FOLVYRIS- folate, vitamin d3 tablet

Drug Labeling and Warnings

Drug Details [pdf]

DESCRIPTION

Folvyris is an orally administered prescription folate product.

INDICATIONS & USAGE

Folvyris is for patients with unique nutritional needs requiring increased folate levels and Vitamin D supplementation due to Vitamin D deficiency.

PRECAUTIONS

Folvyris should be administered under the supervision of a licensed medical practitioner.

WARNINGS

Keep out of reach of children.

DOSAGE & ADMINISTRATION

Take one tablet daily or as directed by a licensed medical practitioner. If you are pregnant or nursing ask a healthcare professional.

OTHER SAFETY INFORMATION

Store at 20ºC - 25ºC (68º-77ºF) [See USP Controlled Room Temperature.]

HOW SUPPLIED

NDC: 85477-921-30

Distributed by:

Oncora Pharma

Dallas, Texas 75228

PRINCIPAL DISPLAY PANEL

pdp

INGREDIENTS AND APPEARANCE

FOLVYRIS 
folate, vitamin d3 tablet

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 85477-823
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
FOLATE SODIUM (UNII: 9P9W8GGU78) (FOLIC ACID - UNII:935E97BOY8)	FOLATE SODIUM	1.7 mg
VITAMIN D (UNII: 9VU1KI44GP) (CHOLECALCIFEROL - UNII:1C6V77QF41)	VITAMIN D	0.125 mg

Inactive Ingredients
Ingredient Name	Strength
CALCIUM CARBONATE (UNII: H0G9379FGK)
STEARIC ACID (UNII: 4ELV7Z65AP)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE (UNII: O7TSZ97GEP)
MAGNESIUM STEARATE (UNII: 70097M6I30)

Product Characteristics
Color	brown (tan)	Score	no score
Shape	OVAL	Size	19mm
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 85477-823-30	30 in 1 BOTTLE; Type 0: Not a Combination Product	05/01/2026

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		05/01/2026

Labeler - Oncora Pharma, LLC (119482542)