MedPath
FDA Product

Dialyvite 3000

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

Basic Information

Dialyvite 3000

10542-014

Regulatory Information

10542-014

October 24, 2019

Dialyvite 3000

HUMAN PRESCRIPTION DRUG LABEL

5

Company Information

Hillestad Pharmaceuticals USA

029291085

Active Ingredients

Pyridoxine Hydrochloride

Quantity: 25 mg in 1 1

Code: 68Y4CF58BV

Class Code: ACTIM

Riboflavin

Quantity: 1.7 mg in 1 1

Code: TLM2976OFR

Class Code: ACTIB

Calcium Pantothenate

Quantity: 10 mg in 1 1

Code: 568ET80C3D

Class Code: ACTIM

Folic Acid

Quantity: 3 mg in 1 1

Code: 935E97BOY8

Class Code: ACTIB

Cobalamin

Quantity: 1 mg in 1 1

Code: 8406EY2OQA

Class Code: ACTIB

Selenocysteine

Quantity: 70 ug in 1 1

Code: 0CH9049VIS

Class Code: ACTIM

Croscarmellose Sodium

Code: M28OL1HH48

Class Code: IACT

Carob

Code: 5MG5Z946UO

Class Code: IACT

Glyceryl Monostearate

Code: 230OU9XXE4

Class Code: IACT

Starch, Corn

Code: O8232NY3SJ

Class Code: IACT

Silicon Dioxide

Code: ETJ7Z6XBU4

Class Code: IACT

Thiamine Mononitrate

Quantity: 1.5 mg in 1 1

Code: 8K0I04919X

Class Code: ACTIR

Niacinamide

Quantity: 20 mg in 1 1

Code: 25X51I8RD4

Class Code: ACTIB

Biotin

Quantity: 300 ug in 1 1

Code: 6SO6U10H04

Class Code: ACTIB

Shellac

Code: 46N107B71O

Class Code: IACT

Calcium Stearate

Code: 776XM7047L

Class Code: IACT

Zinc Citrate

Quantity: 15 mg in 1 1

Code: K72I3DEX9B

Class Code: ACTIM

Microcrystalline Cellulose

Code: OP1R32D61U

Class Code: IACT

Ascorbic Acid

Quantity: 100 mg in 1 1

Code: PQ6CK8PD0R

Class Code: ACTIB

.alpha.-tocopherol succinate, d-

Quantity: 30 [iU] in 1 1

Code: LU4B53JYVE

Class Code: ACTIM

Active Moieties

Pyridoxine

Code: KV2JZ1BI6Z

Riboflavin

Code: TLM2976OFR

Biotin

Code: 6SO6U10H04

Ascorbic Acid

Code: PQ6CK8PD0R

Thiamine Ion

Code: 4ABT0J945J

Niacinamide

Code: 25X51I8RD4

Folic Acid

Code: 935E97BOY8

Cobalamin

Code: 8406EY2OQA

.alpha.-tocopherol, d-

Code: N9PR3490H9

Pantothenic Acid

Code: 19F5HK2737

Zinc Cation

Code: 13S1S8SF37

Selenium

Code: H6241UJ22B

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