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Folic Acid 1 mg Tablet, 100-count — NDC 69315-0127-01 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Folic Acid 1 mg Tablet, 100-count — NDC 69315-127-01 (Billing 69315-0127-01)

by Leading Pharma, LLC · 100 TABLET in 1 BOTTLE

This is a package of 100 tablets of Folic Acid 1 mg Tablet from Leading Pharma, LLC, marketed since Jan 2009 and currently FDA-listed; retail pharmacies pay about $0.0201 per tablet (NADAC).

NDC 69315-0127-01
🏷️ FDA NDC (as labeled) 69315-127-01 billing pads the product segment with a zero
This package
Contains100-count Cost per ea$0.0201 NADAC Per package$2.01 / 100 tablets Pack sizes2 compare ↓
Also priced by: Medicaid pays $0.2300/unit — full pricing hub ↓
Rx only Generic On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

NDC database record

One package, one record: these facts belong to NDC 69315-127-01 alone.

Record
FDA NDC Directory package listing · Human prescription drug
Code segments
69315 labeler · 127 product · 01 package
Package marketed since
Feb 21, 2018
Sample package
No — commercial package
Listing certified through
Dec 31, 2026
Billing quantity
100 EA per package
Barcode (UPC-A, from the NDC)
3 6931512701 8
Medicaid fills, this package
57,188 prescriptions in the last four reported quarters
FDA record last changed
Jul 24, 2026
Past resolved recalls for this product (1)
Class II · Jan 26, 2022 · Terminated — CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions. (CARDINAL HEALTHCARE) · FDA recall D-0183-2024

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 69315-127-01
Product NDC 69315-127
11-digit billing NDC 69315012701
NCPDP billing unit EA — each (per item)
RxCUI 310410
UNII 935E97BOY8
Application # ANDA040796
SPL Set ID 1ba8c407-9613-4319-ac40-0a429cb0f3f4
DEA schedule Non-controlled
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2009-01-12
Route ORAL
Dosage form TABLET
Substance FOLIC ACID
TE code (Orange Book) AA · RLD · RS

Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification

GPI-14 82200010000315
GPI class Folic Acid
GCN Seq No 002366
GCN 94781
HICL code 001062
Ingredient (HICL) Folic Acid
HIC1 code C
Therapeutic class — broad (HIC1) Electrolyte Balance/Metabolism/Nutrition
HIC2 code C6
Therapeutic class — intermediate (HIC2) Vitamins
HIC3 code C6M
Therapeutic class — specific (HIC3) Folic Acid Preparations
AHFS code 88:08.00.00
AHFS class Vitamin B Complex
FDB label name FOLIC ACID 1 MG TABLET
FDB brand name Folic Acid
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 002366
  • GCN: 94781
  • GPI-14 (Medi-Span): 82200010000315
  • HICL (First Databank): 001062
  • AHFS class code: 88:08.00.00
  • RxCUI (RxNorm): 310410
Why two NDCs? The FDA registers this code as 69315-127-01 — 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 → 69315-0127-01. 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.

RxNorm drug class

This medicine belongs to the Folic acid and derivatives class.

Drug family (ATC) Folic acid and derivatives, Other diagnostic agents
Where does this data come from?
Therapeutic classes from RxNorm RxClass (U.S. National Library of Medicine) — Established Pharmacologic Class (FDA), ATC drug family (WHO) and mechanism of action, matched by this product’s RxCUI.

Clinical

Label name FOLIC ACID 1 MG TABLET Ingredient Folic Acid
📖 What it is MedlinePlus · NLM

Folic acid is used to treat or prevent folic acid deficiency. It is a B-complex vitamin needed by the body to manufacture red blood cells. A deficiency of this vitamin causes certain types of anemia (low red blood cell count).

Read the full MedlinePlus article ↗
📗 Our plain-language guide HelloPharmacist
  • It treats megaloblastic anemia caused by low folic acid. This is anemia where your bone marrow makes oversized, immature red blood cells. Replacing the missing folate lets your bod...
  • Take it as your prescriber directs, usually once a day. The oral solutions can be taken with or without food, and you should measure them with an oral dosing syringe from us. Injec...
  • Yes, this matters. Folic acid can hide pernicious anemia, a B12 deficiency anemia, so your blood counts may improve while nerve damage keeps getting worse. Your doctor should rule...
  • It's well tolerated, and side effects are mostly reported at much higher doses. These include nausea, bloating, gas, poor appetite and a bitter taste. Call your doctor right away f...
📖 Read our full Folic Acid guide →
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.

