Oracit

Citric Acid And Sodium Citrate

Cmp Pharma, Inc.
Human Prescription Drug
NDC 46287-014

Oracit also known as Citric Acid And Sodium Citrate is a human prescription drug labeled by 'Cmp Pharma, Inc.'. National Drug Code (NDC) number for Oracit is 46287-014. This drug is available in dosage form of Solution. The names of the active, medicinal ingredients in Oracit drug includes Citric Acid Monohydrate - 640 mg/5mL Trisodium Citrate Dihydrate - 490 mg/5mL . The currest status of Oracit drug is Active.

Drug Information:

Drug NDC:	46287-014
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:	Oracit
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:	Citric Acid And Sodium Citrate
Also known as the generic name, this is usually the active ingredient(s) of the product.
Labeler Name:	Cmp Pharma, Inc.
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:	CITRIC ACID MONOHYDRATE - 640 mg/5mL TRISODIUM CITRATE DIHYDRATE - 490 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:	15 May, 1984
This is the date that the labeler indicates was the start of its marketing of the drug product.
Marketing End Date:	23 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:	CMP Pharma, Inc.
Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC.
RxCUI:	544550 544553
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:	0346287014010
UPC stands for Universal Product Code.
UNII:	2968PHW8QP B22547B95K
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:	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
46287-014-01	500 mL in 1 BOTTLE (46287-014-01)	15 May, 1984	N/A	No
46287-014-15	10 BOTTLE, UNIT-DOSE in 1 CARTON (46287-014-15) / 15 mL in 1 BOTTLE, UNIT-DOSE	15 May, 1984	N/A	No
46287-014-30	10 BOTTLE, UNIT-DOSE in 1 CARTON (46287-014-30) / 30 mL in 1 BOTTLE, UNIT-DOSE	15 May, 1984	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.

Other medicines with the same generic name

Oracit

Citric Acid And Sodium Citrate

Solution
CMP Pharma, Inc.
NDC: 46287-014

Product Elements:

Oracit citric acid and sodium citrate citric acid monohydrate anhydrous citric acid trisodium citrate dihydrate anhydrous citric acid alcohol methylparaben propylparaben

Indications and Usage:

Indications oracit Â® is indicated for the treatment of metabolic acidosis. this solution is also useful in conditions where long term maintenance of alkaline urine is needed (e.g. uric acid and cystine calculi of the urinary tract). oracit Â® is also effective in treatment for acidosis of certain renal tubular disorders.

Dosage and Administration:

Dosage and administration the dose of oracit Â® is 10 to 30 ml, diluted with water, after meals and at bedtime. the dose should be titrated to achieve desired effects.

Contraindications:

Contraindications oracit Â® is contraindicated in patients with severe renal impairment, oliguria or azotemia, untreated addison's disease, adynamia episodica hereditaria, acute dehydration, heat cramp, anuria, severe myocardial damage, and hyperkalemia.

Adverse Reactions:

Adverse reactions citrate solution is generally well tolerated when given in recommended doses when the patient has normal renal functions. to report suspected adverse reactions, contact cmp pharma, inc., toll free at 1-844-321-1443 or the fda at 1-800-fda-1088 or www.fda.gov/medwatch.

Description:

Description the product is a clear, colorless solution containing citric acid usp 640 mg/5 ml, and hydrous sodium citrate usp 490 mg/5 ml. it also contains methylparaben nf and propylparaben nf as preservatives. these concentrations yield 1 meq of sodium, equivalent to 1 meq of bicarbonate per ml of solution.

Clinical Pharmacology:

Action oral citrate solution is used as a systemic and urinary alkalinizer. less than 5% of the citrate is excreted in the urine unchanged, since citrate oxidation is to a great extent complete.

How Supplied:

How supplied oracit Â® is supplied in 500 ml bottles (ndc 46287-014-01), 30 ml unit dose bottles, 10 bottles per carton (ndc 46287-014-30), and 15 ml unit dose bottles, 10 bottles per carton (ndc 46287-014-15). pharmacist dispense in well-closed containers. store at 20Â°-25Â°c (68Â°-77Â°f); excursions permitted to 15Â°-30Â°c (59Â°-86Â°f). [see usp controlled room temperature].

Package Label Principal Display Panel:

Principal display panel - 500 ml bottle label ndc 46287-014-01 500 ml oracit Â® oral citrate (shohl's) solution contains: hydrous sodium citrate usp 490 mg/5 ml; citric acid usp 640 mg/5 ml; methylparaben nf; propylparaben nf; alcohol usp 0.25%. usual dosage: see package insert. dispense in a well-closed container. store at 20Â°-25Â°c (68Â°-77Â°f); excursions permitted to 15Â°-30Â°c (59Â°-86Â°f). [see usp controlled room temperature]. gtin: 00346287014010 rx only cmp pharma farmville, nc 27828 3050 r1017 principal display panel - 500 ml bottle label

Comments/ Reviews:

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