Finished product reference
Folic Acid
Tablet · Oral · 1 mg
- List code
- 562
Indications
INDICATIONS AND USAGE Folic acid, USP is effective in the treatment of megaloblastic anemias due to a deficiency of folic acid, USP (as may be seen in tropical or nontropical sprue) and in anemias of nutritional origin, pregnancy, infancy, or childhood.
Dosage and administration (summary)
DOSAGE AND ADMINISTRATION Oral administration is preferred. Although most patients with malabsorption cannot absorb food folates, they are able to absorb folic acid, USP 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 B12 deficiency has been ruled out or is being adequately treated with cobalamin. Daily doses greater than 1 mg do not enhance the hematologic effect, and most of the excess is excreted unchanged in the urine.
Contraindications
CONTRAINDICATIONS Folic acid, USP is contraindicated in patients who have shown previous intolerance to the drug.
Warnings and precautions
WARNINGS Administration of folic acid alone is improper therapy for pernicious anemia and other megaloblastic anemias in which vitamin B12 is deficient.
Pregnancy
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 ) .
Storage and supply
HOW SUPPLIED Folic Acid Tablets, USP, 1 mg , are supplied as Yellow colored round shaped biconvex uncoated tablet with " ET break line 28 " debossed on one side & plain on other side. They are available as follows: Bottles of 100: NDC 16571-881-01 Bottles of 1,000: NDC 16571-881-10 Dispense in well-closed container with child-resistant closure.
Source: Folic Acid (Folic Acid) — US FDA prescribing information, 2026-07-24, DailyMed. Summarised and shortened; the full label governs. Iranian registration, indications and labelling may differ.
Other presentations of the same active ingredient
Reference information for professional sourcing and registration enquiries, not medical advice or a promotion. Drug information is condensed from US FDA prescribing information (public domain, via openFDA and DailyMed) and does not replace the product’s approved labelling in Iran. Availability, origin and documentation are confirmed per enquiry.
Tell us the quantity, the market and the timing.
Send the molecule or ingredient, the specification and the destination. We reply from Tehran with the questions, the documents and the next step.