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 eaPer package
Retail pharmacies payNADAC · weekly $0.020 $2.01 / 100 tablets
Medicaid paysCMS SDUD · 12 mo $0.2300 $23.00 / 100 tablets
Medicare drug plans payPart D · quarterly No Part D plan price is available for this NDC in our data.
NADAC price history (per ea) — tap or hover for the price & month
Jan 2022 Aug 2022 Jan 2026 Sep 2026 $0.032 $0.019
▼ Down 19% over the last 24 months.
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.

Packaging — all sizes for this product

Package NDCDescription Per unit Per pack Marketing startMarketing endStatus
69315-0127-01 You're viewing this 100 TABLET in 1 BOTTLE $0.0201 / ea $2.01 2018-02-21 — Active
69315-0127-10 69315-127-10 Main listing 1000 TABLET in 1 BOTTLE $0.0201 / ea $20.13 2018-02-21 — Active

You're viewing the smallest of 2 pack sizes for this product.

This pack has the lowest per-ea cost of the 2 priced pack sizes ($0.0201 NADAC).

This pack accounts for about 5.0% of this product's recent Medicaid fills; most go to the 1000 tablets pack. See all packs ↓

Pack size FAQ

What quantity is in this package?
This is a 100-count package — 100 tablet in 1 bottle.
How does this package differ from NDC 69315-0127-10?
Both are Folic Acid 1 mg Tablet — the drug itself is identical. This page's package is the 100-count one, while NDC 69315-0127-10 is the 1000 tablets package.
What NDC number is used to bill for this package of Folic Acid 1 mg Tablet?
Use the 11-digit billing form listed in the identifiers section of this page. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

Prices are the latest CMS NADAC pharmacy acquisition cost per NDC; per-pack figures are per-unit × pack quantity, shown only when the pack is denominated in the same measure NADAC prices.

