Sodium Citrate And Citric Acid

Sodium Citrate And Citric Acid Monohydrate

Westminster Pharmaceuticals, Llc
Human Prescription Drug
NDC 69367-320

Sodium Citrate And Citric Acid also known as Sodium Citrate And Citric Acid Monohydrate is a human prescription drug labeled by 'Westminster Pharmaceuticals, Llc'. National Drug Code (NDC) number for Sodium Citrate And Citric Acid is 69367-320. This drug is available in dosage form of Solution. The names of the active, medicinal ingredients in Sodium Citrate And Citric Acid drug includes Anhydrous Citric Acid - 334 mg/5mL Sodium Citrate, Unspecified Form - 500 mg/5mL . The currest status of Sodium Citrate And Citric Acid drug is Active.

Drug Information:

Drug NDC:	69367-320
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:	Sodium Citrate And Citric 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:	Sodium Citrate And Citric Acid Monohydrate
Also known as the generic name, this is usually the active ingredient(s) of the product.
Labeler Name:	Westminster Pharmaceuticals, Llc
Name of Company corresponding to the labeler code segment of the ProductNDC.
Dosage Form:	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:	ANHYDROUS CITRIC ACID - 334 mg/5mL SODIUM CITRATE, UNSPECIFIED FORM - 500 mg/5mL
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:	UNAPPROVED DRUG OTHER
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:	20 Jul, 2021
This is the date that the labeler indicates was the start of its marketing of the drug product.
Marketing End Date:	25 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.
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:	Westminster Pharmaceuticals, LLC
Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC.
RxCUI:	543014
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.
NUI:	N0000175833 N0000175835 N0000175980 N0000008556 N0000175089
Unique identifier applied to a drug concept within the National Drug File Reference Terminology (NDF-RT).
UNII:	XF417D3PSL 1Q73Q2JULR
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 MOA:	Acidifying Activity [MoA] Calcium Chelating Activity [MoA]
Mechanism of action of the drug—molecular, subcellular, or cellular functional activity—of the drug’s established pharmacologic class. Takes the form of the mechanism of action, followed by `[MoA]` (such as `Calcium Channel Antagonists [MoA]` or `Tumor Necrosis Factor Receptor Blocking Activity [MoA]`.
Pharmacologic Class EPC:	Calculi Dissolution Agent [EPC] Anti-coagulant [EPC]
Established pharmacologic class associated with an approved indication of an active moiety (generic drug) that the FDA has determined to be scientifically valid and clinically meaningful. Takes the form of the pharmacologic class, followed by `[EPC]` (such as `Thiazide Diuretic [EPC]` or `Tumor Necrosis Factor Blocker [EPC]`.
Pharmacologic Class PE:	Decreased Coagulation Factor Activity [PE]
Physiologic effect or pharmacodynamic effect—tissue, organ, or organ system level functional activity—of the drug’s established pharmacologic class. Takes the form of the effect, followed by `[PE]` (such as `Increased Diuresis [PE]` or `Decreased Cytokine Activity [PE]`.
Pharmacologic Class:	Acidifying Activity [MoA] Anti-coagulant [EPC] Calcium Chelating Activity [MoA] Calculi Dissolution Agent [EPC] Decreased Coagulation Factor Activity [PE]
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
69367-320-16	473 mL in 1 BOTTLE (69367-320-16)	20 Jul, 2021	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.

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Product Elements:

Sodium citrate and citric acid sodium citrate and citric acid monohydrate sodium citrate, unspecified form anhydrous citric acid anhydrous citric acid anhydrous citric acid water sodium benzoate sorbitol saccharin sodium

Indications and Usage:

Indications and usage sodium citrate and citric acid oral solution usp is an effective alkalinizing agent. it is useful in those conditions where long-term maintenance of an alkaline urine is desirable, and is of value in the alleviation of chronic metabolic acidosis, such as results from chronic renal insufficiency or the syndrome of renal tubular acidosis, especially when the administration of potassium salts is undesirable or contraindicated. this product is also useful for buffering and neutralizing gastric hydrochloric acid quickly and effectively. sodium citrate and citric acid oral solution usp is concentrated, and when administered after meals and before bedtime, allows one to maintain an alkaline urinary ph around the clock, usually without the necessity of a 2 a.m. dose. this product alkalinizes the urine without producing a systemic alkalosis in the recommended dosage.this product is highly palatable, pleasant tasting,and tolerable, even when a administered for long periods. Read more...

