Citric acid

Overview

A key intermediate in metabolism. It is an acid compound found in citrus fruits. The salts of citric acid (citrates) can be used as anticoagulants due to their calcium-chelating ability. Citric acid is one of the active ingredients in Phexxi, a non-hormonal contraceptive agent that was approved by the FDA on May 2020. It is also used in combination with magnesium oxide to form magnesium citrate, an osmotic laxative.

Indication

No indication information available.

Associated Conditions

Acidosis
Catheter site calcification caused by appetite
Catheter site calcification caused by struvite
Gout
Headache
Heartburn
Kidney Stones
Metabolic Acidosis

Clinical Trials

Title	Posted	Study ID	Phase	Status	Sponsor
Characterization of Bovine Adrenal Medulla as a Model of Non-histaminergic Itch	2023/09/14	NCT06036589	Not Applicable	Completed	Aalborg University
Exploring the Effects of an Intravaginal Lactic Acid Gel on the Vaginal Microbiome	2023/03/03	NCT05753813	Early Phase 1	Recruiting	Queen's Medical Center
TES RCT Fleet Enema vs Oral Mechanical Bowel Prep	2021/12/08	NCT05148494	Phase 4	Recruiting	Nova Scotia Health Authority
Effect of Low Level Laser Therapy on Prevention of Radiotherapy Induced Xerostomia in Cancer Patients.	2021/01/08	NCT04700475	Not Applicable	UNKNOWN	Nada Yousef
Study Assessing CLENPIQ As Bowel Preparation for Pediatric Colonoscopy	2019/10/02	NCT04113382	Phase 1	Recruiting	Ferring Pharmaceuticals
A Cross-sectional Study to Measure Cough in Severe Asthma	2019/06/26	NCT03999203	Not Applicable	Completed	Queen's University, Belfast
The Influence of Citric Acid Bone Surface Etching and Bone Defect Fill on GCF BMP-2 Release Profile	2018/12/07	NCT03769402	Phase 4	Completed	Ain Shams University
Comparison of Clenpiq vs Golytely Bowel Preparation	2017/06/26	NCT03198221	Phase 4	Terminated	The Cleveland Clinic
The Efficacy and Safety of Caffeic Acid for Esophageal Cancer	2017/03/03	NCT03070262	Phase 3	UNKNOWN	The First Affiliated Hospital of Henan University of Science and Technology
The Diagnostic Validity of the Urea Breath Test	2015/02/10	NCT02359942	Not Applicable	Completed	Seoul National University Bundang Hospital

FDA Drug Approvals

Approved Product	Manufacturer	NDC Code	Route	Strength	Effective Date
Sodium Citrate and Citric Acid	Pharmaceutical Associates, Inc.	0121-0595	ORAL	334 mg in 5 mL	12/15/2022
Citric Buffered Normal Saline	Nabriva Therapeutics US, Inc.	72000-030	INTRAVENOUS	166 mg in 270 mL	10/13/2021
TERUFLEX Blood Bag System Anticoagulant Citrate Phosphate Dextrose Adenine (CPDA-1)	Terumo Corporation	53877-001	INTRAVENOUS	2.99 g in 1000 mL	12/7/2018
TERUFLEX Blood Bag System Anticoagulant Citrate Phosphate Dextrose Adenine (CPDA-1)	Terumo Corporation	53877-001	INTRAVENOUS	2.99 g in 1000 mL	12/7/2018
Sodium Citrate and Citric Acid	Cardinal Health 107, LLC	55154-5777	ORAL	334 mg in 5 mL	6/21/2019
CPDA-1	Fenwal, Inc.	0942-9394	INTRAVENOUS	188 mg in 63 mL	11/1/2022
ACD-A	Fenwal, Inc.	0942-0641	INTRAVENOUS	3.65 g in 500 mL	2/11/2022
CPDA-1	Fenwal, Inc.	0942-6326	INTRAVENOUS	209 mg in 70 mL	8/27/2014
Sodium Citrate and Citric Acid	AvPAK	50268-182	ORAL	334 mg in 5 mL	6/13/2023
Anticoagulant Citrate Phosphate Dextrose (CPD) Blood-Pack Units in PL 146 Plastic	Fenwal, Inc.	0942-9201	INTRAVENOUS	105 mg in 35 mL	11/1/2022

EMA Drug Approvals

Approved Product	Authorization Holder	Status	Issued Date
No EMA approvals found for this drug.