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Folic Acid 1 mg 00904-7224-61 Major 100 tablets $0.020 AA Availability likely —
Folic Acid 1 mg 11534-0165-01 SUNRISE 100 tablets $0.020 AA Availability likely —
Folic Acid 1 mg 16571-0881-01 Rising 100 tablets $0.020 AA Availability likely —
Folic Acid 1 mg 53746-0361-01 Amneal 100 tablets $0.020 AA Availability likely —
Folic Acid 1 mg 58657-0151-01 Method 100 tablets $0.020 AA Availability likely —
Folic Acid 1 mg 60687-0681-01 American 100 tablets $0.020 AA Availability likely —
Folic acid 1 mg 62135-0210-01 Chartwell 100 tablets $0.020 AA Availability likely —
Folic Acid 1 mgthis 69315-0127-01 Leading 100 tablets $0.020 AA Availability likely —
Folic Acid 1 mg 70752-0231-10 QUAGEN 100 tablets $0.020 AA Availability likely —
Folic Acid 1 mg 72241-0050-05 Modavar 100 tablets $0.020 AA Availability likely —
Folic Acid 1 mg 00615-8589-05 NCS 15 tablets — AA FDA listed —
Folic Acid 1 mg 43063-0791-30 PD-Rx 30 tablets — AA FDA listed —
Folic Acid 1 mg 50090-3119-00 A-S 100 tablets — AA FDA listed —
Folic Acid 1 mg 50090-6760-00 A-S 90 tablets — AA FDA listed —
Folic Acid 1 mg 50090-7194-00 A-S 100 tablets — AA FDA listed —
Folic Acid 1 mg 50090-7195-00 A-S 90 tablets — AA FDA listed —
Folic Acid 1 mg 55154-2137-00 Cardinal 10 tablets — AA FDA listed —
Folic Acid 1 mg 55154-4306-00 Cardinal 10 tablets — AA FDA listed —
Folic Acid 1 mg 63629-9257-01 Bryant 100 tablets — AA FDA listed —
Folic Acid 1 mg 63629-9258-01 Bryant 1000 tablets — AA FDA listed —
Folic Acid 1 mg 65162-0361-01 Amneal 10 tablets — AA FDA listed —
Folic Acid 1 mg 66267-0217-30 NuCare 30 tablets — AA FDA listed —
Folic Acid 1 mg 67046-0719-03 Coupler 30 tablets — AA FDA listed —
Folic Acid 1 mg 67046-1449-03 Coupler 30 tablets — AA FDA listed —
Folic Acid 1 mg 68071-2992-01 NuCare 100 tablets — AA FDA listed —
Folic Acid 1 mg 68071-3513-01 NuCare 100 tablets — AA FDA listed —
Folic Acid 1 mg 68071-4602-01 NuCare 100 tablets — AA FDA listed —
Folic Acid 1 mg 68788-8557-01 Preferred 100 tablets — AA FDA listed —
Folic Acid 1 mg 68788-8827-01 Preferred 100 tablets — AA FDA listed —
Folic Acid 1 mg 70518-4338-00 REMEDYREPACK 100 tablets — AA FDA listed —
Folic Acid 1 mg 70518-4459-00 REMEDYREPACK 30 tablets — AA FDA listed —
Folic Acid 1 mg 71205-0913-00 Proficient 100 tablets — AA FDA listed —
Folic Acid 1 mg 71209-0007-05 Cadila 100 tablets — AA FDA listed —
Folic Acid 1 mg 71335-0613-01 Bryant 30 tablets — AA FDA listed —
Folic Acid 1 mg 71335-0766-01 Bryant 30 tablets — AA FDA listed —
Folic Acid 1 mg 71335-2547-01 Bryant 30 tablets — AA FDA listed —
Folic Acid 1 mg 71335-2849-01 Bryant 30 tablets — AA FDA listed —
Folic Acid 1 mg 71335-2858-01 Bryant 1000 tablets — AA FDA listed —
Folic Acid 1 mg 71335-9628-01 Bryant 30 tablets — AA FDA listed —
Folic Acid 1 mg 71610-0235-30 Aphena 30 tablets — AA FDA listed —
Folic acid 1 mg 71610-0545-30 Aphena 30 tablets — AA FDA listed —
Folic Acid 1 mg 71610-0656-30 Aphena 30 tablets — AA FDA listed —
Folic Acid 1 mg 71610-0716-30 Aphena 30 tablets — AA FDA listed —
Folic Acid 1 mg 71610-0803-30 Aphena 30 tablets — AA FDA listed —
Folic Acid 1 mg 71610-0952-04 Aphena 4 tablets — AA FDA listed —
Folic Acid 1 mg 72162-1651-00 Bryant 1000 tablets — AA FDA listed —
Folic Acid 1 mg 72162-2413-00 Bryant 1000 tablets — AA FDA listed —
Folic Acid 1 mg 72162-2556-00 Bryant 1000 tablets — AA FDA listed —
Folic Acid 1 mg 72162-2557-00 Bryant 1000 tablets — AA FDA listed —
Folic Acid 1 mg 72189-0199-30 DIRECT 30 tablets — AA FDA listed —
Folic Acid 1 mg 82804-0110-30 Proficient 30 tablets — AA FDA listed —
Folic Acid 1 mg 82868-0004-30 Northwind 30 tablets — AA FDA listed —
Folic Acid 1 mg 87441-0032-01 Unit 30 tablets — AA FDA listed —
Folic Acid 1 mg 70518-4756-00 REMEDYREPACK 30 tablets — AA FDA listed —
About this product: this is a generic version of the medicine. FDA equivalence ratings are shown when available, and other versions are listed above, least expensive first.
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

🏛️
2009
On the market since
Jan 2009
📍
2026
Currently FDA-listed
17 years listed
🔓
·
Generic on the market
this product is a generic
✅This is a generic drug

This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.

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.

