Prenate Essential Capsule, Gelatin Coated
NDC 75854-313

View dosage, usage, ingredients, routes, and UNII mappings.
Table of Contents
  1. Product Information
  2. Product Packages
  3. Product Characteristics
  4. What is NDC 75854-313?
  5. Prenate Essential Uses
  6. Active Ingredients
  7. Active Ingredients UNII Codes
  8. Inactive Ingredients UNII Codes
  9. Pharmacologic Classes

Product Information

Prenate Essential (ascorbic acid, cholecalciferol, .alpha.-tocopherol acetate, dl-, pyridoxine hydrochloride, folic acid, 5-methyltetrahydrofolic acid, cyanocobalamin, biotin, calcium formate, ferrous asparto glycinate, potassium iodide, magnesium oxide, doconexent and icosapent) is a UNAPPROVED DRUG OTHER-approved product labeled by Avion Pharmaceuticals, Llc. This medication contains vitamins, minerals, and fatty acids. It is supplied as a green capsule, gelatin coated for oral administration. This product entry covers the primary NDC 75854-313 and its associated package configuration. This profile includes active and inactive ingredient UNII references and FDA labeling data.

Primary Identification

NDC Product Code:
75854-313
Proprietary Name:
Prenate Essential
Non-Proprietary Name: [1]
Ascorbic Acid, Cholecalciferol, .alpha.-tocopherol Acetate, Dl-, Pyridoxine Hydrochloride, Folic Acid, 5-methyltetrahydrofolic Acid, Cyanocobalamin, Biotin, Calcium Formate, Ferrous Asparto Glycinate, Potassium Iodide, Magnesium Oxide, Doconexent And Icosapent
Substance Name: [2]
.alpha.-tocopherol Acetate, Dl-; 5-methyltetrahydrofolic Acid; Ascorbic Acid; Biotin; Calcium Formate; Cholecalciferol; Cyanocobalamin; Doconexent; Ferrous Asparto Glycinate; Folic Acid; Icosapent; Magnesium Oxide; Potassium Iodide; Pyridoxine Hydrochloride
NDC Directory Status:
Human Prescription Drug
Product Type: [3]
ACTIVE PRODUCT INCLUDED in the NDC Directory
Code Navigator:

Clinical Specifications

Dosage Form:
Capsule, Gelatin Coated - A solid dosage form in which the drug is enclosed within either a hard or soft soluble container made from a suitable form of gelatin; through a banding process, the capsule is coated with additional layers of gelatin so as to form a complete seal.
Administration Route(s): [4]
Oral - Administration to or by way of the mouth.

Labeler & Regulatory Data

Labeler Name: [5]
Avion Pharmaceuticals, Llc
Labeler Code:
75854
Product Label ID:
e5acfb2a-0959-4542-9b4c-790be194d581
Marketing Category: [8]
UNAPPROVED DRUG OTHER - An unapproved drug product in a marketing category that is not reflected on a particular list.

Marketing Timeline

Start Marketing Date: [9]
07-18-2014
Listing Expiration Date: [11]
12-31-2027
Exclude Flag: [12]
N

Product Characteristics

Color(s):
GREEN (C48329)
YELLOW (C48330 - OPAQUE)
Shape:
OVAL (C48345)
Size(s):
24 MM
Imprint(s):
PRENATE
Score:
1

Code Structure Chart

Product Details

What is NDC 75854-313?

The NDC code 75854-313 is assigned by the FDA to the product Prenate Essential. It is commonly known by its generic name, ascorbic acid, cholecalciferol, .alpha.-tocopherol acetate, dl-, pyridoxine hydrochloride, folic acid, 5-methyltetrahydrofolic acid, cyanocobalamin, biotin, calcium formate, ferrous asparto glycinate, potassium iodide, magnesium oxide, doconexent and icosapent. This pharmaceutical product is labeled by Avion Pharmaceuticals, Llc and is currently categorized as listed product. The medication is a capsule, gelatin coated administered via oral route. In terms of distribution, this product is available in a single package configuration. The associated package NDC(s) include: 75854-313-30. Beyond standard identification, this entry provides technical data including pharmacologic classes, UNII ingredient references, and RxNorm cross-referencing for healthcare systems.

What are the uses of this product?

