Fluoride
Approved
Approval ID
0df8f1aa-f3ef-9f59-e063-6294a90a0666
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 2, 2024
Manufacturers
FDA
WINDER LABORATORIES, LLC
DUNS: 965195170
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 Code75826-165
Product Classification
G
Generic Name
Sodium Fluoride
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 2, 2024
FDA Product Classification
INGREDIENTS (8)
MICROCRYSTALLINE CELLULOSE 102Inactive
Code: PNR0YF693Y
Classification: IACT
SUCROSEInactive
Code: C151H8M554
Classification: IACT
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65AP
Classification: IACT
D&C RED NO. 27 ALUMINUM LAKEInactive
Code: ZK64F7XSTX
Classification: IACT
FD&C BLUE NO. 1 ALUMINUM LAKEInactive
Code: J9EQA3S2JM
Classification: IACT
SODIUM FLUORIDEActive
Quantity: 1 mg in 1 1
Code: 8ZYQ1474W7
Classification: ACTIM
Sodium Fluoride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code75826-163
Product Classification
G
Generic Name
Sodium Fluoride
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 2, 2024
FDA Product Classification
INGREDIENTS (8)
MICROCRYSTALLINE CELLULOSE 102Inactive
Code: PNR0YF693Y
Classification: IACT
SUCROSEInactive
Code: C151H8M554
Classification: IACT
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65AP
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
D&C RED NO. 27 ALUMINUM LAKEInactive
Code: ZK64F7XSTX
Classification: IACT
SODIUM FLUORIDEActive
Quantity: 0.25 mg in 1 1
Code: 8ZYQ1474W7
Classification: ACTIM
Sodium Fluoride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code75826-164
Product Classification
G
Generic Name
Sodium Fluoride
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 2, 2024
FDA Product Classification
INGREDIENTS (7)
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65AP
Classification: IACT
SUCROSEInactive
Code: C151H8M554
Classification: IACT
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
MICROCRYSTALLINE CELLULOSE 102Inactive
Code: PNR0YF693Y
Classification: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOA
Classification: IACT
SODIUM FLUORIDEActive
Quantity: 0.5 mg in 1 1
Code: 8ZYQ1474W7
Classification: ACTIM