What it looks like

Color Yellow / Orange
ShapeRound
ImprintEP;127
Size8 mm
ScoringScored — splits in 2
One label can cover several strengths, so colors may be combined — always confirm a loose pill against the dispensed prescription label or a pharmacist.
Where does this data come from?
Physical description (imprint, shape, color, scoring, coating) from this product’s FDA Structured Product Labeling (SPL), mirrored from DailyMed / openFDA.

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.

🧪 Avoiding an ingredient? See Folic Acid inactive ingredients by manufacturer: every current product's list side by side, so you can ask your pharmacy for the version that does not list it.

💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.

  • 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.
  • UNII 5856J3G2A2
    A starch-based powder made from potatoes and processed with sodium. It acts as a disintegrant, helping the tablet or capsule break apart quickly in the stomach so the medicine can be absorbed.
  • UNII O8232NY3SJ
    A plant-based carbohydrate derived from corn kernels. It acts as a filler to add bulk, a binder to hold ingredients together, and a disintegrant to help the tablet break apart in your stomach for absorption.
  • 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.

4 inactive ingredients listed in the exact product block matched to this NDC.

Where does this data come from?
Data sourced from official FDA Structured Product Labeling (SPL) via DailyMed — 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

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.

Manufacturer & labeler

LabelerLeading Pharma, LLC
Application holderLEADING PHARMA LLC
FDA applicationANDA040796 (ANDA)
Labeler code69315
First marketedJan 2009
Product typeHuman Prescription Drug
Portfolio83 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.

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 39 words ▾

INDICATIONS AND USAGE Folic acid is effective in the treatment of megaloblastic anemias due to a deficiency of folic acid (as may be seen in tropical or nontropical sprue) and in anemias of nutritional origin, pregnancy, infancy, or childhood.

⏱️ Dosage and Administration 219 words ▾

DOSAGE AND ADMINISTRATION Oral administration is preferred. Although most patients with malabsorption cannot absorb food folates, they are able to absorb folic acid given orally. Parenteral administration is not advocated but may be necessary in some individuals (e.g., patients receiving parenteral or enteral alimentation).

Doses greater than 0.1 mg should not be used unless anemia due to vitamin B 12 deficiency has been ruled out or is being adequately treated with a cobalamin. Daily doses greater than 1 mg do not enhance the hematologic effect, and most of the excess is excreted unchanged in the urine. The usual therapeutic dosage in adults and children (regardless of age) is up to 1 mg daily.

Resistant cases may require larger doses. When clinical symptoms have subsided and the blood picture has become normal, a daily maintenance level should be used, i.e., 0.1 mg for infants and up to 0.3 mg for children under 4 years of age, 0.4 mg for adults and children 4 or more years of age, and 0.8 mg for pregnant and lactating women, but never less than 0.1 mg/day. Patients should be kept under close supervision and adjustment of the maintenance level made if relapse appears imminent.

In the presence of alcoholism, hemolytic anemia, anticonvulsant therapy, or chronic infection, the maintenance level may need to be increased.

⛔ Contraindications 15 words ▾

CONTRAINDICATIONS Folic acid is contraindicated in patients who have shown previous intolerance to the drug.

⚠️ Warnings 23 words ▾

WARNINGS Administration of folic acid alone is improper therapy for pernicious anemia and other megaloblastic anemias in which vitamin B 12 is deficient.

🤒 Adverse Reactions 206 words ▾

ADVERSE REACTIONS Allergic sensitization has been reported following both oral and parenteral administration of folic acid. Folic acid is relatively nontoxic in man. Rare instances of allergic responses to folic acid preparations have been reported and have included erythema, skin rash, itching, general malaise, and respiratory difficulty due to bronchospasm.

One patient experienced symptoms suggesting anaphylaxis following injection of the drug. Gastrointestinal side effects, including anorexia, nausea, abdominal distention, flatulence, and a bitter or bad taste, have been reported in patients receiving 15 mg folic acid daily for 1 month. Other side effects reported in patients receiving 15 mg daily include altered sleep patterns, difficulty in concentrating, irritability, overactivity, excitement, mental depression, confusion, and impaired judgment.

