Enbrace Hr Capsule, Delayed Release Pellets
NDC 64661-650

View dosage, usage, ingredients, routes, and UNII mappings.
Table of Contents
  1. Product Information
  2. Product Packages
  3. Product Characteristics
  4. What is NDC 64661-650?
  5. Enbrace Hr Uses
  6. Active Ingredients
  7. Active Ingredients UNII Codes
  8. Inactive Ingredients UNII Codes
  9. Pharmacologic Classes

Product Information

Enbrace Hr (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) is a UNAPPROVED DRUG OTHER-approved product labeled by Jaymac Pharmaceuticals, Llc. This medication is a multivitamin, mineral, and fatty acid product used to treat or prevent vitamin deficiency before, during, and after pregnancy. It is supplied as a brown capsule, delayed release pellets for oral administration. This product entry covers the primary NDC 64661-650 and its associated package configuration. This profile includes active and inactive ingredient UNII references and FDA labeling data.

Primary Identification

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
Code Navigator:

Clinical Specifications

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 & Regulatory Data

Labeler Name: [5]
Jaymac Pharmaceuticals, Llc
Labeler Code:
64661
Product Label ID:
6f14fa40-97ab-4ec5-b66b-793d6d1abac9
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]
08-12-2011
Listing Expiration Date: [11]
12-31-2027
Exclude Flag: [12]
N

Product Characteristics

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

Code Structure Chart

Product Details

What is NDC 64661-650?

The NDC code 64661-650 is assigned by the FDA to the product Enbrace Hr. It is commonly known by its generic name, 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. This pharmaceutical product is labeled by Jaymac Pharmaceuticals, Llc and is currently categorized as listed product. The medication is a capsule, delayed release pellets administered via oral route. In terms of distribution, this product is available in a single package configuration. The associated package NDC(s) include: 64661-650-30. 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 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 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.

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".