Folic Acid
Folic acid is a B vitamin (folate) medicine used to treat megaloblastic anemia (anemia with unusually large red blood cells) caused by folic acid deficiency, available as a tablet, oral solution and injection.
🧬 Where this information comes from Click to expand
The clinical label records used on this page are FDA-filed Structured Product Labeling (SPL) retrieved through openFDA. We identified 58 clinical label sets within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. Forms, routes, brands, labelers, strengths, and NDC product-record counts are built separately from matching FDA National Drug Code Directory records. The linked DailyMed document is a representative official source for verification, not the page’s only clinical source. View the linked label on DailyMed →
How we combine label and product data →
Patient information guide — a plain-language walkthrough of Folic Acid, written from its FDA label.
What Folic Acid is used for
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Folic acid treats anemia caused by folate deficiency.
- Megaloblastic anemia due to folic acid deficiency (all products)
- Quiofic and Folic Acid oral solution: adults and children with this condition
- Folic Acid tablets and injection: deficiency seen in sprue, and anemia linked to nutrition, pregnancy, infancy or childhood
How Folic Acid works
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Your body needs folate to make DNA and keep red blood cell production normal. Without enough, the bone marrow makes large, immature cells. Folic acid is converted into tetrahydrofolic acid, which helps build DNA components. This lets the marrow return to making normal red blood cells.
Folic Acid dosage
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Folic acid is usually taken once daily. Tablets and oral solutions are taken by mouth, and the oral solutions can be taken with or without food.
- Treatment often starts higher, then drops to a maintenance level once symptoms ease and blood counts normalize.
- Quiofic and Folic Acid oral solution should be measured with an oral dosing syringe.
- Injection (muscle, vein or under the skin) is used if the disease is exceptionally severe or absorption may be impaired.
- Maintenance needs may be higher with alcoholism, hemolytic anemia, anticonvulsants or chronic infection.
Follow your prescriber and product label.
Dosing details from the FDA-approved label
From the Folic Acid prescribing information (“Dosage and Administration”). Doses are set by your prescriber for your product, condition, kidney function and age — never change a dose on your own.
- Starting dosage in adults and pediatric patients (regardless of age)
- Up to 1 mg orally daily
- Rule out pernicious anemia prior to use of any doses greater than 0.4 mg (except during pregnancy and lactation); oral solution can be taken with or without food
- Maintenance: pediatric patients birth to 23 months
- 0.1 mg orally daily
- Use when clinical symptoms have subsided and the blood picture has become normal
- Maintenance: pediatric patients 2 years to less than 4 years
- Up to 0.3 mg orally daily
- Use when clinical symptoms have subsided and the blood picture has become normal
- Maintenance: adults and pediatric patients 4 years and older
- 0.4 mg orally daily
- Higher maintenance doses may be needed in alcoholism, hemolytic anemia, anticonvulsant therapy, or chronic infection
- Maintenance: pregnant and lactating women
- 0.8 mg orally daily
- But never less than 0.1 mg orally per day
- Parenteral (injection) usual therapeutic dosage in adults and children (regardless of age)
- Up to 1 mg daily by IM, IV or SC route
- Resistant cases may require larger doses
- Used if disease is exceptionally severe or gastrointestinal absorption may be or is known to be impaired
Read the label’s full dosing text
2 DOSAGE AND ADMINISTRATION Recommended starting dosage in adults and pediatric patients (regardless of age) is up to 1 mg orally daily. ( 2 ) Maintenance dosage ( 2 ) - Pediatric patients birth to 23 months: 0.1 mg orally daily - Pediatric patients 2 years to less than 4 years: up to 0.3 mg orally daily - Adults and pediatric patients 4 years and older: 0.4 mg orally daily - Pregnant and Lactating Women: 0.8 mg orally daily; but never less than 0.1 mg orally per day 2.1 Important Administration Information Instruct patients or caregivers to use an oral dosing syringe to correctly measure the prescribed amount of medication. Inform patients that oral dosing syringes may be obtained from their pharmacy. 2.2 Recommended Dosing Initial Dosing The recommended starting dosage of FOLIC ACID oral solution in pediatric and adult patients is up to 1 mg orally daily. FOLIC ACID oral solution can be taken with or without food. Rule out pernicious anemia prior to use of any doses greater than 0.4 mg (except during pregnancy and lactation). Maintenance Dosing When clinical symptoms have subsided and the blood picture has become normal, use a daily maintenance level as follows: - Pediatric patients aged birth to 23 months: 0.1 mg orally daily - Pediatric patients aged 2 years to less than 4 years: up to 0.3 mg orally daily - Pediatric patients aged 4 years and older and adult patients: 0.4 mg orally daily - Pregnant and Lactating Women: 0.8 mg orally daily; but never less than 0.1 mg orally per day Higher maintenance doses may be needed in the presence of alcoholism, hemolytic anemia, anticonvulsant therapy, or chronic infection. Monitor patients frequently for relapse and adjust dose accordingly.
