MedPath
FDA Product

Prenate Essential

Product approved by U.S. Food and Drug Administration (US)

Basic Information

Prenate Essential

75854-313

Regulatory Information

75854-313

January 7, 2021

PRENATE ESSENTIAL

HUMAN PRESCRIPTION DRUG LABEL

6

Company Information

040348516

Active Ingredients

ICOSAPENT

Quantity: 40 mg in 1 1

Code: AAN7QOV9EA

Class Code: ACTIB

GELATIN

Code: 2G86QN327L

Class Code: IACT

GLYCERIN

Code: PDC6A3C0OX

Class Code: IACT

LECITHIN, SOYBEAN

Code: 1DI56QDM62

Class Code: IACT

WHITE WAX

Code: 7G1J5DA97F

Class Code: IACT

WATER

Code: 059QF0KO0R

Class Code: IACT

SOYBEAN OIL

Code: 241ATL177A

Class Code: IACT

TITANIUM DIOXIDE

Code: 15FIX9V2JP

Class Code: IACT

FD&C YELLOW NO. 5

Code: I753WB2F1M

Class Code: IACT

FD&C BLUE NO. 1

Code: H3R47K3TBD

Class Code: IACT

FD&C YELLOW NO. 6

Code: H77VEI93A8

Class Code: IACT

ASCORBIC ACID

Quantity: 90 mg in 1 1

Code: PQ6CK8PD0R

Class Code: ACTIB

CHOLECALCIFEROL

Quantity: 220 [iU] in 1 1

Code: 1C6V77QF41

Class Code: ACTIB

PYRIDOXINE HYDROCHLORIDE

Quantity: 26 mg in 1 1

Code: 68Y4CF58BV

Class Code: ACTIM

FOLIC ACID

Quantity: 400 ug in 1 1

Code: 935E97BOY8

Class Code: ACTIB

5-METHYLTETRAHYDROFOLIC ACID

Quantity: 600 ug in 1 1

Code: TYK22LML8F

Class Code: ACTIM

CYANOCOBALAMIN

Quantity: 13 ug in 1 1

Code: P6YC3EG204

Class Code: ACTIB

BIOTIN

Quantity: 280 ug in 1 1

Code: 6SO6U10H04

Class Code: ACTIB

CALCIUM FORMATE

Quantity: 155 mg in 1 1

Code: NP3JD65NPY

Class Code: ACTIM

FERROUS ASPARTO GLYCINATE

Quantity: 18 mg in 1 1

Code: H7426RGB3L

Class Code: ACTIM

POTASSIUM IODIDE

Quantity: 150 ug in 1 1

Code: 1C4QK22F9J

Class Code: ACTIM

MAGNESIUM OXIDE

Quantity: 50 mg in 1 1

Code: 3A3U0GI71G

Class Code: ACTIM

DOCONEXENT

Quantity: 300 mg in 1 1

Code: ZAD9OKH9JC

Class Code: ACTIB

.ALPHA.-TOCOPHEROL ACETATE, DL-

Quantity: 10 [iU] in 1 1

Code: WR1WPI7EW8

Class Code: ACTIM

Active Moieties

ICOSAPENT

Code: AAN7QOV9EA

ASCORBIC ACID

Code: PQ6CK8PD0R

CHOLECALCIFEROL

Code: 1C6V77QF41

.ALPHA.-TOCOPHEROL, DL-

Code: 7QWA1RIO01

PYRIDOXINE

Code: KV2JZ1BI6Z

FOLIC ACID

Code: 935E97BOY8

5-METHYLTETRAHYDROFOLIC ACID

Code: TYK22LML8F

CYANOCOBALAMIN

Code: P6YC3EG204

BIOTIN

Code: 6SO6U10H04

CALCIUM CATION

Code: 2M83C4R6ZB

FERROUS CATION

Code: GW89581OWR

IODIDE ION

Code: 09G4I6V86Q

MAGNESIUM CATION

Code: T6V3LHY838

DOCONEXENT

Code: ZAD9OKH9JC

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