TRONVite

Manufacturer
AMELLA PHARMA, LLC | Hillestad Pharmaceuticals USA
Effective date
2020-09-15
Label type
DIETARY SUPPLEMENT
Version
3
Source
full-release
Hydrated at
2026-06-01 02:49:43

Label at a glance#

ProductTRONVite
Active ingredientASCORBIC ACID, THIAMINE MONONITRATE, RIBOFLAVIN, NIACINAMIDE, PYRIDOXINE HYDROCHLORIDE, FOLIC ACID, METHYLCOBALAMIN, BIOTIN, PANTOTHENIC ACID
Label structure7 sections

Dosage and administration

Usual adult dose is 1 tablet by mouth once or twice daily or as prescribed by a licensed medical practitioner.

Label contents#

Full prescribing information#

TRONVITE Tablets Dietary SupplementDispensed by Prescription†

STATEMENT OF IDENTITY SECTION

Supplement Facts
Serving Size: 1 Tablet          Serving Per Container: 30
 Amount Per Serving % Daily Value
 Vitamin C (as ascorbic Acid) 100 mg 111%
 Thiamine (as thiamine mononitrate) 1.5 mg 125%
 Riboflavin 1.7 mg 131%
 Niacin (as niacinamide) 20 mg 125%
 Vitamin B6 (as pyridoxine HCl) 10 mg 588%
 Folic Acid (1mg Folic Acid) 1 mg 417%
 Vitamin B12 (as methylcobalamin) 6 mcg 250%
 Biotin 300 mcg  1000%
 Pantothenic Acid (as d-calcium pantothenate) 10 mg 200%

OTHER INGREDIENTS: microcrystalline cellulose, croscarmellose sodium, pharmaceutical glaze, mono- and diglycerides, starch, calcium stearate.

DESCRIPTION

STATEMENT OF IDENTITY SECTION

TRONVITE Tablets is an orally administered prescription vitamin formulation for the clinical dietary management of suboptimal nutritional status in patients where advanced folate supplementation is required and nutritional supplementation in physiologically stressful conditions for maintenance of good health is needed.

TRONVITE is a small, round, yellow, clear-coated tablet, with debossed "A" on one side.

PRECAUTIONS SECTION

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

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

TRONVITE Tablets 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.

Folic acid supplementation may obscure pernicious anemia, in that hematologic remission can occur while neurological manifestations progress.

WARNINGS SECTION

KEEP OUT OF THE REACH OF CHILDREN.

Pregnancy and Lactation:
TRONVITE Tablets is not intended for use in pregnant or lactating patients

ADVERSE REACTIONS
Allergic sensitizations have been reported following oral administration of folic acid. Consult your physician immediately if adverse side effects occur.

DOSAGE AND ADMINISTRATION

DOSAGE & ADMINISTRATION SECTION

Usual adult dose is 1 tablet by mouth once or twice daily or as prescribed by a licensed medical practitioner.

HOW SUPPLIED HEALTH CLAIM:

HEALTH CLAIM SECTION

TRONVITE Tablets are supplied as a small, round, yellow, clear-coated tablet, with debossed "A" on one side. TronVite Tablets is available as the following:
72287-121-30*    30ct       bottle

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

Manufactured for:
Amella Pharma, LLC
E Brunswick, NJ 08816

Call your doctor for medical advice about side effects. You may report side effects to Amella Pharma, LLC at 1-844-385-0850.

Issued: 09/2018   AP1002v2

*Amella Pharma does not represent these product codes to be National Drug Codes (NDC). Product codes are formatted according to standard industry practice, to meet the formatting requirement by pedigree reporting and supply-chain control including pharmacies.

† This product is a prescription-folate with or without other dietary ingredients that – due to increased folate levels increased risk associated with masking of B12 deficiency (pernicious anemia) requires administration under the care of a licensed medical practitioner (61 FR 8760). The most appropriate way to ensure pedigree reporting consistent with these regulatory guidelines and safety monitoring is to dispense this product only by prescription (Rx). This is not an Orange Book product. This product may be administered only under a physician’s supervision and all prescriptions using this product shall be pursuant to state statutes as applicable. The ingredients, indication or claims of this product are not to be construed to be drug claims.

