PureVit DualFe Plus
PureVit DualFe Plus
Approved
Approval ID
71f63741-cad4-43b5-bb3e-c63a188d10a2
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 11, 2023
Manufacturers
FDA
PureTek Corporation
DUNS: 785961046
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Ferrous Fumarate, Polysaccharide Iron Complex
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code59088-112
Product Classification
G
Generic Name
Ferrous Fumarate, Polysaccharide Iron Complex
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 11, 2023
FDA Product Classification
INGREDIENTS (19)
CUPRIC SULFATEActive
Quantity: 0.8 mg in 1 1
Code: LRX7AJ16DT
Classification: ACTIM
FERROUS FUMARATEActive
Quantity: 53 mg in 1 1
Code: R5L488RY0Q
Classification: ACTIM
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
FD&C YELLOW NO. 5Inactive
Code: I753WB2F1M
Classification: IACT
GELATINInactive
Code: 2G86QN327L
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
IRON DEXTRANActive
Quantity: 53 mg in 1 1
Code: 95HR524N2M
Classification: ACTIM
NIACINAMIDEActive
Quantity: 30 mg in 1 1
Code: 25X51I8RD4
Classification: ACTIB
CALCIUM PANTOTHENATEActive
Quantity: 10 mg in 1 1
Code: 568ET80C3D
Classification: ACTIM
PYRIDOXINE HYDROCHLORIDEActive
Quantity: 5 mg in 1 1
Code: 68Y4CF58BV
Classification: ACTIM
FOLIC ACIDActive
Quantity: 1 mg in 1 1
Code: 935E97BOY8
Classification: ACTIB
CYANOCOBALAMINActive
Quantity: 15 ug in 1 1
Code: P6YC3EG204
Classification: ACTIB
SODIUM ASCORBATEActive
Quantity: 200 mg in 1 1
Code: S033EH8359
Classification: ACTIM
THIAMINE MONONITRATEActive
Quantity: 10 mg in 1 1
Code: 8K0I04919X
Classification: ACTIR
ZINC SULFATEActive
Quantity: 18.2 mg in 1 1
Code: 89DS0H96TB
Classification: ACTIM
MANGANESE SULFATEActive
Quantity: 1.3 mg in 1 1
Code: W00LYS4T26
Classification: ACTIM
RIBOFLAVINActive
Quantity: 6 mg in 1 1
Code: TLM2976OFR
Classification: ACTIB