Quick answers
- What is Folic acid used for?
- The FDA-approved label (Folic Acid, Remedyrepack Inc., September 11, 2026) says: “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.” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Folic acid have a boxed warning?
- No. None of the 54 FDA labels we found for this medicine has a boxed warning.
- Is there a shortage of Folic acid?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Folic acid been recalled?
- FDA enforcement reports list 3 recalls of products of this medicine; the newest started January 26, 2022 (Class II). A recall usually concerns specific lots, not every product.
- Who makes Folic acid?
- 30 companies list prescription products of Folic acid in the FDA NDC Directory, including Bryant Ranch Prepack, Aphena Pharma Solutions - Tennessee, LLC and A-S Medication Solutions.
What Folic acid is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
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.
— FDA label: Folic Acid, Remedyrepack Inc., effective September 11, 2026. Read the full label on DailyMed →
The FDA has 54 labels for products of this medicine (different makers and forms); uses can differ between them. Check the label that comes with your own medicine.
This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
Boxed warning
A boxed warning (“black box”) is the FDA’s strongest warning on a drug label, for serious or life-threatening risks.
The label quoted above has no boxed warning.
0 of 54 FDA labels for this medicine have a boxed warning.
Forms and how it is given
| Dosage forms | Tablet · Injection, solution · Solution |
|---|---|
| Route | Oral · Intramuscular · Intravenous · Subcutaneous |
| Prescription products | 58 in the FDA NDC Directory |
| Brand names | Quiofic |
What pharmacies pay (NADAC)
The National Average Drug Acquisition Cost (NADAC) is the average price U.S. retail pharmacies paid to buy one unit of a medicine (one tablet, one mL or one gram), from a monthly survey of pharmacy invoices by the Centers for Medicare & Medicaid Services (CMS). State Medicaid programs use it to pay pharmacies.
This is not the price you pay. What you pay depends on your insurance (copay or coinsurance), your pharmacy and any discounts, and pharmacies also charge for filling a prescription. Ask your pharmacist or your health plan what your price will be.
| Strength and form | Generic or brand | Pharmacies pay |
|---|---|---|
| folic acid 1 mg tablet | Generic | $0.0199 per tablet |
NADAC list of November 4, 2026; these prices took effect on October 21, 2026. Shown only where a package’s NDC code matches the NADAC list exactly, and only for that exact strength and form: nothing is averaged across strengths. Strengths and forms not listed here have no NADAC price.
Source: NADAC (National Average Drug Acquisition Cost) 2026, data.medicaid.gov (CMS) →
Companies that list this medicine
Labelers in the FDA NDC Directory: the company named on the package (maker or distributor), with the number of prescription products.
- Bryant Ranch Prepack12 products
- Aphena Pharma Solutions - Tennessee, LLC6 products
- A-S Medication Solutions4 products
- NuCare Pharmaceuticals, Inc.4 products
- Remedyrepack Inc.3 products
- Coupler LLC2 products
- Preferred Pharmaceuticals Inc.2 products
- Proficient Rx LP2 products
- Cardinal Health 107, LLC2 products
- Unit Dose Solutions, Inc.1 product
- XGen Pharmaceuticals DJB, Inc.1 product
- Amneal Pharmaceuticals of New York LLC1 product
- Sunrise Pharmaceutical, Inc.1 product
- Cadila Pharmaceuticals Limited1 product
- PD-Rx Pharmaceuticals, Inc.1 product
- Leading Pharma, LLC1 product
- Quagen Pharmaceuticals LLC1 product
- Fresenius Kabi USA, LLC1 product
- Solubiomix, LLC1 product
- NCS HealthCare of KY, LLC dba Vangard Labs1 product
- Amneal Pharmaceuticals LLC1 product
- Major Pharmaceuticals1 product
- American Health Packaging1 product
- Chartwell RX, LLC1 product
- Direct_Rx1 product
- Method Pharmaceuticals, LLC1 product
- Modavar Pharmaceuticals LLC1 product
- Ayurax, LLC1 product
- Northwind Health Company, LLC1 product
- Rising Pharma Holdings, Inc.1 product
FDA approval history
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
- ANDA: Abbreviated New Drug Application: how a generic version is approved.
| Application | Sponsor | Approved | Later changes approved |
|---|---|---|---|
| NDA216395 QUIOFIC | Solubiomix | January 26, 2026 | — |
Generic approvals (9)
- ANDA089202Fresenius Kabi USA · February 18, 1986
- ANDA040625Amneal Pharm · July 21, 2005
- ANDA040796Leading · January 12, 2009
- ANDA090035Chartwell Molecular · June 9, 2009
- ANDA091145Aiping Pharm Inc · July 12, 2013
- ANDA202437Cadila Pharms Ltd · January 27, 2014
- ANDA204418Nuvo Pharms Inc · July 28, 2015
- ANDA211064Rising · March 8, 2019
- ANDA202522Xgen Pharms · November 6, 2019
Shortage status
The FDA drug shortage list does not show these products.
Recalls
From FDA enforcement reports, matched by the product’s NDC code. A recall usually covers specific lots only: check the lot number on your package and ask your pharmacist. Do not stop a medicine on your own.
-
January 26, 2022 · Class II · Terminated · D-0183-2024
CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
FOLIC ACID TABLETS, USP, 1MG, 100 Tablets per bottle, Rx Only, Manufactured by: Leading Pharma, LLC, Fairfield, NJ 07004. NDC: 69315-127-10 — CARDINAL HEALTHCARE
-
December 6, 2013 · Class III · Terminated · D-379-2014
Failed Impurities/Degradation specifications: out-of-specification results 14 & 15 month time point
FOLIC ACID INJECTION, USP; 5 mg/mL ; For IM, IV or SC Use; 10 mL; Multiple Dose Vial; Rx only; APP Pharmaceuticals, LLC; Schaumburg, IL 60173 NDC 63323-184-11 — Fresenius Kabi USA, LLC
-
May 21, 2013 · Class III · Terminated · D-688-2013
Failed Impurities/Degradation Specification
Folic Acid Injection, USP, 5 mg/mL, For IM, IV or SC Use, 10 mL, Multiple Dose Vial, Rx only, APP Pharmaceuticals, LLC, Schaumburg, IL 60173, NDC 63323-184-11 — Fresenius Kabi USA, LLC
What do the recall classes mean?
Class I: The most serious type: there is a reasonable chance that using the product will cause serious health problems or death.
Class II: Using the product may cause temporary or medically reversible health problems, or the chance of serious problems is remote.
Class III: Using the product is not likely to cause health problems (for example a labeling or packaging issue).
Official identifiers
| RxCUI (RxNorm) | 237786, 310410 |
|---|---|
| SPL set ID of the quoted label | bda4687e-929a-434d-ab59-909cf2ed73a2 |
| FDA labels (SPL) | 54 |
| FDA applications | NDA216395, 9 ANDA |
| Active ingredients (FDA) | FOLIC ACID |
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Folic Acid, Remedyrepack Inc., effective September 11, 2026; via openFDA, FDA data exported October 30, 2026, retrieved October 31, 2026
- NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
- Drug shortages (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
openFDA data is provided by the FDA as is; it may be incomplete. Always rely on the label that comes with your medicine. FDA Enforcement Report search →