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Vitranol Fe Ferrous Fumarate, Folic Acid 35 ug; 1000 ug; 1500 ug; 3.4 mg; 20 mg; 20 mg; 8 ug; 200 mg; 120 mg; 3 m Tablet, 30-count — NDC 59088-0173-54 package photo

Vitranol Fe Ferrous Fumarate, Folic Acid 35 ug; 1000 ug; 1500 ug; 3.4 mg; 20 mg; 20 mg; 8 ug; 200 mg; 120 mg; 3 m Tablet, 30-count

by PureTek Corporation · 30 TABLET in 1 BOTTLE, PLASTIC (59088-173-54)
NDC 59088-0173-54
🏷️ FDA NDC (as labeled) 59088-173-54 billing pads the product segment with a zero
Rx only On market Non-controlled
🗂️ Data synced Sep 17, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

This page is curated, coded, and maintained by

Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

🆔 Identity & classification

FDA NDC (as labeled) 59088-173-54
Product NDC 59088-173
11-digit billing NDC 59088017354
NCPDP billing unit EA — each (per item)
UNII A150AY412V, 935E97BOY8, 3LE3D9D6OY, TLM2976OFR, 25X51I8RD4, 68Y4CF58BV +12 more
UPC 0359088173541
SPL Set ID b81daf17-430b-6ba2-e053-2a95a90a768b
Established class (EPC) Vitamin B12; Vitamin C; Vitamin D
Chemical class Vitamin B 12; Ascorbic Acid; Vitamin D
DEA schedule Non-controlled
Marketing category UNAPPROVED DRUG OTHER
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2021-01-04
Route ORAL
Dosage form TABLET
Substance CHROMIUM NICOTINATE; FOLIC ACID; VITAMIN A ACETATE; RIBOFLAVIN; NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; CYANOCOBALAMIN; CALCIUM CARBONATE; ASCORBIC ACID; THIAMINE MONONITRATE; ZINC OXIDE; MANGANESE SULFATE; FERROUS FUMARATE; MAGNESIUM OXIDE; MOLYBDENUM; .A
GPI-14 78310000000300
GPI class Vitranol FE
GCN Seq No 081657
GCN 48808
HICL code 046955
Ingredient (HICL) Mv-Mn No.86/Iron/Folic Acid
HIC1 code C
Therapeutic class — broad (HIC1) Electrolyte Balance/Metabolism/Nutrition
HIC2 code C6
Therapeutic class — intermediate (HIC2) Vitamins
HIC3 code C6Z
Therapeutic class — specific (HIC3) Multivitamin Preparations
AHFS code 20:04.04.00
AHFS class Iron Preparations
FDB label name DERMACINRX VITRANOL FE CAPLET
FDB brand name Dermacinrx Vitranol Fe
Legend status Q — Non-drug — dietary supplement, vitamin, medical food, or herbal preparation
Why two NDCs? The FDA registers this code as 59088-173-54 — a 5-3-2 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the product segment → 59088-0173-54. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

🏭 Manufacturer & labeler

LabelerPureTek Corporation
Labeler code59088
First marketedJan 2021
Product typeHuman Prescription Drug
Portfolio178 products on file
The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

🩺 Clinical

Label name DERMACINRX VITRANOL FE CAPLET Ingredient Mv-Mn No.86/Iron/Folic Acid
🧪 What is this product?

Vitranol Fe is an oral tablet containing a combination of vitamins and minerals. The product includes ferrous fumarate, a form of iron typically used to support red blood cell production, along with folic acid and vitamin B12, which are commonly used to support cell function and energy metabolism. It also contains vitamins C and D, various B vitamins, calcium, magnesium, and trace minerals such as chromium, manganese, selenium, and molybdenum. This product is marketed without an approved FDA application.

Supplement & herbal interactions

🌿 Drug–supplement interaction checker →
Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

🧪 Inactive Ingredients / Excipients

Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.

Loading inactive ingredients from the official FDA label in the background. No external source is being called by this page request.
Where does this data come from?
Source: official FDA Structured Product Labeling (SPL) via DailyMed and the openFDA label index. Structured IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.

Inactive ingredient FAQ

Are inactive ingredients the same for every manufacturer?
No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.
Why might an inactive ingredient be missing?
Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.
Can inactive ingredients matter?
Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

💲 Pricing

A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.

