Prenate Chewable Tablet, Chewable
NDC 75854-306

View dosage, usage, ingredients, routes, and UNII mappings.
Table of Contents
  1. Product Information
  2. Product Packages
  3. Product Characteristics
  4. What is NDC 75854-306?
  5. Prenate Chewable Uses
  6. Active Ingredients
  7. Active Ingredients UNII Codes
  8. Inactive Ingredients UNII Codes
  9. Pharmacologic Classes

Product Information

Prenate Chewable (calcium carbonate, cholecalciferol, magnesium oxide, boron, folic acid, pyridoxine hydrochloride, cyanocobalamin, biotin and bilberry) is a UNAPPROVED DRUG OTHER-approved product labeled by Avion Pharmaceuticals, Llc. This medication is typically used as a analogs/derivatives [chemical/ingredient]. It is supplied as a brown tablet, chewable for oral administration. This product entry covers the primary NDC 75854-306 and its associated package configuration. This profile includes active and inactive ingredient UNII references and FDA labeling data.

Primary Identification

NDC Product Code:
75854-306
Proprietary Name:
Prenate Chewable
Non-Proprietary Name: [1]
Calcium Carbonate, Cholecalciferol, Magnesium Oxide, Boron, Folic Acid, Pyridoxine Hydrochloride, Cyanocobalamin, Biotin And Bilberry
Substance Name: [2]
Bilberry; Biotin; Boron; Calcium Carbonate; Cholecalciferol; Cyanocobalamin; Folic Acid; Magnesium Oxide; Pyridoxine Hydrochloride
NDC Directory Status:
Human Prescription Drug
Product Type: [3]
ACTIVE PRODUCT INCLUDED in the NDC Directory
Code Navigator:

Clinical Specifications

Dosage Form:
Tablet, Chewable - A solid dosage form containing medicinal substances with or without suitable diluents that is intended to be chewed, producing a pleasant tasting residue in the oral cavity that is easily swallowed and does not leave a bitter or unpleasant after-taste.
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:
917f02ce-51b9-4819-81e0-522842f6732a
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]
01-16-2013
Listing Expiration Date: [11]
12-31-2026
Exclude Flag: [12]
N

Product Characteristics

Color(s):
BROWN (C48332)
Shape:
ROUND (C48348)
Size(s):
22 MM
Imprint(s):
PRENATECHEW
Score:
2
Flavor(s):

Code Structure Chart

Product Details

What is NDC 75854-306?

The NDC code 75854-306 is assigned by the FDA to the product Prenate Chewable. It is commonly known by its generic name, calcium carbonate, cholecalciferol, magnesium oxide, boron, folic acid, pyridoxine hydrochloride, cyanocobalamin, biotin and bilberry. This pharmaceutical product is labeled by Avion Pharmaceuticals, Llc and is currently categorized as listed product. The medication is a tablet, chewable administered via oral route. In terms of distribution, this product is available in a single package configuration. The associated package NDC(s) include: 75854-306-30. 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?

INDICATIONS: PRENATE CHEWABLE ™ is a multivitamin/multimineral dietary supplement indicated for use in improving the nutritional status of women throughout pregnancy and in the postnatal period for both lactating and nonlactating mothers. PRENATE CHEWABLE ™ can also be beneficial in improving the nutritional status of women prior to conception.

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.
  • BILBERRY 25 mg/1
  • 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.
  • BORON 250 ug/1 - A trace element with the atomic symbol B, atomic number 5, and atomic weight [10.806; 10.821]. Boron-10, an isotope of boron, is used as a neutron absorber in BORON NEUTRON CAPTURE THERAPY.
  • CALCIUM CARBONATE 500 mg/1 - Carbonic acid calcium salt (CaCO3). An odorless, tasteless powder or crystal that occurs in nature. It is used therapeutically as a phosphate buffer in hemodialysis patients and as a calcium supplement.
  • CHOLECALCIFEROL 300 [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 125 mg/1
  • FOLIC ACID 1 mg/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.
  • 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.
  • PYRIDOXINE HYDROCHLORIDE 10 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".