NDC Compounded Drug 5446-0848-01 Dexamethasone

Solution Auricular (otic)

Compounded Drug Product Information

NDC Product Code 5446-0848
NDC Package Code 5446-0848-01
11-Digit NDC Billing Format NDC Format for Billing
For insurance billing purposes the Centers for Medicare & Medicaid Services (CMS) created an 11 digit NDC derivative identifier. If the NDC Package code is less than 11 digits the code must be padded with leading zeros. The leading zeros must be added to the appropriate segment to create a 5-4-2 configuration.
Package Description 1 mL in 1 SYRINGE, PLASTIC
Product Type What kind of product is this?
Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.
Human Compounded Drug
Proprietary Name What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
Dexamethasone 24mg/ml 1ml Syringe
Non-Proprietary Name What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
Dexamethasone 24mg/ml
Substance Name What is the Substance Name?
An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.
Usage Information Product Usage Information
The drug use information is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate. This information is not individual medical advice and does not substitute for the advice of a health care professional. Always ask a health care professional for complete information about this product and your specific health needs.
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.
Dosage Form Solution - A clear, homogeneous liquid1 dosage form that contains one or more chemical substances dissolved in a solvent or mixture of mutually miscible solvents.
Route Name Auricular (otic) - Administration to or by way of the ear.
Labeler Code 5446
Labeler Name What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.
Edge Pharma Llc
Substance Name Dexamethasone
Active Ingredients Information 24 mg/1 mL
Reporting Period 2021-2

NDC Crossover Products Matching Dexamethasone

NDC crossover of Dexamethasone 24mg/ml 1ml Syringe with NDC 5446-0848 a human compounded drug with other similar products matching the same substance name (Dexamethasone) and the same administration route (auricular (otic)) or dosage form (solution).

Frequently Asked Questions

What is the NDC number assigned to Dexamethasone 0.4% 240ml Bottle?

Dexamethasone 0.4% 240ml Bottle was assigned by its manufacturer with NDC product code 5446-0848. This product is a drug classified as a human compounded drug. Compounded drugs are medications created by combining or altering existing drugs to meet the specific needs of certain patients. The NDC directory only includes information about compounded drugs from facilities that choose to assign NDC numbers to their products.

Which are the NDC package codes for Dexamethasone 0.4% 240ml Bottle?

The NDC package code 5446-0848-01 was assigned to a 1 mL in 1 SYRINGE, PLASTIC of dexamethasone administered auricular (otic) via solution.

Who manufactures this product?

Dexamethasone 0.4% 240ml Bottle is manufactured by an outsourced facility and labeled by Edge Pharma Llc. All compounded drugs included in the NDC directory are classified as "Outsourcing Facility Compounded Human Drug Product (Exempt from Approval Requirements)". Outsourcing facilities are a type of drug compounding facility regulated under Section 503B of the FD&C Act could be eligible for exemptions from drug registration if they meet all the conditions specified under Section 503B.

Which are the NDC crossover matchings for this product?

We found 1 matching products that have the same substance, dosage form and administration route. The matching products are manufactured by Edge Pharma LLC with NDC product codes 5446-0622-01.