Overview
Sodium citrate is the sodium salt of citric acid. It is white, crystalline powder or white, granular crystals, slightly deliquescent in moist air, freely soluble in water, practically insoluble in alcohol. Like citric acid, it has a sour taste. From the medical point of view, it is used as alkalinizing agent. It works by neutralizing excess acid in the blood and urine. It has been indicated for the treatment of metabolic acidosis.
Background
Sodium citrate is the sodium salt of citric acid. It is white, crystalline powder or white, granular crystals, slightly deliquescent in moist air, freely soluble in water, practically insoluble in alcohol. Like citric acid, it has a sour taste. From the medical point of view, it is used as alkalinizing agent. It works by neutralizing excess acid in the blood and urine. It has been indicated for the treatment of metabolic acidosis.
Indication
Used as an anticoagulant during plasmophoresis as well as a neutralizing agent in the treatment of upset stomach and acidic urine .
Associated Conditions
- Acidosis
- Allergic Reaction
- Allergic cough
- Asthma
- Asthma Chronic, Cough
- Common Cold
- Cough
- Coughing caused by Bronchitis
- Dehydration
- Gout
- Heartburn
- Metabolic Acidosis
- Phlegm
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2025/05/29 | Not Applicable | Not yet recruiting | |||
2024/01/12 | Phase 2 | Active, not recruiting | |||
2022/01/13 | Phase 4 | Completed | |||
2021/10/05 | Phase 1 | Completed | |||
2020/02/26 | Phase 2 | ENROLLING_BY_INVITATION | |||
2009/08/31 | Early Phase 1 | Completed | |||
1999/10/19 | N/A | Completed | National Center for Research Resources (NCRR) |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Haemonetics Manufacturing Inc | 53157-796 | INTRAVENOUS | 2.20 g in 100 mL | 2/9/2015 | |
| Pharmaceutical Associates, Inc. | 0121-0595 | ORAL | 500 mg in 5 mL | 12/15/2022 | |
| Maco Productions | 14498-005 | INTRAVENOUS | 0.92 g in 35 mL | 8/14/2021 | |
| Maco Productions | 14498-004 | INTRAVENOUS | 0.76 g in 29 mL | 12/21/2017 | |
| PAI Holdings, LLC | 0121-0677 | ORAL | 500 mg in 5 mL | 4/10/2023 | |
| Haemonetics Corporation | 53157-736 | INTRAVENOUS | 1.66 g in 63 mL | 7/19/2023 | |
| Chartwell RX, LLC | 62135-434 | ORAL | 500 mg in 5 mL | 10/5/2023 | |
| Global Life Sciences Solutions USA LLC | 79403-791 | INTRAVENOUS | 0.921 g in 35 mL | 12/20/2023 | |
| ATLANTIC BIOLOGICALS CORP. | 17856-0677 | ORAL | 500 mg in 5 mL | 9/26/2018 | |
| Haemonetics Manufacturing Inc | 53157-798 | INTRAVENOUS | 10.0 g in 250 mL | 2/9/2015 |
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 |
|---|---|---|---|---|---|
| HOVA EXPECTORANT | SIN03251P | SYRUP | 57 mg/5 ml | 6/12/1989 | |
| SEMERIN COUGH SYRUP | SIN03526P | SYRUP | 150 mg/5 ml | 5/25/1989 | |
| REGIOCIT SOLUTION FOR HAEMOFILTRATION | SIN15513P | SOLUTION, STERILE | 5.29 g/l | 7/19/2018 | |
| MINICA S ENEMA | SIN03514P | ENEMA | 9% w/w | 6/15/1989 | |
| SW BENA-EXPECTORANT | SIN02911P | SYRUP | 46 mg/5 ml | 5/22/1989 | |
