Dexamethasone Elixir
NDC Package 10135-795-71

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

Package Information

Dexamethasone elixirs 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 elixir delivery system. Marketed by Marlex Pharmaceuticals, Inc, this product is identified by NDC 10135-795 and is authorized under FDA application ANDA084754.

Identification & Billing

NDC Package Code
10135-795-71
Package Description
237 mL in 1 BOTTLE, GLASS
Product Code
10135-795
11-Digit Billing Format
10135079571
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Dexamethasone
Non-Proprietary Name
Dexamethasone
Substance Name
Dexamethasone
Dosage Form
Elixir - A clear, pleasantly flavored, sweetened hydroalcoholic liquid containing dissolved medicinal agents; it is intended for oral use.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
DEXAMETHASONE .5 mg/5mL
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
Marlex Pharmaceuticals, Inc
Product Type
Human Prescription Drug
FDA Application #
ANDA084754
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
09-21-1976
Listing Expiration
12-31-2026
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.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 10135-795-71 identifies a specific commercial package of 237 ml in 1 bottle, glass of Dexamethasone, a human prescription drug labeled by Marlex Pharmaceuticals, Inc. This elixir is formulated for oral 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 Marlex Pharmaceuticals, Inc on September 21, 1976. 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 Marlex Pharmaceuticals, Inc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 10135079571. 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)
10135-795-71
11-Digit CMS (5-4-2)
10135-0795-71

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