Gammaplex
NDC Package 64208-8234-6
Package Information
Gammaplex is 5% is contraindicated in patients who have had an anaphylactic or severe systemic reaction to the administration of human immune globulin.GAMMAPLEX 5% is contraindicated in patients with hereditary intolerance to fructose, also in infants and neonates for whom sucrose or fructose tolerance has not been established.GAMMAPLEX 5% is contraindicated in IgA-deficient patients with antibodies to IgA and a history of hypersensitivity. Marketed by Bio Products Laboratory Ltd, this product is identified by NDC 64208-8234 and is authorized under FDA application BLA125329.
Identification & Billing
- RxCUI: 1809456 - immunoglobulin G, human 5 % in 100 ML Injection
- RxCUI: 1809456 - 100 ML immunoglobulin G, human 50 MG/ML Injection
- RxCUI: 1809456 - immunoglobulin G, human 5 % per 100 ML Injection
- RxCUI: 1809456 - immunoglobulin G, human 5 GM per 100 ML Injection
- RxCUI: 1809463 - immunoglobulin G, human 5 % in 200 ML Injection
Clinical Specifications
Regulatory & Marketing
Hierarchy Structure
- 64208 - Bio Products Laboratory Ltd
- 64208-8234 - Gammaplex
- 64208-8234-6 - 1 BOTTLE, GLASS in 1 CARTON / 100 mL in 1 BOTTLE, GLASS (64208-8234-2)
- 64208-8234 - Gammaplex
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 (64208-8234). 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 64208-8234-6 identifies a specific commercial package of 1 bottle, glass in 1 carton / 100 ml in 1 bottle, glass (64208-8234-2) of Gammaplex, labeled by Bio Products Laboratory Ltd. This product is billed per "ML" milliliter and contains an estimated amount of 100 billable units per package. 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 Bio Products Laboratory Ltd on November 01, 2010. The current certification is valid through November 04, 2026.
How is this Bio Products Laboratory Ltd product billed for insurance claims?
For medical billing and reimbursement, this package follows the 11-digit CMS format: 64208823406. Quantities are measured in per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.. There are 100 total billable units per package. 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.