Warnings:

Warnings do not exceed recommended dosage. discontinue use if adverse reactions occur.

Dosage and Administration:

Dosage and administration sodium citrate and citric acid oral solution usp should be administered by diluting in water, followed by additional water, if desired. shake well before using. for systemic alkalization: usual adult dosage: 2 to 6 teaspoonfuls (10 to 30 ml), diluted in 1 to 3 ounces of water, after meals and at bedtime, or as directed by a physician. usual pediatric dose: 1 to 3 teaspoonfuls (5 to 15 ml), diluted in 1 to 3 ounces of water,after meals and at bedtime, or as directed by a physician. for children under two years of age, use is based on consultation with a physician. as a neutralizing buffer: 3 teaspoonfuls (15 ml), diluted with 15 ml water, taken as a single dose, or as directed by a physician.

Contraindications:

Contraindications contraindicated in patients with sodium-restricted diets, with severe renal impairment, or known hypersensitivity to any of the ingredients.

Adverse Reactions:

Adverse reactions sodium citrate and citric acid oral solution usp is generally well tolerated, without any unpleasant side effects, when given in recommended doses to patients with normal renal function and urinary output. however, as with any alkalinizing agent, caution must be used in certain patients with abnormal renal mechanisms to avoid development of alkalosis, especially in the presence of hypocalcemia.

Overdosage:

Overdosage overdosage with sodium salts may cause diarrhea, nausea, and vomiting, hypernoia, and convulsions.

Description:

Description sodium citrate and citric acid oral solution usp is a stable and pleasant-tasting systemic alkalizer containing sodium citrate and citric acid in a sugar-free base. it is a nonparticulate neutralizing buffer. sodium citrate and citric acid oral solution usp contains in each teaspoonful (5 ml): sodium citrate dihydrate 500 mg citric acid monohydrate 334 mg each ml contains 1 meq sodium ion, and is equivalent to 1 meq bicarbonate (hco 3 ). inactive ingredients: grape flavor, purified water, sodium benzoate, sodium saccharin, sorbitol solution.

Clinical Pharmacology:

Clinical pharmacology sodium citrate is absorbed and metabolized to sodium bicarbonate, thus acting as a systemic alkalizer. the effects are essentially those of chlorides before absorption and those of bicarbonates subsequently. oxidation is virtually complete so that less than 5% of sodium citrate is excreted in the urine unchanged.

How Supplied:

How supplied sodium citrate and citric acid oral solution usp is a (colorless, grape flavor) solution and is supplied in the following oral dosage form: ndc 69367-320-16 (16 fl oz bottles). storage keep tightly closed. store at controlled room temperature, 20Â°- 25Â°c (68Â°- 77Â°f). protect from freezing. to report a serious adverse event or to obtain product information, contact 1-844-221-7294

Package Label Principal Display Panel:

Principal display panel - 473 ml bottle label ndc: 69367-320-16 rx only sodium citrate and citric acid oral solution usp 500 mg/334 mg per 5 ml a sugar-free systemic alkalizer each teaspoonful (5ml) contains: sodium citrate dihydrate 500 mg citric acid monohydrate 334 mg each ml contains 1 meq sodium ion, and is equivalent to 1 meq bicarbonate (hco 3 ). shake well before use 16 fl oz (473 ml) westminster pharmaceuticals principal display panel - 473 ml bottle label

Comments/ Reviews:

* Data of this site is collected from www.fda.gov. This page is for informational purposes only. Always consult your physician with any questions you may have regarding a medical condition.