Price systemPer eachPer package
Retail pharmacies payNADAC · weekly Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · quarterly No Part D plan price is available for this NDC in our data.
ℹ️
No price is published for this exact package yet. CMS surveys NADAC per package size, so a different pack of the same drug often has one.
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

🔁 Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Vitrexyl plus Iron 35 ug/1; 1000 ug/1; 1500 ug/1; 3.4 mg/1; 20 mg/1; 20 mg/1; 8 ug/1; 200 mg/1; 120 mg/1; 3 m 59088-0165-54 PureTek 30 tablets — — FDA listed —
Vitrexate FE 35 ug/1; 1000 ug/1; 1500 ug/1; 3.4 mg/1; 20 mg/1; 20 mg/1; 8 ug/1; 200 mg/1; 120 mg/1; 3 m 59088-0168-54 PureTek 30 tablets — — FDA listed —
Vitranol Fe 35 ug/1; 1000 ug/1; 1500 ug/1; 3.4 mg/1; 20 mg/1; 20 mg/1; 8 ug/1; 200 mg/1; 120 mg/1; 3 mthis 59088-0173-54 PureTek 30 tablets — — FDA listed —
Venexa FE 35 ug/1; 1000 ug/1; 1500 ug/1; 3.4 mg/1; 20 mg/1; 20 mg/1; 8 ug/1; 200 mg/1; 120 mg/1; 3 m 59088-0177-54 PureTek 30 tablets — — FDA listed —
Ventrixyl Fe 35 ug/1; 1000 ug/1; 1500 ug/1; 3.4 mg/1; 20 mg/1; 20 mg/1; 8 ug/1; 200 mg/1; 120 mg/1; 3 m 59088-0187-54 PureTek 30 tablets — — FDA listed —
About this product: other versions of the same ingredient, strength and form are listed above, least expensive first, with FDA equivalence ratings where available.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

⏳ Availability & generic status

🏛️
2021
On the market since
Jan 2021
📍
2026
Currently FDA-listed
5 years listed
🔒
·
No generic listed yet
brand only
ℹ️No FDA-approved generic found

We did not find an FDA-approved generic match for this exact strength, form and route.

Where does this data come from?
Patents and exclusivity from the FDA Orange Book (small-molecule drugs), refreshed from public FDA data. Generic launch timing is an estimate, not a guarantee.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
59088-0173-54 You're viewing this 30 TABLET in 1 BOTTLE, PLASTIC (59088-173-54) 2021-01-04 Active

🧭 About this NDC listing & data coverage

Finished prescription product Marketed without an FDA application

Listed without an FDA application

This product's marketing category indicates it is marketed without an approved FDA application (no NDA, ANDA, or BLA on file). Having an NDC does not by itself establish FDA approval — the NDC Directory is a listing system, not an approval decision. Approval-linked data such as Orange Book therapeutic-equivalence ratings therefore does not apply.

What data is (and isn’t) available for this NDC — tap to expand
NDC identity (package / product / labeler codes) ✓ Available
Labeler ✓ Available
Product & package description ✓ Available
Marketing category & status ✓ Available
Active ingredient / dosage form / route ✓ Available
FDA label (SPL via DailyMed) ✓ Available
Package photos ✓ Available
Inactive ingredients (structured) — Not published for this NDC The labeler did not submit a structured excipient list, or no SPL is available.
NADAC pharmacy acquisition price (CMS) — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey.
Orange Book / therapeutic-equivalence data — Not published for this NDC Applies only to products approved under an NDA/ANDA; many listings are out of scope.
HCPCS J-code billing crosswalk — Not published for this NDC Most self-administered / retail products have no J-code — that is normal.
Medicaid utilization (CMS SDUD) — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold.
“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.

