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Technical requirements for Medicare NDC entry: Format: 11-digit NDC in 5-4-2 configuration Electronic claim (837P): enter in Loop 2410, Segment LIN, with qualifier N4 Paper claim (CMS-1500): enter in Box 19 Unit of measure qualifier: UN for units, ML for milliliters, or GR for grams Quantity reported: the actual amount administered, not the full vial size Commercial payer NDC requirements work differently

TUEs are only granted for approved pharmaceutical products with documented medical uses and regulatory approval

This may explain why various human protocols using different doses all report positive outcomes

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