EnBrace HR
EnBrace HR™
Approved
Approval ID
6f14fa40-97ab-4ec5-b66b-793d6d1abac9
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 15, 2023
Manufacturers
FDA
Jaymac Pharma
DUNS: 830767260
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
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
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code64661-650
Product Classification
G
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
Product Specifications
Route of AdministrationORAL
Effective DateJune 9, 2019
FDA Product Classification
INGREDIENTS (23)
FOLIC ACIDActive
Quantity: 1 mg in 1 1
Code: 935E97BOY8
Classification: ACTIB
ANNATTOInactive
Code: 6PQP1V1B6O
Classification: IACT
UBIDECARENONEInactive
Code: EJ27X76M46
Classification: IACT
LEVOMEFOLATE MAGNESIUMActive
Quantity: 5.23 mg in 1 1
Code: 1VZZ62R081
Classification: ACTIM
LEUCOVORINActive
Quantity: 2.5 mg in 1 1
Code: Q573I9DVLP
Classification: ACTIB
FERROUS CYSTEINE GLYCINATEActive
Quantity: 13.6 mg in 1 1
Code: 8B4OP7RK5N
Classification: ACTIB
MAGNESIUM ASCORBATEActive
Quantity: 24 mg in 1 1
Code: 0N1G678593
Classification: ACTIB
ZINC ASCORBATEActive
Quantity: 1 mg in 1 1
Code: 9TI35313XW
Classification: ACTIB
COCARBOXYLASEActive
Quantity: 25 ug in 1 1
Code: Q57971654Y
Classification: ACTIB
FLAVIN ADENINE DINUCLEOTIDEActive
Quantity: 25 ug in 1 1
Code: ZC44YTI8KK
Classification: ACTIB
NADHActive
Quantity: 25 ug in 1 1
Code: 4J24DQ0916
Classification: ACTIB
PYRIDOXAL PHOSPHATE ANHYDROUSActive
Quantity: 25 ug in 1 1
Code: F06SGE49M6
Classification: ACTIB
COBAMAMIDEActive
Quantity: 50 ug in 1 1
Code: F0R1QK73KB
Classification: ACTIB
BETAINEActive
Quantity: 500 ug in 1 1
Code: 3SCV180C9W
Classification: ACTIB
MAGNESIUM L-THREONATEActive
Quantity: 1 mg in 1 1
Code: 1Y26ZZ0OTM
Classification: ACTIB
1,2-DOCOSAHEXANOYL-SN-GLYCERO-3-PHOSPHOSERINE CALCIUMActive
Quantity: 6.4 mg in 1 1
Code: 6WJM73T46K
Classification: ACTIB
PHOSPHATIDYL SERINEActive
Quantity: 12 mg in 1 1
Code: 394XK0IH40
Classification: ACTIB
GELATINInactive
Code: 2G86QN327L
Classification: IACT
LECITHIN, SUNFLOWERInactive
Code: 834K0WOS5G
Classification: IACT
PIPERINEInactive
Code: U71XL721QK
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
YELLOW WAXInactive
Code: 2ZA36H0S2V
Classification: IACT
1,2-ICOSAPENTOYL-SN-GLYCERO-3-PHOSPHOSERINE CALCIUMActive
Quantity: 800 ug in 1 1
Code: 9ABD9DRK7B
Classification: ACTIB