||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 OTC Drug. This data element corresponds to the “Document Type” of the SPL submission for the listing.
||Also known as the trade name. It is the name of the product chosen by the labeler.
||NON PROPRIETARY NAME
||VITAMIN A ACETATE, .BETA.-CAROTENE, ASCORBIC ACID, CHOLECALCIFEROL, .ALPHA.-TOCOPHEROL ACETATE, DL-, THIAMINE MONONITRATE, RIBOFLAVIN, NIACINAMIDE, PYRIDOXINE HYDROCHLORIDE, FOLIC ACID, CYANOCOBALAMIN, CALCIUM CARBONATE, FERROUS FUMARATE, ZINC OXIDE, CUPRIC OXIDE
||Sometimes called the generic name, this is usually the active ingredient(s) of the product.
||DOSAGE FORM NAME
||TABLET, FILM COATED
||The translation of the DosageForm Code submitted by the firm.
||The translation of the Route Code submitted by the firm, indicating route of administration.
||START MARKETING DATE
||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.
||Amneal Pharmaceuticals, LLC
||Name of Company corresponding to the labeler code segment of the Product NDC.
||VITAMIN A ACETATE; .BETA.-CAROTENE; ASCORBIC ACID; CHOLECALCIFEROL; .ALPHA.-TOCOPHEROL ACETATE, DL-; THIAMINE MONONITRATE; RIBOFLAVIN; NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; FOLIC ACID; CYANOCOBALAMIN; CALCIUM CARBONATE; FERROUS FUMARATE; ZINC OXIDE; CUPRIC OXIDE
||This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.
||ACTIVE NUMERATOR STRENGTH
||3080; 920; 120; 400; 22; 1.84; 3; 20; 10; 1; 12; 200; 27; 25; 2
||ACTIVE INGRED UNIT
||[iU]/1; [iU]/1; mg/1; [iU]/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; ug/1; mg/1; mg/1; mg/1; mg/1
||Vitamin A [Chemical/Ingredient],Vitamin A [EPC],Vitamin D [Chemical/Ingredient],Vitamin D [EPC],Vitamin B 12 [Chemical/Ingredient],Vitamin B12 [EPC],Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [Chemical/Ingredient],Cations, Divalent [Chemical/Ingredient]