Questions about this listing

Is this NDC FDA-approved?
An NDC listing does not by itself establish FDA approval — the NDC Directory records that a product is listed with FDA, not that it was reviewed and approved. This listing's marketing category is "Unapproved Drug Other". Products approved under an application carry an NDA, ANDA, or BLA number.
Why is there no price listed?
The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The FDA registers it as 59088-173-54, which is what is printed on the packaging and shown on DailyMed. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero: 59088-0173-54, written without dashes as 59088017354. The Identity section at the top of this page lists every form of this code.
What do the three segments of this NDC mean?
In 59088-0173-54, the first segment (59088) is the labeler code FDA assigned to PureTek Corporation; the middle segment (0173) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (54) identifies this exact package size and type. Together they name one specific package of one specific product.
Is this package still being marketed?
Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by PureTek Corporation. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
PureTek Corporation is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
Do I need a prescription for this product?
This NDC is listed with FDA as a prescription product, so it is dispensed under a prescriber's order. Your pharmacist can tell you whether any over-the-counter forms of the same medication exist.
This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.
Where does this data come from?
Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.

📄 Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage ⏱️ Dosage and Administration ⛔ Contraindications ⚠️ Warnings 🤒 Adverse Reactions 🔄 Drug Interactions 🆘 Overdosage 📦 How Supplied / Storage and Handling 📦 Storage and Handling 📋 Description
🎯 Indications and Usage 69 words ▾

INDICATIONS: Vitranol FE is indicated for the treatment of iron deficiency anemia and folate deficiency as in extended convalescence, menorrhagia, pregnancy, puberty, excessive blood loss, and advanced age. Also for treatment of condition in which iron deficiency and vitamin C deficiency occur together, along with a deficient intake or increased need for B-Complex vitamins in chronic and acute illness, as well as cases of metabolic stress, and in convalescence.

⏱️ Dosage and Administration 35 words ▾

DOSAGE AND ADMINISTRATION: Adults (persons over 12 years of age) One (1) Vitranol Fe Multivitamin caplet daily, between meals or as directed by a physician. Do not administer to children under the age of 12.

⛔ Contraindications 43 words ▾

CONTRAINDICATIONS: This product is contraindicated in patients with known hypersensitivity to any of its ingredients; also, all iron compounds are contraindicated in patients with hemosiderosis, hemochromatosis, or hemolytic anemias. Pernicious anemia is a contraindication, as folic acid may obscure its signs and symptoms.

⚠️ Warnings ~2 min read ▾

WARNING: Accidental overdose of iron-containing products is a leading cause of fatal poisoning in children under 6. Keep this product out of reach of children. In case of accidental overdose, call a doctor or poison control center immediately.

Administration of folic acid alone is improper therapy for pernicious anemia and other megaloblastic anemias in which vitamin B 12 is deficient. Precaution Section Folic acid in doses above 0.1 mg daily may obscure pernicious anemia, in that hematologic remission can occur while neurological manifestations remain progressive. There is a potential danger in administering folic acid to patients with undiagnosed anemia, since folic acid may obscure the diagnosis of pernicious anemia by alleviating the hematologic manifestations of the disease while allowing the neurologic complications to progress.

This may result in severe nervous system damage before the correct diagnosis is made. Adequate doses of vitamin B 12 may prevent, halt, or improve the neurologic changes caused by pernicious anemia. The patient’s medical conditions and consumption of other drugs, herbs, and/or supplements should be considered.

For use on the order of a healthcare practitioner. Call your doctor about side effects. To report side effects, call PureTek Corporation at 1-877-921-7873 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Drug Interactions: Vitranol FE is not recommended for and should not be given to patients receiving levodopa because the action of levodopa is antagonized by pyridoxine. There is a possibility of increased bleeding due to pyridoxine interaction with anticoagulants (e.g., Aspirin, Heparin, or Clopidogrel). Adverse Reactions: Folic Acid: Allergic sensitizations have been reported following both oral and parenteral administration of folic acid.

Ferrous Fumarate: Gastrointestinal disturbances (anorexia, nausea, diarrhea, constipation) occur occasionally, but are usually mild and may subside with continuation of therapy. Although the absorption of iron is best when taken between meals, giving Vitranol FE after meals may control occasional gastrointestinal disturbances. Vitranol FE is best absorbed when taken at bedtime.

Adverse reactions have been reported with specific vitamins and minerals but generally at levels substantially higher than those contained herein. However, allergic and idiosyncratic reactions are possible at lower levels. Iron, even at the usual recommended levels, has been associated with gastrointestinal intolerance in some patients.

