Orencia Injection, Solution
NDC Package 0003-2188-91

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. Other Packages
    3. Frequently Asked Questions

Package Information

Orencia (abatacept) injection is a medication used to treat rheumatoid arthritis, a condition in which the body's own defense system (immune system) attacks healthy tissue. This formulation utilizes a injection, solution delivery system. Marketed by E.r. Squibb & Sons, L.l.c., this product is identified by NDC 0003-2188 and is authorized under FDA application BLA125118.

Identification & Billing

NDC Package Code
0003-2188-91
Package Description
1 SYRINGE, GLASS in 1 CARTON / 1 mL in 1 SYRINGE, GLASS
Product Code
0003-2188
11-Digit Billing Format
00003218891
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Orencia
Non-Proprietary Name
Abatacept
Substance Name
Abatacept
Dosage Form
Injection, Solution - A liquid preparation containing one or more drug substances dissolved in a suitable solvent or mixture of mutually miscible solvents that is suitable for injection.
Administration Route
Subcutaneous - Administration beneath the skin; hypodermic. Synonymous with the term SUBDERMAL.
Active Ingredient(s)
ABATACEPT 125 mg/mL
Pharmacologic Class
Usage Information
This medication is used to treat rheumatoid arthritis, a condition in which the body's own defense system (immune system) attacks healthy tissue. This leads to swelling in the joints, which causes pain and makes it harder to move. Abatacept works by weakening your immune system. This effect helps to slow down joint damage and reduce joint pain and swelling so you can move better. This medication is also used to treat other types of arthritis (such as juvenile idiopathic arthritis, psoriatic arthritis).

Regulatory & Marketing

Labeler Name
E.r. Squibb & Sons, L.l.c.
Product Type
Human Prescription Drug
FDA Application #
BLA125118
Marketing Category
BLA - A product marketed under an approved Biologic License Application.
Start Marketing Date
07-29-2011
Listing Expiration
12-31-2026
Exclude Flag
N
Sample Package
Yes

Hierarchy Structure

Code Lineage

The NDC Directory contains ONLY information on final marketed drugs submitted to FDA electronically by labelers. A labeler might be a manufacturer, re-packager or re-labeler. The product information included in the NDC directory does not indicate that FDA has verified the information provided by the product labeler. Assigned NDC numbers are not in any way an indication of FDA approval of the product.

* Please review the full disclaimer at the bottom of this page.

Other Available Packages

The following commercial packages are registered under the same Product NDC (0003-2188). Click a package code to view its specific billing and regulatory data.

0003-2188-11
4 SYRINGE, GLASS in 1 CARTON / 1 mL in 1 SYRINGE, GLASS
0003-2188-21
1 SYRINGE, GLASS in 1 CARTON / 1 mL in 1 SYRINGE, GLASS
0003-2188-50
1 SYRINGE, GLASS in 1 CARTON / 1 mL in 1 SYRINGE, GLASS
0003-2188-51
4 SYRINGE, GLASS in 1 CARTON / 1 mL in 1 SYRINGE, GLASS
0003-2188-90
1 SYRINGE, GLASS in 1 CARTON / 1 mL in 1 SYRINGE, GLASS

* Please review the full disclaimer at the bottom of this page.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 0003-2188-91 identifies a specific commercial package of 1 syringe, glass in 1 carton / 1 ml in 1 syringe, glass of Orencia, a human prescription drug labeled by E.r. Squibb & Sons, L.l.c.. This injection, solution is formulated for subcutaneous use and contains abatacept as the active substance.

Is this product currently listed with the FDA?

Yes, this product is active and verified within the NDC Directory. It was introduced to the market by E.r. Squibb & Sons, L.l.c. on July 29, 2011. The current certification is valid through December 31, 2026.

What are the primary indications for this medication?

This medication is used to treat rheumatoid arthritis, a condition in which the body's own defense system (immune system) attacks healthy tissue. This leads to swelling in the joints, which causes pain and makes it harder to move. Abatacept works by weakening your immune system. This effect helps to slow down joint damage and reduce joint pain and swelling so you can move better. This medication is also used to treat other types of arthritis (such as juvenile idiopathic arthritis, psoriatic arthritis).

How is this E.r. Squibb & Sons, L.l.c. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 00003218891. The table below illustrates the segment conversion from the 10-digit labeler code to the 11-digit provider format.

11-Digit Code Conversion

Billing payers usually require a 5-4-2 segment configuration. Below is the conversion from the 10-digit package format to the 11-digit billing format:

10-Digit Format (4-4-2)
0003-2188-91
11-Digit CMS (5-4-2)
00003-2188-91

Note: The zero is added to the Labeler segment to maintain the 5-4-2 structure.