Flebogamma Dif
NDC Package 61953-0005-2
Package Information
Flebogamma Dif is a medication used to strengthen the body's natural defense system (immune system) to lower the risk of infection in persons with a weakened immune system. Marketed by Grifols Usa, Llc, this product is identified by NDC 61953-0005 and is authorized under FDA application BLA125077.
Identification & Billing
Clinical Specifications
Regulatory & Marketing
Hierarchy Structure
- 61953 - Grifols Usa, Llc
- 61953-0005 - Flebogamma Dif
- 61953-0005-2 - 1 VIAL in 1 CARTON / 100 mL in 1 VIAL (61953-0005-5)
- 61953-0005 - Flebogamma Dif
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 full disclaimer at the bottom of this page.
Other Available Packages
The following commercial packages are registered under the same Product NDC (61953-0005). Click a package code to view its specific billing and regulatory data.
* Please review the full disclaimer at the bottom of this page.
Frequently Asked Questions
What is the distribution configuration for this product package?
The code 61953-0005-2 identifies a specific commercial package of 1 vial in 1 carton / 100 ml in 1 vial (61953-0005-5) of Flebogamma Dif, labeled by Grifols Usa, Llc. This is formulated for use and contains as the active substance.
Is this product currently listed with the FDA?
This product code is currently listed as inactive or excluded from the primary directory. It was introduced to the market by Grifols Usa, Llc on July 27, 2010. The current certification is valid through January 17, 2024.
What are the primary indications for this medication?
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.
How is this Grifols Usa, Llc product billed for insurance claims?
For medical billing and reimbursement, this package follows the 11-digit CMS format: 61953000502. Quantities are measured in per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.. The table below illustrates the segment conversion from the 10-digit labeler code to the 11-digit provider format.
11-Digit Code Conversion
Billing payers usually require a 5-4-2 segment configuration. Below is the conversion from the 10-digit package format to the 11-digit billing format:
Note: The zero is added to the Package segment to maintain the 5-4-2 structure.
