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ANDA I. Freezer between -25 and -10 C -13 14 F A205407 Rx Product/Proprietary Name 59746-0546-01 NDC CVX Code UPC II. Box/ Write-in e.g. 1 Box of 10 Vials PHARMACY ORDER / BILL UNIT Rec. sell unit to customer Gram Milliliter ITEM AND PACKING INFORMATION ORDER INFORMATION What is the NDC selling unit 1 case of 48 bottles WHOLESALER USE ONLY Vendor Whsl. Code Fineline Code 022490515 Is product exempt from DSCSA DRUG SUPPLY CHAIN SECURITY ACT DSCSA INFORMATION Does supplier meet DSCSA definition...
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What is rx product only?
Rx product only refers to products that can only be obtained with a prescription from a licensed healthcare professional.
Who is required to file rx product only?
Manufacturers and distributors of rx products are required to file rx product only.
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To fill out rx product only, manufacturers and distributors must provide detailed information about the product, such as ingredients, dosage, and packaging.
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The purpose of rx product only filing is to ensure the safety and efficacy of prescription medications and to monitor their distribution.
What information must be reported on rx product only?
Information such as product name, manufacturer/distributor information, ingredients, dosage, packaging, and intended use must be reported on rx product only.
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