0642-0207 NDC - STROVITE ONE (VITAMIN A, CALCIUM PANTOTHENATE, ASCORBIC ACID, CHOLECALCIFEROL, .ALPHA.-TOCOPHEROL SUCCINATE, D-, THIAMINE, RIBOFLAVIN, NIACINAMIDE, PYRIDOXINE HYDROCHLORIDE, FOLIC ACID, BIOTIN, CYANOCOBALAMIN, SELENIUM, MAGNESIUM OXIDE, ZINC OXIDE, CUPRIC SULFATE, MANGANESE, CHROMIUM, .ALPHA.-LIPOIC ACID, AND LUTEIN)

Drug Information

Product NDC: 0642-0207
Proprietary Name: Strovite One
Non Proprietary Name: Vitamin A, Calcium Pantothenate, Ascorbic Acid, Cholecalciferol, .Alpha.-Tocopherol Succinate, D-, Thiamine, Riboflavin, Niacinamide, Pyridoxine Hydrochloride, Folic Acid, Biotin, Cyanocobalamin, Selenium, Magnesium Oxide, Zinc Oxide, Cupric Sulfate, Manganese, Chromium, .Alpha.-Lipoic Acid, and Lutein
Active Ingredient(s): 45 ug/1 .ALPHA.-TOCOPHEROL SUCCINATE, D-; 15 mg/1 ALPHA LIPOIC ACID; 300 mg/1 ASCORBIC ACID; 100 ug/1 BIOTIN; 7.5 mg/1 CALCIUM PANTOTHENATE; 25 ug/1 CHOLECALCIFEROL; 50 ug/1 CHROMIUM; 1.5 mg/1 CUPRIC SULFATE; 50 ug/1 CYANOCOBALAMIN; 1700 ug/1 FOLIC ACID; 5 mg/1 LUTEIN; 50 mg/1 MAGNESIUM OXIDE; 1.5 mg/1 MANGANESE; 25 mg/1 NIACINAMIDE; 25 mg/1 PYRIDOXINE HYDROCHLORIDE; 5 mg/1 RIBOFLAVIN; 100 ug/1 SELENIUM; 20 mg/1 THIAMINE; 900 ug/1 VITAMIN A; 25 mg/1 ZINC OXIDE
Administration Route(s): ORAL
Dosage Form(s): TABLET
Pharmacy Class(es): Allergens [CS]; Analogs/Derivatives [Chemical/Ingredient]; Ascorbic Acid [CS]; Calculi Dissolution Agent [EPC]; Cell-mediated Immunity [PE]; Increased Histamine Release [PE]; Increased Large Intestinal Motility [PE]; Inhibition Large Intestine Fluid/Electrolyte Absorption [PE]; Inhibition Small Intestine Fluid/Electrolyte Absorption [PE]; Magnesium Ion Exchange Activity [MoA]; Osmotic Activity [MoA]; Osmotic Laxative [EPC]; Standardized Chemical Allergen [EPC]; Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]; Vitamin A [CS]; Vitamin A [EPC]; Vitamin B 12 [CS]; Vitamin B 6 [Chemical/Ingredient]; Vitamin B12 [EPC]; Vitamin B6 Analog [EPC]; Vitamin C [EPC]; Vitamin D [CS]; Vitamin D [EPC]

Labeler Information

Field Name	Field Value
Labeler Name:	Exeltis USA, Inc.
Product Type:	HUMAN PRESCRIPTION DRUG
FDA Application Number:
Marketing Category:	UNAPPROVED DRUG OTHER
Start Marketing Date:	5/4/2001

Package Information

No.	Package Code	Package Description	Billing Unit
1	0642-0207-03	1 BLISTER PACK in 1 BOX (0642-0207-03) / 3 TABLET in 1 BLISTER PACK
2	0642-0207-90	90 TABLET in 1 BOTTLE (0642-0207-90)	EA

NDC Record

Field Name	Field Value	Definition
PRODUCT NDC	0642-0207	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	Strovite One	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	Caplets	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	Vitamin A, Calcium Pantothenate, Ascorbic Acid, Cholecalciferol, .Alpha.-Tocopherol Succinate, D-, Thiamine, Riboflavin, Niacinamide, Pyridoxine Hydrochloride, Folic Acid, Biotin, Cyanocobalamin, Selenium, Magnesium Oxide, Zinc Oxide, Cupric Sulfate, Manganese, Chromium, .Alpha.-Lipoic Acid, and Lutein	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	TABLET	The translation of the dosage form Code submitted by the firm.
ROUTE NAME	ORAL	The translation of the route code submitted by the firm, indicating route of administration.
START MARKETING DATE	5/4/2001	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.
SUBSTANCE NAME	.ALPHA.-TOCOPHEROL SUCCINATE, D-; ALPHA LIPOIC ACID; ASCORBIC ACID; BIOTIN; CALCIUM PANTOTHENATE; CHOLECALCIFEROL; CHROMIUM; CUPRIC SULFATE; CYANOCOBALAMIN; FOLIC ACID; LUTEIN; MAGNESIUM OXIDE; MANGANESE; NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; RIBOFLAVIN; SELENIUM; THIAMINE; VITAMIN A; ZINC OXIDE	An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.
ACTIVE NUMERATOR STRENGTH	45; 15; 300; 100; 7.5; 25; 50; 1.5; 50; 1700; 5; 50; 1.5; 25; 25; 5; 100; 20; 900; 25
ACTIVE INGRED UNIT	ug/1; mg/1; mg/1; ug/1; mg/1; ug/1; ug/1; mg/1; ug/1; ug/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; ug/1; mg/1; ug/1; mg/1
PHARM CLASSES	Allergens [CS], Analogs/Derivatives [Chemical/Ingredient], Ascorbic Acid [CS], Calculi Dissolution Agent [EPC], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Magnesium Ion Exchange Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Standardized Chemical Allergen [EPC], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE], Vitamin A [CS], Vitamin A [EPC], Vitamin B 12 [CS], Vitamin B 6 [Chemical/Ingredient], Vitamin B12 [EPC], Vitamin B6 Analog [EPC], Vitamin C [EPC], Vitamin D [CS], Vitamin D [EPC]

Drug Information

Labeler Information

Package Information

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