Folic Acid
Cardinal Health 107, Llc
Human Prescription Drug
NDC 55154-4306Folic Acid is a human prescription drug labeled by 'Cardinal Health 107, Llc'. National Drug Code (NDC) number for Folic Acid is 55154-4306. This drug is available in dosage form of Tablet. The names of the active, medicinal ingredients in Folic Acid drug includes Folic Acid - 1 mg/1 . The currest status of Folic Acid drug is Active.
Drug Information:
| Drug NDC: | 55154-4306 |
| The labeler code and product code segments of the National Drug Code number, separated by a hyphen. Asterisks are no longer used or included within the product code segment to indicate certain configurations of the NDC. |
| Proprietary Name: | Folic Acid |
| Also known as the trade name. It is the name of the product chosen by the labeler. |
| Product Type: | Human Prescription Drug |
| Indicates the type of product, such as Human Prescription Drug or Human OTC Drug. This data element corresponds to the “Document Type” of the SPL submission for the listing. |
| Non Proprietary Name: | Folic Acid |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Cardinal Health 107, Llc |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | Tablet |
| The translation of the DosageForm Code submitted by the firm. There is no standard, but values may include terms like `tablet` or `solution for injection`.The complete list of codes and translations can be found www.fda.gov/edrls under Structured Product Labeling Resources. |
| Status: | Active |
| FDA does not review and approve unfinished products. Therefore, all products in this file are considered unapproved. |
| Substance Name: | FOLIC ACID - 1 mg/1
|
| This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted. |
| Route Details: | ORAL
|
| The translation of the Route Code submitted by the firm, indicating route of administration. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources. |
Marketing Information:
An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
| Marketing Category: | ANDA |
| Product types are broken down into several potential Marketing Categories, such as New Drug Application (NDA), Abbreviated New Drug Application (ANDA), BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources. |
| Marketing Start Date: | 07 Mar, 2022 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 22 Dec, 2025 |
| This is the date the product will no longer be available on the market. If a product is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the EndMarketingDate, to reflect the potential for drug product to remain available after manufacturing has ceased. Products that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Products with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached. |
| Application Number: | ANDA040625 |
| This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null. |
| Listing Expiration Date: | 31 Dec, 2024 |
| This is the date when the listing record will expire if not updated or certified by the firm. |
OpenFDA Information:
An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
| Manufacturer Name: | Cardinal Health 107, LLC
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| RxCUI: | 310410
|
| The RxNorm Concept Unique Identifier. RxCUI is a unique number that describes a semantic concept about the drug product, including its ingredients, strength, and dose forms. |
| UPC: | 0055154430609
|
| UPC stands for Universal Product Code. |
| UNII: | 935E97BOY8
|
| Unique Ingredient Identifier, which is a non-proprietary, free, unique, unambiguous, non-semantic, alphanumeric identifier based on a substance’s molecular structure and/or descriptive information. |
Packaging Information:
| Package NDC | Description | Marketing Start Date | Marketing End Date | Sample Available |
|---|
| 55154-4306-0 | 10 BLISTER PACK in 1 BAG (55154-4306-0) / 1 TABLET in 1 BLISTER PACK | 21 Jun, 2022 | N/A | No |
| Package NDC number, known as the NDC, identifies the labeler, product, and trade package size. The first segment, the labeler code, is assigned by the FDA. Description tells the size and type of packaging in sentence form. Multilevel packages will have the descriptions concatenated together. |
Product Elements:
Folic acid folic acid folic acid folic acid an;361
Indications and Usage:
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.
Warnings:
Warning administration of folic acid alone is improper therapy for pernicious anemia and other megaloblastic anemias in which vitamin b 12 is deficient.
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 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,
Read more...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:
Contraindications folic acid is contraindicated in patients who have shown previous intolerance to the drug.
Adverse Reactions:
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 admin
Read more...istered 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.
Overdosage:
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.
Description:
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, odorless, crystalline powder. it 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 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, type a and stearic acid. 1
Clinical Pharmacology:
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 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
Read more... 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 ng/ml to 15 ng/ml; normal cerebrospinal fluid levels are approximately 16 ng/ml to 21 ng/ml. normal erythrocyte folate levels have been reported to range from 175 ng/ml 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 mcg 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 mcg/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 the feces. folic acid is also excreted in the milk of lactating mothers.
How Supplied:
How supplied folic acid tablets usp, 1 mg, are supplied as light yellow colored, round convex tablet debossed "an 361" on one side and bisected on the other side. they are available as follows: overbagged with 10 tablets per bag, ndc 55154-4306-0 distributed by: cardinal health dublin, oh 43017 dispense contents with a child-resistant closure (as required) and in a tight, light-resistant container as defined in the usp. store at 20° to 25°c (68° to 77°f) [see usp controlled room temperature]. protect from light and moisture. to report suspected adverse reactions, contact amneal pharmaceuticals at 1-877-835-5472 or fda at 1-800-fda-1088 or www.fda.gov/medwatch manufactured by: amneal pharmaceuticals pvt. ltd. oral solid dosage unit ahmedabad 382213, india distributed by: amneal pharmaceuticals llc bridgewater, nj 08807 packaged and distributed by: major® pharmaceuticals indianapolis, in 46268 usa refer to package label for distributor's ndc number distributed by: cardinal
Read more... health dublin, oh 43017 rev. 07-2021-00
Package Label Principal Display Panel:
Principal display panel folic acid tablets, usp 1 mg 10 tablets bag label