NewFolic

Manufacturer
Trell Pharma
Effective date
2023-09-21
Label type
DIETARY SUPPLEMENT
Version
1
Source
full-release
Hydrated at
2026-06-01 02:50:53

Label at a glance#

ProductNewFolic
Active ingredientFOLIC ACID, VITAMIN D
Label structure6 sections

Storage and handling

Store at 20°-25°C (68°-77°F); excursions permitted to 15°-30°C (59°-86°F) [see USP Controlled Room Temperature]. Protect from heat, light and moisture. Manufactured for Trell Pharma Tampa, FL  Questions? Call: 813-576-1843

Label contents#

Full prescribing information#

STATEMENT OF IDENTITY

STATEMENT OF IDENTITY SECTION

NewFolic

Other Ingredients: Microcrystalline Cellulose, Magnesium Stearate & Vegatable Capsules

NewFolic is an orally administered prescription folate product for the dietary management of patients with unique nutritional needs requiring increased folate levels and Vitamin D supplementation due to Vitamin D deficiency.

NewFolic is manufactured in accordance with Current Good Manufacturing Practice for foods, using ingredients that have been approved by the U.S. Food and Drug Administration (FDA) as food additives or are Generally Recognized as Safe (GRAS) for their intended use.

DOSAGE

DOSAGE & ADMINISTRATION SECTION

Usual Adult dose is one capsule once daily, or as prescribed by a licensed medical practitioner.
If you are pregnant or nursing, ask a healthcare professional.

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

WARNINGS AND PRECAUTIONS 

PRECAUTIONS SECTION

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

NewFolic should only be used under the direction and supervision of a licensed medical practitioner. Use with caution in patients that may have a medical condition, are pregnant, lactating, trying to conceive, under the age of 18, or taking medications.

Each tablet contains:

Folic Acid ..........................................................................1700 mcg DFE

(Folic Acid 1000mcg)

Vitamin D3 (Cholecalciferol) ...................................... 75 mcg

(3000 IU)

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.

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 1-813-576-1843.

KEEP OUT OF REACH OF CHILDREN

STORAGE AND HANDLING SECTION

SAFE HANDLING WARNING SECTION

Store at 20°-25°C (68°-77°F); excursions permitted to 15°-30°C (59°-86°F) [see USP Controlled Room Temperature].

Protect from heat, light and moisture.

Manufactured for Trell Pharma

Tampa, FL 

Questions? Call: 813-576-1843

HEALTH CLAIM:

HEALTH CLAIM SECTION

NewFolic is used for dietary management of patients with unique nutritional needs requiring increased folate levels, Vitamin D deficiency or are in need of Vitamin D supplementation and other nutritional supplementation.

NewFolic can be taken by women of childbearing age, pregnant women, and lactating and nonlactating mothers.

Package Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image descriptionimage description

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
2665428vitamin D3 75 MCG (3000 UNT) / folate 1700 MCG DFE (1000 mcg folic acid) Oral TabletPSN1
2665428cholecalciferol 0.075 MG / folic acid 1 MG Oral CapsuleSCD1
2665428cholecalciferol 0.075 MG / folate 1 MG Oral CapsuleSY1
2665428vitamin D3 75 MCG (3000 UNT) / folate 1700 MCG DFE (1000 mcg folic acid) Oral TabletSY1

DailyMed Pharmacologic Classes#

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

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
82379-1300-1NewFolic30 in 1 BOTTLECAPSULE301

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
82379-1300NEWFOLIC (FOLIC ACID AND VITAMIN D3) CAPSULE [TRELL PHARMA]11 package rows20230922_c2387434-dd1d-4dae-a984-7a4e168a51f9.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
82379-1300-1EA - Each82379-13004e1c2464-b7a4-45c9-abaa-b3385b76d10512023-10-16

Products#

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

DailyMed product names page 1 of 1 · 7 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
82379-130082379-1300-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 4 matching rows.

