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Drug Approvals and Databases > National Drug Code Directory - FDA
Jun 1, 2011 . NEW VERSION, 2.0: The National Drug Code Directory has been updated with . submissions of drug registration and listing information using Forms 2656, 2657, and . The first segment, the labeler code, is assigned by the FDA. . about whether the product is marketed under an approved application.

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Drug Registration and Listing > Electronic Drug Registration and - FDA
May 27, 2011 . FDA, U.S. Food and Drug Administration . i.e., Form FDA 2656 (Registration of Drug Establishment/Labeler Code Assignment), . as required in New Drug Applications (NDAs), Abbreviated New Drug Applications (ANDAs), .

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National Drug Code Database Background Information - FDA
Jun 18, 2009 . The first segment, the labeler code, is assigned by the FDA. . The second segment, the product code, identifies a specific strength, dosage form, and formulation for a particular firm. . FDA approved application number .

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Import Alerts - FDA
Dec 13, 2011 . These laws apply equally to domestic and imported products. . Forms required to obtain a labeler code (FD 2656) and drug list their product .

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National Drug Code - Wikipedia, the free encyclopedia
While the labeler code is assigned by the FDA, both the product and package segments are . This is the most minimal form of the NDC code with 10 digits only .

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Submitting or Requesting an NDC Labeler Code in SPL Format
Form 2656 NDC Labeler Code & Establishment . Form 2657 Drug Product Listing & Form 2658 . and adopted by FDA as a mechanism for exchanging .