Label: 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 capsule, delayed release pellets

  • NDC Code(s): 64661-711-30
  • Packager: Jaymac Pharmaceuticals LLC
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

DISCLAIMER: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

Drug Label Information

Updated November 21, 2020

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  • SPL UNCLASSIFIED SECTION

    EnLyte®

    with DeltaFolate™

    [2.5 mg F-THf, 1mg PteGlu, 7mg Me-THf]​[50 mcg CBI][1.5 mg FeGC]

    ​JAYMAC Pharmaceuticals, LLC

    Softgels (30ct bottle)

    Prescription Vitamin ​For Therapeutic Use

  • ​Description

    EnLyte® is an orally administered prescription vitamin for therapeutic use formulated for adult patients - ages 12 and up, who are under specific direction and monitoring of homocysteine (HCY) status by a physician. A recent study+ suggested that EnLyte® was effective in lowering homocystine levels in patients that are positive for MTHFR (methylenetetrahydrofolate reductase polymorphism).

    +ClinicalTrials.gov identifier: NCT02709668, Correlation of Clinical Response With Homocysteine Reduction During Therapy With Reduced B Vitamins in Patients with MDD Who Are Posititive for MTHFR C677T or A1298C Polymorphism.

  • INACTIVE INGREDIENT

    OTHER INGREDIENTS: 25 mg ascorbates4 (24 mg magnesium l-ascorbate, 1 mg zinc l-ascorbate), 500 mcg betaine (trimethylglycine), 13.6 mg FeGC3 (1.5 mg elemental iron from ferrous glycine cysteinate), 25 mcg flavin adenine dinucleotide (reduced vitamin B2), 1 mg magnesium l-threonate, 25 mcg nicotinamide adenine dinucleotide hydride (reduced vitamin B3), at least 19.2 mg phospholipid-omega complex5, 25 mcg pyridoxal 5’ phosphate (reduced vitamin B6), 25 mcg thiamine pyrophosphate (reduced vitamin B1).

    EXCIPIENTS: Annatto [colorant], at least 5.5 mg citrates (at least 1.83 mg citric acid, at least 3.67 mg sodium citrates), gelatin (bovine), glycerine, piperine, plant lipids (sunflower), purified water, ubidecarenone, yellow beeswax.
       1 Coenzyme B12 is the primary form most found in mammalian liver
       2 Derived from folinic acid - a provitamer of B12 cofactor, l-methylfolate
       3 Pure amino acid, cysteinated iron chelate as AminoFerTM under exclusive license
       4 30% daily value (DV) of VITAMIN C, and 10% DV IRON for geriatrics
       5 Contains 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)

    CONTAINS FISH/KRILL/SOY. No artificial colorants. No dairy, wheat, sugar or egg.

  • INDICATIONS:

    EnLyte® is indicated in the TREATMENT of vitamin deficiency - specifically vitamin B12 deficiency, and the PREVENTION of vitamin B12-cofactor deficiency, l-methylfolate.

  • MECHANISM OF ACTION:

    VITAMIN B12 [TREATMENT]; FOLATE [PREVENTION]

  • BOXED WARNING (What is this?)

    WARNINGS:

    1. Caution: This product is not suitable for the TREATMENT of vitamin B12 deficiency secondary to either pernicious anemia and/or gastrointestinal malabsorption (i.e., exocrine pancreatic insufficiency).
    2. Caution: The use of vitamin B12 for the TREATMENT of anemnia without direct supervision of a physician may be dangerous.

    Call your medical practitioner about side effects.You may report side effects by calling 337.662-5962.KEEP THIS OUT OF THE REACH OF CHILDREN.

  • ADVERSE REACTIONS:

    Mild transient diarrhea, polycythemia vera, itching, transitory exanthema, feeling of swelling of entire body may occur with administration of vitamin B12. Allergic sensitization has been reported following both oral and parenteral administration of vitamin B9.

  • ​PRECAUTIONS:

    0.1 mg or more of vitamin B9 daily may obscure pernicious anemia in that the hematological remission may occur while neurological manifestations remain progressive. Exclusive use of vitamin B9 in treating vitamin B12-deficient macrocytic anemia could result in progressive and irreversible neurological damage. Specifically, vitamin B12 deficiency allowed to progress over 3 months may produce permanent degenerative lesions of the spinal cord - as observed when vitamin B9 therapy is used as the only hematopoietic agent. Doses of vitamin B12 exceeding 10 mcg daily may produce hematologic response in patients with vitamin B9 deficiency. Indiscriminate administration may mask the true diagnosis. A dietary deficiency of only vitamin B12 is rare; multiple vitamin deficiency is expected in any dietary deficiency. No single regimen fits all cases, and the status of the patient observed in follow-up is the final criterion for adequacy of therapy.

  • DOSAGE AND ADMINISTRATION:

    The adult dose is one capsule daily preferably on an empty stomach.

    Call your medical practitioner about side effects.You may report side effects by calling 337.662-5962.KEEP THIS OUT OF THE REACH OF CHILDREN.

    Do not exceed the recommended dose.

