIENTLQA7B6G8JGORENCIA (ABATACEPT) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION ORENCIA (ABATACEPT) INJECTION, SOLUTION [E.R. SQUIBB & SONS, L.L.C.]15
sodium chlorideINACTIVE INGREDIENT451W47IQ8XORENCIA (ABATACEPT) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION ORENCIA (ABATACEPT) INJECTION, SOLUTION [E.R. SQUIBB & SONS, L.L.C.]15
SODIUM PHOSPHATE, DIBASIC, ANHYDROUSINACTIVE INGREDIENT22ADO53M6FORENCIA (ABATACEPT) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION ORENCIA (ABATACEPT) INJECTION, SOLUTION [E.R. SQUIBB & SONS, L.L.C.]15
sodium phosphate, monobasicINACTIVE INGREDIENT3980JIH2SWORENCIA (ABATACEPT) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION ORENCIA (ABATACEPT) INJECTION, SOLUTION [E.R. SQUIBB & SONS, L.L.C.]15
sodium phosphate, monobasic, monohydrateINACTIVE INGREDIENT593YOG76RNORENCIA (ABATACEPT) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION ORENCIA (ABATACEPT) INJECTION, SOLUTION [E.R. SQUIBB & SONS, L.L.C.]15
sucroseINACTIVE INGREDIENTC151H8M554ORENCIA (ABATACEPT) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION ORENCIA (ABATACEPT) INJECTION, SOLUTION [E.R. SQUIBB & SONS, L.L.C.]15
waterINACTIVE INGREDIENT059QF0KO0RORENCIA (ABATACEPT) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION ORENCIA (ABATACEPT) INJECTION, SOLUTION [E.R. SQUIBB & SONS, L.L.C.]15

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 3 of 56 · 1,117 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Hypertonic SalineSODIUM CHLORIDENAVEH PHARMA (1996) LTD167c7a9c-1228-4fb2-a89c-d3e1483863232026-07-30WarningsExact identifier
unii: 451W47IQ8X
Hypertonic Saline Solution Sodium ChlorideSODIUM CHLORIDENAVEH PHARMA (1996) LTD750ea4b1-de2b-4299-aaa2-331daf383d0d2026-07-30WarningsExact identifier
unii: 451W47IQ8X
DECONIMO ReconstitutionDECONIMO RECONSTITUTIONImage Amazon LLC57ab9b1c-9a18-3786-e063-6394a90a2c632026-07-28WarningsExact identifier
unii: 059QF0KO0R
DelflexDEXTROSE MONOHYDRATE, SODIUM CHLORIDE, SODIUM LACTATE, CALCIUM CHLORIDE, MAGNESIUM CHLORIDEFresenius Medical Care de Mexico, S.A. de C.V.a98facd6-9daa-4d37-8209-63a0599dbfaa2026-07-27Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
Sodium ChlorideSODIUM CHLORIDEFresenius Medical Care de Mexico, S.A. de C.V.9a1220fb-6853-45ae-838c-10d8596e1af72026-07-27Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
Sodium ChlorideSODIUM CHLORIDEFresenius Medical Care Renal Therapies Group, LLCaf5cdf1a-19f4-11e2-892e-0800200c9a662026-07-27Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
PEG 3350 and ElectrolytesPOLYETHYLENE GLYCOL 3350, SODIUM SULFATE ANHYDROUS, SODIUM BICARBONATE, SODIUM CHLORIDE, POTASSIUM CHLORIDEA-S Medication Solutions19daf830-7270-4661-81b1-ded38f867f282026-07-24Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
Sterile WaterWATERCardinal Health 107, LLC9655cd02-82b5-4a75-813b-854b195514812026-07-21Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Whisidom Saline SolutionSODIUM CHLORIDE 0.9% SALINE SOLUTIONJiangxi Yudexi Pharmaceutical Co., LTD4e4e4169-2a14-3466-e063-6394a90a081b2026-07-20WarningsExact identifier
unii: 451W47IQ8X
SalineNASALBEST CHOICE (VALU MERCHANDISERS COMPANY)71485e82-bf54-4b8b-8dd2-2a07615345202026-07-17WarningsExact identifier
unii: 451W47IQ8X
Sodium ChlorideSODIUM CHLORIDELABORATORIOS GRIFOLS SAeb811d79-fdb8-1f1a-c2ad-1cc4bfc7eadf2026-07-15Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
WHWSWB 0.9% SALINESODIUM CHLORIDEYiwu Huanshu E-commerce Co., Ltd5082b773-79b2-2501-e063-6394a90a170f2026-07-11WarningsExact identifier
unii: 451W47IQ8X
SALINE NASALSODIUM CHLORIDEALAINA HEALTHCARE PRIVATE LIMITEDed30a7f9-7132-42da-9bed-63a9b1c80ab22026-07-07WarningsExact identifier
unii: 451W47IQ8X
Dr. Drop NMN Vital Balance (Drop No.1 Cream 90g)NMN (NICOTINAMIDE MONONUCLEOTIDE), ECTOIN (ECTOINE)Reedfresh Co., LTD55d703ca-ff9d-0dbc-e063-6294a90ab6b12026-07-05WarningsExact identifier
unii: 059QF0KO0R
Eyesaline Eyewash ConcentratePURIFIED WATERProtective Industrial Products, Inc.558e5926-9027-d3f6-e063-6294a90ab1212026-07-02WarningsExact identifier
unii: 059QF0KO0R
Fendall 2000 Pure FlowPURIFIED WATERProtective Industrial Products, Inc.55a1d07e-0006-0c75-e063-6394a90a7acc2026-07-02WarningsExact identifier
unii: 059QF0KO0R
Fendall 1000 Pure FlowPURIFIED WATERProtective Industrial Products, Inc.55a2f4da-bb1e-8ead-e063-6394a90af72e2026-07-02WarningsExact identifier
unii: 059QF0KO0R
Sterile Eyesaline EyewashSTERILE EYESALINE EYEWASHProtective Industrial Products, Inc.55a290e8-8310-8be4-e063-6394a90abdce2026-07-02WarningsExact identifier
unii: 059QF0KO0R
Eyesaline Emergency EyewashPURIFIED WATERProtective Industrial Products, Inc.55a261c2-725d-6765-e063-6294a90a32602026-07-02WarningsExact identifier
unii: 059QF0KO0R
RemodulinTREPROSTINILUnited Therapeutics Corporation6c80bb38-e8db-4138-9f0d-dbbf9c6731852026-07-02Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.