Read the full Dosage and Administration section on DailyMed →
Folic Acid side effects
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Common side effects
- Loss of appetite
- Nausea
- Abdominal bloating or gas
- Bitter or bad taste
- Trouble sleeping or changes in sleep
- Irritability or difficulty concentrating
When to get medical help
- Allergic reaction signs: skin rash, redness, itching, general malaise or trouble breathing from wheezing (bronchospasm). Get help right away. One patient had symptoms suggesting anaphylaxis (a severe allergic reaction) after an injection.
- New or worsening nerve symptoms if you have pernicious anemia (a vitamin B12 deficiency anemia), since folic acid can hide it while nerve damage progresses.
- More seizures if you have epilepsy and take phenobarbital, primidone or phenytoin (diphenylhydantoin). Tell your doctor.
- Mood changes such as depression, confusion or impaired judgment, which were reported in people taking much higher daily doses.
Folic acid is relatively nontoxic. Most reported side effects were seen at much higher daily doses.
- Loss of appetite and nausea
- Abdominal bloating and gas
- Bitter or bad taste
- Altered sleep, irritability or trouble concentrating
Rare allergic reactions (rash, itching, wheezing or trouble breathing) need prompt medical help.
Folic Acid warnings and precautions
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Folic acid above 0.1 mg daily can hide pernicious anemia. Blood counts may look better while nerve damage from low B12 keeps progressing.
- Folic acid alone is not proper treatment for anemias where B12 is deficient.
- Doses above 0.4 mg daily should wait until pernicious anemia is ruled out, except in pregnancy and breastfeeding.
- Long-term use may lower vitamin B12 levels.
- Seizures increased in some people with epilepsy taking certain seizure medicines.
Folic Acid interactions
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Many medicines affect folate levels or are affected by folic acid.
- Phenytoin: folic acid can lower its levels and work against its seizure control.
- Methotrexate: folic acid may interfere with its absorption.
- Tetracycline: folic acid may reduce its effectiveness.
- Other anticonvulsants, sulfasalazine, isoniazid, trimethoprim, pyrimethamine and triamterene can lower folate.
- Antacids, H2 blockers, cholestyramine and colestipol can reduce folate absorption.
- Oral contraceptives and nitrous oxide can lower folate activity.
Interactions listed in the FDA-approved label
From the Folic Acid prescribing information (“Drug Interactions”): what the manufacturer studied or reported to the FDA.
- Phenytoin: Anticonvulsant action of phenytoin is antagonized by folic acid, and folic acid therapy in folate-deficient individuals may decrease serum levels of phenytoin. Generally, the time of administration of these drugs should be separated from folic acid.
- Methotrexate: Folic acid may interfere with gastrointestinal absorption of methotrexate. Folic acid supplements are usually avoided on the day of oral methotrexate administration.
- Tetracycline: Folic acid may interfere with the absorption and effectiveness of the antibiotic tetracycline. Generally, the time of administration of these drugs should be separated from folic acid.
- Enzyme-inducing anticonvulsants (phenytoin, primidone, carbamazepine, phenobarbital): They decrease folate availability by increasing hepatic folate metabolism, inhibiting intestinal folate-processing enzymes, raising gastrointestinal pH, or displacing folate from serum proteins. Monitor for reduced efficacy and adjust the dose of folic acid oral solution as needed.
- Valproate and sulfasalazine: They primarily reduce intestinal folate absorption or interfere with folate-dependent metabolic pathways. Monitor for reduced efficacy and adjust the dose of folic acid oral solution as needed.
