EnBrace HR

Registrants1

Companies and organizations registered with the FDA for this drug approval, including their contact information and regulatory details.

Jaymac Pharma

DUNS Number

830767260

Manufacturing Establishments1

FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.

Ocean Healthcare Pvt Ltd

Labeler

Jaymac Pharma

Registrant

Jaymac Pharma

DUNS Number

873673519

Products1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Product Details

NDC Product Code

64661-650

Route of Administration

ORAL

Effective Date

June 9, 2019

Ingredients

Folic acidActive

Code: 935E97BOY8Class: ACTIBQuantity: 1 mg in 1 1

ANNATTOInactive

Code: 6PQP1V1B6OClass: IACT

UBIDECARENONEInactive

Code: EJ27X76M46Class: IACT

levomefolate magnesiumActive

Code: 1VZZ62R081Class: ACTIMQuantity: 5.23 mg in 1 1

LeucovorinActive

Code: Q573I9DVLPClass: ACTIBQuantity: 2.5 mg in 1 1

Ferrous cysteine glycinateActive

Code: 8B4OP7RK5NClass: ACTIBQuantity: 13.6 mg in 1 1

Magnesium ascorbateActive

Code: 0N1G678593Class: ACTIBQuantity: 24 mg in 1 1

Zinc ascorbateActive

Code: 9TI35313XWClass: ACTIBQuantity: 1 mg in 1 1

CocarboxylaseActive

Code: Q57971654YClass: ACTIBQuantity: 25 ug in 1 1

Flavin adenine dinucleotideActive

Code: ZC44YTI8KKClass: ACTIBQuantity: 25 ug in 1 1

NADHActive

Code: 4J24DQ0916Class: ACTIBQuantity: 25 ug in 1 1

Pyridoxal phosphateActive

Code: F06SGE49M6Class: ACTIBQuantity: 25 ug in 1 1

CobamamideActive

Code: F0R1QK73KBClass: ACTIBQuantity: 50 ug in 1 1

BetaineActive

Code: 3SCV180C9WClass: ACTIBQuantity: 500 ug in 1 1

magnesium l-threonateActive

Code: 1Y26ZZ0OTMClass: ACTIBQuantity: 1 mg in 1 1

1,2-Docosahexanoyl-sn-glycero-3-phosphoserineActive

Code: 6WJM73T46KClass: ACTIBQuantity: 6.4 mg in 1 1

Phosphatidyl serineActive

Code: 394XK0IH40Class: ACTIBQuantity: 12 mg in 1 1

GELATINInactive

Code: 2G86QN327LClass: IACT

LECITHIN, SUNFLOWERInactive

Code: 834K0WOS5GClass: IACT

PIPERINEInactive

Code: U71XL721QKClass: IACT

WATERInactive

Code: 059QF0KO0RClass: IACT

YELLOW WAXInactive

Code: 2ZA36H0S2VClass: IACT

1,2-icosapentoyl-sn-glycero-3-phosphoserineActive

Code: 9ABD9DRK7BClass: ACTIBQuantity: 800 ug in 1 1

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EnBrace HR

FDA Approval Summary

Registrants1

Manufacturing Establishments1

Ocean Healthcare Pvt Ltd

Products1

EnBrace HR

Product Details