Maxidex
NDC 0998-0615
View dosage, usage, ingredients, routes, and UNII mappings.
Product Information
This product is EXCLUDED from the official NDC directory because the listing data was discontinued by the firm.
Maxidex is a NDA-approved product labeled by Alcon Laboratories, Inc.. This medication is used to treat certain eye conditions due to inflammation or injury. It is supplied as a product. This product entry covers the primary NDC 0998-0615 and its associated package configuration. This profile includes active and inactive ingredient UNII references and FDA labeling data.
Primary Identification
NDC Product Code:
0998-0615
Proprietary Name:
Maxidex
Product Type: [3]
Code Navigator:
Labeler & Regulatory Data
Labeler Name: [5]
Labeler Code:
0998
Product Label ID:
FDA Application Number: [6]
NDA013422
Marketing Category: [8]
NDA - A product marketed under an approved New Drug Application.
Marketing Timeline
Start Marketing Date: [9]
05-15-1966
End Marketing Date: [10]
08-31-2023
Listing Expiration Date: [11]
08-31-2023
Exclude Flag: [12]
D
Code Structure Chart
Product Details
What is NDC 0998-0615?
The NDC code 0998-0615 is assigned by the FDA to the product Maxidex. This pharmaceutical product is labeled by Alcon Laboratories, Inc. and is currently categorized as listed product. In terms of distribution, this product is available in a single package configuration. The associated package NDC(s) include: 0998-0615-05. Beyond standard identification, this entry provides technical data including pharmacologic classes, UNII ingredient references, and RxNorm cross-referencing for healthcare systems.
What are the uses of this product?
This medication is used to treat certain eye conditions due to inflammation or injury. Dexamethasone works by relieving symptoms such as swelling, redness, and itching. It belongs to a class of drugs known as corticosteroids. This medication may also be used to treat swelling, redness, and itching of the outer ear due to inflammatory conditions.
What is the NDC to RxNorm Crosswalk for this product?
RxNorm is a normalized naming system for generic and branded drugs that assigns unique concept identifier(s) known as RxCUIs to NDC products.The NDC to RxNorm Crosswalk for this produdct indicates multiple concept unique identifiers (RXCUIs) are associated with this product:
- RxCUI: 205669 - Maxidex 0.1 % Ophthalmic Suspension
- RxCUI: 205669 - dexamethasone 1 MG/ML Ophthalmic Suspension [Maxidex]
- RxCUI: 205669 - Maxidex 1 MG/ML Ophthalmic Suspension
- RxCUI: 309692 - dexAMETHasone 0.1 % Ophthalmic Suspension
- RxCUI: 309692 - dexamethasone 1 MG/ML Ophthalmic Suspension
* Please review the full disclaimer at the bottom of this page.
Patient Education
Dexamethasone Ophthalmic
Dexamethasone reduces the irritation, redness, burning, and swelling of eye caused by chemicals, heat, radiation, infection, allergy, or foreign bodies in the eye. It is sometimes used after eye surgery.
[Learn More]
Steroids
You may have heard of anabolic steroids, which can have harmful effects. But there's another type of steroid - sometimes called a corticosteroid - that treats a variety of problems. These steroids are similar to hormones that your adrenal glands make to fight stress associated with illnesses and injuries. They reduce inflammation and affect the immune system.
You may need to take corticosteroids to treat:
- Arthritis
- Asthma
- Autoimmune diseases such as lupus and multiple sclerosis
- Skin conditions such as eczema and rashes
- Some kinds of cancer
Steroids are strong medicines, and they can have side effects, including weakened bones and cataracts. Because of this, you usually take them for as short a time as possible.
[Learn More]
* Please review the full disclaimer at the bottom of this page.
Product & Regulatory Definitions
What is the Labeler Name? Name of Company corresponding to the labeler code segment of the Product NDC.
What is the FDA Application Number? This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.
What is the Marketing Category? Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.
What is the Start Marketing Date? This is the date that the labeler indicates was the start of its marketing of the drug product.
What is the End Marketing Date? This is the date the product will no longer be available on the market. If a product is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the EndMarketingDate, to reflect the potential for drug product to remain available after manufacturing has ceased. Products that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Products with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached.
What is the Listing Expiration Date? This is the date when the listing record will expire if not updated or certified by the product labeler.
What is the NDC Exclude Flag? This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA"s requests for correction to deficient or non-compliant submissions, or because the listing certification is expired, or because the listing data was inactivated by FDA, or because it was discontinued by the labeler. Possible values in this field are: "D", "E", "I", "N", "U".
