Dexamethasone Sodium Phosphate Injection
NDC Package 68083-607-25

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

Package Information

Dexamethasone Sodium Phosphate 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 delivery system. Marketed by Gland Pharma Limited, this product is identified by NDC 68083-607 and is authorized under FDA application ANDA215654.

Identification & Billing

NDC Package Code
68083-607-25
Package Description
25 VIAL, SINGLE-DOSE in 1 CARTON / 1 mL in 1 VIAL, SINGLE-DOSE (68083-607-01)
Product Code
68083-607
11-Digit Billing Format
68083060725
RxNorm Crosswalk
  • RxCUI: 1116927 - dexAMETHasone sodium phosphate 4 MG/ML (dexAMETHasone phosphate equivalent) Injectable Solution
  • RxCUI: 1116927 - dexamethasone phosphate 4 MG/ML Injectable Solution
  • RxCUI: 1116927 - dexamethasone phosphate 4 MG/ML (as dexamethasone sodium phosphate 4.4 MG/ML) Injectable Solution
  • RxCUI: 1812079 - dexAMETHasone sodium phosphate 10 MG in 1 ML Injection
  • RxCUI: 1812079 - 1 ML dexamethasone phosphate 10 MG/ML Injection

Clinical Specifications

Proprietary Name
Dexamethasone Sodium Phosphate
Non-Proprietary Name
Dexamethasone Sodium Phosphate
Substance Name
Dexamethasone Sodium Phosphate
Dosage Form
Injection - A sterile preparation intended for parenteral use; five distinct classes of injections exist as defined by the USP.
Administration Route
  • Intra-articular - Administration within a joint.
  • Intralesional - Administration within or introduced directly into a localized lesion.
  • Intramuscular - Administration within a muscle.
  • Intravenous - Administration within or into a vein or veins.
  • Soft Tissue - Administration into any soft tissue.
Active Ingredient(s)
DEXAMETHASONE SODIUM PHOSPHATE 10 mg/mL
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. This injectable form of dexamethasone is used when a similar drug cannot be taken by mouth or when a very fast response is needed, especially in patients with severe medical conditions. Talk to your doctor about the risks and benefits of dexamethasone, especially if it is to be injected near your spine (epidural). Rare but serious side effects may occur with epidural use.

Regulatory & Marketing

Labeler Name
Gland Pharma Limited
Product Type
Human Prescription Drug
FDA Application #
ANDA215654
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
09-25-2023
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 68083-607-25 identifies a specific commercial package of 25 vial, single-dose in 1 carton / 1 ml in 1 vial, single-dose (68083-607-01) of Dexamethasone Sodium Phosphate, a human prescription drug labeled by Gland Pharma Limited. This injection is formulated for intra-articular; intralesional; intramuscular; intravenous; soft tissue use and contains dexamethasone sodium phosphate 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 Gland Pharma Limited on September 25, 2023. 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. This injectable form of dexamethasone is used when a similar drug cannot be taken by mouth or when a very fast response is needed, especially in patients with severe medical conditions. Talk to your doctor about the risks and benefits of dexamethasone, especially if it is to be injected near your spine (epidural). Rare but serious side effects may occur with epidural use.

How is this Gland Pharma Limited product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 68083060725. 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)
68083-607-25
11-Digit CMS (5-4-2)
68083-0607-25

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