- Isoniazid and cycloserine: They reduce folate utilization through metabolic disruption. Monitor for reduced efficacy and adjust the dose of folic acid oral solution as needed.
- Antifolate agents (trimethoprim, pyrimethamine, methotrexate, triamterene): They directly inhibit dihydrofolate reductase, decreasing the formation of active folate derivatives. Monitor for reduced efficacy and adjust the dose of folic acid oral solution as needed.
- Pentamidine, antacids, cholestyramine, colestipol, and H2 blockers: They impair gastrointestinal folate uptake through pH elevation, transporter inhibition, or binding of dietary folate. Monitor for reduced efficacy and adjust the dose of folic acid oral solution as needed.
- Nitrous oxide: It indirectly decreases folate activity by inactivating vitamin B12 and downstream methylation pathways. Monitor for reduced efficacy and adjust the dose of folic acid oral solution as needed.
- Oral contraceptives: They increase folate turnover and urinary loss. Monitor for reduced efficacy and adjust the dose of folic acid oral solution as needed.
Read the label’s full interactions text
7 DRUG INTERACTIONS Anticonvulsant action of phenytoin is antagonized by folic acid. ( 7 ) Multiple drug classes, including anticonvulsants, antibiotic/antimicrobial agents, folate antagonists, GI-binding agents, and oral contraceptives, may reduce folic acid absorption or folate levels. ( 7 ) 7.1 Impact of Folic Acid on Other Drugs Folic acid may interfere with gastrointestinal absorption of methotrexate. Folic acid therapy in folate-deficient individuals may decrease serum levels of phenytoin. Folic acid may also interfere with the absorption and effectiveness of antibiotic tetracycline. Folic acid supplements are usually avoided on the day of oral methotrexate administration. Generally, the time of administration of these drugs should be separated from folic acid. 7.2 Impact of Other Drugs on Folic Acid A wide range of medications can affect folic acid levels through multiple mechanisms, including impaired absorption, accelerated metabolism, and direct inhibition of folate pathways. Enzyme-inducing anticonvulsants such as phenytoin, primidone, carbamazepine, phenobarbital, and the broader anticonvulsant class increase hepatic folate metabolism, inhibit intestinal folate-processing enzymes, raise gastrointestinal pH, or displace folate from serum proteins, collectively leading to decreased folate availability. Valproate and sulfasalazine primarily reduce intestinal folate absorption or interfere with folate-dependent metabolic pathways, while isoniazid and cycloserine reduce folate utilization through metabolic disruption. Several antifolate agents, including trimethoprim, pyrimethamine, methotrexate, and triamterene, directly inhibit dihydrofolate reductase, decreasing the formation of active folate derivatives. Additional agents such as pentamidine, antacids, cholestyramine, colestipol, and H 2 blockers impair gastrointestinal folate uptake through pH elevation, transporter inhibition, or binding of dietary folate.
Excerpted — the section continues on the label. Read the full Drug Interactions section on DailyMed →
Not a complete list. The label covers the interactions the manufacturer studied or reported, and our own interaction database does not cover every medicine either. Bring your full medication list, including vitamins and herbal products, to your pharmacist.
Before taking Folic Acid
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- Don't use if you've had an allergic reaction to folic acid or its ingredients.
- Tell your doctor if you might have low vitamin B12 or pernicious anemia.
- Pregnant and breastfeeding women have higher folate needs. Folic acid is present in breast milk.
- Pregnant women with folate deficiency in the first trimester have a higher risk of neural tube defects in the baby.
- Children can use it, with maintenance amounts set by age.
Folic Acid overdose
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Doses above 0.4 mg daily shouldn't be used until pernicious anemia is ruled out, except in pregnancy and breastfeeding. In pernicious anemia, extra folic acid can make blood counts look normal while nerve damage from B12 deficiency progresses. Doses above the recommended dietary allowance should not be put in multivitamins.
What Folic Acid does in the body
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Folic acid restores folate-dependent activity in the body. Reticulocytes (young red blood cells) rise within 2 to 5 days, and blood counts normalize within 1 to 2 weeks. Serum folate reflects recent intake, red blood cell folate reflects long-term stores, and plasma homocysteine is a functional marker.
