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FDA Approval

Multivitamin with Fluoride

FDA-approved pharmaceutical product with comprehensive regulatory information, manufacturing details, and complete labeling documentation.

FDA Approval Summary

Company
Effective Date
December 9, 2023
Labeling Type
HUMAN PRESCRIPTION DRUG LABEL
Vitamin A(2500 [iU] in 1 1)
Vitamin C(60 mg in 1 1)
Vitamin D3(400 [iU] in 1 1)
Thiamine(1.05 mg in 1 1)
Riboflavin(1.2 mg in 1 1)
Niacin(13.5 mg in 1 1)
Pyridoxine(1.05 mg in 1 1)
Folic acid(300 ug in 1 1)
Sodium fluoride(0.5 mg in 1 1)
Vitamin B12(4.5 ug in 1 1)

Products1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Multivitamin with Fluoride

Product Details

NDC Product Code
58657-164
Route of Administration
ORAL
Effective Date
December 9, 2023
CITRIC ACID MONOHYDRATEInactive
Code: 2968PHW8QPClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
MANNITOLInactive
Code: 3OWL53L36AClass: IACT
TALCInactive
Code: 7SEV7J4R1UClass: IACT
SUCRALOSEInactive
Code: 96K6UQ3ZD4Class: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61UClass: IACT
XYLITOLInactive
Code: VCQ006KQ1EClass: IACT
Vitamin AActive
Code: 81G40H8B0TClass: ACTIBQuantity: 2500 [iU] in 1 1
Vitamin CActive
Code: PQ6CK8PD0RClass: ACTIBQuantity: 60 mg in 1 1
Code: 9VU1KI44GPClass: ACTIBQuantity: 400 [iU] in 1 1
ThiamineActive
Code: 8K0I04919XClass: ACTIRQuantity: 1.05 mg in 1 1
Code: TLM2976OFRClass: ACTIBQuantity: 1.2 mg in 1 1
NiacinActive
Code: 2679MF687AClass: ACTIBQuantity: 13.5 mg in 1 1
Code: KV2JZ1BI6ZClass: ACTIBQuantity: 1.05 mg in 1 1
Code: 935E97BOY8Class: ACTIBQuantity: 300 ug in 1 1
Code: 8ZYQ1474W7Class: ACTIMQuantity: 0.5 mg in 1 1
Code: P6YC3EG204Class: ACTIBQuantity: 4.5 ug in 1 1
Code: WR1WPI7EW8Class: ACTIMQuantity: 15 [iU] in 1 1
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