FDA.reportPublic FDA data

ORENCIA

Product NDC
0003-2188
Requested package NDC
0003-2188-50
11-digit product format
000032188
Labeler code
0003
Product ID
0003-2188_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
125 mg/mL
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

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage0003-21880003-2188-50DDiscontinued by firm2026-08-11

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 1 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopeProduct NDCPackage NDCCodeStatusReporting periodArchiveSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage0003-21880003-2188-50DDiscontinued by firmexcluded / ndc_excluded.zipd630ba8d3edf…732f749b63fb…

Additional Listing Data#

Finished product
Yes
Brand name base
ORENCIA
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ABATACEPT125 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
7D0YB67S97Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 10 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
616015Internal RxNorm lookup
616018Internal RxNorm lookup
1145929Internal RxNorm lookup
1145932Internal RxNorm lookup
1799228Internal RxNorm lookup
1799230Internal RxNorm lookup
1925254Internal RxNorm lookup
1925255Internal RxNorm lookup
1925256Internal RxNorm lookup
1925257Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
0836c6ac-ee37-5640-2fed-a3185a0b16ebAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
726062af-1135-4707-a1d7-57256991bbf9Product name220250226
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
f1e0dc7e-7d61-4625-b6d9-4894927679d7Product name220211025
e4870509-7e28-6f92-f0be-dd3dd889a9cfProduct name520200810
6e9d4a47-c464-b93e-aebc-ad7bffc9c4cdProduct name220190619
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
c66f593d-4bdb-4760-b82e-ef392e3b1e7bProduct name120170613
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
19c71a3d-ed9c-166b-a7e5-38c250c35631Product name120140508
5668b646-cd56-c3c7-bdea-3f6b1a8840dbProduct name120140508
684ea482-2e8b-14af-5664-b98f1e402036Product name120140508
810ab97e-f109-f41c-7c83-6a652a9cbf43Product name120140508
87711080-88eb-65c5-b2dd-bf99e700a372Product name120140508
8dbefedf-0a0d-a224-5a3c-66dc9e11c2ddProduct name120140508
b060cc1a-fe47-856b-0b77-4448b5963de8Product name120140508
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

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 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

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

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.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ORENCIAABATACEPTE.R. Squibb & Sons, L.L.C.0836c6ac-ee37-5640-2fed-a3185a0b16eb2025-11-13Warnings, Adverse reactionsExact identifier
application number: BLA125118
ndc (package): 0003-2188-50
ndc (product): 0003-2188
ndc11 (package): 00003218850

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
125118Orenciaabatacept351(a)Rx2026-07-01

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1799228abatacept 125 MG in 1 ML Auto-InjectorPSN0836c6ac-ee37-5640-2fed-a3185a0b16eb35
1145929abatacept 125 MG in 1 ML Prefilled SyringePSN0836c6ac-ee37-5640-2fed-a3185a0b16eb35
616015abatacept 250 MG InjectionPSN0836c6ac-ee37-5640-2fed-a3185a0b16eb35
1925254abatacept 50 MG in 0.4 ML Prefilled SyringePSN0836c6ac-ee37-5640-2fed-a3185a0b16eb35
1925256abatacept 87.5 MG in 0.7 ML Prefilled SyringePSN0836c6ac-ee37-5640-2fed-a3185a0b16eb35
1799230ORENCIA 125 MG in 1 ML Auto-InjectorPSN0836c6ac-ee37-5640-2fed-a3185a0b16eb35
1145932ORENCIA 125 MG in 1 ML Prefilled SyringePSN0836c6ac-ee37-5640-2fed-a3185a0b16eb35
616018ORENCIA 250 MG InjectionPSN0836c6ac-ee37-5640-2fed-a3185a0b16eb35
1925255Orencia 50 MG in 0.4 ML Prefilled SyringePSN0836c6ac-ee37-5640-2fed-a3185a0b16eb35
1925257Orencia 87.5 MG in 0.7 ML Prefilled SyringePSN0836c6ac-ee37-5640-2fed-a3185a0b16eb35
19252550.4 ML abatacept 125 MG/ML Prefilled Syringe [Orencia]SBD0836c6ac-ee37-5640-2fed-a3185a0b16eb35
19252570.7 ML abatacept 125 MG/ML Prefilled Syringe [Orencia]SBD0836c6ac-ee37-5640-2fed-a3185a0b16eb35
17992301 ML abatacept 125 MG/ML Auto-Injector [Orencia]SBD0836c6ac-ee37-5640-2fed-a3185a0b16eb35
11459321 ML abatacept 125 MG/ML Prefilled Syringe [Orencia]SBD0836c6ac-ee37-5640-2fed-a3185a0b16eb35
616018abatacept 250 MG Injection [Orencia]SBD0836c6ac-ee37-5640-2fed-a3185a0b16eb35
19252540.4 ML abatacept 125 MG/ML Prefilled SyringeSCD0836c6ac-ee37-5640-2fed-a3185a0b16eb35
19252560.7 ML abatacept 125 MG/ML Prefilled SyringeSCD0836c6ac-ee37-5640-2fed-a3185a0b16eb35
17992281 ML abatacept 125 MG/ML Auto-InjectorSCD0836c6ac-ee37-5640-2fed-a3185a0b16eb35
11459291 ML abatacept 125 MG/ML Prefilled SyringeSCD0836c6ac-ee37-5640-2fed-a3185a0b16eb35
616015abatacept 250 MG InjectionSCD0836c6ac-ee37-5640-2fed-a3185a0b16eb35
19252550.4 Orencia 125 MG/ML Prefilled SyringeSY0836c6ac-ee37-5640-2fed-a3185a0b16eb35
19252570.7 ML Orencia 125 MG/ML Prefilled SyringeSY0836c6ac-ee37-5640-2fed-a3185a0b16eb35
17992301 ML Orencia 125 MG/ML Auto-InjectorSY0836c6ac-ee37-5640-2fed-a3185a0b16eb35
11459321 ML Orencia 125 MG/ML Prefilled SyringeSY0836c6ac-ee37-5640-2fed-a3185a0b16eb35
1799228abatacept 125 MG per 1 ML Auto-InjectorSY0836c6ac-ee37-5640-2fed-a3185a0b16eb35
1145929abatacept 125 MG per 1 ML Prefilled SyringeSY0836c6ac-ee37-5640-2fed-a3185a0b16eb35
1925254abatacept 50 MG per 0.4 ML Prefilled SyringeSY0836c6ac-ee37-5640-2fed-a3185a0b16eb35
1925256abatacept 87.5 MG per 0.7 ML Prefilled SyringeSY0836c6ac-ee37-5640-2fed-a3185a0b16eb35
1799230Orencia 125 MG per 1 ML Auto-InjectorSY0836c6ac-ee37-5640-2fed-a3185a0b16eb35
1145932Orencia 125 MG per 1 ML Prefilled SyringeSY0836c6ac-ee37-5640-2fed-a3185a0b16eb35
616018Orencia 250 MG InjectionSY0836c6ac-ee37-5640-2fed-a3185a0b16eb35
1925255Orencia 50 MG per 0.4 ML Prefilled SyringeSY0836c6ac-ee37-5640-2fed-a3185a0b16eb35
1925257Orencia 87.5 MG per 0.7 ML Prefilled SyringeSY0836c6ac-ee37-5640-2fed-a3185a0b16eb35

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0003-2188-50000032188501 SYRINGE, GLASS in 1 CARTON (0003-2188-50) > 1 mL in 1 SYRINGE, GLASS2016-07-050000-00-00NoNoCurrent