Foltrexyl

openFDA label record#

This page contains supplementary openFDA label data. For the canonical label presentation, use the corresponding DailyMed Structured Product Label.

Verified complete openFDA source JSON (canonical bytes are SHA-256 checked before publication)

Brand name: Foltrexyl
Generic name: FOLIC ACID, VITAMIN D3
Manufacturer: PureTek Corporation
Product type: HUMAN PRESCRIPTION DRUG
SPL set ID: b2d71f92-018f-183e-e053-2995a90a5db0
SPL ID: b2d71f92-018f-183e-e053-2995a90a5db0
Version: 1
Effective date: 2020-10-29
Source export date: 2026-10-27
Source partition: 12
Source file: https://download.open.fda.gov/drug/label/drug-label-0012-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-10-27/977776a6cc37ec1c77259da8a93ae161850a3aa120341096e5a03428b84d016b/drug-label-0012-of-0014.json.zip
Source manifest SHA-256: 6be3667a3beefe6c0ead4c723ea963050533a2bc725a8044d58b07d18b258c55
Import run: 20261027T193451Z
Imported at: 2026-10-27 20:56:35

Harmonized routes table
Harmonized routes
ORAL

Harmonized identifier links#

Every typed identifier imported from the complete openFDA harmonization object is paginated here; values are not reduced to a first match.

Harmonized identifiers page 1 of 1 · 11 matching rows.

Type, Scope, Identifier table
Type	Scope	Identifier	Source field
brand name		Foltrexyl	openfda.brand_name
generic name		FOLIC ACID, VITAMIN D3	openfda.generic_name
manufacturer name		PureTek Corporation	openfda.manufacturer_name
ndc	package	59088-447-54	openfda.package_ndc
ndc	product	59088-447	openfda.product_ndc
ndc11	package	59088044754	derived:openfda.package_ndc
rxcui		1720258	openfda.rxcui
spl id		b2d71f92-018f-183e-e053-2995a90a5db0	id
spl set id		b2d71f92-018f-183e-e053-2995a90a5db0	set_id
unii		935E97BOY8	openfda.unii
unii		9VU1KI44GP	openfda.unii

Warnings cross-check#

openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.

Warnings sections page 1 of 1 · 1 matching rows.

warnings and cautions

WARNINGS AND PRECAUTIONS Tell your doctor if you have: kidney problems, thyroid disease. This medication should be used as directed during pregnancy or while breast-feeding. Consult your doctor about the risks and benefits. Folic acid alone is improper therapy in the treatment of pernicious anemia and other megaloblastic anemias where vitamin B12 is deficient. Folic acid in doses above 0.1 mg daily may obscure pernicious anemia in that hematologic remission can occur while neurological manifestations progress.

Adverse reactions cross-check#

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Adverse reactions sections page 1 of 1 · 1 matching rows.

adverse reactions

ADVERSE REACTIONS Allergic sensitization has been reported following both oral and parenteral administration of folic acid. You should call your doctor for medical advice about serious adverse events. To report adverse side effects or to obtain product information, contact PureTek Corporation, at 1-877-921-7873.

Reported adverse events (FAERS/openFDA)#

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