NDC 0003-2188

ORENCIA

Abatacept

ORENCIA is a Subcutaneous Injection, Solution in the Human Prescription Drug category. It is labeled and distributed by E.r. Squibb & Sons, L.l.c.. The primary component is Abatacept.

• Product ID: 0003-2188_1965849a-8f1d-4015-a434-68f02c6d43c3
• NDC: 0003-2188
• Product Type: Human Prescription Drug
• Proprietary Name: ORENCIA
• Generic Name: Abatacept
• Dosage Form: Injection, Solution
• Route of Administration: SUBCUTANEOUS
• Marketing Start Date: 2011-07-29
• Marketing Category: BLA / BLA
• Application Number: BLA125118
• Labeler Name: E.R. Squibb & Sons, L.L.C.
• Substance Name: ABATACEPT
• Active Ingredient Strength: 125 mg/mL
• Pharm Classes: Decreased Cytokine Activity [PE], Recombinant Fusion Proteins [CS], Selective T Cell Costimulation Modulator [EPC]
• NDC Exclude Flag: N
• Listing Certified Through: 2023-12-31

Packaging

NDC 0003-2188-11

4 SYRINGE, GLASS in 1 CARTON (0003-2188-11) > 1 mL in 1 SYRINGE, GLASS

• Marketing Start Date: 2013-10-01
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0003-2188-21 [00003218821]

ORENCIA INJECTION, SOLUTION

• Marketing Category: BLA
• Application Number: BLA125118
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2013-10-01

NDC 0003-2188-50 [00003218850]

ORENCIA INJECTION, SOLUTION

• Marketing Category: BLA
• Application Number: BLA125118
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2016-07-05

NDC 0003-2188-11 [00003218811]

ORENCIA INJECTION, SOLUTION

• Marketing Category: BLA
• Application Number: BLA125118
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2013-10-01

NDC 0003-2188-41 [00003218841]

ORENCIA INJECTION, SOLUTION

• Marketing Category: BLA
• Application Number: BLA125118
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2011-07-29
• Marketing End Date: 2014-09-30

NDC 0003-2188-82 [00003218882]

ORENCIA INJECTION, SOLUTION

• Marketing Category: BLA
• Application Number: BLA125118
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2011-07-29
• Marketing End Date: 2014-09-30

NDC 0003-2188-31 [00003218831]

ORENCIA INJECTION, SOLUTION

• Marketing Category: BLA
• Application Number: BLA125118
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2011-07-29
• Marketing End Date: 2014-11-30

NDC 0003-2188-91 [00003218891]

ORENCIA INJECTION, SOLUTION

• Marketing Category: BLA
• Application Number: BLA125118
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2013-10-01

NDC 0003-2188-51 [00003218851]

ORENCIA INJECTION, SOLUTION

• Marketing Category: BLA
• Application Number: BLA125118
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2016-06-07

NDC 0003-2188-90 [00003218890]

ORENCIA INJECTION, SOLUTION

• Marketing Category: BLA
• Application Number: BLA125118
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2016-07-12

Drug Details

Active Ingredients

Ingredient	Strength
ABATACEPT	125 mg/mL

OpenFDA Data

• SPL SET ID: 0836c6ac-ee37-5640-2fed-a3185a0b16eb
• Manufacturer:
  • E.R. Squibb & Sons, L.L.C.
• UNII:
  • 7D0YB67S97
• RxNorm Concept Unique ID - RxCUI:
  • 616015
  • 1799228
  • 616018
  • 1799230
  • 1925255
  • 1925254
  • 1925257
  • 1925256
  • 1145929
  • 1145932

Pharmacological Class

• Decreased Cytokine Activity [PE]
• Selective T Cell Costimulation Modulator [EPC]
• Recombinant Fusion Proteins [CS]

NDC Crossover Matching brand name "ORENCIA" or generic name "Abatacept"

NDC	Brand Name	Generic Name
0003-2187	ORENCIA	abatacept
0003-2188	ORENCIA	abatacept
0003-2814	ORENCIA	abatacept
0003-2818	ORENCIA	abatacept