Decreased vitamin B 12 serum levels may occur in patients receiving prolonged folic acid therapy. In an uncontrolled study, orally administered folic acid was reported to increase the incidence of seizures in some epileptic patients receiving phenobarbital, primidone, or diphenylhydantoin. Another investigator reported decreased diphenylhydantoin serum levels in folate-deficient patients receiving diphenylhydantoin who were treated with 5 mg or 15 mg of folic acid daily.

CALL YOUR DOCTOR FOR MEDICAL ADVICE ABOUT SIDE EFFECTS. YOU MAY REPORT SIDE EFFECTS TO THE FDA AT 1-800-FDA-1088 OR LEADING PHARMA, LLC AT 1-844-740-7500.

🔄 Drug Interactions 111 words ▾

Drug Interactions There is evidence that the anticonvulsant action of phenytoin is antagonized by folic acid. A patient whose epilepsy is completely controlled by phenytoin may require increased doses to prevent convulsions if folic acid is given. Folate deficiency may result from increased loss of folate, as in renal dialysis and/or interference with metabolism (e.g., folic acid antagonists such as methotrexate); the administration of anticonvulsants, such as diphenylhydantoin, primidone, and barbiturates; alcohol consumption and, especially, alcoholic cirrhosis; and the administration of pyrimethamine and nitrofurantoin.

False low serum and red cell folate levels may occur if the patient has been taking antibiotics, such as tetracycline, which suppress the growth of Lactobacillus casei.

🤰 Pregnancy 94 words ▾

Pregnancy Teratogenic Effects Pregnancy Category A Folic acid is usually indicated in the treatment of megaloblastic anemias of pregnancy. Folic acid requirements are markedly increased during pregnancy, and deficiency will result in fetal damage (see INDICATIONS AND USAGE ). Studies in pregnant women have not shown that folic acid increases the risk of fetal abnormalities if administered during pregnancy.

If the drug is used during pregnancy, the possibility of fetal harm appears remote. Because studies cannot rule out the possibility of harm, however, folic acid should be used during pregnancy only if clearly needed.

🆘 Overdosage 96 words ▾

OVERDOSAGE Except during pregnancy and lactation, folic acid should not be given in therapeutic doses greater than 0.4 mg daily until pernicious anemia has been ruled out. Patients with pernicious anemia receiving more than 0.4 mg of folic acid daily who are inadequately treated with vitamin B 12 may show reversion of the hematologic parameters to normal, but neurologic manifestations due to vitamin B 12 deficiency will progress. Doses of folic acid exceeding the Recommended Dietary Allowance (RDA) should not be included in multivitamin preparations; if therapeutic amounts are necessary, folic acid should be given separately.

🧬 Clinical Pharmacology ~2 min read ▾

CLINICAL PHARMACOLOGY Folic acid acts on megaloblastic bone marrow to produce a normoblastic marrow. In man, exogenous source of folate is required for nucleoprotein synthesis and the maintenance of normal erythropoiesis. Folic acid is the precursor of tetrahydrofolic acid, which is involved as a cofactor for transformylation reactions in the biosynthesis of purines and thymidylates of nucleic acids.

Impairment of thymidylate synthesis in patients with folic acid deficiency is thought to account for the defective deoxyribonucleic acid (DNA) synthesis that leads to megaloblast formation and megaloblastic and macrocytic anemias. Folic acid is absorbed rapidly from the small intestine, primarily from the proximal portion. Naturally occurring conjugated folates are reduced enzymatically to folic acid in the gastrointestinal tract prior to absorption.

Folic acid appears in the plasma approximately 15 to 30 minutes after an oral dose; peak levels are generally reached within 1 hour. After intravenous administration, the drug is rapidly cleared from the plasma. Cerebrospinal fluid levels of folic acid are several times greater than serum levels of the drug.

Folic acid is metabolized in the liver to 7, 8-dihydrofolic acid and eventually to 5, 6, 7, 8-tetrahydrofolic acid with the aid of reduced diphosphopyridine nucleotide (DPNH) and folate reductases. Tetrahydrofolic acid is linked in the N 5 or N 10 positions with formyl, hydroxymethyl, methyl or formimino groups. N 5 -formyltetrahydrofolic acid is leucovorin.

