MedPath
FDA Product

Folitin-Z

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

Basic Information

Folitin-Z

59088-181

Regulatory Information

59088-181

January 11, 2023

Folitin-Z™

HUMAN PRESCRIPTION DRUG LABEL

5

Company Information

785961046

Active Ingredients

MICROCRYSTALLINE CELLULOSE

Code: OP1R32D61U

Class Code: IACT

CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED

Code: K679OBS311

Class Code: IACT

ICODEXTRIN

Code: 2NX48Z0A9G

Class Code: IACT

STEARIC ACID

Code: 4ELV7Z65AP

Class Code: IACT

FD&C YELLOW NO. 6

Code: H77VEI93A8

Class Code: IACT

ASCORBIC ACID

Quantity: 250 mg in 1 1

Code: PQ6CK8PD0R

Class Code: ACTIB

VITAMIN A ACETATE

Quantity: 1500 ug in 1 1

Code: 3LE3D9D6OY

Class Code: ACTIM

CHOLECALCIFEROL

Quantity: 13.75 ug in 1 1

Code: 1C6V77QF41

Class Code: ACTIB

RIBOFLAVIN

Quantity: 3.35 mg in 1 1

Code: TLM2976OFR

Class Code: ACTIB

NIACINAMIDE

Quantity: 22.5 mg in 1 1

Code: 25X51I8RD4

Class Code: ACTIB

THIAMINE MONONITRATE

Quantity: 3.25 mg in 1 1

Code: 8K0I04919X

Class Code: ACTIR

FOLIC ACID

Quantity: 500 ug in 1 1

Code: 935E97BOY8

Class Code: ACTIB

PYRIDOXINE HYDROCHLORIDE

Quantity: 6 mg in 1 1

Code: 68Y4CF58BV

Class Code: ACTIM

CYANOCOBALAMIN

Quantity: 13 ug in 1 1

Code: P6YC3EG204

Class Code: ACTIB

PANTOTHENIC ACID

Quantity: 15 mg in 1 1

Code: 19F5HK2737

Class Code: ACTIB

CALCIUM CARBONATE

Quantity: 75 mg in 1 1

Code: H0G9379FGK

Class Code: ACTIM

FERROUS FUMARATE

Quantity: 9 mg in 1 1

Code: R5L488RY0Q

Class Code: ACTIM

ZINC OXIDE

Quantity: 15 mg in 1 1

Code: SOI2LOH54Z

Class Code: ACTIM

CUPROUS OXIDE

Quantity: 1 mg in 1 1

Code: T8BEA5064F

Class Code: ACTIB

SELENIUM

Quantity: 30 ug in 1 1

Code: H6241UJ22B

Class Code: ACTIB

CHROMIUM NICOTINATE

Quantity: 37.5 ug in 1 1

Code: A150AY412V

Class Code: ACTIB

MANGANESE SULFATE

Quantity: 0.75 mg in 1 1

Code: W00LYS4T26

Class Code: ACTIM

POTASSIUM CHLORIDE

Quantity: 24.5 mg in 1 1

Code: 660YQ98I10

Class Code: ACTIM

BORON

Quantity: 25 ug in 1 1

Code: N9E3X5056Q

Class Code: ACTIB

CROSPOVIDONE

Code: 2S7830E561

Class Code: IACT

SILICON DIOXIDE

Code: ETJ7Z6XBU4

Class Code: IACT

MAGNESIUM STEARATE

Code: 70097M6I30

Class Code: IACT

DEXTROSE MONOHYDRATE

Code: LX22YL083G

Class Code: IACT

TITANIUM DIOXIDE

Code: 15FIX9V2JP

Class Code: IACT

BIOTIN

Quantity: 100 ug in 1 1

Code: 6SO6U10H04

Class Code: ACTIB

POTASSIUM IODIDE

Quantity: 25 ug in 1 1

Code: 1C4QK22F9J

Class Code: ACTIM

MAGNESIUM OXIDE

Quantity: 37.5 mg in 1 1

Code: 3A3U0GI71G

Class Code: ACTIM

MOLYBDENUM

Quantity: 25 ug in 1 1

Code: 81AH48963U

Class Code: ACTIB

.ALPHA.-TOCOPHEROL ACETATE, DL-

Quantity: 45 mg in 1 1

Code: WR1WPI7EW8

Class Code: ACTIM

Active Moieties

ASCORBIC ACID

Code: PQ6CK8PD0R

CHOLECALCIFEROL

Code: 1C6V77QF41

VITAMIN A

Code: 81G40H8B0T

THIAMINE ION

Code: 4ABT0J945J

.ALPHA.-TOCOPHEROL, DL-

Code: 7QWA1RIO01

RIBOFLAVIN

Code: TLM2976OFR

FOLIC ACID

Code: 935E97BOY8

PANTOTHENIC ACID

Code: 19F5HK2737

NIACINAMIDE

Code: 25X51I8RD4

BIOTIN

Code: 6SO6U10H04

CALCIUM CATION

Code: 2M83C4R6ZB

IODIDE ION

Code: 09G4I6V86Q

PYRIDOXINE

Code: KV2JZ1BI6Z

CYANOCOBALAMIN

Code: P6YC3EG204

FERROUS CATION

Code: GW89581OWR

MAGNESIUM CATION

Code: T6V3LHY838

SELENIUM

Code: H6241UJ22B

CUPROUS OXIDE

Code: T8BEA5064F

ZINC CATION

Code: 13S1S8SF37

MANGANESE CATION (2+)

Code: H6EP7W5457

MOLYBDENUM

Code: 81AH48963U

NIACIN

Code: 2679MF687A

POTASSIUM CATION

Code: 295O53K152

BORON

Code: N9E3X5056Q

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