  • HOW SUPPLIED:

    Oval, brownish-orange softgel capsule with “ENL”7 on one side, in bottles of 30 with NDC 64661-711-30.

  • ​STORAGE:

    STORAGE: Store at 20°-25° C (68°-77° F)

    (Tamper Evident: Do not use if seal is broken or missing.)

    JAYMAC Pharmaceuticals, LLC, Sunset, LA 70584

    MANUFACTURED AND/OR PACKAGED IN USA/CANADA

    ​Rev Nov 19 2020

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL - 30 MULTIPHASIC SOFTGELS Bottle Label

    PRINCIPAL DISPLAY PANEL - 30 tablets

  • INGREDIENTS AND APPEARANCE
    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 capsule, delayed release pellets
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:64661-711
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LEUCOVORIN (UNII: Q573I9DVLP) (LEUCOVORIN - UNII:Q573I9DVLP) LEUCOVORIN2.5 mg
    FOLIC ACID (UNII: 935E97BOY8) (FOLIC ACID - UNII:935E97BOY8) FOLIC ACID1 mg
    LEVOMEFOLATE MAGNESIUM (UNII: 1VZZ62R081) (LEVOMEFOLIC ACID - UNII:8S95DH25XC) LEVOMEFOLIC ACID7 mg
    FERROUS CYSTEINE GLYCINATE (UNII: 8B4OP7RK5N) (FERROUS CATION - UNII:GW89581OWR) FERROUS CYSTEINE GLYCINATE13.6 mg
    1,2-DOCOSAHEXANOYL-SN-GLYCERO-3-PHOSPHOSERINE CALCIUM (UNII: 6WJM73T46K) (1,2-DOCOSAHEXANOYL-SN-GLYCERO-3-PHOSPHOSERINE - UNII:DVY07ILF1W) 1,2-DOCOSAHEXANOYL-SN-GLYCERO-3-PHOSPHOSERINE CALCIUM6.4 mg
    1,2-ICOSAPENTOYL-SN-GLYCERO-3-PHOSPHOSERINE CALCIUM (UNII: 9ABD9DRK7B) (1,2-ICOSAPENTOYL-SN-GLYCERO-3-PHOSPHOSERINE - UNII:C3019D8IIA) 1,2-ICOSAPENTOYL-SN-GLYCERO-3-PHOSPHOSERINE CALCIUM800 ug
    PHOSPHATIDYL SERINE (UNII: 394XK0IH40) (PHOSPHATIDYL SERINE - UNII:394XK0IH40) PHOSPHATIDYL SERINE12 mg
    PYRIDOXAL PHOSPHATE ANHYDROUS (UNII: F06SGE49M6) (PYRIDOXAL PHOSPHATE ANHYDROUS - UNII:F06SGE49M6) PYRIDOXAL PHOSPHATE ANHYDROUS25 ug
    FLAVIN ADENINE DINUCLEOTIDE (UNII: ZC44YTI8KK) (FLAVIN ADENINE DINUCLEOTIDE - UNII:ZC44YTI8KK) FLAVIN ADENINE DINUCLEOTIDE25 ug
    NADH (UNII: 4J24DQ0916) (NADH - UNII:4J24DQ0916) NADH25 ug
    COBAMAMIDE (UNII: F0R1QK73KB) (COBAMAMIDE - UNII:F0R1QK73KB) COBAMAMIDE50 ug
    COCARBOXYLASE (UNII: Q57971654Y) (COCARBOXYLASE - UNII:Q57971654Y) COCARBOXYLASE25 ug
    MAGNESIUM ASCORBATE (UNII: 0N1G678593) (ASCORBIC ACID - UNII:PQ6CK8PD0R) MAGNESIUM ASCORBATE24 mg
    ZINC ASCORBATE (UNII: 9TI35313XW) (ASCORBIC ACID - UNII:PQ6CK8PD0R) ZINC ASCORBATE1 mg
    MAGNESIUM L-THREONATE (UNII: 1Y26ZZ0OTM) (THREONIC ACID, L- - UNII:75B0PMW2JF) MAGNESIUM L-THREONATE1 mg
    BETAINE (UNII: 3SCV180C9W) (BETAINE - UNII:3SCV180C9W) BETAINE500 ug
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) (ANHYDROUS CITRIC ACID - UNII:XF417D3PSL) ANHYDROUS CITRIC ACID1.83 mg
    SODIUM CITRATE (UNII: 1Q73Q2JULR) (SODIUM CATION - UNII:LYR4M0NH37) SODIUM CITRATE3.67 mg
    Inactive Ingredients
    Ingredient NameStrength
    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)  
    Product Characteristics
    ColorBROWN (annatto) Scoreno score
    ShapeOVALSize14mm
    FlavorORANGE (creamy orange) Imprint Code ENL
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:64661-711-3030 in 1 BOTTLE; Type 0: Not a Combination Product08/12/2011
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other08/12/2011
    Labeler - Jaymac Pharmaceuticals LLC (830767260)
    Registrant - Jaymac Pharmaceuticals LLC (830767260)
    Establishment
    NameAddressID/FEIBusiness Operations
    Viva Pharmaceuticals INC253288898manufacture(64661-711)