NDC 68982-840-04 Octagam Immune Globulin (human)
Immune Globulin Solution Intravenous

Package Information

What is NDC 68982-840-04?

The NDC Code 68982-840-04 is assigned to a package of 200 ml in 1 bottle, glass of Octagam Immune Globulin (human), a plasma derivative labeled by Octapharma Usa Inc. The product's dosage form is solution and is administered via intravenous form.This product is billed per "ML" milliliter and contains an estimated amount of 200 billable units per package. The following table has all the important details about this NDC code, including the 11-Digit NDC Billing number, billing units, wholesale price, RxNorm crosswalk, active ingredients, pharmacologic clasess, etc.

Field Name Field Value
NDC Code 68982-840-04
Package Description 200 mL in 1 BOTTLE, GLASS
Product Code 68982-840
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.		 Octagam Immune Globulin (human)
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.		 Immune Globulin
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.		 Octagam 5% liquid is contraindicated in patients who have acute severe hypersensitivity reactions to human immunoglobulin. Octagam 5% liquid contains trace amounts of IgA (not more than 0.2 mg/ml in a 5% solution). It is contraindicated in IgA deficient patients with antibodies against IgA and history of hypersensitivity (See Description [ 11 ]). Octagam 5% liquid is contraindicated in patients with acute hypersensitivity reaction to corn. Octagam 5% liquid contains maltose, a disaccharide sugar which is derived from corn. Patients known to have corn allergies should avoid using Octagam 5% liquid.
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.		 68982084004
Billing Unit ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
Estimated Billable Units per Package 200 ML
NDC to RxNorm Crosswalk
  • RxCUI: 1809447 - immunoglobulin G, human 5 % in 50 ML Injection
  • RxCUI: 1809447 - 50 ML immunoglobulin G, human 50 MG/ML Injection
  • RxCUI: 1809447 - immunoglobulin G, human 2.5 GM per 50 ML Injection
  • RxCUI: 1809447 - immunoglobulin G, human 5 % per 50 ML Injection
  • RxCUI: 1809456 - immunoglobulin G, human 5 % in 100 ML Injection
    • 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.    		 Plasma Derivative
    Labeler Name Octapharma Usa Inc
    Dosage Form Solution - A clear, homogeneous liquid1 dosage form that contains one or more chemical substances dissolved in a solvent or mixture of mutually miscible solvents.
    Administration Route(s)
    • Intravenous - Administration within or into a vein or veins.
    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.    		 BLA125062
    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.    		 05-21-2004
    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.    		 12-31-2023
    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 68982-840-04 HCPCS crosswalk information with package details and bill units information.

    NDC Billing CodeHCPCS CodeHCPCS Code Desc.DosagePackage SizePackage QuantityBillable UnitsBillable Units / Pkg
    68982084004J1568Octagam injection500 MG20012020

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    Other Product Packages

    The following packages are also available for Octagam Immune Globulin (human) with product NDC 68982-840.

    NDC Package CodePackage Description
    68982-840-0120 mL in 1 BOTTLE, GLASS
    68982-840-0250 mL in 1 BOTTLE, GLASS
    68982-840-03100 mL in 1 BOTTLE, GLASS
    68982-840-05500 mL in 1 BOTTLE, GLASS

    * Please review the disclaimer below.