{
  "meta": {
    "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.",
    "terms": "https://open.fda.gov/terms/",
    "license": "https://open.fda.gov/license/",
    "last_updated": "2026-07-11",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 2
    }
  },
  "results": [
    {
      "spl_product_data_elements": [
        "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 LEVOMEFOLATE MAGNESIUM LEVOMEFOLIC ACID LEUCOVORIN LEUCOVORIN FOLIC ACID FOLIC ACID FERROUS CYSTEINE GLYCINATE FERROUS CATION MAGNESIUM ASCORBATE ASCORBIC ACID ZINC ASCORBATE ASCORBIC ACID COCARBOXYLASE COCARBOXYLASE FLAVIN ADENINE DINUCLEOTIDE FLAVIN ADENINE DINUCLEOTIDE NADH NADH PYRIDOXAL PHOSPHATE ANHYDROUS PYRIDOXAL PHOSPHATE ANHYDROUS COBAMAMIDE COBAMAMIDE BETAINE BETAINE MAGNESIUM L-THREONATE THREONIC ACID, DL- 1,2-DOCOSAHEXANOYL-SN-GLYCERO-3-PHOSPHOSERINE CALCIUM 1,2-DOCOSAHEXANOYL-SN-GLYCERO-3-PHOSPHOSERINE 1,2-ICOSAPENTOYL-SN-GLYCERO-3-PHOSPHOSERINE CALCIUM 1,2-ICOSAPENTOYL-SN-GLYCERO-3-PHOSPHOSERINE PHOSPHATIDYL SERINE PHOSPHATIDYL SERINE ANNATTO GELATIN LECITHIN, SUNFLOWER PIPERINE WATER UBIDECARENONE YELLOW WAX ANNATTO oval ENL"
      ],
      "spl_unclassified_section": [
        "EnBrace HR ® with DeltaFolate™ [15 mg DFE Folate ] [50 mcg CBl] [1.5 mg Cys-Fe] ANTI-ANEMIA PREPARATION Low-IRON Prescription Prenatal Vitamin For Therapeutic Use SOFTGEL (30ct bottle) NDC 64661- 650 -30 Rx Only GLUTEN-FREE",
        "Rx ONLY KEEP OUT OF THE REACH OF CHILDREN. Tamper-Evident: Do not use if the seal is broken or missing. MANUFACTURED FOR: JayMac Pharmaceuticals, LLC; Sunset, LA 70584. MANUFACTURED IN INDIA / PACKAGED IN USA PATENTS: Patent applications pending . TRADEMARKS: EnBrace HR® is a registered mark of JayMac Pharmaceuticals. DeltaFolate™ is a use-trademark of JayMac Pharmaceuticals. Revision (February 4, 2026)"
      ],
      "description": [
        "DESCRIPTION: EnBrace HR® is an orally administered prescription prenatal vitamin for therapeutic use formulated for adult patients who are under specific and direct monitoring of a licensed medical practitioner. EnBrace HR® contains a small amount of iron and may be taken concurrently with iron supplementation. ​INGREDIENTS: Folic acid, DHF+ (B 9 -Provitamin) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . (1.7 mg DFE) 1 mg Folinic acid (B 9 -vitamer). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . (4.25 mg DFE) 2.5 mg Levomefolic acid (B 9 & B 12 - cofactor) . . . . . . . . . . . . . . . . . . . . . . . . . . (9 mg DFE) 5.23 mg Vitamin B 12 [cobamamide] . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .50 mcg 1 FeGC (1.5 mg elemental iron from ferrous glycine cysteinate) . . . . . . . . . . . . 13.6 mg 2,3"
      ],
      "inactive_ingredient": [
        "FUNCTIONAL EXCIPIENTS: 25 mg ascorbates 3,4 (24 mg magnesium l-ascorbate, 1 mg zinc l-ascorbate), 500 mcg betaine (trimethylglycine), flavin adenine dinucleotide 6 (FAD), 1 mg magnesium l-threonate, 25 mcg nicotinamide adenine dinucleotide hydride 6 (NADH), at least 23.33 mg phospholipid-omega 3 complex 5 [marine lipids], 25 mcg pyridoxal 5’ phosphate 6 (P5P), 25 mcg thiamine pyrophosphate 6 . OTHER EXCIPIENTS: Annatto [colorant], citrates (citric, sodium) [stabilizers], gelatin (bovine), glycerine, plant lipids (sunflower) [lecithin], natural orange flavor [masking], piperine [bioavailability enhancer], purified water, ubidecarenone [antioxidant], yellow beeswax. 1 The form most found in mammalian liver. 2 Pure amino acid, cysteinated iron chelate. 3 20% Daily Value (DV) of VITAMIN C, and 5% DV IRON for pregnancy. 4 NOT a significant source of magnesium and zinc. 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). 6 Contains less than 2% (<25 mcg/each) of vitamins B 1 , B 2 , B 3 , and B 6 ."
      ],
      "mechanism_of_action": [
        "MECHANISM OF ACTION: Vitamin B 12 [ TREATMENT ]; FOLATE [ PREVENTION ]; OTHER [ SUPPLEMENTATION ];"
      ],
      "indications_and_usage": [
        "INDICATIONS: EnBrace HR ® is indicated in the TREATMENT of vitamin deficiency - specifically vitamin B 12 deficiency, and the PREVENTION of vitamin B 12 -cofactor deficiency, l-methylfolate. Requirements of vitamin B 9 and/or vitamin B 12 in excess of normal due to pregnancy can usually be met with oral supplementation."
