NDC 64661-650 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

NDC Product Code 64661-650

NDC CODE: 64661-650

Proprietary Name: Enbrace Hr What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.

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 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.

Drug Use Information

Drug Use Information
The drug use information is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate. This information is not individual medical advice and does not substitute for the advice of a health care professional. Always ask a health care professional for complete information about this product and your specific health needs.

  • Folic acid is the man-made form of folate. Folate is a B-vitamin naturally found in some foods. It is needed to form healthy cells, especially red blood cells. Folic acid supplements may come in different forms (such as L-methylfolate, levomefolate, methyltetrahydrofolate). They are used to treat or prevent low folate levels. Low folate levels can lead to certain types of anemia. Conditions that can cause low folate levels include poor diet, pregnancy, alcoholism, liver disease, certain stomach/intestinal problems, kidney dialysis, among others. Women of childbearing age should receive adequate amounts of folic acid either through their diet or supplements to prevent infant spinal cord birth defects.
  • This medication is used to treat high levels of a certain important body chemical (homocysteine) due to an inherited disorder (homocystinuria). Decreasing high homocysteine levels may help prevent serious blood clots, abnormal bone formation, brittle bones (osteoporosis), and eye problems (e.g., dislocated eye lens, nearsightedness). This medication works by decreasing blood levels of homocysteine. It does not correct the inherited disorder that causes the disease.

Product Characteristics

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

NDC Code Structure

  • 64661 - Jaymac Pharmaceuticals, Llc

NDC 64661-650-30

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

NDC Product Information

Enbrace Hr with NDC 64661-650 is a a human prescription drug product labeled by Jaymac Pharmaceuticals, Llc. 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.

Labeler Name: Jaymac Pharmaceuticals, Llc

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.

Product Type: Human Prescription Drug 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.

Enbrace Hr Active Ingredient(s)

What is the Active Ingredient(s) List?
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.

  • LEVOMEFOLATE MAGNESIUM 5.23 mg/1
  • LEUCOVORIN 2.5 mg/1
  • FOLIC ACID 1 mg/1
  • FERROUS CYSTEINE GLYCINATE 13.6 mg/1
  • MAGNESIUM ASCORBATE 24 mg/1
  • ZINC ASCORBATE 1 mg/1
  • COCARBOXYLASE 25 ug/1
  • FLAVIN ADENINE DINUCLEOTIDE 25 ug/1
  • NADH 25 ug/1
  • PYRIDOXAL PHOSPHATE ANHYDROUS 25 ug/1
  • COBAMAMIDE 50 ug/1
  • BETAINE 500 ug/1
  • MAGNESIUM L-THREONATE 1 mg/1
  • 1,2-DOCOSAHEXANOYL-SN-GLYCERO-3-PHOSPHOSERINE CALCIUM 6.4 mg/1
  • 1,2-ICOSAPENTOYL-SN-GLYCERO-3-PHOSPHOSERINE CALCIUM 800 ug/1
  • PHOSPHATIDYL SERINE 12 mg/1

Inactive Ingredient(s)

About the Inactive Ingredient(s)
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.

  • ANNATTO (UNII: 6PQP1V1B6O)
  • SODIUM CITRATE (UNII: 1Q73Q2JULR)
  • CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
  • GELATIN (UNII: 2G86QN327L)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • LECITHIN, SUNFLOWER (UNII: 834K0WOS5G)
  • ORANGE (UNII: 5EVU04N5QU)
  • OLIVE OIL (UNII: 6UYK2W1W1E)
  • PIPERINE (UNII: U71XL721QK)
  • WATER (UNII: 059QF0KO0R)
  • UBIDECARENONE (UNII: EJ27X76M46)
  • YELLOW WAX (UNII: 2ZA36H0S2V)

Administration Route(s)

What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.

  • Oral - Administration to or by way of the mouth.
  • Oral - Administration to or by way of the mouth.

Pharmacological Class(es)

What is a Pharmacological Class?
These are the reported pharmacological class categories corresponding to the SubstanceNames listed above.

  • Folate Analog - [EPC] (Established Pharmacologic Class)
  • Folic Acid - [CS]
  • Vitamin C - [EPC] (Established Pharmacologic Class)
  • Ascorbic Acid - [CS]
  • Vitamin C - [EPC] (Established Pharmacologic Class)
  • Ascorbic Acid - [CS]
  • Methylating Activity - [MoA] (Mechanism of Action)
  • Methylating Agent - [EPC] (Established Pharmacologic Class)

Product Labeler Information

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

Labeler Name: Jaymac Pharmaceuticals, Llc
Labeler Code: 64661
Marketing Category: UNAPPROVED DRUG OTHER - 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.

Start Marketing Date: 08-12-2011 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

Listing Expiration Date: 12-31-2020 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.

Exclude Flag: N 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. Values = ‘Y’ or ‘N’.

* Please review the disclaimer below.

