Ludent
Sodium Fluoride Chewable Tablets
Approved
Approval ID
6e7a7e17-7538-4763-810c-7e56bd630494
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 29, 2009
Manufacturers
FDA
Sancilio & Company Inc
DUNS: 176681257
Products 3
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 Code44946-1017
Product Classification
G
Generic Name
Sodium Fluoride
Product Specifications
Route of AdministrationORAL
Effective DateDecember 29, 2009
FDA Product Classification
INGREDIENTS (8)
Sodium FluorideActive
Quantity: 1.0 mg in 1 1
Code: 8ZYQ1474W7
Classification: ACTIB
Citric Acid MonohydrateInactive
Code: 2968PHW8QP
Classification: IACT
Cellulose, MicrocrystallineInactive
Code: OP1R32D61U
Classification: IACT
Malic AcidInactive
Code: 817L1N4CKP
Classification: IACT
XylitolInactive
Code: VCQ006KQ1E
Classification: IACT
TalcInactive
Code: 7SEV7J4R1U
Classification: IACT
Magnesium StearateInactive
Code: 70097M6I30
Classification: IACT
SucraloseInactive
Code: 96K6UQ3ZD4
Classification: IACT
Sodium Fluoride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code44946-1016
Product Classification
G
Generic Name
Sodium Fluoride
Product Specifications
Route of AdministrationORAL
Effective DateDecember 29, 2009
FDA Product Classification
INGREDIENTS (8)
Sodium FluorideActive
Quantity: 0.5 mg in 1 1
Code: 8ZYQ1474W7
Classification: ACTIB
Cellulose, MicrocrystallineInactive
Code: OP1R32D61U
Classification: IACT
SucraloseInactive
Code: 96K6UQ3ZD4
Classification: IACT
TalcInactive
Code: 7SEV7J4R1U
Classification: IACT
XylitolInactive
Code: VCQ006KQ1E
Classification: IACT
Magnesium StearateInactive
Code: 70097M6I30
Classification: IACT
Citric Acid MonohydrateInactive
Code: 2968PHW8QP
Classification: IACT
Malic AcidInactive
Code: 817L1N4CKP
Classification: IACT
Sodium Fluoride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code44946-1015
Product Classification
G
Generic Name
Sodium Fluoride
Product Specifications
Route of AdministrationORAL
Effective DateDecember 29, 2009
FDA Product Classification
INGREDIENTS (8)
Sodium FluorideActive
Quantity: 0.25 mg in 1 1
Code: 8ZYQ1474W7
Classification: ACTIB
Malic AcidInactive
Code: 817L1N4CKP
Classification: IACT
Cellulose, MicrocrystallineInactive
Code: OP1R32D61U
Classification: IACT
SucraloseInactive
Code: 96K6UQ3ZD4
Classification: IACT
XylitolInactive
Code: VCQ006KQ1E
Classification: IACT
TalcInactive
Code: 7SEV7J4R1U
Classification: IACT
Magnesium StearateInactive
Code: 70097M6I30
Classification: IACT
Citric Acid MonohydrateInactive
Code: 2968PHW8QP
Classification: IACT