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Tri-Vite Drops with Fluoride

Tri-Vite Drops with Fluroide 0_5 mg

Approved
Approval ID

5acff360-8d44-44d7-864d-52f213501d03

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Dec 12, 2023

Manufacturers
FDA

Method Pharmaceuticals, LLC

DUNS: 060216698

Products 1

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

ASCORBIC ACID, SODIUM FLUORIDE, VITAMIN A and VITAMIN D

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code58657-324
Product Classification
G
Generic Name
ASCORBIC ACID, SODIUM FLUORIDE, VITAMIN A and VITAMIN D
Product Specifications
Route of AdministrationORAL
Effective DateDecember 12, 2023
FDA Product Classification

INGREDIENTS (12)

EDETIC ACIDInactive
Code: 9G34HU7RV0
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
POTASSIUM SORBATEInactive
Code: 1VPU26JZZ4
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SODIUM BENZOATEInactive
Code: OJ245FE5EU
Classification: IACT
ASCORBIC ACIDActive
Quantity: 35 mg in 1 mL
Code: PQ6CK8PD0R
Classification: ACTIB
VITAMIN DActive
Quantity: 400 [iU] in 1 mL
Code: 9VU1KI44GP
Classification: ACTIB
SODIUM FLUORIDEActive
Quantity: 0.5 mg in 1 mL
Code: 8ZYQ1474W7
Classification: ACTIM
SORBITOLInactive
Code: 506T60A25R
Classification: IACT
SUCRALOSEInactive
Code: 96K6UQ3ZD4
Classification: IACT
VITAMIN AActive
Quantity: 1500 [iU] in 1 mL
Code: 81G40H8B0T
Classification: ACTIB

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Tri-Vite Drops with Fluoride - FDA Drug Approval Details