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
NDC Product Code75826-165
Application NumberN/A
Marketing CategoryN/A
Route of AdministrationORAL
Effective DateJanuary 2, 2024
Generic NameSodium Fluoride
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
NDC Product Code75826-163
Application NumberN/A
Marketing CategoryN/A
Route of AdministrationORAL
Effective DateJanuary 2, 2024
Generic NameSodium Fluoride
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
NDC Product Code75826-164
Application NumberN/A
Marketing CategoryN/A
Route of AdministrationORAL
Effective DateJanuary 2, 2024
Generic NameSodium Fluoride
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