Gamastan Injection, Solution
NDC Package 13533-635-04
Package Information
Gamastan (immune globulin (human)) injection is a medication used to provide protection (antibodies) against certain virus infections (hepatitis A, measles, chickenpox, rubella) in people who have not been vaccinated or have not had the infection before. This formulation utilizes a injection, solution delivery system. Marketed by Grifols Usa, Llc, this product is identified by NDC 13533-635 and is authorized under FDA application BLA101134.
Identification & Billing
- RxCUI: 1809032 - immunoglobulin G, human 15-18 % in 2 ML Injection
- RxCUI: 1809032 - 2 ML immunoglobulin G, human 180 MG/ML Injection
- RxCUI: 1809032 - immunoglobulin G, human 15-18 % per 2 ML Injection
- RxCUI: 1809034 - GamaSTAN 15-18 % in 2 ML Injection
- RxCUI: 1809034 - 2 ML immunoglobulin G, human 180 MG/ML Injection [GamaSTAN]
Clinical Specifications
Regulatory & Marketing
Hierarchy Structure
- 13533 - Grifols Usa, Llc
- 13533-635 - Gamastan
- 13533-635-04 - 1 VIAL in 1 CARTON / 2 mL in 1 VIAL (13533-635-40)
- 13533-635 - Gamastan
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.
Billing & HCPCS Mapping
To facilitate insurance claims and reimbursement, this drug package is mapped to specific HCPCS administrative codes. This crosswalk aligns clinical data with the billing standards used in ASP (Average Sales Price), AWP, and OPPS payment systems. Use the cards below to identify the correct billable units for provider claims.
Note for Medical Coders: These mappings are synthesized from various CMS datasets including OPPS, PrEP, and DAC (Data Analysis and Coding) contractors. Always confirm unit conversions against the current quarter's pricing files before final submission.
* 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 (13533-635). 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 13533-635-04 identifies a specific commercial package of 1 vial in 1 carton / 2 ml in 1 vial (13533-635-40) of Gamastan, a plasma derivative labeled by Grifols Usa, Llc. This injection, solution is formulated for intramuscular 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 August 14, 1996. The current certification is valid through December 31, 2026.
What are the primary indications for this medication?
This medication is used to provide protection (antibodies) against certain virus infections (hepatitis A, measles, chickenpox, rubella) in people who have not been vaccinated or have not had the infection before. It is also used to strengthen the body's natural defense system (immune system) to lower the risk of infection in persons with a certain immune system problem (immunoglobulin deficiency). This medication is made from healthy human blood that has high levels of certain defensive substances (antibodies), which help fight infections. Routine vaccination is usually the best way to protect against infection. Talk with your doctor about a recommended vaccination schedule.
How is this Grifols Usa, Llc product billed for insurance claims?
For medical billing and reimbursement, this package follows the 11-digit CMS format: 13533063504. 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 Product segment to maintain the 5-4-2 structure.
