Anticoagulant Citrate Dextrose A

Anhydrous Citric Acid, Dextrose Monohydrate, And Trisodium Citrate Dihydrate

Citra Labs Llc
Human Prescription Drug
NDC 23731-6051

Anticoagulant Citrate Dextrose A also known as Anhydrous Citric Acid, Dextrose Monohydrate, And Trisodium Citrate Dihydrate is a human prescription drug labeled by 'Citra Labs Llc'. National Drug Code (NDC) number for Anticoagulant Citrate Dextrose A is 23731-6051. This drug is available in dosage form of Solution. The names of the active, medicinal ingredients in Anticoagulant Citrate Dextrose A drug includes Anhydrous Citric Acid - .073 g/10mL Dextrose Monohydrate - .245 g/10mL Trisodium Citrate Dihydrate - .22 g/10mL . The currest status of Anticoagulant Citrate Dextrose A drug is Active.

Drug Information:

Drug NDC:	23731-6051
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:	Anticoagulant Citrate Dextrose A
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:	Anhydrous Citric Acid, Dextrose Monohydrate, And Trisodium Citrate Dihydrate
Also known as the generic name, this is usually the active ingredient(s) of the product.
Labeler Name:	Citra Labs 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 - .073 g/10mL DEXTROSE MONOHYDRATE - .245 g/10mL TRISODIUM CITRATE DIHYDRATE - .22 g/10mL
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.
Route Details:	EXTRACORPOREAL
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:	NDA
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:	26 Aug, 2003
This is the date that the labeler indicates was the start of its marketing of the drug product.
Marketing End Date:	16 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:	BN020037
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:	Citra Labs LLC
Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC.
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 LX22YL083G 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 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
23731-6051-1	10 VIAL, SINGLE-USE in 1 CASE (23731-6051-1) / 30 mL in 1 VIAL, SINGLE-USE (23731-6051-3)	26 Aug, 2003	N/A	No
23731-6051-2	25 VIAL, SINGLE-USE in 1 CASE (23731-6051-2) / 30 mL in 1 VIAL, SINGLE-USE (23731-6051-3)	26 Aug, 2003	N/A	No
23731-6051-3	30 mL in 1 VIAL, SINGLE-USE (23731-6051-3)	26 Aug, 2003	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

Anticoagulant Citrate Dextrose A

Anhydrous Citric Acid, Dextrose Monohydrate, And Trisodium Citrate Dihydrate

Solution
Citra Labs LLC
NDC: 23731-6051

Product Elements:

Anticoagulant citrate dextrose a anhydrous citric acid, dextrose monohydrate, and trisodium citrate dihydrate dextrose monohydrate anhydrous dextrose anhydrous citric acid anhydrous citric acid trisodium citrate dihydrate anhydrous citric acid

Indications and Usage:

Indications and usage anticoagulant citrate dextrose solution, solution a, u.s.p. (acd-a), is intended for use as an anticoagulant in the extracorporeal blood processing with autologous prp systems in production of platelet rich plasma (prp). refer to the manufacturer's operator's manual of the autologous prp system for the directions for use.

Warnings:

Warnings not for direct intravenous infusion

General Precautions:

General aseptic technique must be maintained at all times. acd-a solution is a clear and colorless solution. if the product shows any cloudiness or turbidity, the product should be discarded. the closure system provides a biological barrier and should be intact â discard product if system is compromised.

Dosage and Administration:

Dosage and administration refer to the manufacturer's operator's manual of the autologous prp system for the directions for use.

Contraindications:

Contraindications not for direct intravenous infusion

Adverse Reactions:

Adverse reactions not applicable. this product is used as an anticoagulant in the extracorporeal blood processing with autologous prp systems in production of platelet rich plasma (prp).

Use in Pregnancy:

Pregnancy long-term studies in animals have not been performed to evaluate the effects of acd- a on pregnant women.

