MedPath

Calcium lactate

Generic Name
Calcium lactate
Drug Type
Small Molecule
Chemical Formula
C6H10CaO6
CAS Number
814-80-2
Unique Ingredient Identifier
2URQ2N32W3

Overview

Calcium lactate is a salt that consists of two lactate anions for each calcium cation (Ca2+). It is prepared commercially by the neutralization of lactic acid with calcium carbonate or calcium hydroxide. Approved by the FDA as a direct food substance affirmed as generally recognized as safe, calcium lactate is used as a firming agent, flavoring agent, leavening agent, stabilizer, and thickener . Calcium lactate is also found in daily dietary supplements as a source of calcium. It is also available in various hydrate forms, where calcium lactate pentahydrate is the most common.

Background

Calcium lactate is a salt that consists of two lactate anions for each calcium cation (Ca2+). It is prepared commercially by the neutralization of lactic acid with calcium carbonate or calcium hydroxide. Approved by the FDA as a direct food substance affirmed as generally recognized as safe, calcium lactate is used as a firming agent, flavoring agent, leavening agent, stabilizer, and thickener . Calcium lactate is also found in daily dietary supplements as a source of calcium. It is also available in various hydrate forms, where calcium lactate pentahydrate is the most common.

Indication

Indicated for use as the nutritional supplement.

Associated Conditions

  • Calcium Deficiency

Clinical Trials

Title
Posted
Study ID
Phase
Status
Sponsor

No clinical trials found

No clinical trials found for this drug

FDA Approved Products

Product Name
Manufacturer
Route
Strength
Approved
NDC Code
DENTAL
0.02 mg in 20 mg
2025/04/21
82711-106

EMA Approved Products

Medicine Name
EMA Number
Auth. Holder
Country
Drug Type
Status
Issued
Opinion
Revision

No EMA products found

No EMA products found for this drug

HSA Approved Products

Product Name
Manufacturer
Dosage Form
Strength
Approved
Approval No.

No HSA products found

No HSA products found for this drug

NMPA Approved Products

Product Name
Approval No.
Manufacturer
Dosage Form
Trade Name
Strength
Type
Status
Date
Import
国药准字H64020201
片剂
N/A
0.5g
Chemical Drug
Approved
2014/12/22
Domestic
国药准字H22021533
片剂
N/A
0.5g
Chemical Drug
Approved
2020/10/21
Domestic
国药准字H41023923
片剂
N/A
0.5克
Chemical Drug
Approved
2015/07/17
Domestic
国药准字H63020063
片剂
N/A
0.5g
Chemical Drug
Approved
2020/05/25
Domestic
国药准字H53021130
片剂
N/A
0.5g
Chemical Drug
Approved
2020/07/06
Domestic
国药准字H44025209
片剂
N/A
0.5g
Chemical Drug
Approved
2020/04/10
Domestic
国药准字H62020573
片剂
N/A
0.25g
Chemical Drug
Approved
2020/07/17
Domestic
国药准字H53021131
片剂
N/A
0.25g
Chemical Drug
Approved
2020/07/06
Domestic
国药准字H23021329
片剂(素片)
N/A
0.5g
Chemical Drug
Approved
2020/06/22
Domestic
国药准字H44023236
片剂
N/A
0.5g
Chemical Drug
Approved
2020/09/29
Domestic

PPB Approved Products

Product Name
Registration Code
Company
Category
Sale Type
Reg. Date

No PPB products found

No PPB products found for this drug

TGA Approved Products

Product Name
ARTG ID
Sponsor
Status
Reg. Date
Ingredient
396040
Active
2022/09/16
calcium lactate pentahydrate
326728
Active
2019/11/26
calcium lactate
484905
Active
2025/04/01
calcium lactate pentahydrate
79737
Z & C Krpan
Active
2001/08/02
calcium lactate pentahydrate
100428
Active
2004/03/29
calcium lactate pentahydrate
347551
Active
2020/11/06
calcium lactate pentahydrate
439030
Active
2024/01/31
calcium lactate
147146
Active
2007/11/09
calcium lactate pentahydrate
484906
Active
2025/04/01
calcium lactate pentahydrate
428870
Active
2023/11/28
calcium lactate pentahydrate
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