MedPath

Niferex

Iron Supplement Niferex  Tablets Rx Only Dietary Supplement

Approved
Approval ID

899f97fb-85f1-4e78-9708-b916a1646129

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Jan 23, 2024

Manufacturers
FDA

Avion Pharmaceuticals, LLC

DUNS: 040348516

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

ferrous asparto glycinate, iron, ascorbic acid, folic acid, cyanocobalamin, zinc, succinic acid, and intrinsic factor

PRODUCT DETAILS

NDC Product Code75854-321
Application NumberN/A
Marketing CategoryN/A
Route of AdministrationORAL
Effective DateJanuary 7, 2021
Generic Nameferrous asparto glycinate, iron, ascorbic acid, folic acid, cyanocobalamin, zinc, succinic acid, and intrinsic factor

INGREDIENTS (14)

CALCIUM PHOSPHATE, DIBASIC, ANHYDROUSInactive
Code: L11K75P92J
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
IRON DEXTRANActive
Quantity: 100 mg in 1 1
Code: 95HR524N2M
Classification: ACTIM
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
ASCORBIC ACIDActive
Quantity: 60 mg in 1 1
Code: PQ6CK8PD0R
Classification: ACTIB
FERROUS ASPARTO GLYCINATEActive
Quantity: 50 mg in 1 1
Code: H7426RGB3L
Classification: ACTIM
LEVOMEFOLIC ACIDActive
Quantity: 750 ug in 1 1
Code: 8S95DH25XC
Classification: ACTIB
FOLIC ACIDActive
Quantity: 250 ug in 1 1
Code: 935E97BOY8
Classification: ACTIB
CYANOCOBALAMINActive
Quantity: 25 ug in 1 1
Code: P6YC3EG204
Classification: ACTIB
ZINCActive
Quantity: 15 mg in 1 1
Code: J41CSQ7QDS
Classification: ACTIB
SUCCINIC ACIDActive
Quantity: 50 mg in 1 1
Code: AB6MNQ6J6L
Classification: ACTIB
INTRINSIC FACTORActive
Quantity: 100 mg in 1 1
Code: 70BT6OQT2Q
Classification: ACTIB

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Niferex - FDA Drug Approval Details