Tetrahydrofolic acid derivatives are distributed to all body tissues but are stored primarily in the liver. Normal serum levels of total folate have been reported to be 5 to 15ng/mL; normal cerebrospinal fluid levels are approximately 16 to 21ng/mL. Normal erythrocyte folate levels have been reported to range from 175 to 316 ng/mL.

In general, folate serum levels below 5 ng/mL indicate folate deficiency, and levels below 2 ng/mL usually result in megaloblastic anemia. After a single oral dose of 100 µg of folic acid in a limited number of normal adults, only a trace amount of the drug appeared in the urine. An oral dose of 5 mg in 1 study and a dose of 40 µg /kg of body weight in another study resulted in approximately 50% of the dose appearing in the urine.

After a single oral dose of 15 mg, up to 90% of the dose was recovered in the urine. A majority of the metabolic products appeared in the urine after 6 hours; excretion was generally complete within 24 hours. Small amounts of orally administered folic acid have also been recovered in feces.

Folic acid is also excreted in the milk of lactating mothers.

📦 How Supplied / Storage and Handling 81 words ▾

HOW SUPPLIED Folic acid tablets, USP 1 mg are yellow to orange color, round, bisected compressed tablets, debossed “EP” above bisect and “127” below the bisect on one side and plain on the other side in bottles of 100 (NDC 69315-127-01) and 1000 (NDC 69315-127-10). Dispense in a well-closed container as defined in the USP, using a child-resistant closure. Store at 20°-25° C (68°-77° F). [See USP controlled room temperature.] Manufactured by: Leading Pharma, LLC Fairfield, NJ 07004 Rev.

02 04/17

📋 Description 196 words ▾

DESCRIPTION Folic acid, N-p-[[(2-amino-4-hydroxy-6-pteridinyl) methyl]amino] benzoyl]- L-glutamic acid, is a B complex vitamin containing a pteridine moiety linked by a methylene bridge to para- aminobenzoic acid, which is joined by a peptide linkage to glutamic acid. Conjugates of folic acid are present in a wide variety of foods, particularly liver, kidneys, yeast and leafy green vegetables. Commercially available folic acid is prepared synthetically.

Folic acid occurs as a yellow or yellowish-orange crystalline powder and is very slightly soluble in water and insoluble in alcohol. Folic acid is readily soluble in dilute solutions of alkali hydroxides and carbonates, and solutions of the drug may be prepared with the aid of sodium hydroxide or sodium carbonate, thereby forming the soluble sodium salt of folic acid (sodium folate). Aqueous solutions of folic acid are heat sensitive and rapidly decompose in the presence of light and/or riboflavin; solutions should be stored in a cool place protected from light.

The structural formula of folic acid is as follows: Each tablet, for oral administration, contains 1 mg folic acid. Folic acid tablets, USP 1 mg contain the following inactive ingredients: corn starch, microcrystalline cellulose, sodium starch glycolate and stearic acid. Chemical structure

⚠️ Precautions ~2 min read ▾

PRECAUTIONS General Folic acid in doses above 0.1 mg daily may obscure pernicious anemia in that hematologic remission can occur while neurologic 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. Drug Interactions There is evidence that the anticonvulsant action of phenytoin is antagonized by folic acid. A patient whose epilepsy is completely controlled by phenytoin may require increased doses to prevent convulsions if folic acid is given.

Folate deficiency may result from increased loss of folate, as in renal dialysis and/or interference with metabolism (e.g., folic acid antagonists such as methotrexate); the administration of anticonvulsants, such as diphenylhydantoin, primidone, and barbiturates; alcohol consumption and, especially, alcoholic cirrhosis; and the administration of pyrimethamine and nitrofurantoin. False low serum and red cell folate levels may occur if the patient has been taking antibiotics, such as tetracycline, which suppress the growth of Lactobacillus casei.

Carcinogenesis, Mutagenesis, Impairment of Fertility Long-term studies in animals to evaluate carcinogenic potential and studies to evaluate the mutagenic potential or effect on fertility have not been conducted. Pregnancy Teratogenic Effects Pregnancy Category A Folic acid is usually indicated in the treatment of megaloblastic anemias of pregnancy. Folic acid requirements are markedly increased during pregnancy, and deficiency will result in fetal damage (see INDICATIONS AND USAGE ).

