MedPath
FDA Product

Niferex

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

Basic Information

Niferex

75854-344

Regulatory Information

75854-344

April 8, 2025

Iron Supplement Niferex Tablets

HUMAN PRESCRIPTION DRUG LABEL

7

Company Information

040348516

Active Ingredients

CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE

Code: O7TSZ97GEP

Class Code: IACT

CROSCARMELLOSE SODIUM

Code: M28OL1HH48

Class Code: IACT

MAGNESIUM STEARATE

Code: 70097M6I30

Class Code: IACT

STEARIC ACID

Code: 4ELV7Z65AP

Class Code: IACT

SILICON DIOXIDE

Code: ETJ7Z6XBU4

Class Code: IACT

CELLULOSE, MICROCRYSTALLINE

Code: OP1R32D61U

Class Code: IACT

FERROUS ASPARTO GLYCINATE

Quantity: 75 mg in 1 1

Code: H7426RGB3L

Class Code: ACTIM

SUCCINIC ACID

Quantity: 150 mg in 1 1

Code: AB6MNQ6J6L

Class Code: ACTIB

ASCORBIC ACID

Quantity: 175 mg in 1 1

Code: PQ6CK8PD0R

Class Code: ACTIB

FOLIC ACID

Quantity: 250 ug in 1 1

Code: 935E97BOY8

Class Code: ACTIB

CYANOCOBALAMIN

Quantity: 25 ug in 1 1

Code: P6YC3EG204

Class Code: ACTIB

ZINC

Quantity: 15 mg in 1 1

Code: J41CSQ7QDS

Class Code: ACTIB

FD&C BLUE NO. 1

Code: H3R47K3TBD

Class Code: IACT

FD&C RED NO. 40

Code: WZB9127XOA

Class Code: IACT

FD&C YELLOW NO. 6

Code: H77VEI93A8

Class Code: IACT

HYDROXYPROPYL METHYLCELLULOSE

Code: 3NXW29V3WO

Class Code: IACT

TITANIUM DIOXIDE

Code: 15FIX9V2JP

Class Code: IACT

TRIACETIN

Code: XHX3C3X673

Class Code: IACT

LEVOMEFOLATE GLUCOSAMINE

Quantity: 750 ug in 1 1

Code: Q65PL71Q1A

Class Code: ACTIB

Active Moieties

LEVOMEFOLATE GLUCOSAMINE

Code: Q65PL71Q1A

FOLIC ACID

Code: 935E97BOY8

SUCCINIC ACID

Code: AB6MNQ6J6L

FERROUS CATION

Code: GW89581OWR

ASCORBIC ACID

Code: PQ6CK8PD0R

CYANOCOBALAMIN

Code: P6YC3EG204

ZINC

Code: J41CSQ7QDS

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