NDC 0003-2187-13 Orencia

Abatacept

  1. Labeler Index
  2. E.r. Squibb & Sons, L.l.c.
  3. 0003-2187
  4. NDC Code: 0003-2187-13 Orencia

NDC Package Code 0003-2187-13

The NDC Code 0003-2187-13 is assigned to a package of 1 vial, single-use in 1 carton > 15 ml in 1 vial, single-use of Orencia, a human prescription drug labeled by E.r. Squibb & Sons, L.l.c.. The product's dosage form is injection, powder, lyophilized, for solution and is administered via intravenous form.

Field Name Field Value
NDC Code 0003-2187-13
Package Description 1 VIAL, SINGLE-USE in 1 CARTON > 15 mL in 1 VIAL, SINGLE-USE
Proprietary Name Orencia What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
Non-Proprietary Name Abatacept What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
Drug Uses 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).
11-Digit NDC Billing Format 00003218713 NDC Format for Billing
For insurance billing purposes the Centers for Medicare & Medicaid Services (CMS) created an 11 digit NDC derivative identifier. If the NDC Package code is less than 11 digits the code must be padded with leading zeros. The leading zeros must be added to the appropriate segment to create a 5-4-2 configuration.
Billing Unit EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Product Type Human Prescription Drug What kind of product is this?
Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.
Labeler Name E.r. Squibb & Sons, L.l.c.
Dosage Form Injection, Powder, Lyophilized, For Solution - A dosage form intended for the solution prepared by lyophilization ("freeze drying"), a process which involves the removal of water from products in the frozen state at extremely low pressures; this is intended for subsequent addition of liquid to create a solution that conforms in all respects to the requirements for Injections.
Administration Route(s)
  • Intravenous - Administration within or into a vein or veins.
  • Intravenous - Administration within or into a vein or veins.
Active Ingredient(s)
  • ABATACEPT 250 mg/15mL
Pharmacological Class(es)
  • Decreased Cytokine Activity - [PE] (Physiologic Effect)
  • Selective T Cell Costimulation Modulator - [EPC] (Established Pharmacologic Class)
  • Recombinant Fusion Proteins - [CS]
Sample Package No Sample Package?
This field Indicates whether this package is a sample packaging or not.
Marketing Category BLA - A product marketed under an approved Biologic License Application. What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.
FDA Application Number BLA125118 What is the FDA Application Number?
This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.
Start Marketing Date 01-01-2009 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.
Listing Expiration Date 12-31-2020 What is the Listing Expiration Date?
This is the date when the listing record will expire if not updated or certified by the product labeler.
Exclude Flag N What is the NDC Exclude Flag?
This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA’s requests for correction to deficient or non-compliant submissions. Values = ‘Y’ or ‘N’.

NDC Code Structure

  • 0003 - E.r. Squibb & Sons, L.l.c.
    • 0003-2187 - Orencia
      • 0003-2187-13 - 1 VIAL, SINGLE-USE in 1 CARTON

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.

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NDC HCPCS Crosswalk

This crosswalk is intended to help the public understand which drug products (identified by NDCs) are assigned to which HCPCS billing codes.

NDC 0003-2187-13 HCPCS crosswalk information with package details and bill units information.

NDC Billing CodeHCPCS CodeHCPCS Code Desc.DosagePackage SizePackage QuantityBillable UnitsBillable Units / Pkg
00003218713J0129Abatacept injection10 MG112525

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Other Product Packages

The following packages are also available for Orencia with product NDC 0003-2187.

NDC Package CodePackage Description
0003-2187-101 VIAL, SINGLE-USE in 1 CELLO PACK > 15 mL in 1 VIAL, SINGLE-USE

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