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  4. NDC Product Code: 53002-8690 Sulfacetamide Sodium And Prednisolone Sodium Phosphate

NDC 53002-8690 Sulfacetamide Sodium And Prednisolone Sodium Phosphate

View Dosage, Usage, Ingredients, Routes, UNII

Table of Contents

  1. Product Information
  2. Product Packages
  3. What is NDC 53002-8690?
  4. Sulfacetamide Sodium And Prednisolone Sodium Phosphate Uses
  5. Active Ingredients UNII Codes
  6. Inactive Ingredients UNII Codes
  7. NDC to RxNorm Crosswalk
  8. Patient Education

Product Information

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.

Get all the details for National Drug Code (NDC) 53002-8690 in one place. This page breaks down everything you need to know about the NDC, including proprietary name, active and inactive substances, package configurations, billing units, labeler information, and routes of administration. It also includes enhanced data such as HCPCS codes, FDA product labels with images, UNIIs, and RxNorm cross-references. Whether you're a healthcare professional verifying drug data or a consumer researching medication, this NDC page helps you make informed, accurate decisions.

NDC Product Code:
53002-8690
Proprietary Name:
Sulfacetamide Sodium And Prednisolone Sodium Phosphate
Product Type: [3]
INACTIVATED PRODUCT and EXCLUDED the from NDC Directory
Labeler Name: [5]
Rpk Pharmaceuticals, Inc.
Labeler Code:
53002
Product Label ID:
f3e88cc8-90df-4119-8c81-4c92f3cef5aa
FDA Application Number: [6]
ANDA074449
Marketing Category: [8]
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date: [9]
12-29-1995
Listing Expiration Date: [11]
12-31-2024
Exclude Flag: [12]
I
Code Navigator:

Code Structure Chart

Product Details

What is NDC 53002-8690?

The NDC code 53002-8690 is assigned by the FDA to the product Sulfacetamide Sodium And Prednisolone Sodium Phosphate which is product labeled by Rpk Pharmaceuticals, Inc.. The product's dosage form is . The product is distributed in 2 packages with assigned NDC codes 53002-8690-1 5 ml in 1 bottle, dropper , 53002-8690-2 10 ml in 1 bottle, dropper . This page includes all the important details about this product, including active and inactive ingredients, pharmagologic classes, product uses and characteristics, UNII information and RxNorm crosswalk.

What are the uses for Sulfacetamide Sodium And Prednisolone Sodium Phosphate?

Sulfacetamide Sodium and Prednisolone Sodium Phosphate Ophthalmic Solution is indicated for corticosteroid-responsive inflammatory ocular conditions for which a corticosteroid is indicated and where superficial bacterial ocular infection or a risk of bacterial ocular infection exists.Ocular corticosteroids are indicated in inflammatory conditions of the palpebral and bulbar conjunctiva, cornea, and anterior segment of the globe where the inherent risk of corticosteroid use in certain infective conjunctivitides is accepted to obtain diminution in edema and inflammation. They are also indicated in chronic anterior uveitis and corneal injury from chemical, radiation, or thermal burns or penetration of foreign bodies.The use of a combination drug with an anti-infective component is indicated where the risk of superficial ocular infection is high or where there is an expectation that potentially dangerous numbers of bacteria will be present in the eye.The particular anti-infective drug in this product is active against the following common bacterial eye pathogens: Escherichia coli, Staphylococcus aureus, Streptococcus pneumoniae, Streptococcus (viridans group), Haemophilus influenzae, Klebsiella species, and Enterobacter species.This product does not provide adequate coverage against: Neisseria species, Serratia marcescens.A significant percentage of staphylococcal isolates are completely resistant to sulfa drugs.

Which are Sulfacetamide Sodium And Prednisolone Sodium Phosphate UNII Codes?

The UNII codes for the active ingredients in this product are:

Which are Sulfacetamide Sodium And Prednisolone Sodium Phosphate Inactive Ingredients UNII Codes?

The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product. The UNII codes for the inactive ingredients in this product are:

What is the NDC to RxNorm Crosswalk for Sulfacetamide Sodium And Prednisolone Sodium Phosphate?

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: 1012021 - prednisoLONE sodium phosphate 0.25 % / sulfacetamide sodium 10 % Ophthalmic Solution
  • RxCUI: 1012021 - prednisolone sodium phosphate 2.5 MG/ML / sulfacetamide sodium 100 MG/ML Ophthalmic Solution
  • RxCUI: 1012021 - prednisolone sodium phosphate 0.25 % / sulfacetamide sodium 10 % Ophthalmic Solution

* Please review the disclaimer below.

Patient Education

Prednisolone Ophthalmic


Ophthalmic prednisolone reduces the irritation, redness, burning, and swelling of eye inflammation caused by chemicals, heat, radiation, infection, allergy, or foreign bodies in the eye. It sometimes is used after eye surgery. Prednisolone is in a class of medications called steroids. It prevents swelling and redness by changing the way the immune system works.
[Learn More]


Sulfacetamide Ophthalmic


Ophthalmic sulfacetamide stops the growth of bacteria that cause certain eye infections. It is used to treat eye infections and to prevent them after injuries.
[Learn More]


* Please review the disclaimer below.

Product Footnotes

[5] What is the Labeler Name? - Name of Company corresponding to the labeler code segment of the Product NDC.

[6] 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.

[8] 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.

[9] What is the Start Marketing Date? - This is the date that the labeler indicates was the start of its marketing of the drug product.

[11] 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.

[12] 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".