How your body processes Folic Acid
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Folic acid is absorbed mainly in the upper small intestine. It appears in blood 15 to 30 minutes after an oral dose and peaks within about 1 hour. The liver converts it to its active forms, which are stored mainly in the liver. It is cleared mostly through urine, generally within 24 hours, and a small amount appears in feces and breast milk.
How to store Folic Acid
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Dispense in a well-closed container with child-resistant closure. Store at 20°-25°C (68°-77°F).
Written from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →
Folic Acid: pharmacist answers to common questions
Quick, plain-English answers to the questions patients ask most about Folic Acid — the kind of thing our pharmacy team would talk through with you at the counter.
What is folic acid being used for here?
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How should I take it?
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Do I need a B12 check before starting?
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What side effects should I expect?
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Can I take it with my other medicines?
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Is it safe in pregnancy or while breastfeeding?
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Is Folic Acid available over the counter?
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When was Folic Acid first available?
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Who makes Folic Acid?
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Answers drafted from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →
More about Folic Acid on HelloPharmacist
Folic Acid forms and strengths (how it comes)
Folic Acid is available in 3 forms. Different forms and brands can have different approved uses, doses, schedules, and directions. Follow the instructions for your exact product, and do not switch forms without guidance from your prescriber or pharmacist.
Tablet
How this form is used
- Folic Acid tablets are used for megaloblastic anemia due to folic acid deficiency, including that seen in sprue, and anemias of nutritional origin, pregnancy, infancy or childhood.
- Folic Acid tablets are taken by mouth, which the label describes as the preferred route.
- Folic Acid tablets are usually reduced to a lower daily maintenance level once blood counts normalize.
Injection
How this form is used
- Folic Acid Injection is used for megaloblastic anemia due to folic acid deficiency, including that seen in sprue, nutritional anemia, pregnancy, infancy or childhood.
- Folic Acid Injection may be given into a muscle, vein or under the skin if the disease is exceptionally severe or gut absorption is impaired.
- Folic Acid Injection should be checked visually for particles and discoloration before use when the solution and container allow.
Oral solution
How this form is used
- Quiofic and Folic Acid oral solution are used for megaloblastic anemia due to folic acid deficiency in adults and children.
- Quiofic and Folic Acid oral solution are taken by mouth once daily, with or without food.
- Quiofic and Folic Acid oral solution should be measured with an oral dosing syringe from your pharmacy.
- Quiofic and Folic Acid oral solution are not for people with a past allergic reaction to folic acid or its ingredients.
Folic Acid on the U.S. market: products, makers and brands
How Folic Acid appears in the FDA’s National Drug Code Directory — including its dosage forms, strengths, brand names, manufacturers, and FDA-listed product records. These are directory records, not sales or prescription volume.
49 companies list 147 Folic Acid product records with the FDA, mostly as tablet, injection, oral solution; the earliest marketing or approval year on record is 1946. Brand names on the directory include Folicet, Folvite, Quiofic and 1 more; the rest are generics.
FDA-listed product records by dose form (tablet variants merged) — FDA National Drug Code Directory. Record counts are not sales or prescription volume.
Also listed with the FDA, not a patient dose form: Powder (7) — bulk drug substance sold to compounders/manufacturers and multi-item kits. These aren’t counted in the dose-form total above.
Share of FDA-listed product records by manufacturer — FDA National Drug Code Directory. Record counts are not sales or prescription volume.
How widely Folic Acid is used (Medicaid data)
A general measure of how commonly Folic Acid is prescribed, based on Medicaid — one of the largest public drug programs. The figure below is prescriptions filled in Q1–Q4 2025, summed across every form and brand of the drug.
Think of this as a proxy for how widely Folic Acid is used, drawn from freely available public data. Medicaid is just one program — these numbers don’t include Medicare, other government coverage, or commercial and cash-pay prescriptions, so real-world use is higher than what’s shown here.
How commonly is Folic Acid prescribed? Of the 1,600 medications we measure, Folic Acid ranks #65 by Medicaid prescriptions — more than 96% of them.
