NDC 68345-100 Repara Silver Nitrate Applicators

View Dosage, Usage, Ingredients, Routes, UNII

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) 68345-100 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:
68345-100
Proprietary Name:
Repara Silver Nitrate Applicators
Product Type: [3]
INACTIVATED PRODUCT and EXCLUDED the from NDC Directory
Labeler Code:
68345
Marketing Category: [8]
UNAPPROVED DRUG OTHER - An unapproved drug product in a marketing category that is not reflected on a particular list.
Start Marketing Date: [9]
10-26-2012
Listing Expiration Date: [11]
12-31-2017
Exclude Flag: [12]
I
Code Navigator:

Code Structure Chart

Product Details

What is NDC 68345-100?

The NDC code 68345-100 is assigned by the FDA to the product Repara Silver Nitrate Applicators which is product labeled by Pss World Medical, Inc.. The product's dosage form is . The product is distributed in a single package with assigned NDC code 68345-100-60 10 box in 1 case / 10 vial in 1 box / 100 stick in 1 vial. 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 Repara Silver Nitrate Applicators?

Repara® Silver Nitrate Applicators must not be used for genital warts. Continued application to mucous membranes and open wounds leads to argyria, a blush-black discoloration of the skin due to depositions of granules of silver compounds in the connective tissues. This condition persists indefinitely or disappears very slowly. Poisoning by oral ingestion is unlikely with the quantities involved, but treatment for poisoning is the immediate ingestion of large amounts of salt water followed by an emetic. Then administer a dose of Epsom salts followed with milk. Immediately call a physician.

Which are Repara Silver Nitrate Applicators UNII Codes?

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

What is the NDC to RxNorm Crosswalk for Repara Silver Nitrate Applicators?

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: 1117536 - potassium nitrate 25 % / silver nitrate 75 % Medicated Pad
  • RxCUI: 1117536 - potassium nitrate 250 MG/ML / silver nitrate 750 MG/ML Medicated Pad
  • RxCUI: 1117536 - K+ nitrate 250 MG/ML / AgNO3 750 MG/ML Medicated Pad
  • RxCUI: 1117536 - Pot nitrate 250 MG/ML / AgNO3 750 MG/ML Medicated Pad
  • RxCUI: 1117536 - potassium nitrate 25 % / silver nitrate 75 % Topical Sponge

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Product Footnotes

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

[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".