Multivitamin with Fluoride
Multivitamin with Fluoride 0.5 mg Prescribing Information
Approved
Approval ID
94fd63f1-76a1-4bd3-8e84-394f90dad4a1
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Sep 2, 2022
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.
Sodium Fluoride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code59088-108
Product Classification
G
Generic Name
Sodium Fluoride
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 2, 2022
FDA Product Classification
INGREDIENTS (20)
SUCROSEInactive
Code: C151H8M554
Classification: IACT
D&C RED NO. 27Inactive
Code: 2LRS185U6K
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65AP
Classification: IACT
SODIUM FLUORIDEActive
Quantity: 0.5 mg in 1 1
Code: 8ZYQ1474W7
Classification: ACTIM
VITAMIN AActive
Quantity: 750 ug in 1 1
Code: 81G40H8B0T
Classification: ACTIB
SODIUM ASCORBATEActive
Quantity: 36 mg in 1 1
Code: S033EH8359
Classification: ACTIM
ASCORBIC ACIDActive
Quantity: 24 mg in 1 1
Code: PQ6CK8PD0R
Classification: ACTIB
RIBOFLAVINActive
Quantity: 1.2 mg in 1 1
Code: TLM2976OFR
Classification: ACTIB
THIAMINE MONONITRATEActive
Quantity: 1.05 mg in 1 1
Code: 8K0I04919X
Classification: ACTIR
FOLIC ACIDActive
Quantity: 300 ug in 1 1
Code: 935E97BOY8
Classification: ACTIB
PYRIDOXINE HYDROCHLORIDEActive
Quantity: 1.05 mg in 1 1
Code: 68Y4CF58BV
Classification: ACTIM
CYANOCOBALAMINActive
Quantity: 4.5 ug in 1 1
Code: P6YC3EG204
Classification: ACTIB
ASPARTAMEInactive
Code: Z0H242BBR1
Classification: IACT
CHOLECALCIFEROLActive
Quantity: 10 ug in 1 1
Code: 1C6V77QF41
Classification: ACTIB
NIACINAMIDEActive
Quantity: 13.5 mg in 1 1
Code: 25X51I8RD4
Classification: ACTIB
.ALPHA.-TOCOPHEROL ACETATE, DL-Active
Quantity: 10 mg in 1 1
Code: WR1WPI7EW8
Classification: ACTIM