MedPath
FDA Product

Prometa

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

Basic Information

Prometa

59088-172

Regulatory Information

59088-172

February 8, 2023

Prometa & Prenatryl

HUMAN PRESCRIPTION DRUG LABEL

10

Company Information

785961046

Active Ingredients

CROSCARMELLOSE SODIUM

Code: M28OL1HH48

Class Code: IACT

MAGNESIUM STEARATE

Code: 70097M6I30

Class Code: IACT

MICROCRYSTALLINE CELLULOSE

Code: OP1R32D61U

Class Code: IACT

CROSPOVIDONE

Code: 2S7830E561

Class Code: IACT

STEARIC ACID

Code: 4ELV7Z65AP

Class Code: IACT

POLYETHYLENE GLYCOL 400

Code: B697894SGQ

Class Code: IACT

MAGNESIUM OXIDE

Quantity: 200 mg in 1 1

Code: 3A3U0GI71G

Class Code: ACTIB

HYDROXYMETHYL CELLULOSE

Code: 273FM27VK1

Class Code: IACT

MANGANESE SULFATE

Quantity: 2.6 mg in 1 1

Code: W00LYS4T26

Class Code: ACTIM

SILICON DIOXIDE

Code: ETJ7Z6XBU4

Class Code: IACT

VITAMIN A ACETATE

Quantity: 1500 ug in 1 1

Code: 3LE3D9D6OY

Class Code: ACTIM

ASCORBIC ACID

Quantity: 120 mg in 1 1

Code: PQ6CK8PD0R

Class Code: ACTIB

THIAMINE MONONITRATE

Quantity: 3 mg in 1 1

Code: 8K0I04919X

Class Code: ACTIR

RIBOFLAVIN

Quantity: 3.4 mg in 1 1

Code: TLM2976OFR

Class Code: ACTIB

CHOLECALCIFEROL

Quantity: 20 ug in 1 1

Code: 1C6V77QF41

Class Code: ACTIB

NIACINAMIDE

Quantity: 20 mg in 1 1

Code: 25X51I8RD4

Class Code: ACTIB

PYRIDOXINE HYDROCHLORIDE

Quantity: 50 mg in 1 1

Code: 68Y4CF58BV

Class Code: ACTIM

CYANOCOBALAMIN

Quantity: 10 ug in 1 1

Code: P6YC3EG204

Class Code: ACTIB

FOLIC ACID

Quantity: 1000 ug in 1 1

Code: 935E97BOY8

Class Code: ACTIB

CALCIUM CARBONATE

Quantity: 200 mg in 1 1

Code: H0G9379FGK

Class Code: ACTIM

FERROUS FUMARATE

Quantity: 27 mg in 1 1

Code: R5L488RY0Q

Class Code: ACTIM

ZINC OXIDE

Quantity: 25 mg in 1 1

Code: SOI2LOH54Z

Class Code: ACTIM

MOLYBDENUM

Quantity: 50 ug in 1 1

Code: 81AH48963U

Class Code: ACTIB

SELENIUM

Quantity: 70 ug in 1 1

Code: H6241UJ22B

Class Code: ACTIB

CHOLINE BITARTRATE

Quantity: 55 mg in 1 1

Code: 6K2W7T9V6Y

Class Code: ACTIM

CHROMIUM NICOTINATE

Quantity: 45 ug in 1 1

Code: A150AY412V

Class Code: ACTIB

POTASSIUM IODIDE

Quantity: 150 ug in 1 1

Code: 1C4QK22F9J

Class Code: ACTIB

.ALPHA.-TOCOPHEROL ACETATE, DL-

Quantity: 30 mg in 1 1

Code: WR1WPI7EW8

Class Code: ACTIM

Active Moieties

MAGNESIUM CATION

Code: T6V3LHY838

PYRIDOXINE

Code: KV2JZ1BI6Z

ASCORBIC ACID

Code: PQ6CK8PD0R

CHOLECALCIFEROL

Code: 1C6V77QF41

VITAMIN A

Code: 81G40H8B0T

RIBOFLAVIN

Code: TLM2976OFR

MANGANESE CATION (2+)

Code: H6EP7W5457

.ALPHA.-TOCOPHEROL, DL-

Code: 7QWA1RIO01

THIAMINE ION

Code: 4ABT0J945J

NIACINAMIDE

Code: 25X51I8RD4

FOLIC ACID

Code: 935E97BOY8

CYANOCOBALAMIN

Code: P6YC3EG204

CALCIUM CATION

Code: 2M83C4R6ZB

FERROUS CATION

Code: GW89581OWR

ZINC CATION

Code: 13S1S8SF37

MOLYBDENUM

Code: 81AH48963U

CHOLINE

Code: N91BDP6H0X

SELENIUM

Code: H6241UJ22B

CHROMIC CATION

Code: X1N4508KF1

IODIDE ION

Code: 09G4I6V86Q

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