| SW-BENA PAEDIATRIC EXPECTORANT | SIN07609P | SYRUP | 50 mg/5 ml | 1/14/1994 | |
| Ural Effervescent Granules | SIN14374P | GRANULE, EFFERVESCENT | 0.63g | 6/26/2013 | |
| XSP-BENA EXPECTORANT | SIN03335P | SUSPENSION | 57.5 mg/5 ml | 6/16/1989 |
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| Sodium Citrate Injection for Transfusion | 国药准字H20153149 | 化学药品 | 注射剂 | 5/9/2020 | |
| Sodium Citrate Injection for Transfusion | 国药准字H37022699 | 化学药品 | 注射剂 | 5/7/2020 | |
| Sodium Citrate Injection for Transfusion | 国药准字H20013323 | 化学药品 | 注射剂 | 5/7/2020 | |
| Hemofiltration Replacement Fluid of Sodium Citrate | 国药准字H20253005 | 化学药品 | 注射剂 | 1/2/2025 | |
| Hemofiltration Replacement Fluid of Sodium Citrate | 国药准字H20253505 | 化学药品 | 注射剂 | 3/4/2025 | |
| Hemofiltration Replacement Fluid of Sodium Citrate | 国药准字HJ20210035 | 化学药品 | 注射剂 | 5/19/2021 | |
| Sodium Citrate Injection for Anticoagulant | 国药准字H20043967 | 化学药品 | 注射剂 | 9/30/2020 | |
| Sodium Citrate Injection for Anticoagulant | 国药准字H20055065 | 化学药品 | 注射剂(注射液) | 7/13/2020 | |
| Sodium Citrate Injection for Anticoagulant | 国药准字H20073118 | 化学药品 | 注射剂(注射液) | 7/13/2020 | |
| Sodium Citrate Injection for Anticoagulant | 国药准字H31020830 | 化学药品 | 注射剂 | 4/7/2024 |
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| DIPHENMIN EXPECTORANT | N/A | N/A | N/A | 4/27/1979 | |
| U-BANOL "S" EXPECTORANT | N/A | synco (h.k.) limited | N/A | N/A | 4/20/1979 |
| GUSILON COUGH LINCTUS | N/A | karen laboratories o/b karen pharmaceutical co ltd | N/A | N/A | 5/17/1982 |
| NA-DRAMINE EXPECTORANT (BROWN) | N/A | national pharmaceutical co ltd | N/A | N/A | 5/3/1979 |
| MIST EXPECT STIM | N/A | N/A | N/A | 2/25/1984 | |
| REGIOCIT SOLUTION FOR HAEMOFILTRATION | N/A | N/A | N/A | 8/11/2017 | |
| DIPHENHYDRAMINE COMPOUND LINCTUS | N/A | N/A | N/A | 4/30/1998 | |
| CORY SYRUP | N/A | neochem pharmaceutical laboratories ltd. | N/A | N/A | 4/27/1979 |
| BANOLIN EXPECTORANT | N/A | unicorn laboratories o/b american unicorn laboratories limited | N/A | N/A | 1/7/1984 |
| BENYL EXPECTORANT SYRUP | N/A | N/A | N/A | 4/14/1987 |
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| APOHEALTH Cystitis Relief oral powder sachet | 227717 | Medicine | A | 9/8/2014 | |
| Chemists' Own Cystitis Relief effervescent granules sachet | 297741 | Medicine | A | 12/19/2017 | |
| Gout Shield | 445410 | Medicine | A | 4/5/2024 | |
| URIZ URINARY ALKALINISER effervescent granules oral powder sachet | 314267 | Medicine | A | 2/15/2019 | |
| PHARMACY HEALTH CYSTITIS RELIEF powder for oral liquid sachet | 314974 | Medicine | A | 3/1/2019 | |
| URACT CRANBERRY FLAVOUR EFFERVESCENT POWDER oral sachet | 482087 | Medicine | A | 3/7/2025 | |
| AMCAL URICALM EFFERVESCENT CYSTITIS RELIEF powder for oral liquid sachet | 479007 | Medicine | A | 2/14/2025 | |
| GUARDIAN URICALM EFFERVESCENT CYSTITIS RELIEF powder for oral liquid sachet | 479008 | Medicine | A | 2/14/2025 | |
| Citrate Buffer 500 mL | 477665 | Medicine | A | 2/4/2025 | |
| AMCAL URICALM EFFERVESCENT granules oral powder sachet | 210402 | Medicine | A | 5/31/2013 |