Utilization by Folic Acid product
Pick a product to see its own Medicaid numbers. Each chip is one clinical product — a specific strength & dosage form as defined by RxNorm — with brand-name and generic versions combined.
folic acid 1 MG Oral Tablet Most dispensed
Summed across the 21 of 243 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 310410
folic acid 5 MG/ML Injectable Solution
Summed across the 2 of 3 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 237786
Shares are of the Medicaid prescriptions shown here. Product grouping follows RxNorm (the National Library of Medicine’s drug terminology), so “one product” means one strength & dosage form regardless of manufacturer. Dollar figures are gross Medicaid reimbursement before mandatory rebates — rebates (often large, especially for brand-name drugs) are confidential, so actual net cost to Medicaid is lower than shown.
Source: Medicaid State Drug Utilization Data (CMS), aggregated by generic ingredient — summed across every NDC (all brands, strengths, salt forms and dosage forms) of Folic Acid, and across all states and both fee-for-service and managed-care claims. A general popularity signal; it excludes Medicare, commercial insurance and cash prescriptions, so it is not total U.S. use. Based on the 23 of 246 listed Folic Acid NDCs with Medicaid activity.
Compare Folic Acid products
A representative set of FDA-listed product records for Folic Acid — across manufacturers, strengths, and dosage forms, grouped by form with each product’s manufacturer and how the FDA approved it. The same medicine may be made and packaged by different companies, so a single drug can have many directory entries. (It’s also why a refill can look different — a new shape, color, or box — even though it contains the same medication.)
| Strength | Route | Manufacturer / Labeler | Category ⓘ | Details |
|---|---|---|---|---|
| 💊Injection | ||||
| 5 mg/mL | Intramuscular, Intravenous, Subcutaneous | Fresenius Kabi USA, LLC | ANDA | View NDC → |
| 5 mg/mL | Intramuscular; Intravenous; Subcutaneous | Fresenius Kabi USA, LLC | ANDA | View NDC → |
| 5 mg/mL | Intramuscular, Intravenous, Subcutaneous | XGen Pharmaceuticals DJB, Inc. | ANDA | View NDC → |
| 5 mg/mL | Intramuscular; Intravenous; Subcutaneous | XGen Pharmaceuticals DJB, Inc. | ANDA | View NDC → |
| 💊Oral solution | ||||
| 1 mg/5 mL | Oral | Ayurax, LLC | NDA AUTHORIZED GENERIC | View NDC → |
| 1 mg/5 mL | Oral | Solubiomix, LLC | NDA | View NDC → |
| 💊Tablet | ||||
| 1 mg | Oral | A-S Medication Solutions × 10 listings | ANDA | View NDC → |
| 1 mg | Oral | AiPing Pharmaceutical, Inc. × 2 listings | ANDA | View NDC → |
| 1 mg | Oral | American Health Packaging × 3 listings | ANDA | View NDC → |
| 1 mg | Oral | Amneal Pharmaceuticals LLC × 3 listings | ANDA | View NDC → |
| 1 mg | Oral | Amneal Pharmaceuticals of New York LLC × 3 listings | ANDA | View NDC → |
| 1 mg | Oral | Aphena Pharma Solutions - Tennessee, LLC × 7 listings | ANDA | View NDC → |
| 1 mg | Oral | Athem | ANDA | View NDC → |
| 1 mg | Oral | Athem LLC | ANDA | View NDC → |
| 1 mg | Oral | AvPAK | ANDA | View NDC → |
| 1 mg | Oral | Bryant Ranch Prepack × 20 listings | ANDA | View NDC → |
| 1 mg | Oral | Cadila Pharmaceuticals Limited × 2 listings | ANDA | View NDC → |
| 1 mg | Oral | Cardinal Health | ANDA | View NDC → |
| 1 mg | Oral | Cardinal Health 107, LLC × 5 listings | ANDA | View NDC → |
| 1 mg | Oral | Chartwell RX, LLC. × 3 listings | ANDA | View NDC → |
| 1 mg | Oral | Clinical Solutions Wholesale, LLC | ANDA | View NDC → |
| 1 mg | Oral | Coupler LLC × 2 listings | ANDA | View NDC → |
