![]() ![]() ![]() For example: 4 BOTTLES in 1 CARTON/100 TABLETS in 1 BOTTLE.ĭefines whether given package serves sample purposes. Multilevel packages will have the descriptions concatenated together. Asterisks are no longer used or included within the product and package code segments to indicate certain configurations of the NDC.Ī description of the size and type of packaging in sentence form. The labeler code, product code, and package code segments of the National Drug Code number, separated by hyphens. Therefore, all products having "unfinished" status are considered unapproved. Including the marketing categories of Active Pharmaceutical Ingredient (API),ĭrug for Further Processing, Bulk for Human Drug Compounding, and Bulk for Animal Drug Compounding.įDA does not review and approve unfinished products. Unfinished (Unapproved) The following status describes submitted unfinished drugs,.Name of Company corresponding to the labeler code segment of the ProductNDC. The complete list of codes and translations can be found at under Structured Product Labeling Resources. This data element corresponds to the “Document Type” of the SPL submission for the listing. Indicates the type of product, such as Human Prescription Drug or Human OTC Drug. Sometimes called the generic name, this is usually the active ingredient(s) of the product.
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