Studies in pregnant women have not shown that folic acid increases the risk of fetal abnormalities if administered during pregnancy. If the drug is used during pregnancy, the possibility of fetal harm appears remote. Because studies cannot rule out the possibility of harm, however, folic acid should be used during pregnancy only if clearly needed.

Nursing Mothers Folic acid is excreted in the milk of lactating mothers. During lactation, folic acid requirements are markedly increased; however, amounts present in human milk are adequate to fulfill infant requirements, although supplementation may be needed in low-birth-weight infants, in those who are breast-fed by mothers with folic acid deficiency (50 µg daily), or in those with infections or prolonged diarrhea.

🍼 Nursing Mothers 62 words ▾

Nursing Mothers Folic acid is excreted in the milk of lactating mothers. During lactation, folic acid requirements are markedly increased; however, amounts present in human milk are adequate to fulfill infant requirements, although supplementation may be needed in low-birth-weight infants, in those who are breast-fed by mothers with folic acid deficiency (50 µg daily), or in those with infections or prolonged diarrhea.

📄 Package Label / Principal Display Panel 6 words ▾

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL 100tabs 1000tabs

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗

Medicaid utilization & spend

📍 This exact package only: Medicaid data is reported per full 11-digit NDC — labeler, product and pack size — so every number here is for this package alone, not the drug overall. Other pack sizes report separately.
💊 Pharmacy benefit only: These are Medicaid outpatient pharmacy claims, billed by NDC. They exclude the medical benefit — clinic- or hospital-administered drugs billed under HCPCS J-codes — so drugs used mostly that way (e.g. Avastin, Lucentis, Keytruda) can look low or missing here. That’s expected, not an error.
📅 Q1 2025 – Q4 2025 · 4 quarters of data
ⓘ The newest quarter is usually incomplete when first published; states restate recent quarters in later CMS releases, so the latest figures typically revise upward. State coverage-policy changes can also shift quarter-to-quarter totals.
Prescriptions last 4 qtrs
57.2K
Units reimbursed last 4 qtrs
2.1M
Gross reimbursed last 4 qtrs
$480.6K
Avg / prescription
$8.40
Avg / unit
$0.2300
Latest quarter Q4 2025
12.8KRx
Medicaid pays / ea
$0.2300
gross reimbursed
vs
NADAC / ea
$0.0201
acquisition cost
=
Spread
+$0.2099
+1044% vs cost
What Medicaid paid per ea (before rebates; includes the pharmacy’s dispensing fee) compared with NADAC — the average price pharmacies pay to buy the drug. A positive spread means Medicaid reimbursed more than the purchase price, before manufacturer rebates.
Fee-for-service vs managed care ⓘ
51% FFS 49% MCO
Fee-for-service · 29,195 Rx Managed care · 27,993 Rx
State Medicaid map
Alaska: 4,171 units · 569 per 100k residents AK Maine: 14,734 units · 1,056 per 100k residents ME Washington: 48,964 units · 627 per 100k residents WA Idaho: 15,468 units · 788 per 100k residents ID Montana: 9,218 units · 814 per 100k residents MT North Dakota: 7,236 units · 924 per 100k residents ND Minnesota: 103,665 units · 1,807 per 100k residents MN Wisconsin: no data reported WI Michigan: 105,233 units · 1,048 per 100k residents MI New York: 378,645 units · 1,935 per 100k residents NY Vermont: 12,636 units · 1,953 per 100k residents VT New Hampshire: 22,637 units · 1,615 per 100k residents NH Oregon: 18,153 units · 429 per 100k residents OR Nevada: 8,627 units · 270 per 100k residents NV Wyoming: 1,483 units · 254 per 100k residents WY South Dakota: 5,569 units · 606 per 100k residents SD Iowa: 20,148 units · 628 per 100k residents IA Illinois: 45,219 units · 360 per 100k residents IL Indiana: 58,897 units · 858 per 100k residents IN Ohio: 68,997 units · 585 per 100k residents OH Pennsylvania: 82,780 units · 639 per 100k residents PA New Jersey: 78,741 units · 848 per 100k residents NJ Massachusetts: 26,908 units · 384 per 100k residents MA California: 265,708 units · 682 per 100k residents CA Utah: 11,435 units · 335 per 100k residents UT Colorado: 29,822 units · 507 per 100k residents CO Nebraska: no data reported NE Missouri: 44,465 units · 718 per 100k residents MO Kentucky: 60,459 units · 1,336 per 100k residents KY West Virginia: 36,082 units · 2,039 per 100k residents WV Virginia: 32,101 units · 368 per 100k residents VA Maryland: 20,719 units · 335 per 100k residents MD Connecticut: 56,133 units · 1,552 per 100k residents CT Rhode Island: 2,158 units · 197 per 100k residents RI Arizona: 89,460 units · 1,204 per 100k residents AZ New Mexico: 11,198 units · 530 per 100k residents NM Kansas: 13,636 units · 464 per 100k residents KS Arkansas: 49,458 units · 1,613 per 100k residents AR Tennessee: 17,381 units · 244 per 100k residents TN North Carolina: 14,857 units · 137 per 100k residents NC South Carolina: 2,204 units · 41.0 per 100k residents SC Delaware: 2,040 units · 198 per 100k residents DE Oklahoma: 9,401 units · 232 per 100k residents OK Louisiana: 29,337 units · 641 per 100k residents LA Mississippi: 7,054 units · 240 per 100k residents MS Alabama: 8,257 units · 162 per 100k residents AL Georgia: 8,447 units · 76.6 per 100k residents GA D.C.: no data reported DC Hawaii: no data reported HI Texas: 60,034 units · 197 per 100k residents TX Florida: 23,613 units · 104 per 100k residents FL
Units reimbursed · per 100k residents
41.02,039
gray = no data reported ⓘ
Colors are per 100,000 residents, so big states don’t automatically dominate. Tap or hover a state for its actual totals.
Tap or hover a state
…for its Medicaid breakdown
🏆 Top states by units · per 100k residents
1 West Virginia 2,039 /100k
2 Vermont 1,953 /100k
3 New York 1,935 /100k
4 Minnesota 1,807 /100k
5 New Hampshire 1,615 /100k
6 Arkansas 1,613 /100k
7 Connecticut 1,552 /100k
8 Kentucky 1,336 /100k
National units — by quarter
💵 About the dollar figures: “reimbursed” is what Medicaid paid pharmacies before confidential manufacturer rebates, so the program’s real net cost is lower than these numbers. Fee-for-service and managed-care claims are combined unless split above. Source: CMS State Drug Utilization Data; per-100k rates use 2023 Census population estimates.

