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– It should be a unique identification of the drug product and the manufacturer or distributor of the product.
– It can be any single letter or number or any combination of letters and numbers.
– This is applicable for solid oral dosage form drug product.- This reply was modified 4 months, 2 weeks ago by .
Yes, FDA requires for any solid dosage drug products of prescription or OTC be it tablets or capsules to have imprint code for product identification and to prevent fraud.
@FRD
You can reduce the debossing/imprinting code or you can omit it with proper justification.
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