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 7 of 54 · 1,067 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ConnectionANACARDIUM ORIENTALE, AURUM MURIATICUM NATRONATUM, CAMPHORA, DNA, GERMANIUM METALLICUM, HELLEBORUS NIGER, HYDROGEN, LAC CANINUM, LAC MATERNA HUMANUM, LITHIUM CARBONICUM, LITHIUM CARBONICUM, MAGNESIA OXYDATA, NATRUM CARBONICUM, NEON, OXYTOCIN, PLACENTA TOTALIS SUIS, RHUS GLABRA, SACCHARUM OFFICINALE, STRAMONIUM, THUJA OCCIDENTALISDeseret Biologicals, Inc.4a8be3aa-9bd9-4bb1-af98-a940c13b2bd02026-04-10WarningsExact identifier
unii: C151H8M554
ConnectionANACARDIUM ORIENTALE, AURUM MURIATICUM NATRONATUM, CAMPHORA, DNA, GERMANIUM METALLICUM, HELLEBORUS NIGER, HYDROGEN, LAC CANINUM, LAC MATERNA HUMANUM, LITHIUM CARBONICUM, LITHIUM CARBONICUM, MAGNESIA OXYDATA, NATRUM CARBONICUM, NEON, OXYTOCIN, PLACENTA TOTALIS SUIS, RHUS GLABRA, SACCHARUM OFFICINALE, STRAMONIUM, THUJA OCCIDENTALISDeseret Biologicals, Inc.214eb19a-e7a2-421c-9f34-724ce430185c2026-04-10WarningsExact identifier
unii: C151H8M554
H-Focus FormulaAGNUS CASTUS, AVENA SATIVA, BARYTA CARBONICA, IGNATIA AMARA, LYCOPODIUM CLAVATUM, NATRUM CARBONICUM, NATRUM MURIATICUM, PHOSPHORICUM ACIDUM, SILICEA, ZINCUM METALLICUMHealing Natural Oils LLC4ee42911-3064-7f55-e063-6294a90abcc72026-04-07WarningsExact identifier
unii: 451W47IQ8X
H-Mood FormulaAGRIMONIA EUPATORIA, FLOS, ANACARDIUM ORIENTALE, AURUM METALLICUM, AVENA SATIVA, BORAGO OFFICINALIS, CAPSICUM ANNUUM, CARPINUS BETULUS, FLOS, CIMICIFUGA RACEMOSA, CINCHONA OFFICINALIS, HYPERICUM PERFORATUM, KALI BROMATUM, LARIX DECIDUA, FLOS, NATRUM CARBONICUM, NATRUM MURIATICUM, NATRUM SULPHURICUM, PHOSPHORICUM ACIDUM, PHOSPHORUS, PULSATILLA, SILICEA, SINAPSIS ARVENSIS, FLOS, TABACUMHealing Natural Oils LLC4ee5c82e-9edf-c36e-e063-6394a90a237f2026-04-07WarningsExact identifier
unii: 451W47IQ8X
Dibasic Sodium Phosphate, Monobasic Potassium Phosphate and Monobasic Sodium PhosphateDIBASIC SODIUM PHOSPHATE, MONOBASIC POTASSIUM PHOSPHATE AND MONOBASIC SODIUM PHOSPHATERising Pharma Holdings, Inc.b01eac95-dbe3-4b21-a922-187e0fc8ad232026-04-07Adverse reactionsExact identifier
unii: 22ADO53M6F
unii: 593YOG76RN
Walgreens Sodium Chloride Ophthalmic 5 Percent Hypertonicity EyeSODIUM CHLORIDEWalgreen Companybda3b9db-5fc4-408c-a5ae-d1eeb3ee308d2026-04-06WarningsExact identifier
unii: 451W47IQ8X
Sodium Chloride Ophthalmic 5 Percent Hypertonicity EyeSODIUM CHLORIDEHanlim4ee80e16-1bb1-8238-e063-6294a90aa7192026-04-04WarningsExact identifier
unii: 451W47IQ8X
KIDS TOOTHPASTE, FOR CAVITY PROTECTIONKIDS TOOTHPASTE FOR CAVITY PROTECTIONShulisa (Foshan) Daily ChemicalIndustry Co., Ltd4e8fab9e-f05c-5e2f-e063-6294a90aecf92026-04-03WarningsExact identifier
unii: 059QF0KO0R
BACTERIOSTATIC SODIUM CHLORIDESODIUM CHLORIDEHospira, Inc.376093e7-e09e-4a57-3199-195e452518662026-04-03Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
Migraine and HeadacheIRIS VERSICOLOR ROOT AND SODIUM CHLORIDEForces of Nature0dd2f2e2-78e2-435e-b7b2-ca590953ff942026-04-01WarningsExact identifier
unii: 451W47IQ8X
