Folvyris

Manufacturer
Oncora Pharma, LLC
Effective date
2026-05-18
Label type
HUMAN PRESCRIPTION DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 22:20:06

Label at a glance#

ProductFolvyris
Active ingredientFOLATE SODIUM, VITAMIN D
Label structure8 sections

Label contents#

Full prescribing information#

DESCRIPTION SECTION

Folvyris is an orally administered prescription folate product.

INDICATIONS & USAGE SECTION

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

PRECAUTIONS SECTION

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

WARNINGS SECTION

Keep out of reach of children.

DOSAGE & ADMINISTRATION SECTION

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 SECTION

NDC 85477-823-30

Distributed by:

Oncora Pharma

Dallas, Texas 75228

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

pdp
pdp

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1720258vitamin D3 125 MCG (5000 UNT) / folate 1700 MCG DFE (1000 mcg folic acid) Oral TabletPSN2
1720258cholecalciferol 5000 UNT / folic acid 1 MG Oral TabletSCD2
1720258Cholecalciferol 5000 UNT / folate 1 MG Oral TabletSY2
1720258vitamin D3 125 MCG / folic acid 1000 MCG Oral TabletSY2
1720258vitamin D3 5000 UNT / folic acid 1 MG Oral TabletSY2

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
CHOLECALCIFEROL Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130854770823303GTIN-13: 0854770823303
EAN-13: 0854770823303
GTIN-12: 854770823303
UPC-A: 854770823303
GTIN storage (14 digits): 00854770823303
folvyris-1.jpg

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
91c62db0-0295-c81c-d10a-0856c259edd6Product name220200428
d32bc2b8-0bb7-2216-87aa-24639646e202Product name320190619
60c52429-fcef-eb54-2387-43bc9e4f296bProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
85477-823-30Folvyris30 in 1 BOTTLETABLET302

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 11 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
85477-82385477-823-30

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 7 matching rows.

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
12026-05-11weekly-update2026-06-03 18:02:55

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
FolvyrisFOLATE, VITAMIN D3Oncora Pharma, LLCbe98da83-85fd-4b8e-91da-91de179e86bd2026-05-18WarningsExact identifier
ndc (package): 85477-823-30
ndc (product): 85477-823
ndc11 (package): 85477082330
spl id: f1b8c012-47a6-4d0a-a971-97ca8eef4cda
spl set id: be98da83-85fd-4b8e-91da-91de179e86bd

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.