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

EnBrace HR is a Oral Capsule, Delayed Release Pellets in the Human Prescription Drug category. It is labeled and distributed by Jaymac Pharma. The primary component is 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.

• Product ID: 64661-650_1251bc0d-1b8b-4597-a23a-c94dab3b1fb5
• NDC: 64661-650
• Product Type: Human Prescription Drug
• Proprietary 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
• Dosage Form: Capsule, Delayed Release Pellets
• Route of Administration: ORAL
• Marketing Start Date: 2011-08-12
• Marketing Category: UNAPPROVED DRUG OTHER / UNAPPROVED DRUG OTHER
• Labeler Name: Jaymac Pharma
• 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
• Active Ingredient Strength: 6 mg/1; ug/1; ug/1; ug/1; ug/1; mg/1; ug/1; mg/1; mg/1; mg/1; mg/1; mg/1; ug/1; mg/1; ug/1; mg/1
• Pharm Classes: Ascorbic Acid [CS], Ascorbic Acid [CS], Folate Analog [EPC], Folic Acid [CS], Methylating Activity [MoA], Methylating Agent [EPC], Vitamin C [EPC], Vitamin C [EPC]
• NDC Exclude Flag: N
• Listing Certified Through: 2023-12-31

Packaging

NDC 64661-650-30

30 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE (64661-650-30)

• Marketing Start Date: 2011-08-12
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 64661-650-30 [64661065030]

EnBrace HR CAPSULE, DELAYED RELEASE PELLETS

• Marketing Category: UNAPPROVED DRUG OTHER
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2011-08-12

Drug Details

Active Ingredients

Ingredient	Strength
LEVOMEFOLATE MAGNESIUM	5.23 mg/1

OpenFDA Data

• SPL SET ID: 6f14fa40-97ab-4ec5-b66b-793d6d1abac9
• Manufacturer:
  • JAYMAC Pharmaceuticals, LLC
• UNII:
  • 1VZZ62R081
  • 8B4OP7RK5N
  • F0R1QK73KB
  • 3SCV180C9W
  • ZC44YTI8KK
  • 9ABD9DRK7B
  • F06SGE49M6
  • 0N1G678593
  • Q573I9DVLP
  • 1Y26ZZ0OTM
  • 394XK0IH40
  • Q57971654Y
  • 4J24DQ0916
  • 935E97BOY8
  • 6WJM73T46K
  • 9TI35313XW
• PHarm Class EPC:
  • Folate Analog [EPC]
• UPC Code:
  • 0364661650302
• NUI Code:
  • N0000178369
  • N0000175452
  • N0000007151

Pharmacological Class

• Folate Analog [EPC]
• Folic Acid [Chemical/Ingredient]
• Analogs/Derivatives [Chemical/Ingredient]
• Vitamin C [EPC]
• Ascorbic Acid [CS]
• Vitamin C [EPC]
• Ascorbic Acid [CS]
• Methylating Activity [MoA]
• Methylating Agent [EPC]