NDC 64661-711 Enlyte

Leucovorin, Folic Acid, Levomefolate Magnesium, Ferrous Cysteine Glycinate, 1, 2-docosahexanoyl-sn-glycero-3-phosphoserine Calcium, 1, 2-icosapentoyl-sn-glycero-3-phosphoserine Calcium, Phosphatidyl Serine, Pyridoxal 5-phosphate, Flavin Adenine Dinucleotide, Nadh, Cobamamide, Cocarboxylase (thiamine Pyrophosphate), Magnesium Ascorbate, Zinc Ascorbate, Magnesium L-threonate And Betaine

NDC Product Code 64661-711

NDC CODE: 64661-711

Proprietary Name: Enlyte 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: Leucovorin, Folic Acid, Levomefolate Magnesium, Ferrous Cysteine Glycinate, 1, 2-docosahexanoyl-sn-glycero-3-phosphoserine Calcium, 1, 2-icosapentoyl-sn-glycero-3-phosphoserine Calcium, Phosphatidyl Serine, Pyridoxal 5-phosphate, Flavin Adenine Dinucleotide, Nadh, Cobamamide, Cocarboxylase (thiamine Pyrophosphate), Magnesium Ascorbate, Zinc Ascorbate, Magnesium L-threonate And Betaine 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: OVAL (C48345)
Size(s):
14 MM
Imprint(s):
ENL
Score: 1
Flavor(s):
ORANGE (C73406 - CREAMY ORANGE)

NDC Code Structure

  • 64661 - Jaymac Pharmaceuticals Llc

NDC 64661-711-30

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

NDC Product Information

Enlyte with NDC 64661-711 is a a human prescription drug product labeled by Jaymac Pharmaceuticals Llc. The generic name of Enlyte is leucovorin, folic acid, levomefolate magnesium, ferrous cysteine glycinate, 1, 2-docosahexanoyl-sn-glycero-3-phosphoserine calcium, 1, 2-icosapentoyl-sn-glycero-3-phosphoserine calcium, phosphatidyl serine, pyridoxal 5-phosphate, flavin adenine dinucleotide, nadh, cobamamide, cocarboxylase (thiamine pyrophosphate), magnesium ascorbate, zinc ascorbate, magnesium l-threonate and betaine. 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.

Enlyte 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.

  • LEUCOVORIN 2.5 mg/1
  • FOLIC ACID 1 mg/1
  • LEVOMEFOLATE MAGNESIUM 7 mg/1
  • FERROUS CYSTEINE GLYCINATE 13.6 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
  • PYRIDOXAL PHOSPHATE ANHYDROUS 25 ug/1
  • FLAVIN ADENINE DINUCLEOTIDE 25 ug/1
  • NADH 25 ug/1
  • COBAMAMIDE 50 ug/1
  • COCARBOXYLASE 25 ug/1
  • MAGNESIUM ASCORBATE 24 mg/1
  • ZINC ASCORBATE 1 mg/1
  • MAGNESIUM L-THREONATE 1 mg/1
  • BETAINE 500 ug/1
  • CITRIC ACID MONOHYDRATE 1.83 mg/1
  • SODIUM CITRATE 3.67 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)
  • GELATIN (UNII: 2G86QN327L)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • LECITHIN, SUNFLOWER (UNII: 834K0WOS5G)
  • 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.

  • Acidifying Activity - [MoA] (Mechanism of Action)
  • Calculi Dissolution Agent - [EPC] (Established Pharmacologic Class)
  • Anti-coagulant - [EPC] (Established Pharmacologic Class)
  • Decreased Coagulation Factor Activity - [PE] (Physiologic Effect)
  • Calcium Chelating Activity - [MoA] (Mechanism of Action)
  • Osmotic Laxative - [EPC] (Established Pharmacologic Class)
  • Increased Large Intestinal Motility - [PE] (Physiologic Effect)
  • Inhibition Large Intestine Fluid/Electrolyte Absorption - [PE] (Physiologic Effect)
  • Osmotic Activity - [MoA] (Mechanism of Action)
  • 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.

Enlyte 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

EnLyte®with DeltaFolate™[50 mcg B12] [2.5 mg F-THf, 1mg PteGlu, 7mg Me-THf]ANTI-PERNICIOUS ANEMIA B12-PREPARATION with B12-cofactor levomefolic acid, magnesium salt.Prescription Hematinic Drug For Therapeutic UseSoftgel Capsules (30ct bottle)NDC 64661-711-30Rx 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)

Description

EnLyte® is an orally administered prescription hematinic drugfor therapeutic use formulated for adult macrocytic anemia patients ages 12 and up, who are under specific direction and monitoring of vitamin B12 status by a physician

Inactive Ingredient

FUNCTIONAL EXCIPIENTS: 13.6 mg FeGC as ferrous glycine cysteinate (1.5 mg elemental iron30% daily value (DV) of VITAMIN C, and 10% DV IRON.) [colorant], 25 mg ascorbates1,NOT a significant source of magnesium and zinc. (24 mg magnesium l-ascorbate, 1 mg zinc l-ascorbate) [antioxidant], at least 5.5 mg citrates (at least 1.83 mg citric acid, at least 3.67 mg sodium citrates) [stabilizers], 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], flavin adenine dinucleotideContains less than 2% (<25 mcg/each) of vitamins B1, B2, B3 and B6 (FAD), gelatin (bovine), glycerine, plant lipids (sunflower) [lecithin], natural orange flavor [masking], nicotinamide adenine dinucleotide hydride4 (NADH), pyridoxal 5 phosphate6 (P5P), piperine [bioavailability enhancer], purified water, thiamine pyrophosphate4, 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]; Vitamin B9 [prevention]

Indications:

EnLyte® is indicated in the treatment of pernicious anemia, and the prevention of vitamin B9 deficiency.

Warnings:

  • 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.

Adverse Reactions:

Allergic sensitization has been reported following both oral and parenteral administration of vitamin B9.

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 “ENL” 7 on one side, in bottles of 30 with NDC 64661-711-30.

Storage And Handling

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.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:EnLyte® is a registered mark of JayMac Pharmaceuticals. DeltaFolate™ is a use-trademark of JayMac Pharmaceuticals.Rev August 2017

* Please review the disclaimer below.