Packaging

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PackagingPackaging

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
348025ascorbic acid 100 MG / D-biotin 0.3 MG / folic acid 1 MG / niacinamide 20 MG / pantothenic acid 10 MG / pyridoxine hydrochloride 10 MG / riboflavin 1.7 MG / thiamine 1.5 MG / vitamin B12 0.006 MG Oral TabletSCD3
348025ascorbic acid 100 MG / D-biotin 0.3 MG / folic acid 1 MG / niacinamide 20 MG / pantothenic acid 10 MG / pyridoxine hydrochloride 10 MG / riboflavin 1.7 MG / thiamine 1.5 MG / cyanocobalamin 0.006 MG Oral TabletSY3
348025vit-C 100 MG / D-biotin 0.3 MG / folate 1 MG / niacinamide 20 MG / pantothenic acid 10 MG / vit-B6 hydrochloride 10 MG / riboflavin 1.7 MG / vit-B1 1.5 MG / vitamin B12 0.006 MG Oral TabletSY3
348025vit-C 100 MG / D-biotin 0.3 MG / folate 1 MG / niacinamide 20 MG / pantothenic acid 10 MG / vit-B6 hydrochloride 10 MG / riboflavin 1.7 MG / vitamin B1 1.5 MG / vitamin B12 0.006 MG Oral TabletSY3
348025vit-C 100 MG / D-biotin 0.3 MG / folate 1 MG / niacinamide 20 MG / pantothenic acid 10 MG / vitamin B6 hydrochloride 10 MG / riboflavin 1.7 MG / vit-B1 1.5 MG / vitamin B12 0.006 MG Oral TabletSY3
348025vit-C 100 MG / D-biotin 0.3 MG / folate 1 MG / niacinamide 20 MG / pantothenic acid 10 MG / vitamin B6 hydrochloride 10 MG / riboflavin 1.7 MG / vitamin B1 1.5 MG / vitamin B12 0.006 MG Oral TabletSY3
348025vitamin C 100 MG / D-biotin 0.3 MG / folate 1 MG / niacinamide 20 MG / pantothenic acid 10 MG / vit-B6 hydrochloride 10 MG / riboflavin 1.7 MG / vit-B1 1.5 MG / vitamin B12 0.006 MG Oral TabletSY3
348025vitamin C 100 MG / D-biotin 0.3 MG / folate 1 MG / niacinamide 20 MG / pantothenic acid 10 MG / vit-B6 hydrochloride 10 MG / riboflavin 1.7 MG / vitamin B1 1.5 MG / vitamin B12 0.006 MG Oral TabletSY3
348025vitamin C 100 MG / D-biotin 0.3 MG / folate 1 MG / niacinamide 20 MG / pantothenic acid 10 MG / vitamin B6 hydrochloride 10 MG / riboflavin 1.7 MG / vit-B1 1.5 MG / vitamin B12 0.006 MG Oral TabletSY3
348025vitamin C 100 MG / D-biotin 0.3 MG / folate 1 MG / niacinamide 20 MG / pantothenic acid 10 MG / vitamin B6 hydrochloride 10 MG / riboflavin 1.7 MG / vitamin B1 1.5 MG / vitamin B12 0.006 MG Oral TabletSY3

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
ASCORBIC ACID Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813
PYRIDOXINE Pharmacologic Class Indexing1Indexing - Pharmacologic Class20170310

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
cf050ccd-1144-f76a-e00d-e5698d8597d4Product name620250625
59361619-24d9-b610-eca6-5a7f25ed5e03Product name520240909
91c62db0-0295-c81c-d10a-0856c259edd6Product name220200428
d32bc2b8-0bb7-2216-87aa-24639646e202Product name320190619
5e18e798-5614-cf5c-0185-38b1cb77a093Product name220160822

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72287-121-30TRONVite30 in 1 BOTTLETABLET, COATED303

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72287-121TRONVITE (VITAMIN C, THIAMINE, RIBOFLAVIN, NIACIN, VITAMIN B6, FOLIC ACID, VITAMIN B12, BIOTIN, PANTOTHENIC ACID) TABLET, COATED [AMELLA PHARMA, LLC]31 package rows20200917_eeb07bc9-4820-4a19-87bf-7910ba12b922.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72287-121-30EA - Each72287-121d9f140d3-9ac3-4d72-82d3-5896ac44583312018-06-11

Products#

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

DailyMed product names page 1 of 1 · 20 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
72287-12172287-121-30

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 15 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 1 · 4 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Ascorbic AcidASCORBIC ACIDRenova Pharmaceuticals LLCa6481bae-2397-44c7-a51d-4f47ad91bd2c2026-08-19Warnings, Adverse reactionsName fallback
generic name: ASCORBIC ACID
AscorASCORBIC ACIDMcGuff Pharmaceuticals, Inc.388aad52-fc01-4784-9791-1dbc80c693062026-05-29Warnings, Adverse reactionsName fallback
generic name: ASCORBIC ACID
Ascorbic AcidASCORBIC ACIDFresenius Kabi USA, LLC1606e29f-0e80-4069-b688-daab9cbff20a2025-12-17Warnings, Adverse reactionsName fallback
generic name: ASCORBIC ACID
Skin Renewing SerumASCORBIC ACIDGuangzhou Danting Bath&Body Care Industry Co. Ltd396c2a8d-ac95-cbef-e063-6294a90aff392025-08-23WarningsName fallback
generic name: ASCORBIC ACID

Reported adverse events (FAERS/openFDA)#

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