enbrace hr

Generic: 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

Labeler: jaymac pharmaceuticals, llc
NDC Directory HUMAN PRESCRIPTION DRUG UNAPPROVED DRUG OTHER Inactive Finished

Drug Facts

Product Profile

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
Labeler jaymac pharmaceuticals, llc
Dosage Form CAPSULE, DELAYED RELEASE PELLETS
Routes
ORAL
Active Ingredients

1,2-docosahexanoyl-sn-glycero-3-phosphoserine calcium 6.4 mg/1, 1,2-icosapentoyl-sn-glycero-3-phosphoserine calcium 800 ug/1, betaine 500 ug/1, cobamamide 50 ug/1, cocarboxylase 25 ug/1, ferrous cysteine glycinate 13.6 mg/1, flavin adenine dinucleotide 25 ug/1, folic acid 1 mg/1, leucovorin 2.5 mg/1, levomefolate magnesium 5.23 mg/1, magnesium ascorbate 24 mg/1, magnesium l-threonate 1 mg/1, nadh 25 ug/1, phosphatidyl serine 12 mg/1, pyridoxal phosphate anhydrous 25 ug/1, zinc ascorbate 1 mg/1

Manufacturer
Jaymac Pharmaceuticals, LLC

Identifiers & Regulatory

Product NDC 64661-650
Product ID 64661-650_f9057685-e197-4b3d-a632-2d6263f606b2
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category UNAPPROVED DRUG OTHER
Listing Expiration 2027-12-31
Marketing Start 2011-08-12

Pharmacologic Class

Established (EPC)
methylating agent [epc] folate analog [epc]
Mechanism of Action
methylating activity [moa]
Chemical Structure
folic acid [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 64661650
Hyphenated Format 64661-650

Supplemental Identifiers

UPC
0364661650302
UNII
6WJM73T46K 9ABD9DRK7B 3SCV180C9W F0R1QK73KB Q57971654Y 8B4OP7RK5N ZC44YTI8KK 935E97BOY8 Q573I9DVLP 1VZZ62R081 0N1G678593 1Y26ZZ0OTM 4J24DQ0916 394XK0IH40 F06SGE49M6 9TI35313XW
NUI
N0000175804 N0000175805 N0000178369 M0008658

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name enbrace hr (source: ndc)
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 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 6.4 mg/1
  • 800 ug/1
  • 500 ug/1
  • 50 ug/1
  • 25 ug/1
  • 13.6 mg/1
  • 1 mg/1
  • 2.5 mg/1
  • 5.23 mg/1
  • 24 mg/1
  • 12 mg/1
source: ndc
Packaging
  • 30 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE (64661-650-30)
source: ndc

Packages (1)

Ingredients (16)

1,2-docosahexanoyl-sn-glycero-3-phosphoserine calcium (6.4 mg/1) 1,2-icosapentoyl-sn-glycero-3-phosphoserine calcium (800 ug/1) betaine (500 ug/1) cobamamide (50 ug/1) cocarboxylase (25 ug/1) ferrous cysteine glycinate (13.6 mg/1) flavin adenine dinucleotide (25 ug/1) folic acid (1 mg/1) leucovorin (2.5 mg/1) levomefolate magnesium (5.23 mg/1) magnesium ascorbate (24 mg/1) magnesium l-threonate (1 mg/1) nadh (25 ug/1) phosphatidyl serine (12 mg/1) pyridoxal phosphate anhydrous (25 ug/1) zinc ascorbate (1 mg/1)

Linked Drug Pages (1)

Raw FDA Data

View complete raw FDA NDC JSON payload
{"route": ["ORAL"], "spl_id": "f9057685-e197-4b3d-a632-2d6263f606b2", "openfda": {"nui": ["N0000175804", "N0000175805", "N0000178369", "M0008658"], "upc": ["0364661650302"], "unii": ["6WJM73T46K", "9ABD9DRK7B", "3SCV180C9W", "F0R1QK73KB", "Q57971654Y", "8B4OP7RK5N", "ZC44YTI8KK", "935E97BOY8", "Q573I9DVLP", "1VZZ62R081", "0N1G678593", "1Y26ZZ0OTM", "4J24DQ0916", "394XK0IH40", "F06SGE49M6", "9TI35313XW"], "spl_set_id": ["6f14fa40-97ab-4ec5-b66b-793d6d1abac9"], "pharm_class_cs": ["Folic Acid [CS]"], "pharm_class_epc": ["Methylating Agent [EPC]", "Folate Analog [EPC]"], "pharm_class_moa": ["Methylating Activity [MoA]"], "manufacturer_name": ["Jaymac Pharmaceuticals, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE (64661-650-30)", "package_ndc": "64661-650-30", "marketing_start_date": "20110812"}], "brand_name": "EnBrace HR", "product_id": "64661-650_f9057685-e197-4b3d-a632-2d6263f606b2", "dosage_form": "CAPSULE, DELAYED RELEASE PELLETS", "pharm_class": ["Ascorbic Acid [CS]", "Ascorbic Acid [CS]", "Folate Analog [EPC]", "Folate Analog [EPC]", "Folic Acid [CS]", "Folic Acid [CS]", "Methylating Activity [MoA]", "Methylating Agent [EPC]", "Vitamin C [EPC]", "Vitamin C [EPC]"], "product_ndc": "64661-650", "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", "labeler_name": "Jaymac Pharmaceuticals, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "EnBrace HR", "active_ingredients": [{"name": "1,2-DOCOSAHEXANOYL-SN-GLYCERO-3-PHOSPHOSERINE CALCIUM", "strength": "6.4 mg/1"}, {"name": "1,2-ICOSAPENTOYL-SN-GLYCERO-3-PHOSPHOSERINE CALCIUM", "strength": "800 ug/1"}, {"name": "BETAINE", "strength": "500 ug/1"}, {"name": "COBAMAMIDE", "strength": "50 ug/1"}, {"name": "COCARBOXYLASE", "strength": "25 ug/1"}, {"name": "FERROUS CYSTEINE GLYCINATE", "strength": "13.6 mg/1"}, {"name": "FLAVIN ADENINE DINUCLEOTIDE", "strength": "25 ug/1"}, {"name": "FOLIC ACID", "strength": "1 mg/1"}, {"name": "LEUCOVORIN", "strength": "2.5 mg/1"}, {"name": "LEVOMEFOLATE MAGNESIUM", "strength": "5.23 mg/1"}, {"name": "MAGNESIUM ASCORBATE", "strength": "24 mg/1"}, {"name": "MAGNESIUM L-THREONATE", "strength": "1 mg/1"}, {"name": "NADH", "strength": "25 ug/1"}, {"name": "PHOSPHATIDYL SERINE", "strength": "12 mg/1"}, {"name": "PYRIDOXAL PHOSPHATE ANHYDROUS", "strength": "25 ug/1"}, {"name": "ZINC ASCORBATE", "strength": "1 mg/1"}], "marketing_category": "UNAPPROVED DRUG OTHER", "marketing_start_date": "20110812", "listing_expiration_date": "20271231"}