Pyridoxine Hci
Hf Acquisition Co Llc, Dba Healthfirst
Human Prescription Drug
NDC 51662-1410Pyridoxine Hci is a human prescription drug labeled by 'Hf Acquisition Co Llc, Dba Healthfirst'. National Drug Code (NDC) number for Pyridoxine Hci is 51662-1410. This drug is available in dosage form of Injection, Solution. The names of the active, medicinal ingredients in Pyridoxine Hci drug includes Pyridoxine Hydrochloride - 100 mg/mL . The currest status of Pyridoxine Hci drug is Active.
Drug Information:
| Drug NDC: | 51662-1410 |
| 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: | Pyridoxine Hci |
| 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: | Pyridoxine Hci |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Hf Acquisition Co Llc, Dba Healthfirst |
| 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: | PYRIDOXINE HYDROCHLORIDE - 100 mg/mL
|
| This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted. |
| Route Details: | INTRAMUSCULAR
INTRAVENOUS
|
| 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: | 08 Oct, 2019 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 20 Jan, 2026 |
| 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: | ANDA080618 |
| 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: | HF Acquisition Co LLC, DBA HealthFirst
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| RxCUI: | 312736
|
| 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: | 0363323180010
|
| UPC stands for Universal Product Code. |
| UNII: | 68Y4CF58BV
|
| 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. |
| Pharmacologic Class: | Analogs/Derivatives [Chemical/Ingredient]
Vitamin B 6 [Chemical/Ingredient]
Vitamin B6 Analog [EPC]
|
| These are the reported pharmacological class categories corresponding to the SubstanceNames listed above. |
Packaging Information:
| Package NDC | Description | Marketing Start Date | Marketing End Date | Sample Available |
|---|
| 51662-1410-1 | 1 mL in 1 VIAL (51662-1410-1) | 08 Oct, 2019 | N/A | No |
| 51662-1410-3 | 25 POUCH in 1 CASE (51662-1410-3) / 1 VIAL in 1 POUCH (51662-1410-2) / 1 mL in 1 VIAL | 11 Dec, 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:
Pyridoxine hci pyridoxine hci pyridoxine hydrochloride pyridoxine chlorobutanol sodium hydroxide
Indications and Usage:
Indications & usage pyridoxine hydrochloride injection is effective for the treatment of pyridoxine deficiency as seen in the following: inadequate dietary intake. drug-induced deficiency, as from isoniazid (inh) or oral contraceptives. inborn errors of metabolism, e.g., vitamin b6 dependent convulsions or vitamin b6 responsive anemia. the parenteral route is indicated when oral administration is not feasible as in anorexia, nausea and vomiting, and preoperative and postoperative conditions. it is also indicated when gastrointestinal absorption is impaired.
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.
Dosage and Administration:
Dosage & administration pyridoxine hydrochloride injection may be administered intramuscularly or intravenously. in cases of dietary deficiency, the dosage is 10 to 20 mg daily for 3 weeks. follow-up treatment is recommended daily for several weeks with an oral therapeutic multivitamin preparation containing 2 to 5 mg pyridoxine. poor dietary habits should be corrected, and an adequate, well balanced diet should be prescribed. the vitamin b6 dependency syndrome may require a therapeutic dosage of as much as 600 mg a day and a daily intake of 30 mg for life. in deficiencies due to inh, the dosage is 100 mg daily for 3 weeks followed by a 30 mg maintenance dose daily. in poisoning caused by ingestion of more than 10 g of inh, an equal amount of pyridoxine should be given â 4 g intravenously followed by 1 g intramuscularly every 30 minutes. parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and con
Read more...tainer permit.
Contraindications:
Contraindications a history of sensitivity to pyridoxine or to any of the ingredients in pyridoxine hydrochloride injection, usp is a contraindication.
Adverse Reactions:
Adverse reactions paresthesia, somnolence, and low serum folic acid levels have been reported.
Overdosage:
Overdosage pyridoxine given to animals in amounts of 3 to 4 g/kg of body weight produces convulsions and death. in man, a dose of 25 mg/kg of body weight is well tolerated.
Description:
Description pyridoxine hydrochloride injection, usp is a sterile solution of pyridoxine hydrochloride in water for injection. each ml contains 100 mg pyridoxine hydrochloride and 0.5% chlorobutanol anhydrous (chloral deriv.). ph adjusted with sodium hydroxide if necessary (2.0 to 3.8). pyridoxine hydrochloride is a colorless or white crystal or a white crystalline powder. one gram dissolves in 5 ml of water. it is stable in air and is slowly affected by sunlight. the chemical name is 2-methyl-3-hydroxy-4,5-bis (hydroxymethyl) pyridine hydrochloride. the structural formula is: structure
Clinical Pharmacology:
Clinical pharmacology natural substances that have vitamin b6 activity are pyridoxine in plants and pyridoxal or pyridoxamine in animals. all 3 are converted to pyridoxal phosphate by the enzyme pyridoxal kinase. the physiologically active forms of vitamin b6 are pyridoxal phosphate (codecarboxylase) and pyridoxamine phosphate. riboflavin is required for the conversion of pyridoxine phosphate to pyridoxal phosphate. vitamin b6 acts as a coenzyme in the metabolism of protein, carbohydrate, and fat. in protein metabolism, it participates in the decarboxylation of amino acids, conversion of tryptophan to niacin or to serotonin (5-hydroxtryptamine), deamination, and transamination and transulfuration of amino acids. in carbohydrate metabolism, it is responsible for the breakdown of glycogen to glucose-1-phosphate. the total adult body pool consists of 16 to 25 mg of pyridoxine. its half-life appears to be 15 to 20 days. vitamin b6 is degraded to 4-pyridoxic acid in the liver. this metaboli
Read more...te is excreted in the urine. the need for pyridoxine increases with the amount of protein in the diet. the tryptophan load test appears to uncover early vitamin b6 deficiency by detecting xanthinurea. the average adult minimum daily requirement is about 1.25 mg. the âârecommended dietary allowanceââ of the national academy of sciences is estimated to be as much as 2.2 mg for adults and 2.5 mg for pregnant and lactating women. the requirements are more in persons having certain genetic defects or those being treated with isonicotinic acid hydrazide (inhj) or oral contraceptives.
How Supplied:
How supplied pyridoxine hci injection, usp is supplied in the following dosage forms. ndc 51662-1410-1 pyridoxine hci injection, usp 100mg per ml 1ml vial ndc 51662-1410-2 pyridoxine hci injection, usp 100mg per ml 1ml vial, 1 vial per pouch ndc 51662-1410-3 pyridoxine hci injection, usp 100mg per ml 1ml vial, 1 vial per pouch, 25 pouches per case hf acquisition co llc, dba healthfirst mukilteo, wa 98275 protect from light. use only if solution is clear and seal intact. sterile. store at 20° to 25°c (68° to 77°f) [see usp controlled room temperature].
Package Label Principal Display Panel:
Principal display panel, vial label vial pt1 vial pt 2 vial pt 3
Principal display panel, serialized labeling serialized labeling
Principal display panel - ndc 51662-1410-2 pouch labeling ndc 51662-1410-2 pouch labeling pouch labeling vial label
Principal display panel - ndc 51662-1410-3 case labeling ndc 51662-1410-3 case labeling ndc 51662-1410-3 serialized rfid labeling case labeling serialized rfid labeling