Name | Description | Type | Additional information |
---|---|---|---|
ProductId | The internally assigned numeric Gold Standard product identifier. | integer |
Required |
TherapeuticEquivalences | The product’s FDA Orange Book Therapeutic Equivalence Rating Code(s) (if populated). | Collection of string |
None. |
DESIStatusId | The product’s DESI Status identifier. | integer |
Required |
DESIStatusText | The DESI status textual description. | string |
Required |
ProductModifiers | A list of product modifiers available for the product. | Collection of ProductModifierName |
None. |
ProductNameLong | The unabbreviated trademarked product name, as published by the marketer. The full, marketed name for the product, which, in addition to the product name, could include the strength, unit, route, and dosage form. | string |
Required |
ProductNameType | Describes the name type of the product long name (Generic Name, Trademarked Name). Product name types describe the type of name that appears in the ProductNameLong field of the drug product data. | string |
Required |
ProductNameShort | The 30-character abbreviated name developed to conform to NCPDP telecommunication standards. The Product Short Name is a version of the Product Long Name. This is a shortened name, 30-character field length, and complies with NCPDP 5.1 telecommunication standards for Rx claims adjudications and industry expectations. The Product Short Name can be used for prescription labels and product pick lists. | string |
Required |
Marketer | The company name for the company that is marketing the drug (i.e., the NDA, aNDA or BLA holder). This could be the original manufacturer of the drug product, a distributor, or a re-packager. (Also known as the ‘Company’) | string |
Required |
LegendStatus | Contains the Legend Status (Rx, OTC) for this product. The Legend Status reflects whether the product is labeled as Rx-only (requires a prescription) or not (over-the-counter, no prescription required). Gold Standard populates the Legend Status value based on what is listed in the product’s labeling. | string |
Required |
BrandGenericStatus | Contains the product’s brand or generic status. The Brand/Generic Status reflects the marketer’s intent to position the product in the marketplace as either brand or generic. | string |
Required |
FederalDEAClass | Contains the Federal Drug Enforcement Agency’s (DEA) classification of controlled substances for this product, if applicable. | string |
Required |
ReplacedByProductId | (if applicable) The Gold Standard product identifier of a product that has taken the place of (i.e., replaced) the product as a result of mergers, acquisitions, product purchase, or other NDC changes. Frequently, products and packages change marketers, which may result in the creation of a new NDC, UPC, or NHRIC. Gold Standard associates these changes through the ‘ReplacedByProductId’ value. Inclusion of ‘ReplacedByProductId’ value provides the ability to track the history of changes for a product by marketer. | integer |
None. |
LicenseType | Contains the license type (e.g., NDA, aNDA, Authorized Generic, NA) assigned to this drug product. The License Type can be used to assist in determining Trademarked (Brand)/Generic Status, if there is disagreement with the reported Brand/Generic status. | string |
None. |
MarketStatus | Identifies the product as either OnMarket or OffMarket. Valid Enumeration Values: OnMarket, OffMarket | MarketStatusEnum |
Required |
IngredientStrengthRouteFormInfo | A collection of ingredient strength, route, and form information for the product. | Collection of IngredientStrengthRouteForm |
None. |
ProductDetailTE
Represents product therapeutic equivalence detail.