Folic Acid
Xgen Pharmaceuticals Djb, Inc.
Human Prescription Drug
NDC 39822-1100Folic Acid is a human prescription drug labeled by 'Xgen Pharmaceuticals Djb, Inc.'. National Drug Code (NDC) number for Folic Acid is 39822-1100. This drug is available in dosage form of Injection, Solution. The names of the active, medicinal ingredients in Folic Acid drug includes Folic Acid - 5 mg/mL . The currest status of Folic Acid drug is Active.
Drug Information:
| Drug NDC: | 39822-1100 |
| 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: | Xgen Pharmaceuticals Djb, Inc. |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | Injection, Solution |
| 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 - 5 mg/mL
|
| This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted. |
| Route Details: | INTRAMUSCULAR
INTRAVENOUS
SUBCUTANEOUS
|
| 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: | 17 Nov, 2019 |
| 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: | ANDA202522 |
| 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, 2023 |
| 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: | XGen Pharmaceuticals DJB, Inc.
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| RxCUI: | 237786
|
| 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. |
| Original Packager: | Yes
|
| Whether or not the drug has been repackaged for distribution. |
| UPC: | 0339822110018
|
| 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 |
|---|
| 39822-1100-1 | 1 VIAL, MULTI-DOSE in 1 CARTON (39822-1100-1) / 10 mL in 1 VIAL, MULTI-DOSE | 17 Nov, 2019 | 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 edetate sodium benzyl alcohol hydrochloric acid sodium hydroxide folic acid folic acid
Indications and Usage:
Indications and usage: folic acid injection, usp alone is effective in the treatment of megaloblastic anemias due to a deficiency of folic acid as may be seen in tropical or nontropical sprue, in anemias of nutritional origin, pregnancy, infancy or childhood.
Warnings:
Warnings: warning: this product contains aluminum that may be toxic. aluminum may reach toxic levels with prolonged parenteral administration if kidney function is impaired. premature neonates are particularly at risk because their kidneys are immature, and they require large amounts of calcium and phosphate solutions, which contain aluminum. research indicates that patients with impaired kidney function, including premature neonates, who receive parenteral levels of aluminum at greater than 4 to 5 mcg/kg/day accumulate aluminum at levels associated with central nervous system and bone toxicity. tissue loading may occur at even lower rates of administration. folic acid alone is improper therapy in the treatment of pernicious anemia and other megaloblastic anemias where vitamin b 12 is deficient. this product contains benzyl alcohol. benzyl alcohol has been reported to be associated with a fatal âgasping syndromeâ in premature infants.
Dosage and Administration:
Dosage and administration: parenteral administration : intramuscular (im), intravenous (iv) and subcutaneous (sc) routes may be used if the disease is exceptionally severe or if gastrointestinal absorption may be, or is known to be, impaired. usual therapeutic dosage â in adults and children (regardless of age): up to 1 mg daily. resistant cases may require larger doses. maintenance level : when clinical symptoms have subsided and the blood picture has become normal, a maintenance level should be used, i.e., 0.1 mg for infants and up to 0.3 mg for children under four years of age, 0.4 mg for adults and children four or more years of age, and 0.8 mg for pregnant and lactating women, per day, but never less than 0.1 mg per day. patient 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 increas
Read more...ed. parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.
Adverse Reactions:
Adverse reactions: allergic sensitization has been reported following both oral and parenteral administration of folic acid. to report suspected adverse reactions, contact xgen pharmaceuticals djb, inc. at 1-866- 390-4411 or fda at 1-800-fda-1088 or www.fda. gov/medwatch.
Description:
Description: folic acid injection, usp is a sterile, nonpyrogenic solution of sodium folate (prepared by the addition of sodium hydroxide to folic acid) in water for injection, usp intended for intramuscular (im), intravenous (iv) or subcutaneous (sc) use. folic acid is a complex organic compound present in liver, yeast and other substances, which may be prepared synthetically. it is a yellow or yellowish orange, odorless crystalline powder. it is very slightly soluble in water, insoluble in alcohol, chloroform, ether; readily dissolves in dilute solutions of alkali hydroxides and carbonates. it is chemically designated as: l-glutamic acid, n-[4-[[(2-amino-1-4-dihydro-4-oxo-6-pteridinyl) methyl] amino]benzoyl]-, and has the following structural formula. c 19 h 19 n 7 o 6 ; m.w. 441.40 each ml contains: sodium folate (equivalent to 5 mg folic acid); edetate disodium 2 mg; benzyl alcohol 15 mg (added as preservative); water for injection, usp q.s. hydrochloric acid and/or sodium hydroxide for ph adjustment (8.0 to 11.0). folic acid structure
Clinical Pharmacology:
Clinical pharmacology: in man, an exogenous source of folate is required for nucleoprotein synthesis and maintenance of normal erythropoiesis. folic acid, whether given by mouth or parenterally, stimulates specifically the production of red blood cells, white blood cells and platelets in persons suffering from certain megaloblastic anemias.
How Supplied:
How supplied: folic acid injection, usp 50 mg per 10 ml (5 mg per ml) is available as: product ndc: 39822-1100-1 10 ml multiple dose, in a flip-top vial, packaged individually. store at 20° to 25°c (68° to 77°f) [see usp controlled room temperature]. protect from light. retain vial in carton until contents are used. manufactured for: xgen pharmaceuticals djb, inc. big flats, ny 14814 revised: september 2020 foli-pi-03 logo
Package Label Principal Display Panel:
Package label - principal display - folic acid 10 ml vial label ndc 39822-1100-1 folic acid injection, usp 50 mg per 10 ml (5 mg per ml) for intramuscular, intravenous or subcutaneous use. 10 ml multiple dose vial rx only package label - principal display - folic acid 10 ml vial carton ndc 39822-1100-1 folic acid injection, usp 50 mg per 10 ml (5 mg per ml) for intramuscular, intravenous or subcutaneous use. 10 ml multiple dose vial rx only foli-vl-01-djb foli-cs-01-djb