Epysqli Injection, Solution
NDC Package 51759-208-13
Package Information
Epysqli (eculizumab-aagh) injection is a medication used to treat a certain blood disorder (paroxysmal nocturnal hemoglobinuria). This formulation utilizes a injection, solution delivery system. Marketed by Teva Pharmaceuticals Usa, Inc., this product is identified by NDC 51759-208 and is authorized under FDA application BLA761340.
Identification & Billing
- RxCUI: 2706338 - eculizumab-aagh 300 MG in 30 ML Injection
- RxCUI: 2706338 - 30 ML eculizumab-aagh 10 MG/ML Injection
- RxCUI: 2706338 - eculizumab-aagh 300 MG per 30 ML Injection
- RxCUI: 2706345 - Epysqli 300 MG in 30 ML Injection
- RxCUI: 2706345 - 30 ML eculizumab-aagh 10 MG/ML Injection [Epysqli]
Clinical Specifications
Regulatory & Marketing
Hierarchy Structure
- 51759 - Teva Pharmaceuticals Usa, Inc.
- 51759-208 - Epysqli
- 51759-208-13 - 1 VIAL, SINGLE-DOSE in 1 CARTON / 30 mL in 1 VIAL, SINGLE-DOSE
- 51759-208 - Epysqli
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.
Frequently Asked Questions
What is the distribution configuration for this product package?
The code 51759-208-13 identifies a specific commercial package of 1 vial, single-dose in 1 carton / 30 ml in 1 vial, single-dose of Epysqli, a human prescription drug labeled by Teva Pharmaceuticals Usa, Inc.. This injection, solution is formulated for intravenous use and contains eculizumab 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 Teva Pharmaceuticals Usa, Inc. on April 07, 2025. The current certification is valid through December 31, 2027.
What are the primary indications for this medication?
This medication is used to treat a certain blood disorder (paroxysmal nocturnal hemoglobinuria). This disorder can cause a decrease in red blood cells (anemia). This medication helps to block the decrease in red blood cells and can improve the symptoms of anemia (e.g., tiredness, shortness of breath) and decrease the need for blood transfusions. This medication may also be used to treat a certain immune system disorder (atypical Hemolytic Uremic Syndrome). It helps to prevent blood clots caused by this disorder. Eculizumab is also used to treat a certain muscle condition (generalized Myasthenia Gravis). It may help to improve symptoms of this condition (such as difficulty swallowing, trouble breathing). Eculizumab is also used to treat a certain nervous system disorder that affects the spinal cord and eye nerve (neuromyelitis optica spectrum disorder). It may help to reduce the number of hospital stays due to the disease.
How is this Teva Pharmaceuticals Usa, Inc. product billed for insurance claims?
For medical billing and reimbursement, this package follows the 11-digit CMS format: 51759020813. 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.