MedPath
FDA Product

Prenate Elite

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

Basic Information

Prenate Elite

75854-314

Regulatory Information

75854-314

January 7, 2021

PRENATE ELITE

HUMAN PRESCRIPTION DRUG LABEL

6

Company Information

040348516

Active Ingredients

POWDERED CELLULOSE

Code: SMD1X3XO9M

Class Code: IACT

SILICON DIOXIDE

Code: ETJ7Z6XBU4

Class Code: IACT

CROSCARMELLOSE SODIUM

Code: M28OL1HH48

Class Code: IACT

STEARIC ACID

Code: 4ELV7Z65AP

Class Code: IACT

MAGNESIUM STEARATE

Code: 70097M6I30

Class Code: IACT

HYPROMELLOSES

Code: 3NXW29V3WO

Class Code: IACT

TRIACETIN

Code: XHX3C3X673

Class Code: IACT

TITANIUM DIOXIDE

Code: 15FIX9V2JP

Class Code: IACT

BIOTIN

Quantity: 330 ug in 1 1

Code: 6SO6U10H04

Class Code: ACTIB

POTASSIUM IODIDE

Quantity: 150 ug in 1 1

Code: 1C4QK22F9J

Class Code: ACTIM

MAGNESIUM OXIDE

Quantity: 25 mg in 1 1

Code: 3A3U0GI71G

Class Code: ACTIM

.BETA.-CAROTENE

Quantity: 2600 [iU] in 1 1

Code: 01YAE03M7J

Class Code: ACTIB

ASCORBIC ACID

Quantity: 75 mg in 1 1

Code: PQ6CK8PD0R

Class Code: ACTIB

CHOLECALCIFEROL

Quantity: 600 [iU] in 1 1

Code: 1C6V77QF41

Class Code: ACTIB

THIAMINE MONONITRATE

Quantity: 3 mg in 1 1

Code: 8K0I04919X

Class Code: ACTIR

RIBOFLAVIN

Quantity: 3.5 mg in 1 1

Code: TLM2976OFR

Class Code: ACTIB

NIACINAMIDE

Quantity: 21 mg in 1 1

Code: 25X51I8RD4

Class Code: ACTIB

PYRIDOXINE HYDROCHLORIDE

Quantity: 21 mg in 1 1

Code: 68Y4CF58BV

Class Code: ACTIB

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

CALCIUM FORMATE

Quantity: 155 mg in 1 1

Code: NP3JD65NPY

Class Code: ACTIM

FERROUS ASPARTO GLYCINATE

Quantity: 20 mg in 1 1

Code: H7426RGB3L

Class Code: ACTIM

CYANOCOBALAMIN

Quantity: 13 ug in 1 1

Code: P6YC3EG204

Class Code: ACTIB

ZINC OXIDE

Quantity: 15 mg in 1 1

Code: SOI2LOH54Z

Class Code: ACTIM

CUPRIC OXIDE

Quantity: 1.5 mg in 1 1

Code: V1XJQ704R4

Class Code: ACTIM

.ALPHA.-TOCOPHEROL ACETATE, DL-

Quantity: 40 [iU] in 1 1

Code: WR1WPI7EW8

Class Code: ACTIM

Active Moieties

.BETA.-CAROTENE

Code: 01YAE03M7J

ASCORBIC ACID

Code: PQ6CK8PD0R

CHOLECALCIFEROL

Code: 1C6V77QF41

.ALPHA.-TOCOPHEROL, DL-

Code: 7QWA1RIO01

THIAMINE ION

Code: 4ABT0J945J

RIBOFLAVIN

Code: TLM2976OFR

NIACINAMIDE

Code: 25X51I8RD4

PYRIDOXINE

Code: KV2JZ1BI6Z

FOLIC ACID

Code: 935E97BOY8

5-METHYLTETRAHYDROFOLIC ACID

Code: TYK22LML8F

CALCIUM CATION

Code: 2M83C4R6ZB

FERROUS CATION

Code: GW89581OWR

CYANOCOBALAMIN

Code: P6YC3EG204

BIOTIN

Code: 6SO6U10H04

IODIDE ION

Code: 09G4I6V86Q

MAGNESIUM CATION

Code: T6V3LHY838

ZINC CATION

Code: 13S1S8SF37

CUPRIC CATION

Code: 8CBV67279L

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