NDC 50474-710-79 Cimzia

Certolizumab Pegol

  1. Labeler Index
  2. Ucb, Inc.
  3. 50474-710
  4. NDC Package Code: 50474-710-79 Cimzia

NDC Package Code 50474-710-79

The NDC Code 50474-710-79 is assigned to a package of 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 50474-710-79
Package Description 2 SYRINGE, GLASS in 1 CARTON > 1 mL in 1 SYRINGE, GLASS
Product Code 50474-710
Proprietary Name Cimzia 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 Certolizumab Pegol 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 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 50474071079 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.
Estimated Billable Units per Package 2 EA
NADAC Wholesale Price per Unit $4944.14000
Estimated Wholesale Price per Package $9888.28
RxNorm Crosswalk
  • RxCUI: 795081
  • RxCUI: 795085
  • RxCUI: 849597
  • RxCUI: 849599
    • 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 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)
    Pharmacological Class(es)
    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 BLA125160 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 05-14-2009 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 12-31-2022 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 ("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".

    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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    National Average Drug Acquisition Cost (NADAC)

    The National Average Drug Acquisition Cost (NADAC) wholesale price per unit for NDC 50474-710-79 is $4944.14000 and is up-to-date as of 06-15-2022. This product is billed for "EA" each discreet unit and contains an estimated amount of 2 billable units per package. The estimated wholesale price for the this package based on the lastest NADAC pricing survey is $9888.28.

    The NADAC survey price is the average drug invoice price paid by retail community pharmacies to wholesalers. The Centers for Medicare and Medicaid Services (CMS) compile the NADAC data based on random monthly surveys on more than 60,000 pharmacies from all 50 states and the District of Columbia. NADAC pricing information is NOT the price paid by end-customers but instead the price paid by pharmacies to drug wholesalers and distributors.

    Field Name Field Value
    Price per Unit $4944.14000
    Effective Date 03-23-2022 Effective Date
    The effective date of the NADAC Per Unit cost.
    Pricing Unit EA Pricing Unit
    Indicates the pricing unit for the associated NDC (ML, GM or EA).
    Pharmacy Type Indicator C/I - Chain or Independent Pharmacy Pharmacy Type Indicator
    The source of pharmacy survey data used to calculate the NADAC. 'C/I' indicates data was collected from surveys of Chain/Independent pharmacies. Other pharmacy type indicators are not used at this time.
    Explanation Code Code 4: The NADAC was carried forward from the previous file.
    Code 5: The NADAC was calculated based on package size. Explanation Code
    The source of pharmacy survey data used to calculate the NADAC. 'C/I' indicates data was collected from surveys of Chain/Independent pharmacies. Other pharmacy type indicators are not used at this time.
    Classification for Rate Setting B - Brand Classification for Rate Setting
    Indicates whether the NDC was considered brand (B) or generic (G) for the NADAC rate calculation process. If the NDC was considered brand (B) and approved under an Abbreviated New Drug Application (ANDA), the indicator is shown as (B-ANDA).
    As of Date 06-15-2022
    View Pricing Details

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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 50474-710-79 HCPCS crosswalk information with package details and bill units information.

    NDC Billing CodeHCPCS CodeHCPCS Code Desc.DosagePackage SizePackage QuantityBillable UnitsBillable Units / Pkg
    50474071079J0717Certolizumab pegol inj 1mg1 MG12200400

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    Other Product Packages

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

    NDC Package CodePackage Description
    50474-710-802 SYRINGE, GLASS in 1 CARTON > 1 mL in 1 SYRINGE, GLASS
    50474-710-813 CARTON in 1 BOX > 2 SYRINGE, GLASS in 1 CARTON > 1 mL in 1 SYRINGE, GLASS

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