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Small Business Assistance
Center for Drug Evaluation and Research
Human Drug Establishment Registration and Drug Listing Compliance
How to Register and List
Quick Quiz
Match the right question with the answers that appear.
NDC Code Example:
Information Identified
A. What is a Drug Product Listing SPL?
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B
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Firms can look here to confirm that its establishment registration information has been received with the FDA.
B. What is the Drug Establishments Current Registration Site?
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B
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Firms can look here to confirm that a finished dosage form has been successfully listed with the FDA.
C. What is a Labeler Code Request SPL?
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B
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Use this kind of Structured Product Labeling file to submit human drug information to the FDA.
D. What is the Out of Business Notification SPL?
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B
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Use this kind of Structured Product Labeling file to indicate that a firm has ceased manufacturing activities.
E. What is the NDC Directory?
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Use this kind of Structured Product Labeling file to assign the first segment of an NDC number.
F. What is the Establishment Registration?
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B
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Use this kind of Structured Product Labeling file to submit human drug establishment registration information.
USER INSTRUCTIONS:
Match the right question with the answers that appear, then select NEXT to continue.
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