0642-0093 NDC - VITAFOL (DOCONEXENT, NIACINAMIDE, .ALPHA.-TOCOPHEROL ACETATE, DL-, CHOLECALCIFEROL, .BETA.-CAROTENE, ASCORBIC ACID, THIAMINE MONONITRATE, RIBOFLAVIN, PYRIDOXINE HYDROCHLORIDE, CYANOCOBALAMIN, IRON, ZINC OXIDE, CUPRIC OXIDE, POTASSIUM IODIDE, MAGNESIUM OXIDE, FOLIC ACID, AND LEVOMEFOLATE CALCIUM)

Drug Information

Product NDC: 0642-0093
Proprietary Name: Vitafol
Non Proprietary Name: Doconexent, Niacinamide, .Alpha.-Tocopherol Acetate, DL-, Cholecalciferol, .Beta.-Carotene, Ascorbic Acid, Thiamine Mononitrate, Riboflavin, Pyridoxine Hydrochloride, Cyanocobalamin, Iron, Zinc Oxide, Cupric Oxide, Potassium Iodide, Magnesium Oxide, Folic Acid, and Levomefolate Calcium
Active Ingredient(s): 9 mg/1 .ALPHA.-TOCOPHEROL ACETATE, DL-; 30 mg/1 ASCORBIC ACID; 330 ug/1 BETA CAROTENE; 25 ug/1 CHOLECALCIFEROL; 2 mg/1 CUPRIC OXIDE; 12 ug/1 CYANOCOBALAMIN; 200 mg/1 DOCONEXENT; 680 ug/1 FOLIC ACID; 29 mg/1 IRON; 1020 ug/1 LEVOMEFOLATE CALCIUM; 20 mg/1 MAGNESIUM OXIDE; 15 mg/1 NIACINAMIDE; 150 ug/1 POTASSIUM IODIDE; 2.5 mg/1 PYRIDOXINE HYDROCHLORIDE; 1.8 mg/1 RIBOFLAVIN; 1.6 mg/1 THIAMINE MONONITRATE; 25 mg/1 ZINC OXIDE
Administration Route(s): ORAL
Dosage Form(s): CAPSULE, LIQUID FILLED
Pharmacy Class(es): Analogs/Derivatives [Chemical/Ingredient]; Ascorbic Acid [CS]; Calculi Dissolution Agent [EPC]; Folate Analog [EPC]; Folic Acid [CS]; 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]; Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]; 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:	9/23/2013

Package Information

No.	Package Code	Package Description	Billing Unit
1	0642-0093-03	1 BLISTER PACK in 1 BOX (0642-0093-03) / 4 CAPSULE, LIQUID FILLED in 1 BLISTER PACK
2	0642-0093-30	5 BLISTER PACK in 1 BOX (0642-0093-30) / 6 CAPSULE, LIQUID FILLED in 1 BLISTER PACK	EA

NDC Record

Field Name	Field Value	Definition
PRODUCT NDC	0642-0093	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	Vitafol	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	Ultra	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	Doconexent, Niacinamide, .Alpha.-Tocopherol Acetate, DL-, Cholecalciferol, .Beta.-Carotene, Ascorbic Acid, Thiamine Mononitrate, Riboflavin, Pyridoxine Hydrochloride, Cyanocobalamin, Iron, Zinc Oxide, Cupric Oxide, Potassium Iodide, Magnesium Oxide, Folic Acid, and Levomefolate Calcium	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	CAPSULE, LIQUID FILLED	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	9/23/2013	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 ACETATE, DL-; ASCORBIC ACID; BETA CAROTENE; CHOLECALCIFEROL; CUPRIC OXIDE; CYANOCOBALAMIN; DOCONEXENT; FOLIC ACID; IRON; LEVOMEFOLATE CALCIUM; MAGNESIUM OXIDE; NIACINAMIDE; POTASSIUM IODIDE; PYRIDOXINE HYDROCHLORIDE; RIBOFLAVIN; THIAMINE MONONITRATE; 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	9; 30; 330; 25; 2; 12; 200; 680; 29; 1020; 20; 15; 150; 2.5; 1.8; 1.6; 25
ACTIVE INGRED UNIT	mg/1; mg/1; ug/1; ug/1; mg/1; ug/1; mg/1; ug/1; mg/1; ug/1; mg/1; mg/1; ug/1; mg/1; mg/1; mg/1; mg/1
PHARM CLASSES	Analogs/Derivatives [Chemical/Ingredient], Ascorbic Acid [CS], Calculi Dissolution Agent [EPC], Folate Analog [EPC], Folic Acid [CS], 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], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE], 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

NDC Record

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