FOLIC ACID tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

FOLIC ACID (UNII: 935E97BOY8) (FOLIC ACID - UNII:935E97BOY8)

Available from:

Amneal Pharmaceuticals LLC

INN (International Name):

FOLIC ACID

Composition:

FOLIC ACID 1 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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

Product summary:

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 Dispense in well-closed container with child-resistant closure. Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Distributed by: Amneal Pharmaceuticals LLC Bridgewater, NJ 08807 Rev. 05-2018-01

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

FOLIC ACID- FOLIC ACID TABLET
AMNEAL PHARMACEUTICALS LLC
----------
FOLIC ACID TABLETS, USP
RX ONLY
DESCRIPTION
Folic acid, 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 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, 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 (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:
C
H
N O 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.
CLINICAL PHARMACOLOGY
Folic acid acts on megaloblastic bone marrow to produce a normoblastic
marrow.
In man, an 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