| 1 mg | Oral | Denton Pharma, Inc. DBA Northwind Pharmaceuticals × 4 listings | ANDA | View NDC → |
| 1 mg | Oral | Direct Rx × 2 listings | ANDA | View NDC → |
| 1 mg | Oral | Eci Pharmaceuticals Llc | ANDA | View NDC → |
| 1 mg | — | Elysium Pharmaceuticals Limited | DRUG FOR FURTHER PROCESSING | View NDC → |
| 1 mg | Oral | Leading Pharma, LLC | ANDA | View NDC → |
| 1 mg | Oral | Major Pharmaceuticals × 2 listings | ANDA | View NDC → |
| 1 mg | Oral | Marlex Pharmaceuticals Inc | ANDA | Find on DailyMed ↗ |
| 1 mg | Oral | McKesson Corporation dba SKY Packaging | ANDA | Find on DailyMed ↗ |
| 1 mg | Oral | Method Pharmaceuticals, LLC × 3 listings | ANDA | View NDC → |
| 1 mg | Oral | Modavar Pharmaceuticals LLC | ANDA | View NDC → |
| 1 mg | Oral | NCS HealthCare of KY, LLC dba Vangard Labs × 4 listings | ANDA | View NDC → |
| 1 mg | Oral | Northwind Health Company, LLC × 2 listings | ANDA | View NDC → |
| 1 mg | Oral | Northwind Pharmaceuticals, LLC | ANDA | View NDC → |
| 1 mg | Oral | NuCare Pharmaceuticals, Inc. × 2 listings | ANDA | View NDC → |
| 1 mg | Oral | NuCare Pharmaceuticals,Inc. × 9 listings | ANDA | View NDC → |
| 1 mg | Oral | PD-Rx Pharmaceuticals, Inc. × 5 listings | ANDA | View NDC → |
| 1 mg | Oral | Preferred Pharmaceuticals Inc. × 6 listings | ANDA | View NDC → |
| 1 mg | Oral | Proficient Rx LP × 2 listings | ANDA | View NDC → |
| 1 mg | Oral | Quagen Pharmaceuticals Llc × 2 listings | ANDA | View NDC → |
| 1 mg | Oral | Remedyrepack Inc. × 14 listings | ANDA | View NDC → |
| 1 mg | Oral | Rising Pharma Holdings, Inc. × 2 listings | ANDA | View NDC → |
| 1 mg | Oral | Sunrise Pharmaceutical, Inc. × 2 listings | ANDA | View NDC → |
| 1 mg | Oral | Unit Dose Solutions, Inc. | ANDA | View NDC → |
| 💊Bulk drug substance | ||||
| 1 kg/kg | — | DSM Nutritional Products, LLC | BULK INGREDIENT | View NDC → |
| 1 kg/kg | — | DSM Nutritional Products LLC × 2 listings | BULK INGREDIENT | View NDC → |
| 1 kg/kg | — | DSM Nutritional Products Ltd. | BULK INGREDIENT | View NDC → |
| 1 kg/kg | — | Hebei Jiheng Pharmaceutical Co., Ltd. | BULK INGREDIENT | View NDC → |
| 1 g/g | — | Spectrum Laboratory Products, Inc. | BULK INGREDIENT | View NDC → |
| 1 kg/kg | — | Sri Krishna Pharmaceutical Ltd. Unit I | BULK INGREDIENT | View NDC → |
Showing 147 of 147 products — FDA National Drug Code Directory. See every product, package size and price: browse all 147 Folic Acid NDCs →
Folic Acid side effects reported to the FDA (FAERS)
After a medicine reaches the market, patients, doctors and drugmakers can send the FDA reports of problems they think may be linked to it. Here’s what’s been reported for Folic Acid — a signal of what to watch for, not proof the drug caused it.
Source: openFDA, from the FDA Adverse Event Reporting System (FAERS). These are voluntary reports — they don’t prove the drug caused the effect, and counts reflect how often something was reported, not how often it actually happens. Reports also often name the very problem the medicine is taken for — a common reason to file one is that the drug didn’t help — so for a pain reliever you may see “pain” high on the list; that points to why the report was filed, not to the drug causing the symptom. This counts every report that lists Folic Acid in any role, so the total runs higher than the FDA’s official dashboard, which counts only cases where the drug is the suspect. For the authoritative figures, see the FDA FAERS Public Dashboard. Always talk to your pharmacist or doctor.
Folic Acid FDA approval history
How Folic Acid went from FDA review to the pharmacy shelf — the key milestones in its regulatory journey.
