Dexycu Injection, Suspension
NDC Package 71879-001-01
Package Information
Dexycu (dexamethasone) injection is dexamethasone is used to treat conditions such as arthritis, blood/hormone disorders, allergic reactions, skin diseases, eye problems, breathing problems, bowel disorders, cancer, and immune system disorders. This formulation utilizes a injection, suspension delivery system. Marketed by Eyepoint Pharmaceuticals Us, Inc, this product is identified by NDC 71879-001 and is authorized under FDA application NDA208912.
Identification & Billing
- RxCUI: 2045404 - dexAMETHasone 9 % in 0.005 ML Intraocular Injection
- RxCUI: 2045404 - 0.005 ML dexamethasone 103.4 MG/ML Injection
- RxCUI: 2045404 - dexamethasone 517 MCG per 0.005 ML Intraocular Injection
- RxCUI: 2045404 - dexamethasone 9 % per 0.005 ML Intraocular Injection
- RxCUI: 2045409 - DEXYCU 9 % in 0.005 ML Intraocular Injection
Clinical Specifications
Regulatory & Marketing
Hierarchy Structure
- 71879 - Eyepoint Pharmaceuticals Us, Inc
- 71879-001 - Dexycu
- 71879-001-01 - 1 VIAL, GLASS in 1 CARTON / .5 mL in 1 VIAL, GLASS
- 71879-001 - Dexycu
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.
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Frequently Asked Questions
What is the distribution configuration for this product package?
The code 71879-001-01 identifies a specific commercial package of 1 vial, glass in 1 carton / .5 ml in 1 vial, glass of Dexycu, a human prescription drug labeled by Eyepoint Pharmaceuticals Us, Inc. This injection, suspension is formulated for intraocular use and contains dexamethasone 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 Eyepoint Pharmaceuticals Us, Inc on May 22, 2018. The current certification is valid through December 31, 2026.
What are the primary indications for this medication?
Dexamethasone is used to treat conditions such as arthritis, blood/hormone disorders, allergic reactions, skin diseases, eye problems, breathing problems, bowel disorders, cancer, and immune system disorders. It is also used as a test for an adrenal gland disorder (Cushing's syndrome). Dexamethasone belongs to a class of drugs known as corticosteroids. It decreases your immune system's response to various diseases to reduce symptoms such as swelling and allergic-type reactions.
How is this Eyepoint Pharmaceuticals Us, Inc product billed for insurance claims?
For medical billing and reimbursement, this package follows the 11-digit CMS format: 71879000101. 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.