Enbrace Hr Product Label Images

Enbrace Hr Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Labeling Index

Other

EnBrace® HRwith DeltaFolate™ [50 mcg B12] [15 mg DFE Folate]ANTI-PERNICIOUS ANEMIA B12-PREPARATION with 9mg DFE l-methylfolate magnesium and 6mg DFE other folates.Prescription Prenatal/Vitamin DrugFor Therapeutic UseMulti-phasic Capsules (30ct bottle)NDC 64661-650-30Rx Only [DRUG]GLUTEN-FREE

INGREDIENTS Adenosylcobalamin (coenzyme B12) 50 mcg Formyltetrahydrofolic acid (B9-vitamer) 2.5 mg6 mg DFE folate (vitamin B9) of at least 15 mg DFE total folate Folic acid, DHF - (provitamin B9) 1 mg​* Levomefolic acid, magnesium salt (B12 cofactor) 7 mgFrom 9 mg l-methylfolate (molar equivalent)

MANUFACTURED FOR:JayMac Pharmaceuticals, LLC; Sunset, LA 70584.MANUFACTURED AND/OR PACKAGED IN USA/CANADA.PATENTS: US Patent No 7,935,365; and other patent applications pending.TRADEMARKS:EnBrace® HR is a registered mark of JayMac Pharmaceuticals. DeltaFolate™ is a use-trademark of JayMac Pharmaceuticals.Rev August 2017

Description:

EnBrace® HR is an orally administered prescription prenatal/vitamindrugfor therapeutic use formulated for female macrocytic anemia patients that are in need of treatment, and are under specific direction and monitoring of vitamin B12 status by a physician.  EnBrace® HR is intended for women of childbearing age who are – or desire to become, pregnant.

Inactive Ingredient

FUNCTIONAL EXCIPIENTS: 13.6 mg FeGC as ferrous glycine cysteinate (1.5 mg elemental iron3) [colorant], 25 mg ascorbates20% daily value (DV) of VITAMIN C, and 5% DV IRON.,NOT a significant source of magnesium and zinc. (24 mg magnesium l-ascorbate, 1 mg zinc l-ascorbate) [antioxidant], at least 23.33 mg phospholipid-omega3 complexContains at least 12 mg phosphatidylserine (PS) of which approximately 6.4 mg as PS-DHA-Ca, and less than 1% EPA (<800 mcg PS-EPA-Ca) [marine lipids], 500 mcg betaine (trimethylgycine) [acidifier], 1 mg magnesium l-threonate [stabilizer].OTHER EXCIPIENTS: Annatto [colorant], citrates (citric, sodium) [stabilizers], flavin adenine dinucleotide​4 (FAD), gelatin (bovine), glycerine, plant lipids (sunflower) [lecithin], natural orange flavor [masking], nicotinamide adenine dinucleotide hydride​4 (NADH), pyridoxal 5 phosphateContains less than 2% (<25 mcg/each) of vitamins B1, B2, B3 and B6. (P5P), piperine [bioavailability enhancer], purified water, thiamine pyrophosphate​4, ubidecarnone [antioxidant], yellow beeswax.CONTAINS FISH/KRILL/SOY.Certified 3rd-party GLUTEN-FREE. No artificial colorants. No dairy, wheat, sugar or egg.

Mechanism Of Action

Vitamin B12[active]; Folate[prophylactic]

Indications

EnBrace® HR is indicated in the treatment of pernicious anemias of pregnancy, and prophylactic folate supplementation.

Warning

  • USE OF THIS PRODUCT WITHOUT DIRECT SUPERVISION OF A PHYSICIAN IS DANGEROUS.Some patients afflicted with pernicious anemia may or not respond to the orally ingested vitamin B12, and there is no known way to predict which patients may respond and which patients may cease to respond.Periodic examination and laboratory studies of pernicious anemia patients are essential and recommended. The parenteral administration of (cyano)cobalamin – or vitamin B12, is generally recognized as a fully effective treatment of pernicious anemia. Parenteral alkyl-cobalamin preparations have not been and are not authorized for use except by or on the prescription of a physician.

Precautions

0.1 mg or more of folic acid daily may obscure pernicious anemia in that the hematological remission may occur while neurological manifestations remain progressive. The safe tolerable limit for vitamin folic acid is 1 mg.

Adverse Reactions

Allergic sensitization has been reported following both oral and parenteral administration of folic acid.

Dosage And Administration

The adult dose is one capsule daily preferably on an empty stomach.Do not exceed recommended dose. Call your medical practitioner about side effects. You may report side effects by calling 866-280-5961.

How Supplied

Oval, brownish-orange softgel capsule with ENLUpper case on one side, in bottles of 30 with NDC 64661-650-30.

Storage

Store at 20°-25°C (68°-77°F). Protect from light and moisture as contact with moisture may produce surface discoloration and/or erosion.KEEP OUT OF THE REACH OF CHILDREN.Tamper Evident:Do not use if seal is broken or missing.

* Please review the disclaimer below.