HSA Drug Approvals

Approved Product	Manufacturer	Approval Number	Dosage Form	Strength	Approval Date
POTCIT MIXTURE	BEACONS PHARMACEUTICALS PTE LTD	SIN05148P	SOLUTION	200 mg/5 ml	10/16/1990
POTASSIUM CITRATE MIXTURE BP	ICM PHARMA PTE. LTD.	SIN06732P	SOLUTION	5% w/v	12/19/1991
ALKA-SELTZER TABLET (Lemon Flavour)	BAYER DE MEXICO SA DE CV	SIN08632P	TABLET	1223 mg	4/4/1996
E-Z-GAS II GRANULES	Tower Laboratories	SIN06442P	GRANULE	1.54 g/4 g	7/11/1991
PICOPREP Powder for Oral Solution	Ferring Pharmaceuticals (China) Co., Ltd.	SIN14303P	POWDER, FOR SOLUTION	12 g	1/30/2013
Ural Effervescent Granules	Aspen Pharma Pty Ltd	SIN14374P	GRANULE, EFFERVESCENT	0.72g	6/26/2013
PICO-SWIFT POWDER FOR ORAL SOLUTION	IND-SWIFT LIMITED	SIN17163P	POWDER, FOR SOLUTION	12000 mg	1/16/2025

NMPA Drug Approvals

Approved Product	Company	Approval Number	Drug Type	Dosage Form	Approval Date
No NMPA approvals found for this drug.

PPB Drug Approvals

Approved Product	Registration No.	Company	Licence No.	Strength	Registration Date
LEMON FLAVOURED ENO FRUIT SALT	N/A	Haleon Hong Kong Limited	N/A	N/A	8/8/1983

TGA Drug Approvals

Approved Product	ARTG ID	Sponsor	Registration Type	Status	Registration Date
MEDIX Dry Cough Medicine	283737	Nova Pharmaceuticals Australasia Pty Ltd	Medicine	A	12/17/2016
Hydralyte Orange Electrolyte Powder (Tub)	292256	The Hydration Pharmaceuticals Trust	Medicine	A	7/31/2017
Overnight Cleanse	344734	Internal Healing Pty Ltd	Medicine	A	9/28/2020
Hydralyte Tropical Flavoured Effervescent Electrolyte Tablets	370691	Care Pharmaceuticals Pty Ltd	Medicine	A	7/7/2021
APOHEALTH Cystitis Relief oral powder sachet	227717	Arrotex Pharmaceuticals Pty Ltd	Medicine	A	9/8/2014
Everyday Hydration Mixed Berry	408802	Sublux P/L	Medicine	A	5/11/2023
Hydrate + Energy Raspberry Burst	468609	Procter & Gamble Australia Pty Ltd	Medicine	A	11/14/2024
Hydralyte Lemon Lime Effervescent Electrolyte Tablets	217300	Care Pharmaceuticals Pty Ltd	Medicine	A	11/14/2013
Chemists' Own Cystitis Relief effervescent granules sachet	297741	Arrotex Pharmaceuticals Pty Ltd	Medicine	A	12/19/2017
Help at Hand for Irritating Dry Coughs	295064	Nova Pharmaceuticals Australasia Pty Ltd	Medicine	A	10/13/2017

Health Canada Drug Approvals

Approved Product	Company	DIN	Dosage Form	Strength	Market Date
ORAL PURGATIVE	odan laboratories ltd	02370271	Powder For Solution - Oral	12 G / PCK	11/16/2011
HEMOSATE ULTRA HS4125	chief medical supplies ltd	02413922	Solution - Haemodialysis	6.91 G / L	3/30/2020
HEMOSATE ULTRA HS1125	chief medical supplies ltd	02413892	Solution - Haemodialysis	6.91 G / L	3/30/2020
HEMOSATE ULTRA HS2150	chief medical supplies ltd	02413957	Solution - Haemodialysis	6.91 G / L	3/4/2020
HEMASATE ULTRA HS4125	chief medical supplies ltd	02422417	Solution - Haemodialysis	7.18 G / L	N/A
UBICOENZYME	Biologische Heilmittel Heel Gmbh	02236503	Liquid - Oral	8 D	2/6/1998
HEMOSATE ULTRA HS3150	chief medical supplies ltd	02413965	Solution - Haemodialysis	6.91 G / L	N/A
CITRASATE C2150	chief medical supplies ltd	02366606	Solution - Haemodialysis	6.91 G / L	2/21/2013
ANTICOAGULANT SOLUTION CITRATE PHOSPHATE DEXTROSE (CPD)	maco pharma	02444100	Solution - 0-Unassigned	3.27 G / L	8/22/2016
CITRACLEEN	laboratorios casen-fleet, s.l.u.	02437880	Powder For Solution - Oral	10.97 G / 15.08 G	N/A

CIMA AEMPS Drug Approvals

Approved Product	Company	Registration Number	Pharmaceutical Form	Prescription Type	Status
No CIMA AEMPS (Spain) approvals found for this drug.

Philippines FDA Drug Approvals

Approved Product	Company	License Number	Dosage Form	Strength	Approval Date
No Philippines FDA approvals found for this drug.

Saudi SFDA Drug Approvals

Approved Product	Company	License Number	Dosage Form	Strength	Approval Date
No Saudi SFDA approvals found for this drug.

Malaysia NPRA Drug Approvals

Approved Product	Company	Registration Number	Dosage Form	Strength	Approval Date
No Malaysia NPRA approvals found for this drug.

UK EMC Drug Information

Medicine Name	MA Holder	MA Number	Pharmaceutical Form	Active Ingredient	Authorization Date
No UK EMC drug information found for this drug.

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