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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
Bryant Ranch Prepack
DUNS: 171714327
Effective Date
March 1, 2023
Labeling Type
HUMAN PRESCRIPTION DRUG LABEL
Folic acid(300 ug in 1 1)
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)
Vitamin B12(4.5 ug in 1 1)
Sodium fluoride(0.5 mg in 1 1)

Registrants1

Companies and organizations registered with the FDA for this drug approval, including their contact information and regulatory details.

Bryant Ranch Prepack

171714327

Manufacturing Establishments1

FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.

Bryant Ranch Prepack

Bryant Ranch Prepack

Bryant Ranch Prepack

171714327

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
63629-1136
Route of Administration
ORAL
Effective Date
December 30, 2021
Code: 935E97BOY8Class: ACTIBQuantity: 300 ug in 1 1
CITRIC ACID MONOHYDRATEInactive
Code: 2968PHW8QPClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
MANNITOLInactive
Code: 3OWL53L36AClass: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61UClass: IACT
SUCRALOSEInactive
Code: 96K6UQ3ZD4Class: IACT
TALCInactive
Code: 7SEV7J4R1UClass: 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: P6YC3EG204Class: ACTIBQuantity: 4.5 ug in 1 1
Code: 8ZYQ1474W7Class: ACTIMQuantity: 0.5 mg in 1 1
Code: WR1WPI7EW8Class: ACTIMQuantity: 15 [iU] in 1 1
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