Source: Drugs@FDA.
Folic Acid recall history
A recall is when a specific batch of a medicine is pulled from the market — usually a manufacturing issue, not a problem with the drug itself. Class I is most serious, Class III least.
The FDA’s enforcement reports list one Folic Acid recall since July 2021. It is no longer listed as ongoing. A recall names specific lots from one company, so check the lot number on your own bottle rather than assuming every product is affected; your pharmacist can check whether your supply came from an affected lot.
- FOLIC ACID TABLETS, USP, 1MG, 100 Tablets per bottle, Rx Only, Manufactured by: Leading Pharma, LLC, Fairfield, NJ 07004. NDC: 69315-127-10 Lots: Batch H08221 FDA record D-0183-2024 →
Source: FDA enforcement (recall) reports, via openFDA; our copy was last updated Sep 24, 2026.
RxNorm Concept Web — From Ingredient to Every Form and Strength
This page starts with one ingredient concept (IN). The branches below show its dose-form concepts (SCDF), then the available clinical drug and strength concepts (SCD). Combination products remain separate concepts with their own pages.
RxCUI 4511 4 dose forms · 15 strengths
-
Dose form (SCDF) Injectable Solution RxCUI 619047In current FDA listingsClinical drug / strength (SCD) 5 MG/MLRxCUI 237786 -
Dose form (SCDF) Oral Capsule RxCUI 619037No current FDA listingClinical drug / strength (SCD) 0.8 MGRxCUI 2524632 MGRxCUI 13748075 MGRxCUI 26000120 MGRxCUI 260002 -
Dose form (SCDF) Oral Solution RxCUI 619039In current FDA listingsClinical drug / strength (SCD) 0.08 MG/MLRxCUI 1083620.2 MG/MLRxCUI 27073610.5 MG/MLRxCUI 4227700.8 MG/MLRxCUI 7557631 MG/MLRxCUI 755764 -
Dose form (SCDF) Oral Tablet RxCUI 619044In current FDA listingsClinical drug / strength (SCD) 0.1 MGRxCUI 4398410.4 MGRxCUI 1986400.8 MGRxCUI 1986411 MGRxCUI 3104105 MGRxCUI 199318
Look up RxCUI 4511 in the RxCUI Atlas →
RxNorm is the U.S. National Library of Medicine’s normalized drug vocabulary. Its concept hierarchy can include forms that are not currently marketed; the status on each branch compares that concept with current FDA listings. RxCUIs identify vocabulary concepts, not individual packages or manufacturers.
Folic Acid supply and shortage status
Whether Folic Acid is in short supply in the U.S. right now, plus any shortage history the FDA has on record. A shortage usually reflects a manufacturing or demand issue — not a safety problem with the drug.
Source: openFDA, from the FDA Drug Shortages database.
Folic Acid brand names
Folic Acid is sold under 4 brand names in the FDA directory — Folicet, Folvite, Quiofic, Folacin. A brand and its generic contain the same active ingredient; the brand name belongs to one company's product.
Who makes Folic Acid: manufacturers and labelers
40 companies list Folic Acid products with the FDA. By number of product records, the largest are Bryant Ranch Prepack, Remedyrepack Inc., A-S Medication Solutions. Labelers include manufacturers and repackagers; the product in your bottle depends on which one your pharmacy stocks.
…and 16 more on the FDA NDC directory.
Folic Acid drug class (RxNorm)
Folic Acid belongs to the Folic acid and derivatives class.
Classified by RxNorm RxClass — the U.S. National Library of Medicine's standardized drug-classification service (Established Pharmacologic Class from the FDA, the ATC drug family from the WHO, and mechanism of action). Reference only, not medical advice.
Sources for this Folic Acid page
Core label, product, RxNorm, safety, and utilization data on this page come from the sources identified below. AI-written, editorial, and licensed sections are labeled separately.
How this page is built
HelloPharmacist combines public FDA and NLM records and does not author the underlying clinical facts. The plain-language sections are written with AI from the FDA-approved label text and reviewed by our pharmacy team before publication. Ayurax, LLC is the representative DailyMed label linked for verification and dates. This is general education, not medical advice: always talk to your doctor or pharmacist about your own medicines. How we build and review drug pages →