🤒 Adverse Reactions 115 words ▾

Adverse Reactions: Folic Acid: Allergic sensitizations have been reported following both oral and parenteral administration of folic acid. Ferrous Fumarate: Gastrointestinal disturbances (anorexia, nausea, diarrhea, constipation) occur occasionally, but are usually mild and may subside with continuation of therapy. Although the absorption of iron is best when taken between meals, giving Vitranol FE after meals may control occasional gastrointestinal disturbances.

Vitranol FE is best absorbed when taken at bedtime. Adverse reactions have been reported with specific vitamins and minerals but generally at levels substantially higher than those contained herein. However, allergic and idiosyncratic reactions are possible at lower levels.

Iron, even at the usual recommended levels, has been associated with gastrointestinal intolerance in some patients.

🔄 Drug Interactions 44 words ▾

Drug Interactions: Vitranol FE is not recommended for and should not be given to patients receiving levodopa because the action of levodopa is antagonized by pyridoxine. There is a possibility of increased bleeding due to pyridoxine interaction with anticoagulants (e.g., Aspirin, Heparin, or Clopidogrel).

🆘 Overdosage 119 words ▾

OVERDOSE: Iron: Signs and Symptoms: Iron is toxic. Acute overdosage of iron may cause nausea and vomiting and, in severe cases, cardiovascular collapse and death. Other symptoms include pallor and cyanosis, melena, shock, drowsiness, and coma.

The estimated overdose of orally ingested iron is 300 mg/kg body weight. When overdoses are ingested by children, severe reactions, including fatalities, have resulted. Vitranol FE should be stored beyond the reach of children to prevent against accidental iron poisoning.

Keep this and all other drugs out of reach of children. Treatment: For specific therapy, exchange transfusion and chelating agents should be used. For general management, perform gastric lavage with sodium bicarbonate solution or milk.

Administer intravenous fluids and electrolytes and use oxygen.

📦 How Supplied / Storage and Handling 55 words ▾

HOW SUPPLIED: Vitranol FE are beige speckled, oblong, coated caplets, in bottles containing 30 caplets – NDC 59088-173-54. Dispense in a tight, light-resistant container as defined in the USP/NF with a child-resistant closure. Store at controlled room temperature 20° to 25°C (68° to 77°F). [See USP]. Protect from light and moisture and avoid excessive heat.

📦 Storage and Handling 55 words ▾

STORAGE: Do not use if bottle seal is broken. KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN. Store at controlled room temperature 20° to 25°C (68° to 77°F). [See USP]. Protect from light and moisture and avoid excessive heat. To report a serious adverse event or to obtain product information, contact 877-921-7873.

📋 Description 150 words ▾

DESCRIPTION: Each caplet contains: Vitamin A (as retinyl acetate)……………….. 1500 mcg (5000 IU) Vitamin C (as ascorbic acid)……………………………… 120 mg Vitamin D3 (as cholecalciferol)………………….. 20 mcg (800 IU) Vitamin E (dl-alpha tocopheryl acetate)…………… 30 mg (30 IU) Thiamin (as thiamine mononitrate)………………………….

3 mg Riboflavin (vitamin B2)……………………………………. 3.4 mg Niacin (as niacinamide)…………………………………… 20 mg Vitamin B6 (as pyridoxine hydrochloride)…………………. 20 mg Folate (as folic acid)………..

1700 mcg DFE (1000 mcg folic acid) Vitamin B12 (as cyanocobalamin)………………………….. 8 mcg Calcium (as calcium carbonate)…………………………. 200 mg Iron (as ferrous fumarate)………………………………… 27 mg Magnesium (as magnesium oxide)……………………… 200 mg Zinc (as zinc oxide)………………………………………..

25 mg Selenium (as selenium amino acid chelate)………………. 55 mcg Manganese (as manganese sulfate)……………………… 2.3 mg Chromium (as chromium polynicotinate)……………….. 35 mcg Molybdenum (as molybdenum amino acid chelate)……… 45 mcg Other Ingredients: Organic cocoa powder, croscarmellose sodium, crospovidone, magnesium stearate, microcrystalline cellulose, silicon dioxide, stearic acid.

Clear coating: (hydroxypropyl methylcellulose, PEG-8).

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 59088-0172-54 · PureTek 59088-0176-54 · PureTek →
For educational and professional reference only — not medical advice. Pricing reflects published NADAC and CMS ASP (free public data) and may differ from your acquisition cost; always verify before billing or dispensing.