PRODUCT NDC | 0642-0075 | The labeler code and product code segments of the National Drug Code number, separated by a hyphen. Asterisks are no longer used or included within the product code segment to indicate certain configurations of the NDC. |
PRODUCT TYPE NAME | HUMAN PRESCRIPTION DRUG | Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing. |
PROPRIETARY NAME | Select-OB Plus DHA | The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes. |
PROPRIETARY NAME SUFFIX | Prenatal Supplement Plus DHA | A suffix to the proprietary name, a value here should be appended to the ProprietaryName field to obtain the complete name of the product. This suffix is often used to distinguish characteristics of a product such as extended release (“XR”) or sleep aid (“PM”). Although many companies follow certain naming conventions for suffices, there is no recognized standard. |
NON PROPRIETARY NAME | .BETA.-CAROTENE, VITAMIN A ACETATE, ASCORBIC ACID, CHOLECALCIFEROL, .ALPHA.-TOCOPHEROL ACETATE, DL-, Thiamine Mononitrate, Riboflavin, NIACINAMIDE, Pyridoxine Hydrochloride, Folic Acid, LEVOMEFOLATE CALCIUM, Cobalamin, Iron, MAGNESIUM OXIDE, ZINC OXIDE, and DOCONEXANT | The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product. |
DOSAGE FORM NAME | KIT | The translation of the dosage form Code submitted by the firm. |
START MARKETING DATE | 4/8/2009 | This is the date that the labeler indicates was the start of its marketing of the drug product. |
MARKETING CATEGORY NAME | UNAPPROVED DRUG OTHER | Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources. |
LABELER NAME | Exeltis USA, Inc. | Name of Company corresponding to the labeler code segment of the Product NDC. |