FDA.reportPublic FDA data

ORENCIA

Product NDC
0003-2188
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

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 Identifiers#

Field, Values table
FieldValues
Unii7D0YB67S97
Rxcui616015, 616018, 1145929, 1145932, 1799228, 1799230, 1925254, 1925255, 1925256, 1925257

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

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
0003-2188-11000032188114 SYRINGE, GLASS in 1 CARTON (0003-2188-11) / 1 mL in 1 SYRINGE, GLASS2013-10-010000-00-00NoNoCurrent
0003-2188-21000032188211 SYRINGE, GLASS in 1 CARTON (0003-2188-21) > 1 mL in 1 SYRINGE, GLASS2013-10-010000-00-00NoNoCurrent
0003-2188-50000032188501 SYRINGE, GLASS in 1 CARTON (0003-2188-50) > 1 mL in 1 SYRINGE, GLASS2016-07-050000-00-00NoNoCurrent
0003-2188-51000032188514 SYRINGE, GLASS in 1 CARTON (0003-2188-51) / 1 mL in 1 SYRINGE, GLASS2016-06-070000-00-00NoNoCurrent
0003-2188-90000032188901 SYRINGE, GLASS in 1 CARTON (0003-2188-90) / 1 mL in 1 SYRINGE, GLASS2016-07-120000-00-00YesNoCurrent
0003-2188-91000032188911 SYRINGE, GLASS in 1 CARTON (0003-2188-91) / 1 mL in 1 SYRINGE, GLASS2013-10-010000-00-00YesNoCurrent