NDC 64661-650 Enbrace Hr

Levomefolate Magnesium,Leucovorin,Folic Acid,Ferrous Cysteine Glycinate,Magnesium - View Dosage, Usage, Ingredients, Routes, UNII

Product Information

NDC Product Code:
64661-650
Proprietary Name:
Enbrace Hr
Non-Proprietary Name: [1]
Levomefolate Magnesium, Leucovorin, Folic Acid, Ferrous Cysteine Glycinate, Magnesium Ascorbate, Zinc Ascorbate, Cocarboxylase, Flavin Adenine Dinucleotide, Nadh, Pyridoxal Phosphate Anhydrous, Cobamamide, Betaine, Magnesium L-threonate, 1, 2-docosahexanoyl-sn-glycero-3-phosphoserine Calcium, 1, 2-icosapentoyl-sn-glycero-3-phosphoserine Calcium, And Phosphatidyl Serine
Substance Name: [2]
1,2-docosahexanoyl-sn-glycero-3-phosphoserine Calcium; 1,2-icosapentoyl-sn-glycero-3-phosphoserine Calcium; Betaine; Cobamamide; Cocarboxylase; Ferrous Cysteine Glycinate; Flavin Adenine Dinucleotide; Folic Acid; Leucovorin; Levomefolate Magnesium; Magnesium Ascorbate; Magnesium L-threonate; Nadh; Phosphatidyl Serine; Pyridoxal Phosphate Anhydrous; Zinc Ascorbate
NDC Directory Status:
Human Prescription Drug
Product Type: [3]
ACTIVE PRODUCT INCLUDED in the NDC Directory
Dosage Form:
Capsule, Delayed Release Pellets - A solid dosage form in which the drug is enclosed within either a hard or soft soluble container or "shell" made from a suitable form of gelatin; the drug itself is in the form of granules to which enteric coating has been applied, thus delaying release of the drug until its passage into the intestines.
Administration Route(s): [4]
  • Oral - Administration to or by way of the mouth.
  • Labeler Name: [5]
    Jaymac Pharma
    Labeler Code:
    64661
    Marketing Category: [8]
    UNAPPROVED DRUG OTHER - An unapproved drug product in a marketing category that is not reflected on a particular list.
    Start Marketing Date: [9]
    08-12-2011
    Listing Expiration Date: [11]
    12-31-2024
    Exclude Flag: [12]
    N
    Code Structure:
    Code Navigator:

    Product Characteristics

    Color(s):
    BROWN (C48332 - ANNATTO)
    Shape:
    CAPSULE (C48336)
    Size(s):
    14 MM
    Imprint(s):
    ENL
    Score:
    1

    Product Packages

    NDC Code 64661-650-30

    Package Description: 30 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE

    Price per Unit: $4.73937 per EA

    Product Details

    What is NDC 64661-650?

    The NDC code 64661-650 is assigned by the FDA to the product Enbrace Hr which is a human prescription drug product labeled by Jaymac Pharma. The generic name of Enbrace Hr is levomefolate magnesium, leucovorin, folic acid, ferrous cysteine glycinate, magnesium ascorbate, zinc ascorbate, cocarboxylase, flavin adenine dinucleotide, nadh, pyridoxal phosphate anhydrous, cobamamide, betaine, magnesium l-threonate, 1, 2-docosahexanoyl-sn-glycero-3-phosphoserine calcium, 1, 2-icosapentoyl-sn-glycero-3-phosphoserine calcium, and phosphatidyl serine. The product's dosage form is capsule, delayed release pellets and is administered via oral form. The product is distributed in a single package with assigned NDC code 64661-650-30 30 capsule, delayed release pellets in 1 bottle . This page includes all the important details about this product, including active and inactive ingredients, pharmagologic classes, product uses and characteristics, UNII information and RxNorm crosswalk.

    What are the uses for Enbrace Hr?

    This medication is a multivitamin, mineral, and fatty acid product used to treat or prevent vitamin deficiency before, during, and after pregnancy. Vitamins, minerals, and fatty acids are important building blocks of the body and help keep you in good health. This combination product also contains iron and folic acid. Women of childbearing age should maintain adequate levels of folic acid either through diet or supplements to prevent infant spinal cord defects in the developing baby.

    What are Enbrace Hr Active Ingredients?

    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.

    Which are Enbrace Hr UNII Codes?

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

    Which are Enbrace Hr Inactive Ingredients 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 for Enbrace Hr?

    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.

    * Please review the disclaimer below.

    Product Footnotes

    [1] 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.

    [2] 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.

    [3] 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.

    [4] What are the Administration Routes? - The translation of the route code submitted by the firm, indicating route of administration.

    [5] What is the Labeler Name? - Name of Company corresponding to the labeler code segment of the Product NDC.

    [8] 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.

    [9] What is the Start Marketing Date? - This is the date that the labeler indicates was the start of its marketing of the drug product.

    [11] 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.

    [12] 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 ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".