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How to fill out ndc attachment compound detaildoc

1. The NDC attachment compound detaildoc is typically required for companies or individuals involved in the manufacturing, labeling, or distribution of drug products in the United States. This includes pharmaceutical manufacturers, repackagers, relabelers, and private label distributors.
2. To fill out the ndc attachment compound detaildoc, start by providing basic identification information. This includes the title of the document, company name, address, contact details, and any relevant identifiers such as the FDA Establishment Identifier (FEI).
3. Next, include a section for the National Drug Code (NDC) information. This involves specifying the NDC number, product name, strength, dosage form, route of administration, and the type of drug product (prescription, over-the-counter, or both).
4. The ndc attachment compound detaildoc also requires information on the active ingredients used in the drug product. This includes listing each active ingredient separately, along with its strength, unit of measure, and any additional relevant details.
5. Additionally, the document should include a section for inactive ingredients. These are substances used in the formulation of the drug product that do not have any therapeutic effect. Examples of inactive ingredients may include binders, fillers, preservatives, and flavorings. Each inactive ingredient should be listed individually, along with its purpose and quantity.
6. It is important to ensure that all information provided in the ndc attachment compound detaildoc is accurate and up to date. This includes verifying the correct spelling and formatting of each entry, as well as reviewing the information for consistency and completeness.
7. Lastly, it is recommended to consult the official guidance documents provided by the FDA for additional instructions and specific requirements for filling out the ndc attachment compound detaildoc. These resources can provide further clarity on any uncertainties or ambiguities that may arise during the completion of the document.

In summary, the ndc attachment compound detaildoc is a document that needs to be filled out by companies or individuals involved in the drug product manufacturing, labeling, or distribution process. It requires detailed information about the NDC, active and inactive ingredients, and accurate identification details. Following the provided guidelines and referring to official FDA guidance documents can help ensure the correct completion of the ndc attachment compound detaildoc.

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