RVP

Drug Catalog - Product Detail

Folic Acid 1mg Tablet 1000

NDC Mfr Size Str Form
65162-0361-11 AMNEAL PHARMACEUTICALS 1000 1MG TABLET
Product Image
Generic Name
Substance Name
Product Type
Route
Application Number
Description
DESCRIPTION Folic acid, USP, N-[ p -[[(2-amino-4- hydroxy-6-pteridinyl) methyl]- amino] benzoyl]-Lglutamic 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, USP are present in a wide variety of foods, particularly liver, kidneys, yeast, and leafy green vegetables. Commercially available folic acid, USP is prepared synthetically. Folic acid, USP occurs as a yellow or yellowish-orange crystalline powder and is very slightly soluble in water and insoluble in alcohol. Folic acid, USP 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, USP (sodium folate). Aqueous solutions of folic acid, USP 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, USP is as follows: C 19 H 19 N 7 O 6 M.W. 441.40 Each tablet, for oral administration, contains 1 mg folic acid, USP. Folic acid tablets, USP 1 mg contain the following inactive ingredients: lactose monohydrate, microcrystalline cellulose, sodium starch glycolate and stearic acid. 81cbf78d-figure-01
How Supplied
HOW SUPPLIED Folic Acid Tablets, USP, 1 mg, are supplied as round, yellow tablets imprinted “AN” and “361” on one side and scored on the other side. They are available as follows: Bottles of 10: NDC 65162-361-01 Bottles of 100: NDC 65162-361-10 Bottles of 500: NDC 65162-361-50 Bottles of 1000: NDC 65162-361-11 Folic Acid Tablets, USP, 1 mg are available from Cardinal Health in cards of 28 tablets and in cards of 30 tablets. Folic Acid Tablets, USP, 1 mg are available from Cardinal Health in cartons of 100 tablets. 1 mg, carton of 100 tablets, NDC 55154-2538-4 Dispense in well-closed container with child-resistant closure. Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].
Indications & Usage
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
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 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 (regard less 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.