MedPath
FDA Product

Niferex

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

Basic Information

Niferex

75854-321

Regulatory Information

75854-321

January 7, 2021

Iron Supplement Niferex  Tablets Rx Only Dietary Supplement

HUMAN PRESCRIPTION DRUG LABEL

6

Company Information

040348516

Active Ingredients

CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS

Code: L11K75P92J

Class Code: IACT

CELLULOSE, MICROCRYSTALLINE

Code: OP1R32D61U

Class Code: IACT

CROSCARMELLOSE SODIUM

Code: M28OL1HH48

Class Code: IACT

IRON DEXTRAN

Quantity: 100 mg in 1 1

Code: 95HR524N2M

Class Code: ACTIM

MAGNESIUM STEARATE

Code: 70097M6I30

Class Code: IACT

SILICON DIOXIDE

Code: ETJ7Z6XBU4

Class Code: IACT

ASCORBIC ACID

Quantity: 60 mg in 1 1

Code: PQ6CK8PD0R

Class Code: ACTIB

FERROUS ASPARTO GLYCINATE

Quantity: 50 mg in 1 1

Code: H7426RGB3L

Class Code: ACTIM

LEVOMEFOLIC ACID

Quantity: 750 ug in 1 1

Code: 8S95DH25XC

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

SUCCINIC ACID

Quantity: 50 mg in 1 1

Code: AB6MNQ6J6L

Class Code: ACTIB

INTRINSIC FACTOR

Quantity: 100 mg in 1 1

Code: 70BT6OQT2Q

Class Code: ACTIB

Active Moieties

FERROUS CATION

Code: GW89581OWR

FERRIC CATION

Code: 91O4LML611

ASCORBIC ACID

Code: PQ6CK8PD0R

LEVOMEFOLIC ACID

Code: 8S95DH25XC

FOLIC ACID

Code: 935E97BOY8

CYANOCOBALAMIN

Code: P6YC3EG204

ZINC

Code: J41CSQ7QDS

SUCCINIC ACID

Code: AB6MNQ6J6L

INTRINSIC FACTOR

Code: 70BT6OQT2Q

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