MedPath
FDA Product

Vitafol Ultra

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

Basic Information

Vitafol Ultra

0642-0093

Regulatory Information

0642-0093

March 14, 2023

0642-0093-30 Vitafol Ultra Prenatal Supplement with DHA Rx

HUMAN PRESCRIPTION DRUG LABEL

8

Company Information

Exeltis USA, Inc.

071170534

Active Ingredients

GLYCERIN

Code: PDC6A3C0OX

Class Code: IACT

WATER

Code: 059QF0KO0R

Class Code: IACT

YELLOW WAX

Code: 2ZA36H0S2V

Class Code: IACT

MANNITOL

Code: 3OWL53L36A

Class Code: IACT

GELATIN, UNSPECIFIED

Code: 2G86QN327L

Class Code: IACT

SORBITOL

Code: 506T60A25R

Class Code: IACT

LECITHIN, SOYBEAN

Code: 1DI56QDM62

Class Code: IACT

TITANIUM DIOXIDE

Code: 15FIX9V2JP

Class Code: IACT

SOYBEAN OIL

Code: 241ATL177A

Class Code: IACT

SUNFLOWER OIL

Code: 3W1JG795YI

Class Code: IACT

FD&C BLUE NO. 1

Code: H3R47K3TBD

Class Code: IACT

ETHYL VANILLIN

Code: YC9ST449YJ

Class Code: IACT

NIACINAMIDE

Quantity: 15 mg in 1 1

Code: 25X51I8RD4

Class Code: ACTIB

DOCONEXENT

Quantity: 200 mg in 1 1

Code: ZAD9OKH9JC

Class Code: ACTIB

OLIVE OIL

Code: 6UYK2W1W1E

Class Code: IACT

CELLULOSE, MICROCRYSTALLINE

Code: OP1R32D61U

Class Code: IACT

CHOLECALCIFEROL

Quantity: 25 ug in 1 1

Code: 1C6V77QF41

Class Code: ACTIB

BETA CAROTENE

Quantity: 330 ug in 1 1

Code: 01YAE03M7J

Class Code: ACTIB

THIAMINE MONONITRATE

Quantity: 1.6 mg in 1 1

Code: 8K0I04919X

Class Code: ACTIR

ASCORBIC ACID

Quantity: 30 mg in 1 1

Code: PQ6CK8PD0R

Class Code: ACTIB

RIBOFLAVIN

Quantity: 1.8 mg in 1 1

Code: TLM2976OFR

Class Code: ACTIB

PYRIDOXINE HYDROCHLORIDE

Quantity: 2.5 mg in 1 1

Code: 68Y4CF58BV

Class Code: ACTIB

IRON

Quantity: 29 mg in 1 1

Code: E1UOL152H7

Class Code: ACTIB

CYANOCOBALAMIN

Quantity: 12 ug in 1 1

Code: P6YC3EG204

Class Code: ACTIB

ZINC OXIDE

Quantity: 25 mg in 1 1

Code: SOI2LOH54Z

Class Code: ACTIB

POTASSIUM IODIDE

Quantity: 150 ug in 1 1

Code: 1C4QK22F9J

Class Code: ACTIM

CUPRIC OXIDE

Quantity: 2 mg in 1 1

Code: V1XJQ704R4

Class Code: ACTIM

MAGNESIUM OXIDE

Quantity: 20 mg in 1 1

Code: 3A3U0GI71G

Class Code: ACTIB

FOLIC ACID

Quantity: 680 ug in 1 1

Code: 935E97BOY8

Class Code: ACTIB

LEVOMEFOLATE CALCIUM

Quantity: 1020 ug in 1 1

Code: A9R10K3F2F

Class Code: ACTIB

.ALPHA.-TOCOPHEROL ACETATE, DL-

Quantity: 9 mg in 1 1

Code: WR1WPI7EW8

Class Code: ACTIM

Active Moieties

NIACINAMIDE

Code: 25X51I8RD4

CHOLECALCIFEROL

Code: 1C6V77QF41

DOCONEXENT

Code: ZAD9OKH9JC

RIBOFLAVIN

Code: TLM2976OFR

PYRIDOXINE

Code: KV2JZ1BI6Z

THIAMINE ION

Code: 4ABT0J945J

.ALPHA.-TOCOPHEROL, DL-

Code: 7QWA1RIO01

BETA CAROTENE

Code: 01YAE03M7J

ASCORBIC ACID

Code: PQ6CK8PD0R

CYANOCOBALAMIN

Code: P6YC3EG204

IRON

Code: E1UOL152H7

ZINC OXIDE

Code: SOI2LOH54Z

CUPRIC CATION

Code: 8CBV67279L

IODIDE ION

Code: 09G4I6V86Q

FOLIC ACID

Code: 935E97BOY8

MAGNESIUM CATION

Code: T6V3LHY838

LEVOMEFOLIC ACID

Code: 8S95DH25XC

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