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The complete list of codes and translations can be found at under Structured Product Labeling Resources.īULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING 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. Asterisks are no longer used or included within the product code segment to indicate certain configurations of the NDC. The labeler code and product code segments of the National Drug Code number, separated by a hyphen. Converting NDCs from a 10-digit to 11-digit format requires a strategically placed zero, dependent upon the 10-digit format. Proper billing of an NDC requires an 11-digit number in a 5-4-2 format. It should be noted that many NDCs are displayed on drug packaging in a 10-digit format.

These are the units to be used with the strength values above, listed in the same order as the SubstanceName and SubstanceNumber. These are the strength values (to be used with units below) of each active ingredient, listed in the same order as the SubstanceName field above. Name of Company corresponding to the labeler code segment of the ProductNDC.

The date that a record was last updated or changed. 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,.

The complete list of codes and translations can be found under Structured Product Labeling Resources. The translation of the DosageForm Code submitted by the firm. Each ingredient name is the preferred term of the UNII code submitted.

ALPHA.-TOCOPHEROL ACETATE CYCLOMETHICONE 5 METHYLCHLOROISOTHIAZOLINONE Sometimes called the generic name, this is usually the active ingredient(s) of the product.ĪLOE VERA LEAF SORBITOL WATER ETHYLHEXYL STEARATE EDETATE DISODIUM POLAWAX POLYSORBATE. For example: 4 BOTTLES in 1 CARTON/100 TABLETS in 1 BOTTLE. 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.