Pediatric Use:

Pediatric use the safety and effectiveness of acd-a in children have not been established.

Overdosage:

Overdosage not applicable. this product is used as an anticoagulant in the extracorporeal blood processing with autologous prp systems in production of platelet rich plasma (prp).

Description:

Description anticoagulant citrate dextrose solution, solution a, u.s.p., (acd-a), is a sterile, non-pyrogenic solution of citric acid, sodium citrate, and dextrose, in water for injection. each 10 ml of solution contains: citric acid, anhydrous, usp 0.073 g sodium citrate, dihydrate, usp 0.220 g dextrose, monohydrate, usp 0.245 g water for injection, usp q.s. ph: 4.5 â 5.5 single patient use only, on a single occasion. single use

Clinical Pharmacology:

Clinical pharmacology acd-a acts as an anticoagulant by the action of the citrate ion chelating free ionized calcium, thus making calcium unavailable to the coagulation system.

Carcinogenesis and Mutagenesis and Impairment of Fertility:

Carcinogenesis, mutagenesis, impairment of fertility long-term studies in animals have not been performed to evaluate the carcinogenic potential of acd-a.

How Supplied:

How supplied anticoagulant citrate dextrose solution, solution a, u.s.p., (acd-a) ref size case pn 9350-10 30 ml 10 vials/case pn 9350-25 30 ml 25 vials/case it is recommended that the product be stored at ambient room temperature, 24 Â°c (75 Â°f); however, the product can be stored between 15 Â°c (59 Â°f) and 30 Â°c (86 Â°f). protect from freezing and exposure to excessive heat should be minimized.

Information for Patients:

Information for patients none.

Package Label Principal Display Panel:

Principal display panel - 10 vial case label c e 0044 acd-a anticoagulant citrate dextrose solution, 10 vials / case solution a, u.s.p., acd-a, 30 ml ref pn 9350-10 warning: not for direct intravenous infusion used as an anticoagulant in the extracorporeal blood processing with autologous prp systems in production of platelet rich plasma (prp). refer to prp systems manufacturer's directions for use. manufactured & distributed by: citra labs a biomet inc. company. citra labs, llc. 55 messina drive, braintree, ma 02184 1-800-299-3411 ec rep authorized representative: biomet global supply chain center b.v. hazeldonk 6530 4836 ld breda the netherlands sterile â¢ non-pyrogenic composition per 10 ml of solution: citric acid, (anhydrous), u.s.p. 0.073 g. sodium citrate, (dihydrate), u.s.p. 0.220 g. dextrose, (monohydrate), u.s.p. 0.245 g. caution: single procedure use-discard unused portion do not use unless solution is clear and seal is intact. store between 15 Â°c - 30 Â°c (59 Â°f - 86 Â°f). rx only: exp date lot la9350-10b 01/20 symbols label

Principal display panel - 25 vial case label c e 0044 acd-a anticoagulant citrate dextrose solution, 25 vials / case solution a, u.s.p., acd-a, 30 ml ref pn 9350-25 warning: not for direct intravenous infusion used as an anticoagulant in the extracorporeal blood processing with autologous prp systems in production of platelet rich plasma (prp). refer to prp systems manufacturer's directions for use. manufactured & distributed by: citra labs a biomet inc. company. citra labs, llc. 55 messina drive, braintree, ma 02184 1-800-299-3411 ec rep authorized representative: biomet global supply chain center b.v. hazeldonk 6530 4836 ld breda the netherlands sterile â¢ non-pyrogenic composition per 10 ml of solution: citric acid, (anhydrous), u.s.p. 0.073 g. sodium citrate, (dihydrate), u.s.p. 0.220 g. dextrose, (monohydrate), u.s.p. 0.245 g. caution: single procedure use-discard unused portion do not use unless solution is clear and seal is intact. store between 15 Â°c - 30 Â°c (59 Â°f - 86 Â°f). rx only: exp date lot la9350-25 01/20 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.