NDC 50474-710-81 Cimzia
Certolizumab Pegol Injection, Solution Subcutaneous

Package Information

The NDC Code 50474-710-81 is assigned to a package of 3 carton in 1 box > 2 syringe, glass in 1 carton > 1 ml in 1 syringe, glass of Cimzia, a human prescription drug labeled by Ucb, Inc.. The product's dosage form is injection, solution and is administered via subcutaneous form.

Field Name Field Value
NDC Code 50474-710-81
Package Description 3 CARTON in 1 BOX > 2 SYRINGE, GLASS in 1 CARTON > 1 mL in 1 SYRINGE, GLASS
Product Code 50474-710
Proprietary Name 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.
Cimzia
Non-Proprietary Name 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.
Certolizumab Pegol
Usage Information Product Usage Information
The drug use information is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate. This information is not individual medical advice and does not substitute for the advice of a health care professional. Always ask a health care professional for complete information about this product and your specific health needs.
This medication is used to reduce pain and swelling due to certain inflammatory conditions (such as rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, plaque psoriasis). Some brands may also be used to treat a certain type of spine condition (axial spondyloarthritis) or a certain bowel condition (Crohn's disease). Certolizumab belongs to a class of drugs known as tumor necrosis factor (TNF) blockers. It works by blocking TNF, a substance made by the body that causes inflammation.
11-Digit NDC Billing Format 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.
50474071081
Billing Unit EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Estimated Billable Units per Package 6 EA
NDC to RxNorm Crosswalk
  • RxCUI: 795081 - certolizumab pegol 200 MG Injection
  • RxCUI: 795085 - Cimzia 200 MG Injection
  • RxCUI: 795085 - certolizumab pegol 200 MG Injection [Cimzia]
  • RxCUI: 849597 - certolizumab pegol 200 MG in 1 ML Prefilled Syringe
  • RxCUI: 849597 - 1 ML certolizumab pegol 200 MG/ML Prefilled Syringe
  • Product Type 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.
    Human Prescription Drug
    Labeler Name Ucb, Inc.
    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(s)
    • Subcutaneous - Administration beneath the skin; hypodermic. Synonymous with the term SUBDERMAL.
    Active Ingredient(s)
    Pharmacologic Class(es)
    Sample Package Sample Package?
    This field Indicates whether this package is a sample packaging or not.
    No
    Marketing Category 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.
    BLA - A product marketed under an approved Biologic License Application.
    FDA Application Number 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.
    BLA125160
    Start Marketing Date What is the Start Marketing Date?
    This is the date that the labeler indicates was the start of its marketing of the drug product.
    05-14-2009
    Listing Expiration Date 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.
    12-31-2022
    Exclude Flag 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 ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".
    N
    NDC Code Structure

    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 50474-710-81 HCPCS crosswalk information with package details and bill units information.

    NDC Billing CodeHCPCS CodeHCPCS Code Desc.DosagePackage SizePackage QuantityBillable UnitsBillable Units / Pkg
    50474071081J0717Certolizumab pegol inj 1mg1 MG162001200

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    Other Product Packages

    The following packages are also available for Cimzia with product NDC 50474-710.

    NDC Package CodePackage Description
    50474-710-792 SYRINGE, GLASS in 1 CARTON > 1 mL in 1 SYRINGE, GLASS
    50474-710-802 SYRINGE, GLASS in 1 CARTON > 1 mL in 1 SYRINGE, GLASS

    * Please review the disclaimer below.