NDC Package 61953-0004-4 Flebogamma Dif

Immune Globulin (human) Injection, Solution Intravenous - View Billable Units, 11-Digit Format, RxNorm

Package Information

Find all the important details about this NDC Package code, including the 11-Digit NDC Billing number, billing units, wholesale price, RxNorm crosswalk, active ingredients, pharmacologic clasess, etc.

NDC Package Code:
61953-0004-4
Package Description:
1 VIAL in 1 CARTON / 200 mL in 1 VIAL (61953-0004-9)
Product Code:
Proprietary Name:
Flebogamma Dif
Non-Proprietary Name:
Immune Globulin (human)
Substance Name:
Human Immunoglobulin G
Usage Information:
This medication is used to strengthen the body's natural defense system (immune system) to lower the risk of infection in persons with a weakened immune system. This medication is made from healthy human blood that has a high level of certain defensive substances (antibodies), which help fight infections. It is also used to increase the blood count (platelets) in persons with a certain blood disorder (idiopathic thrombocytopenia purpura-ITP). Platelets are needed to stop bleeding and form blood clots. Some immune globulin products may also be used to treat a certain type of muscle weakness problem (multifocal motor neuropathy) or a certain nerve disorder (chronic inflammatory demyelinating polyneuropathy-CIDP). Some products may also be used to prevent certain blood vessel disorders in people with Kawasaki syndrome.
11-Digit NDC Billing Format:
61953000404
Billing Unit:
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
NDC to RxNorm Crosswalk:
  • RxCUI: 1809427 - immunoglobulin G, human 5 % in 10 ML Injection
  • RxCUI: 1809427 - 10 ML immunoglobulin G, human 50 MG/ML Injection
  • RxCUI: 1809427 - immunoglobulin G, human 0.5 GM per 10 ML Injection
  • RxCUI: 1809427 - immunoglobulin G, human 5 % per 10 ML Injection
  • RxCUI: 1809429 - Flebogamma 5 % in 10 ML Injection
  • Product Type:
    Plasma Derivative
    Labeler Name:
    Grifols Usa, Llc
    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):
  • Intravenous - Administration within or into a vein or veins.
  • Active Ingredient(s):
    Sample Package:
    No
    FDA Application Number:
    BLA125077
    Marketing Category:
    BLA - A product marketed under an approved Biologic License Application.
    Start Marketing Date:
    12-21-2006
    Listing Expiration Date:
    12-31-2025
    Exclude Flag:
    N
    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.

    * Please review the disclaimer below.

    Other Product Packages

    The following packages are also available for this product:

    NDC Package CodePackage Description
    61953-0004-11 VIAL in 1 CARTON / 10 mL in 1 VIAL (61953-0004-6)
    61953-0004-31 VIAL in 1 CARTON / 100 mL in 1 VIAL (61953-0004-8)
    61953-0004-51 VIAL in 1 CARTON / 400 mL in 1 VIAL (61953-0004-0)

    * Please review the disclaimer below.

    Frequently Asked Questions

    What is NDC 61953-0004-4?

    The NDC Packaged Code 61953-0004-4 is assigned to a package of 1 vial in 1 carton / 200 ml in 1 vial (61953-0004-9) of Flebogamma Dif, a plasma derivative labeled by Grifols Usa, Llc. The product's dosage form is injection, solution and is administered via intravenous form.

    Is NDC 61953-0004 included in the NDC Directory?

    Yes, Flebogamma Dif with product code 61953-0004 is active and included in the NDC Directory. The product was first marketed by Grifols Usa, Llc on December 21, 2006 and its listing in the NDC Directory is set to expire on December 31, 2025 if the product is not updated or renewed by the manufacturer.

    What is the NDC billing unit for package 61953-0004-4?

    The contents of this package are billed per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.

    What is the 11-digit format for NDC 61953-0004-4?

    The 11-digit format is 61953000404. The 11-digit billing format might be required by the Centers for Medicare & Medicaid Services (CMS) and other payers in billing claim forms.

    This package code is originally configured in a 5-4-1 segment 10-digit format and by adding a zero within the original NDC package code we can obtain the converted 11-digit format in a 5-4-2 segment configuration. The table below shows the 11-digit code conversion:

    10-Digit Format10-Digit Original Code11-Digit Format11-Digit Code
    5-4-161953-0004-45-4-261953-0004-04