MedPath

NewVite

NEWVITE

Approved
Approval ID

87b08d72-b7a1-4a97-a47d-fe2770cb7364

Product Type

DIETARY SUPPLEMENT

Effective Date

Jun 23, 2025

Manufacturers
FDA

Trivia Pharmaceuticals, LLC

DUNS: 119353862

Products 1

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

Vitamin

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code84781-012
Product Classification
G
Generic Name
Vitamin
Product Specifications
Route of AdministrationORAL
Effective DateJune 23, 2025
FDA Product Classification

INGREDIENTS (12)

ASCORBIC ACIDActive
Quantity: 90 mg in 1 1
Code: PQ6CK8PD0R
Classification: ACTIB
BIOTINActive
Quantity: 30 ug in 1 1
Code: 6SO6U10H04
Classification: ACTIB
CHOLECALCIFEROLActive
Quantity: 10 ug in 1 1
Code: 1C6V77QF41
Classification: ACTIB
CYANOCOBALAMINActive
Quantity: 9 ug in 1 1
Code: P6YC3EG204
Classification: ACTIB
FOLIC ACIDActive
Quantity: 400 ug in 1 1
Code: 935E97BOY8
Classification: ACTIB
NIACINAMIDEActive
Quantity: 20 mg in 1 1
Code: 25X51I8RD4
Classification: ACTIB
CALCIUM PANTOTHENATEActive
Quantity: 10 mg in 1 1
Code: 568ET80C3D
Classification: ACTIM
PYRIDOXINE HYDROCHLORIDEActive
Quantity: 3 mg in 1 1
Code: 68Y4CF58BV
Classification: ACTIB
VITAMIN A ACETATEActive
Quantity: 1500 ug in 1 1
Code: 3LE3D9D6OY
Classification: ACTIM
RIBOFLAVINActive
Quantity: 3.4 mg in 1 1
Code: TLM2976OFR
Classification: ACTIB
THIAMINE MONONITRATEActive
Quantity: 3 mg in 1 1
Code: 8K0I04919X
Classification: ACTIR
.ALPHA.-TOCOPHEROL ACETATE, DL-Active
Quantity: 13.5 mg in 1 1
Code: WR1WPI7EW8
Classification: ACTIM

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 6/23/2025

Label:

NewVite Label

HEALTH CLAIM SECTION

LOINC: 69719-3Updated: 6/23/2025

Health Claim Section:

NewVite Tablets

image description

Other ingredients:
microcrystalline cellulose, gelatin, stearic acid, hypromellose, croscarmellose sodium, starch, silicon dioxide, magnesium stearate, dicalcium phosphate, FD&C Red #40 lake, sucrose, mineral oil, polyethylene glycol, titanium dioxide, sodium ascorbate, FD&C Yellow #6 lake, tocopherols, triglycerides, tricalcium phosphate, sodium benzoate, BHT, ascorbyl palmitate, sorbic acid, and talc.

STATEMENT OF IDENTITY SECTION

LOINC: 69718-5Updated: 6/23/2025

Description:

NewVite Tablets are supplied as brown, oblong tablets dispensed in plastic bottles of 30 ct.

84781-012-01

Reserved for Professional Recommendation

All prescriptions using this product shall be pursuant to state statutes as applicable. This is not an Orange Book product. This product may be administered only under a physician’s supervision. There are no implied or explicit claims on therapeutic equivalence.

Manufactured for:
Trivia Pharmaceuticals

Gilbert, AZ

WARNINGS SECTION

LOINC: 34071-1Updated: 6/23/2025

Warnings and Precautions:

This product is contraindicated in patients with a known hypersensitivity to any of the ingredients.

As with any supplement, if you are pregnant, nursing, taking medication, or have a medical condition, ask a health professional before taking this product.

These statements have not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease.

DOSAGE & ADMINISTRATION SECTION

LOINC: 34068-7Updated: 6/23/2025

Dosage and Administration:

Adults - One caplet daily as a dietary supplement, preferably with a meal, or as recommended by your health professional.

PRECAUTIONS SECTION

LOINC: 42232-9Updated: 6/23/2025

Precautions:

CONTRAINDICATIONS
This product is contraindicated in patients with known hypersensitivity to any of the ingredients.

PRECAUTIONS
This product is contraindicated in patients with a known hypersensitivity to any of the ingredients.

ADVERSE REACTIONS
Allergic sensitizations have been reported following oral administration of folic acid. Consult your physician immediately if adverse side effects occur.

KEEP OUT OF THE REACH OF CHILDREN.

SAFE HANDLING WARNING SECTION

LOINC: 50741-8Updated: 6/23/2025

Storage:

Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F).

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