      ],
      "precautions": [
        "PRECAUTIONS ​: GENERAL: 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 folic acid (in preparations) is 1 mg [emphasis added]. Folic acid is not a substitute for vitamin B 12 - although it may improve vitamin B 12 -deficient megaloblastic anemia. Exclusive use of folic acid in treating vitamin B 12 -deficient megaloblastic anemia could result in progressive and irreversible neurologic damage. Specifically, vitamin B 12 deficiency allowed to progress over 3 months may produce permanent degenerative lesions of the spinal cord - as observed when folate therapy is used as the only hematopoietic agent. Doses of vitamin B 12 exceeding 10 mcg daily may produce hematologic response in patients with folate deficiency. Indiscriminate administration may mask the true diagnosis. A dietary deficiency of only vitamin B 12 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. DRUG INTERACTIONS: Colchicine, para-aminosalicylic acid, and heavy alcohol intake for longer than 2 weeks may produce malabsorption of vitamin B 12 . CARCINOGENESIS, MUTAGENESIS, IMPAIRMENT OF FERTILITY: There is no evidence from long-term use in patients with pernicious anemia that vitamin B 12 or folate is carcinogenic. Pernicious anemia is associated with increased incidence of carcinoma of the stomach, but this is believed to be related to the underlying pathology and not to treatment with vitamin B 12 . PREGNANCY, NURSING MOTHERS, PEDIATRIC USE: Vitamin B 9 and vitamin B 12 are essential vitamins and requirements are increased during pregnancy. Amounts of vitamin B 9 and vitamin B 12 that are recommended by the Food and Nutrition Board, National Academy of Science - National Research Council for lactating women should be consumed during pregnancy. Vitamin B 12 and vitamin B 9 appear in the milk of nursing mothers in concentrations which approximate the mother’s vitamin B 12 and vitamin B 9 blood level. Amounts of vitamin B12 that are recommended by the Food and Nutrition Board, National Academies of Science - National Research Council for lactating women should be consumed during lactation. Intake in pediatric patients should be in the amount recommended by the Food and Nutrition Board, National Academy of Science - National Research Council."
      ],
      "adverse_reactions": [
        "ADVERSE REACTIONS: Mild transient diarrhea, polycythemia vera, itching, transitory exanthema, feeling of swelling of entire body may occur with administration of vitamin B 12 . Allergic sensitization has been reported following both oral and parenteral administration of folic acid."
      ],
      "dosage_and_administration": [
        "DOSAGE AND ADMINISTRATION ​: The recommended dosage is one (1) capsule daily, preferably on an empty stomach. Dosage may be adjusted by a healthcare provider based on individual patient needs. As a general rule reticulocyte plasma count, folate and vitamin B 12 status must be obtained prior to treatment. Do not exceed the recommended dose. Call your medical practitioner about side effects. You may report side effects by calling (866) 280-5961."
      ],
      "how_supplied": [
        "HOW SUPPLIED: Oval, brownish-orange softgel capsule with imprint ENL ."
      ],
      "storage_and_handling": [
        "STORAGE: Store at 20°-25°C (68°-77°F). Protect from light and moisture."
      ],
      "package_label_principal_display_panel": [
        "PRINCIPAL DISPLAY PANEL: EnBrace HR ® with DeltaFolate TM NDC 64661- 650 -30 Rx Only [15 mg DFE Folate] [50 mcg CBI][1.5 MG FeGC] ANTI-ANEMIA PREPARATION Low-IRON JayMac Pharmaceuticals, LLC SOFTGEL (30 ct BOTTLE) Prescription Prenatal Vitamin For Therapeutic Use image description"
      ],
      "set_id": "6f14fa40-97ab-4ec5-b66b-793d6d1abac9",
      "id": "f9057685-e197-4b3d-a632-2d6263f606b2",
      "effective_time": "20260210",
      "version": "17",
      "openfda": {
        "brand_name": [
          "EnBrace HR"
        ],
        "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"
        ],
        "manufacturer_name": [
          "Jaymac Pharmaceuticals, LLC"
        ],
        "product_ndc": [
          "64661-650"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "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"
        ],
        "spl_id": [
          "f9057685-e197-4b3d-a632-2d6263f606b2"
        ],
        "spl_set_id": [
          "6f14fa40-97ab-4ec5-b66b-793d6d1abac9"
        ],
        "package_ndc": [
          "64661-650-30"
        ],
        "is_original_packager": [
          true
        ],
        "upc": [
          "0364661650302"
        ],
        "nui": [
          "N0000175804",
          "N0000175805",
          "N0000178369",
          "M0008658"
        ],
        "pharm_class_moa": [
          "Methylating Activity [MoA]"
        ],
        "pharm_class_epc": [
          "Methylating Agent [EPC]",
          "Folate Analog [EPC]"
        ],
        "pharm_class_cs": [
          "Folic Acid [CS]"
        ],
        "unii": [
          "6WJM73T46K",
          "9ABD9DRK7B",
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          "Q57971654Y",
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          "F06SGE49M6",
          "9TI35313XW"
        ]
      }
    }
  ]
}