National Drug Code (NDC Labeler Code)
NDC labeler code is a ten digit unique, three-segment number which serves as a product identifier for human drugs. The NDC will be in one of the following configurations: 4-4-2, 5-3-2, or 5-4-1. First segment of NDC Labeler code identifies the establishment; FDA will assign this number and will be unique for each establishment (manufacturer, packer, labeler etc...). Second segment of NDC Labeler code identifies the drug (strength, dosage and formulation). Third segment of NDC Labeler code identifies the package size and package type. The second and third segments are assigned by the labeler.Assignment of NDC number does not denote FDA approval of the drug or manufacturer.
The NDC Labeler code request to FDA should submit in SPL (structured Product Labeling) format via FDA ESG (electronic submission gateway).
LMG provide assistance in preparing and submitting SPL file for NDC Labeler code request to FDA. LMG also assist you in drug establishment registration and drug listing with U.S. FDA.
Please note, you must have at least one drug listing to keep the labeler code active.
|FDA Registration, US Agent, Labeler code||USD 649 (Annually)|
|Drug listing||USD 399 / Drug|
|Label Review||USD 649 / Drug|
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