Cold Sore FormulaDULCAMARA, GLYCYRRHIZA GLABRA, RANUNCULUS BULBOSUS, RHUS TOX, NATRUM MURIATICUM, FAGOPYRUM ESCULENTUM, NATRUM MURIATICUM, ACONITUM NAPELLUS, CYTOMEGALOVIRUS NOSODE, HERPES SIMPLEX I AND II NOSODE, SEPIA, EPSTEIN BARR VIRUS NOSODE, HERPES ZOSTER NOSODE, ADENOVIREN NOSODENutritional Specialties, Inc.f4e7e469-baaf-4c61-af44-80b0832eadf02026-03-31WarningsExact identifier
unii: 451W47IQ8X
Sodium Chloride Normal SaltSODIUM CHLORIDETWIN MED LLC10230c8a-e5e5-44f1-b41d-80930899d6b92026-03-31WarningsExact identifier
unii: 451W47IQ8X
H-Allergy FormulaALLIUM CEPA, AMBROSIA ARTEMISIAEFOLIA, ARUM TRIPHYLLUM, ARUNDO MAURITANICA, EUPHRASIA OFFICINALIS, GALPHIMIA GLAUCA, HISTAMINUM HYDROCHLORICUM, KALI BICHROMICUM, NATRUM MURIATICUM, SOLIDAGO VIRGAUREA, STICTA PULMONARIA, SULPHUR, TRIFOLIUM PRATENSE, WYETHIA HELENIOIDESHealing Natural Oils LLC4e586360-b3c4-1ce0-e063-6394a90ab6b82026-03-31WarningsExact identifier
unii: 451W47IQ8X
Acne HPCARBO ANIMALIS, CARBO VEGETABILIS, KALI BICHROMICUM, NATRUM MURIATICUM, PULSATILLA (VULGARIS), SEPIA, SILICEA, SULPHUR, ZINCUM METALLICUMBioActive Nutritional, Inc.2ab4ff53-4274-40c7-b05c-44d918d809be2026-03-31WarningsExact identifier
unii: 451W47IQ8X
Cold Sore FormulaDULCAMARA, GLYCYRRHIZA GLABRA, RANUNCULUS BULBOSUS, RHUS TOX, NATRUM MURIATICUM, FAGOPYRUM ESCULENTUM, NATRUM HYPOCHLOROUS, ACONITUM NAPELLUS, CYTOMEGALOVIRUS NOSODE, HERPES SIMPLEX I AND II NOSODE, SEPIA, EPSTEIN BARR VIRUS NOSODE, HERPES ZOSTER NOSODE, ADENOVIREN NOSODENutritional Specialties, Inc.ad6a08ec-5eba-405b-8a07-79ac86ab3e7a2026-03-31WarningsExact identifier
unii: 451W47IQ8X
ANX HPARSENICUM ALBUM, CALCAREA CARBONICA, IGNATIA AMARA, KALI CARBONICUM, LACHESIS MUTUS, NATRUM MURIATICUMBioActive Nutritional, Inc.96035891-aea3-4138-bb26-801ad819f6392026-03-30WarningsExact identifier
unii: 451W47IQ8X
Spleen LiquescenceQUERCUS ROBUR, CEANOTHUS AMERICANUS, SPLEEN (BOVINE), NATRUM MURIATICUM, HELIANTHUS ANNUUSNutritional Specialties, Inc.d800456d-60f0-413d-b310-91b8b881f6b92026-03-30WarningsExact identifier
unii: 451W47IQ8X
DepressoforcePICRICUM ACIDUM, ARSENICUM ALBUM, AURUM METALLICUM, IGNATIA AMARA, NATRUM MURIATICUM, NITRICUM ACIDUM, PULSATILLA (PRATENSIS), SEPIABioActive Nutritional, Inc.e6b98979-a38c-4f13-af03-f5ffa962b4fa2026-03-27WarningsExact identifier
unii: 451W47IQ8X
AdrenaparARALIA QUINQUEFOLIA, AVENA SATIVA, GLANDULA SUPRARENALIS SUIS, HYPOTHALAMUS SUIS, ARSENICUM IODATUM, CALCAREA CARBONICA, IGNATIA AMARA, LYCOPODIUM CLAVATUM, NATRUM MURIATICUM, NUX VOMICA, PHOSPHORICUM ACIDUM, PHOSPHORUS, ZINCUM METALLICUMEnergique, Inc.077a9171-283d-47b6-bddc-34c739f6d69d2026-03-27WarningsExact identifier
unii: 451W47IQ8X
Buffer pHCHAMOMILLA, GRAPHITES, KALI CARBONICUM, KALI OXALICUM, KALI PHOSPHORICUM, MAGNESIA PHOSPHORICA, NATRUM MURIATICUM, NATRUM PHOSPHORICUM, NATRUM SULPHURICUM, NUX VOMICA, RHEUM (PALMATUM), ROBINIA PSEUDOACACIANaturalCare2161a2e2-613d-4dac-a5f6-796d40e849d92026-03-25WarningsExact identifier
unii: 451W47IQ8X

Reported adverse events (FAERS/openFDA)#

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