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Drug listing data elements include information about the product (proprietary and nonproprietary names, ingredients, ingredient strengths, dosage forms, routes of administration, appearance, DEA schedule) and the packaging (package quantity and type).

The Structured Product Labeling (SPL) is a document markup standard approved by Health Level Seven (HL7) and adopted by FDA as a mechanism for exchanging product and facility information.

About NSDE All data in the NDC SPL Data Element (NSDE) file, with the exception of billing unit, is generated from SPL documents sent to FDA for inclusion in the FDA Online Label Repository at labels.fda.gov. The information in the SPL documents is for products in final marketed form.

FDA regulations require that all medication labels include: Name of Product. Table of Drug Facts. Active Ingredients. Proper Use and Purpose.

The labeler code is assigned by FDA. must be submitted, which is 5 days within going into commercial distribution. – Labeler Code Request must be submitted and completed prior to drug listings. If you do not have to list any drugs with FDA, you do not need to apply for a labeler code .

The Structured Product Labeling (SPL) is a document markup standard approved by Health Level Seven (HL7) and adopted by FDA as a mechanism for exchanging product and facility information.

Listing process Select the appropriate SPL document type for the product (human Rx drug, human OTC, bulk ingredient, etc.) Fill out all required listing data elements. Create a section within the SPL file for each section of content for labeling (e.g., highlights, warnings, how supplied) and enter the text for each.

Drug establishment registration and drug listing are mandatory requirements for APIs (bulk drugs) commercially marketed in the USA. Manufacturer of API must register their drug establishment where the product is manufactured, packed or processed and list all the drugs which are in the commercial distribution.