Dextenza Insert
NDC Package 70382-204-99

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. Other Packages
    3. Frequently Asked Questions

Package Information

Dextenza (dexamethasone) inserts 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 insert delivery system. Marketed by Ocular Therapeutix, Inc., this product is identified by NDC 70382-204 and is authorized under FDA application NDA208742.

Identification & Billing

NDC Package Code
70382-204-99
Package Description
1 POUCH in 1 BOX, UNIT-DOSE / 1 INSERT in 1 POUCH (70382-204-88)
Product Code
70382-204
11-Digit Billing Format
70382020499
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Dextenza
Non-Proprietary Name
Dexamethasone
Substance Name
Dexamethasone
Dosage Form
Insert - A specially formulated and shaped non-encapsulated solid preparation intended to be placed into a non-rectal orifice of the body, where drug is released, generally for localized effects.
Administration Route
Ophthalmic - Administration to the external eye.
Active Ingredient(s)
DEXAMETHASONE .4 mg/1
Pharmacologic Class
Usage Information
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.

Regulatory & Marketing

Labeler Name
Ocular Therapeutix, Inc.
Product Type
Human Prescription Drug
FDA Application #
NDA208742
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
01-07-2019
Listing Expiration
12-31-2027
Exclude Flag
N
Sample Package
No

Hierarchy Structure

Code Lineage

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 (70382-204). Click a package code to view its specific billing and regulatory data.

70382-204-01
1 POUCH in 1 BOX, UNIT-DOSE / 1 INSERT in 1 POUCH (70382-204-88)
70382-204-10
10 POUCH in 1 BOX, UNIT-DOSE / 1 INSERT in 1 POUCH (70382-204-88)

* 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 70382-204-99 identifies a specific commercial package of 1 pouch in 1 box, unit-dose / 1 insert in 1 pouch (70382-204-88) of Dextenza, a human prescription drug labeled by Ocular Therapeutix, Inc.. This insert is formulated for intracanalicular; ophthalmic 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 Ocular Therapeutix, Inc. on January 07, 2019. The current certification is valid through December 31, 2027.

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 Ocular Therapeutix, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 70382020499. 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:

10-Digit Format (5-3-2)
70382-204-99
11-Digit CMS (5-4-2)
70382-0204-99

Note: The zero is added to the Product segment to maintain the 5-4-2 structure.