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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.
http://www.fda.gov/Drugs/InformationOnDrugs/ucm142438.htm

 
     
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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), .
http://www.fda.gov/edrls

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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 .
http://www.fda.gov/drugs/developmentapprovalprocess/ucm070829

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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 .
http://www.fda.gov/forindustry/importprogram/importalerts/default.htm

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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 .
http://en.wikipedia.org/wiki/National_Drug_Code

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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 .
http://spl-work-group.wikispaces.com/file/view/ndc_lcr_er_spl_r4_training_session_module_one.pdf