Ventrixyl 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
🆔 Identity & classification
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🏭 Manufacturer & labeler
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🩺 Clinical
Ventrixyl Fe is an oral tablet containing a combination of vitamins and minerals. The product includes ferrous fumarate, an iron salt typically used to help maintain iron levels, along with B vitamins (cyanocobalamin, folic acid, pyridoxine, riboflavin, and niacinamide) commonly included in nutritional formulations. It also contains vitamin C, vitamin D, vitamin E, and trace minerals such as chromium, manganese, molybdenum, and selenium, as well as calcium and magnesium. This is an unapproved drug product marketed without an FDA-approved application.
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💊 What it looks like
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🧪 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.
💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.
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UNII D9108TZ9KG
Cocoa is a natural powder made from roasted cacao beans. It's used as a flavoring and coloring agent to make medicines taste better and appear brown.
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UNII M28OL1HH48
Croscarmellose sodium is a plant-based substance derived from cellulose. It acts as a disintegrant, helping tablets and capsules break down quickly in the digestive system so the medicine can be absorbed.
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UNII 2S7830E561
Crospovidone is a synthetic polymer derived from povidone. It acts as a disintegrant, helping the tablet or capsule break apart quickly in the stomach so the active ingredient can be absorbed.
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UNII 3NXW29V3WO
Hypromellose is a plant-based thickener made from cellulose. It's used in medicines as a binder to hold ingredients together, a coating for tablets, and a thickener for liquids.
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UNII 70097M6I30
Magnesium stearate is a salt made from magnesium and stearic acid, a fatty substance. It's used in tablets and capsules as a lubricant and glidant to help ingredients flow smoothly during manufacturing and prevent sticking.
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UNII OP1R32D61U
Microcrystalline cellulose is a purified form of cellulose, a natural fiber from plant sources. It acts as a binder and filler in tablets and capsules, helping hold ingredients together and give the medicine its shape and size.
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UNII B697894SGQ
Polyethylene glycol 400 is a clear, thick liquid made from petroleum-derived polymers. It acts as a solvent and humectant in medicines, helping dissolve active ingredients and retain moisture in the formulation.
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UNII ETJ7Z6XBU4
Silicon dioxide is a naturally occurring mineral used as a glidant and anti-caking agent. It helps powder ingredients flow smoothly and prevents clumping during manufacturing and storage.
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UNII 4ELV7Z65AP
Stearic acid is a fatty acid derived from plant or animal sources. It acts as a binder and lubricant in tablets and capsules, helping them hold together and flow smoothly during manufacturing.
9 inactive ingredients listed in the exact product block matched to this NDC.
Where does this data come from?
ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.Inactive ingredient FAQ
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💲 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 system | Per each | Per 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. | |
Where does this data come from?
🔁 Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price 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 m 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 mthis 59088-0187-54 | PureTek | 30 tablets | — | — | FDA listed | — |
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⏳ Availability & generic status
We did not find an FDA-approved generic match for this exact strength, form and route.
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🔬 Reported adverse events (FAERS)
Top reported reactions
Age at onset
Reporter sex
Serious outcomes
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📦 Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Status |
|---|---|---|---|
| 59088-0187-54 You're viewing this | 30 TABLET in 1 BOTTLE, PLASTIC (59088-187-54) | 2021-08-11 | Active |
🧭 About this NDC listing & data coverage
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) | ✓ 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. |
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📄 Full prescribing information FDA SPL
🎯 Indications and Usage ▾
Indications and Usage: Ventrixyl™ 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 the treatment of conditions 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 ▾
Dosage and Administration: Adults (persons over 12 years of age) One (1) Ventrixyl™ FE caplet daily, between meals or as directed by a physician. Do not administer to children under the age of 12.
⛔ Contraindications ▾
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 ▾
Warnings: 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. Precautions: 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 B12 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: Ventrixyl TM 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 Ventrixyl ™ FE after meals may control occasional gastrointestinal disturbances. Ventrixyl ™ 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 usually recommended levels, has been associated with gastrointestinal intolerance in some patients.
🤒 Adverse Reactions ▾
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 Ventrixyl ™ FE after meals may control occasional gastrointestinal disturbances.
Ventrixyl ™ 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 usually recommended levels, has been associated with gastrointestinal intolerance in some patients.
🔄 Drug Interactions ▾
Drug Interactions: Ventrixyl TM 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 ▾
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. Ventrixyl™ 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 ▾
How Supplied: Ventrixyl™ FE are beige speckled, oblong, coated caplets, in bottles containing 30 caplets – NDC 59088-187-54. 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 ▾
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 ▾
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).