Enbrace Hr Capsule, Delayed Release Pellets
NDC Package 64661-650-30

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. Frequently Asked Questions

Package 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) capsules is a medication a multivitamin, mineral, and fatty acid product used to treat or prevent vitamin deficiency before, during, and after pregnancy. This formulation utilizes a capsule, delayed release pellets delivery system. Marketed by Jaymac Pharmaceuticals, Llc, this product is identified by NDC 64661-650.

Identification & Billing

NDC Package Code
64661-650-30
Package Description
30 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE
Product Code
64661-650
11-Digit Billing Format
64661065030
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
30 EA

Clinical Specifications

Proprietary Name
Enbrace Hr
Non-Proprietary 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
Substance Name
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
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
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
Pharmacologic Class
Usage Information
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.

Regulatory & Marketing

Labeler Name
Jaymac Pharmaceuticals, Llc
Product Type
Human Prescription Drug
Marketing Category
UNAPPROVED DRUG OTHER - An unapproved drug product in a marketing category that is not reflected on a particular list.
Start Marketing Date
08-12-2011
Listing Expiration
12-31-2027
Exclude Flag
N
Sample Package
No

Hierarchy Structure

Code Lineage

The NDC Directory contains ONLY information on final marketed drugs submitted to FDA electronically by labelers. A labeler might be a manufacturer, re-packager or re-labeler. The product information included in the NDC directory does not indicate that FDA has verified the information provided by the product labeler. Assigned NDC numbers are not in any way an indication of FDA approval of the product.

* Please review the full disclaimer at the bottom of this page.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 64661-650-30 identifies a specific commercial package of 30 capsule, delayed release pellets in 1 bottle of Enbrace Hr, a human prescription drug labeled by Jaymac Pharmaceuticals, Llc. This capsule, delayed release pellets is formulated for oral use and contains 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 as the active substance.

Is this product currently listed with the FDA?

Yes, this product is active and verified within the NDC Directory. It was introduced to the market by Jaymac Pharmaceuticals, Llc on August 12, 2011. The current certification is valid through December 31, 2027.

What are the primary indications for this medication?

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.

How is this Jaymac Pharmaceuticals, Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 64661065030. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 30 total billable units per package. The table below illustrates the segment conversion from the 10-digit labeler code to the 11-digit provider format.

11-Digit Code Conversion

Billing payers usually require a 5-4-2 segment configuration. Below is the conversion from the 10-digit package format to the 11-digit billing format:

10-Digit Format (5-3-2)
64661-650-30
11-Digit CMS (5-4-2)
64661-0650-30

Note: The zero is added to the Product segment to maintain the 5-4-2 structure.