Gamunex-c Injection
NDC Package 13533-805-45
Package Information
Gamunex-c (immune globulin (human)) injection is a medication used in people with a certain type of weakened immune system (primary immune deficiency) to strengthen it and to lower the risk of infection. This formulation utilizes a injection delivery system. Marketed by Grifols Usa, Llc, this product is identified by NDC 13533-805 and is authorized under FDA application BLA125046.
Identification & Billing
- RxCUI: 1809414 - immunoglobulin G, human 10 % in 50 ML Injection
- RxCUI: 1809414 - 50 ML immunoglobulin G, human 100 MG/ML Injection
- RxCUI: 1809414 - immunoglobulin G, human 10 % per 50 ML Injection
- RxCUI: 1809414 - immunoglobulin G, human 5 GM per 50 ML Injection
- RxCUI: 1809421 - immunoglobulin G, human 10 % in 100 ML Injection
Clinical Specifications
Regulatory & Marketing
Hierarchy Structure
- 13533 - Grifols Usa, Llc
- 13533-805 - Gamunex-c
- 13533-805-45 - 1 BAG in 1 CARTON / 400 mL in 1 BAG (13533-805-44)
- 13533-805 - Gamunex-c
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 (13533-805). 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 13533-805-45 identifies a specific commercial package of 1 bag in 1 carton / 400 ml in 1 bag (13533-805-44) of Gamunex-c, a plasma derivative labeled by Grifols Usa, Llc. This injection is formulated for intravenous use and contains human immunoglobulin g as the active substance.
Is this product currently listed with the FDA?
Yes, this product is active and verified within the NDC Directory. It was introduced to the market by Grifols Usa, Llc on October 13, 2010. The current certification is valid through December 31, 2027.
What are the primary indications for this medication?
This medication is used in people with a certain type of weakened immune system (primary immune deficiency) to strengthen it and to lower the risk of infection. This medication is made from human blood that has a high level of antibodies which help fight infections. This product is also used to increase the number of certain blood cells (platelets) in people with a certain blood disorder (idiopathic thrombocytopenic purpura-ITP). Platelets are needed to stop bleeding and to form normal blood clots. In addition, this medication is used to treat a certain nerve disorder (chronic inflammatory demyelinating polyneuropathy-CIDP). This disorder causes weakness and numbness/tingling/pain in the arms and legs. This medication helps to improve these symptoms and prevents relapse.
How is this Grifols Usa, Llc product billed for insurance claims?
For medical billing and reimbursement, this package follows the 11-digit CMS format: 13533080545. 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 Product segment to maintain the 5-4-2 structure.
