MedPath
FDA Product

Dialyvite 5000

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

Basic Information

Dialyvite 5000

10542-011

Regulatory Information

10542-011

October 24, 2019

Dialyvite 5000

HUMAN PRESCRIPTION DRUG LABEL

4

Company Information

Hillestad Pharmaceuticals USA

029291085

Active Ingredients

Ascorbic Acid

Quantity: 100 mg in 1 1

Code: PQ6CK8PD0R

Class Code: ACTIB

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

Folic Acid

Quantity: 5 mg in 1 1

Code: 935E97BOY8

Class Code: ACTIB

Biotin

Quantity: 300 ug in 1 1

Code: 6SO6U10H04

Class Code: ACTIB

Cobalamin

Quantity: 2 mg in 1 1

Code: 8406EY2OQA

Class Code: ACTIB

Selenocysteine

Quantity: 70 ug in 1 1

Code: 0CH9049VIS

Class Code: ACTIM

Microcrystalline Cellulose

Code: OP1R32D61U

Class Code: IACT

Zinc Citrate

Quantity: 25 mg in 1 1

Code: K72I3DEX9B

Class Code: ACTIM

Shellac

Code: 46N107B71O

Class Code: IACT

Glyceryl Monostearate

Code: 230OU9XXE4

Class Code: IACT

Blueberry

Code: 253RUG1X1A

Class Code: IACT

Starch, Corn

Code: O8232NY3SJ

Class Code: IACT

Calcium Stearate

Code: 776XM7047L

Class Code: IACT

Silicon Dioxide

Code: ETJ7Z6XBU4

Class Code: IACT

Riboflavin

Quantity: 1.7 mg in 1 1

Code: TLM2976OFR

Class Code: ACTIB

Pyridoxine Hydrochloride

Quantity: 50 mg in 1 1

Code: 68Y4CF58BV

Class Code: ACTIM

Calcium Pantothenate

Quantity: 10 mg in 1 1

Code: 568ET80C3D

Class Code: ACTIM

Croscarmellose Sodium

Code: M28OL1HH48

Class Code: IACT

.alpha.-tocopherol succinate, d-

Quantity: 30 [iU] in 1 1

Code: LU4B53JYVE

Class Code: ACTIM

Active Moieties

Ascorbic Acid

Code: PQ6CK8PD0R

Riboflavin

Code: TLM2976OFR

Thiamine Ion

Code: 4ABT0J945J

Pyridoxine

Code: KV2JZ1BI6Z

Folic Acid

Code: 935E97BOY8

Niacinamide

Code: 25X51I8RD4

Biotin

Code: 6SO6U10H04

Pantothenic Acid

Code: 19F5HK2737

Cobalamin

Code: 8406EY2OQA

Zinc Cation

Code: 13S1S8SF37

.alpha.-tocopherol, d-

Code: N9PR3490H9

Selenium

Code: H6241UJ22B

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