This medication contains vitamins, minerals, and fatty acids. It is used to treat or prevent a lack of these nutrients during pregnancy or due to poor diet or certain illnesses. Vitamins, minerals, and fatty acids are important building blocks of the body and help keep you in good health. This combination product may contain folic acid. Women who are or may become pregnant should maintain adequate levels of folic acid through either diet or supplements to prevent spinal cord birth defects. Some supplement products have been found to contain possibly harmful impurities/additives. Check with your pharmacist for more details about the brand you use. The FDA has not reviewed this product for safety or effectiveness. Consult your doctor or pharmacist for more details.

What are Active Ingredients of this product?

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.
  • .ALPHA.-TOCOPHEROL ACETATE, DL- 10 [iU]/1
  • 5-METHYLTETRAHYDROFOLIC ACID 600 ug/1
  • ASCORBIC ACID 90 mg/1 - A six carbon compound related to glucose. It is found naturally in citrus fruits and many vegetables. Ascorbic acid is an essential nutrient in human diets, and necessary to maintain connective tissue and bone. Its biologically active form, vitamin C, functions as a reducing agent and coenzyme in several metabolic pathways. Vitamin C is considered an antioxidant.
  • BIOTIN 280 ug/1 - A water-soluble, enzyme co-factor present in minute amounts in every living cell. It occurs mainly bound to proteins or polypeptides and is abundant in liver, kidney, pancreas, yeast, and milk.
  • CALCIUM FORMATE 155 mg/1
  • CHOLECALCIFEROL 220 [iU]/1 - Derivative of 7-dehydroxycholesterol formed by ULTRAVIOLET RAYS breaking of the C9-C10 bond. It differs from ERGOCALCIFEROL in having a single bond between C22 and C23 and lacking a methyl group at C24.
  • CYANOCOBALAMIN 13 ug/1
  • DOCONEXENT 300 mg/1
  • FERROUS ASPARTO GLYCINATE 18 mg/1
  • FOLIC ACID 400 ug/1 - A member of the vitamin B family that stimulates the hematopoietic system. It is present in the liver and kidney and is found in mushrooms, spinach, yeast, green leaves, and grasses (POACEAE). Folic acid is used in the treatment and prevention of folate deficiencies and megaloblastic anemia.
  • ICOSAPENT 40 mg/1
  • MAGNESIUM OXIDE 50 mg/1 - Magnesium oxide (MgO). An inorganic compound that occurs in nature as the mineral periclase. In aqueous media combines quickly with water to form magnesium hydroxide. It is used as an antacid and mild laxative and has many nonmedicinal uses.
  • POTASSIUM IODIDE 150 ug/1 - An inorganic compound that is used as a source of iodine in thyrotoxic crisis and in the preparation of thyrotoxic patients for thyroidectomy. (From Dorland, 27th ed)
  • PYRIDOXINE HYDROCHLORIDE 26 mg/1 - The 4-methanol form of VITAMIN B 6 which is converted to PYRIDOXAL PHOSPHATE which is a coenzyme for synthesis of amino acids, neurotransmitters (serotonin, norepinephrine), sphingolipids, aminolevulinic acid. Although pyridoxine and Vitamin B 6 are still frequently used as synonyms, especially by medical researchers, this practice is erroneous and sometimes misleading (EE Snell; Ann NY Acad Sci, vol 585 pg 1, 1990).

Which are the associated UNII Codes?

The UNII codes for the active ingredients in this product are:

Which are the Inactive Ingredients associated UNII Codes?

The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product. The UNII codes for the inactive ingredients in this product are:

Which are the Pharmacologic Classes of this product?

A pharmacologic class is a group of drugs that share the same scientifically documented properties. The following is a list of the reported pharmacologic class(es) corresponding to the active ingredients of this product.

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Product & Regulatory Definitions
What is the Non-Proprietary Name? The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
What is the Substance Name? 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.
What kind of product is this? 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.
What are the Administration Routes? The translation of the route code submitted by the firm, indicating route of administration.
What is the Labeler Name? Name of Company corresponding to the labeler code segment of the Product NDC.
What is the Marketing Category? 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.
What is the Start Marketing Date? This is the date that the labeler indicates was the start of its marketing of the drug product.
What is the Listing Expiration Date? This is the date when the listing record will expire if not updated or certified by the product labeler.
What is the NDC Exclude Flag? This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA"s requests for correction to deficient or non-compliant submissions, or because the listing certification is expired, or because the listing data was inactivated by FDA, or because it was discontinued by the labeler. Possible values in this field are: "D", "E", "I", "N", "U".