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 4 · 61 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Folic AcidFOLIC ACIDREMEDYREPACK INC.bda4687e-929a-434d-ab59-909cf2ed73a22026-09-11Warnings, Adverse reactionsName fallback
generic name: FOLIC ACID
Folic AcidFOLIC ACIDREMEDYREPACK INC.368b69a8-a021-47e3-a6d7-e3497d7363b12026-09-04Warnings, Adverse reactionsName fallback
generic name: FOLIC ACID
Folic AcidFOLIC ACIDRising Pharma Holdings, Inc.0baa10dd-6d1d-4946-8236-566451132da32026-07-24Warnings, Adverse reactionsName fallback
generic name: FOLIC ACID
Folic AcidFOLIC ACIDNorthwind Health Company, LLC03b0aee4-804a-de63-e063-6394a90a66352026-07-13Warnings, Adverse reactionsName fallback
generic name: FOLIC ACID
FOLIC ACIDFOLIC ACIDUnit Dose Solutions, Inc.54db8b21-87b9-5e0c-e063-6394a90ae8ea2026-06-22Warnings, Adverse reactionsName fallback
generic name: FOLIC ACID
VitramynFOLIC ACIDPureTek Corporationc8af7616-5178-6df0-e053-2a95a90a334d2026-06-18Warnings, Adverse reactionsName fallback
generic name: FOLIC ACID
FOLIC ACIDFOLIC ACIDCoupler LLC544e394d-3555-8ab1-e063-6394a90ade002026-06-15Warnings, Adverse reactionsName fallback
generic name: FOLIC ACID
Folic AcidFOLIC ACIDMajor Pharmaceuticals7778ac96-7817-455a-a177-22ecb276c67f2026-05-26Warnings, Adverse reactionsName fallback
generic name: FOLIC ACID
Folic AcidFOLIC ACIDQUAGEN PHARMACEUTICALS LLC354366ea-3702-4706-9fc0-0244b7278bd82026-05-20Warnings, Adverse reactionsName fallback
generic name: FOLIC ACID
Folic AcidFOLIC ACIDCardinal Health 107, LLC624469a1-ded9-453a-973e-c5a2f0602bb02026-05-15Warnings, Adverse reactionsName fallback
generic name: FOLIC ACID
Folic AcidFOLIC ACIDCardinal Health 107, LLC6dd867fe-597e-4915-8baf-98a605bf93242026-05-06Warnings, Adverse reactionsName fallback
generic name: FOLIC ACID
Folic AcidFOLIC ACIDBryant Ranch Prepacka1b71c5d-c842-43fd-9557-2bb4e934b9142026-04-23Warnings, Adverse reactionsName fallback
generic name: FOLIC ACID
Folic AcidFOLIC ACIDPreferred Pharmaceuticals Inc.b4c3a754-64cd-499a-a32f-a6e935c413552026-04-22Warnings, Adverse reactionsName fallback
generic name: FOLIC ACID
Folic AcidFOLIC ACIDAmneal Pharmaceuticals of New York LLCfd85395e-6a0b-4072-a80b-36095c0c6dd62026-04-15Warnings, Adverse reactionsName fallback
generic name: FOLIC ACID
MultitamFOLIC ACIDPureTek Corporationcee15842-4a9e-c6ba-e053-2a95a90aebc52026-04-13Warnings, Adverse reactionsName fallback
generic name: FOLIC ACID
Folic AcidFOLIC ACIDXGen Pharmaceuticals DJB, Inc.c5b2b84d-9f5e-4b81-ba10-9f2854e5dce92026-01-21Warnings, Adverse reactionsName fallback
generic name: FOLIC ACID
Folic AcidFOLIC ACIDAphena Pharma Solutions - Tennessee, LLC40ab3c91-5a5b-fa1d-e063-6394a90a74542025-12-10Warnings, Adverse reactionsName fallback
generic name: FOLIC ACID
Folic AcidFOLIC ACIDAmerican Health Packagingfc6dc1e1-f63e-4239-a1eb-67525569f68c2025-11-13Warnings, Adverse reactionsName fallback
generic name: FOLIC ACID
Folic AcidFOLIC ACIDBryant Ranch Prepack4889d474-bd72-46ba-81d6-5511d8a85abb2025-11-04Warnings, Adverse reactionsName fallback
generic name: FOLIC ACID
Folic AcidFOLIC ACIDBryant Ranch Prepack41914ac8-f4f5-4d70-b9f2-9f88c59d67a62025-10-29Warnings, Adverse reactionsName fallback
generic name: FOLIC ACID

Reported adverse events (FAERS/openFDA)#

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