Medicaid utilization by pack size

Medicaid (SDUD) totals over the four most recent reported quarters for every package size of this drug — handy when a specific package (e.g. a starter/titration pack) carries little or no Medicaid volume on its own.
1000 tablets69315-0127-10 1,077,093 Rx · $8,571,578
100 tablets this page69315-0127-01 57,188 Rx · $480,559
Drug total (last 4 qtrs): 1,134,281 Rx · 40,797,013 units · $9,052,137 gross reimbursed
Tap a pack size to open its page. Source: CMS State Drug Utilization Data, last 4 quarters.

Medicare Part D spend CMS · PART D · 2026 (Q1)

Medicare Part D (outpatient prescription) spending for Folic Acid — the program that covers self-administered drugs. 12 manufacturers.
⚠️ Drug-level data: CMS publishes Part D spending by drug, not by NDC — these figures combine every manufacturer, strength and package size sold under the name Folic Acid. That’s a different level of aggregation than the Medicaid card above, which is specific to this exact 11-digit NDC (pack size included), so the two aren’t directly comparable.
Period
Total Part D spend
$870.8K
Claims incl. refills
257.4K
Beneficiaries
188.1K
Spend / beneficiary
$4.63
Spend / claim
$3.38
Trend by period
💵 About the dollar figures: spending is what Part D plans paid before confidential manufacturer rebates, so the program’s real net cost is lower. A blank patient count means fewer than 11 people — CMS hides counts that small to protect privacy. Source: CMS Medicare Quarterly Part D Spending by Drug (data.cms.gov), updated quarterly.
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.