Foltira

Manufacturer: Oncora Pharma, LLC
Effective date: 2025-12-15
Label type: HUMAN PRESCRIPTION DRUG LABEL
Version: 1
Source: full-release
Hydrated at: 2026-05-31 21:50:09

Label at a glance#

ProductFoltira

Active ingredientFOLATE SODIUM, VITAMIN D

Label structure8 sections

Label contents#

Full prescribing information#

DESCRIPTION SECTION

Foltira is an orally administered prescription folate product.

INDICATIONS & USAGE SECTION

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

PRECAUTIONS SECTION

Foltira 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 85477-921-30

Distributed by:

Oncora Pharma

Dallas, Texas 75228

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
1720258	vitamin D3 125 MCG (5000 UNT) / folate 1700 MCG DFE (1000 mcg folic acid) Oral Tablet	PSN	1
1720258	cholecalciferol 5000 UNT / folic acid 1 MG Oral Tablet	SCD	1
1720258	Cholecalciferol 5000 UNT / folate 1 MG Oral Tablet	SY	1
1720258	vitamin D3 125 MCG / folic acid 1000 MCG Oral Tablet	SY	1
1720258	vitamin D3 5000 UNT / folic acid 1 MG Oral Tablet	SY	1

DailyMed Pharmacologic Classes#

Class, Version, Type table
Class	Version	Type	Effective
CHOLECALCIFEROL Pharmacologic Class Indexing	2	Indexing - Pharmacologic Class	20180813

Product Linked Resources#

Resource, Code type, Value table
Resource	Code type	Value	Equivalent identifiers	Source image
Barcode	EAN-13	0385477000006	GTIN-13: 0385477000006 EAN-13: 0385477000006 GTIN-12: 385477000006 UPC-A: 385477000006 GTIN storage (14 digits): 00385477000006	foltira.jpg

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
91c62db0-0295-c81c-d10a-0856c259edd6	Product name	2	20200428
d32bc2b8-0bb7-2216-87aa-24639646e202	Product name	3	20190619
60c52429-fcef-eb54-2387-43bc9e4f296b	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
85477-921-30	Foltira	30 in 1 BOTTLE	TABLET	30		1

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
85477-921-30	EA - Each	85477-921	c6851de0-1153-49a2-9f4f-08a06dd12043	1	2026-02-05

Products#

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

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

Foltira
Folate, Vitamin D3
FOLATE SODIUM
FOLIC ACID
VITAMIN D
CHOLECALCIFEROL
CALCIUM CARBONATE
STEARIC ACID
CELLULOSE, MICROCRYSTALLINE
CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE
MAGNESIUM STEARATE

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
85477-921	85477-921-30

Ingredients#

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

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

Name, UNII, Kind table
Name	UNII	Kind
FOLATE SODIUM	9P9W8GGU78	ACTIB
VITAMIN D	9VU1KI44GP	ACTIB
CALCIUM CARBONATE	H0G9379FGK	IACT
STEARIC ACID	4ELV7Z65AP	IACT
CELLULOSE, MICROCRYSTALLINE	OP1R32D61U	IACT
CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE	O7TSZ97GEP	IACT
MAGNESIUM STEARATE	70097M6I30	IACT

Source Document#

Source XML

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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Foltira	FOLATE, VITAMIN D3	Oncora Pharma, LLC	46025cb4-fe1a-5da5-e063-6294a90af293	2025-12-15	Warnings	Exact identifier ndc (package): 85477-921-30 ndc (product): 85477-921 ndc11 (package): 85477092130 spl id: 46025cb4-fe1b-5da5-e063-6294a90af293 spl set id: 46025cb4-fe1a-5da5-e063-6294a90af293

Reported adverse events (FAERS/openFDA)#

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