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Calcium carbonate

Generic Name
Calcium carbonate
Brand Names
Alka-seltzer Fruit Chews, Alka-seltzer Heartburn Plus Gas Relief, Alkums, Bayer Womens, Cal Gest, Chooz, Diphen, Duo Fusion, Healthy Mama, Irospan 24/6 Kit, Magnebind 400 Rx, Meijer, Mi-acid Double Strength, Mylanta Tonight, Nutralox, Pepcid Complete, Pepto-bismol, Phazyme, Pregvit, Rolaids Advanced, Rolaids Reformulated Aug 2006, Rolaids Ultra Strength, Titralac, Titralac Plus, Tums
Drug Type
Small Molecule
Chemical Formula
CCaO3
CAS Number
471-34-1
Unique Ingredient Identifier
H0G9379FGK

Overview

Calcium carbonate is an inorganic salt used as an antacid. It is a basic compound that acts by neutralizing hydrochloric acid in gastric secretions. Subsequent increases in pH may inhibit the action of pepsin. An increase in bicarbonate ions and prostaglandins may also confer cytoprotective effects. Calcium carbonate may also be used as a nutritional supplement or to treat hypocalcemia.

Indication

For relief of heartburn and acid indigestion. May also be used as a nutritional supplement or to treat hypocalcemia.

Associated Conditions

  • Bloating
  • Calcium Deficiency
  • Calcium Metabolism Disorders
  • Calcium and Vitamin D Deficiencies
  • Colic
  • Dyspepsia
  • Gastric Ulcer
  • Gastroesophageal Reflux
  • Haemorrhoids
  • Heartburn
  • Hot Flashes
  • Hyperacidity
  • Hyperphosphataemia
  • Low Bone Density
  • Osteodystrophy
  • Osteomalacia
  • Osteoporosis
  • Post Operative Gas
  • Postmenopausal Osteoporosis
  • Proctitis
  • Reflux Acid
  • Rickets
  • Vertebral Fractures
  • Calcium loss
  • Gastrointestinal ulceration

Clinical Trials

Title
Posted
Study ID
Phase
Status
Sponsor
2025/07/09
Not Applicable
Completed
2024/10/28
Phase 4
Recruiting
China National Center for Cardiovascular Diseases
2022/09/29
Not Applicable
Completed
2022/04/06
Phase 4
Completed
2021/11/05
Phase 1
Completed
2021/06/07
Phase 1
Completed
2018/08/17
Phase 3
Completed
2018/08/02
Phase 1
Withdrawn
2018/06/08
Not Applicable
Completed
2018/02/08
Phase 4
Completed
Campus Bio-Medico University

FDA Drug Approvals

Approved Product
Manufacturer
NDC Code
Route
Strength
Effective Date
AvPAK
50268-677
ORAL
200 mg in 1 1
4/12/2022
Mollec Inc
82179-005
ORAL
500 mg in 1 1
6/23/2025
PureTek Corporation
59088-193
ORAL
200 mg in 1 1
1/11/2023
Haleon US Holdings LLC
0135-0181
ORAL
1000 mg in 1 1
5/22/2025
Haleon US Holdings LLC
0135-0180
ORAL
1000 mg in 1 1
5/22/2025
Carilion Materials Management
68151-2640
ORAL
200 mg in 1 1
4/1/2013
FSA STORE INC.
81522-361
ORAL
750 mg in 1 1
4/18/2025
BFY LLC
72427-2000
ORAL
200 mg in 7 g
5/7/2025
Carilion Materials Management
68151-4243
oral
80 mg in 1 1
4/9/2014
Novian Pharmaceuticals
83146-003
ORAL
200 mg in 1 1
10/6/2023

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
GAVISCON LIQUID
SIN09494P
SUSPENSION
160 mg/10 ml
9/13/1997
GAVISCON DOUBLE ACTION TABLETS
SIN14194P
TABLET, CHEWABLE
187.5MG
7/17/2012
RENNIE TABLET
SIN08733P
TABLET
680 mg
5/27/1996
GAVISCON LIQUID SACHETS
SIN13738P
SUSPENSION
160MG/10ML
11/23/2009
GAVISCON PEPPERMINT TABLETS
SIN13947P
TABLET, CHEWABLE
80MG
4/14/2011
GASCOVID LIQUID
SIN16041P
SUSPENSION
160 mg/10ml
11/17/2020
GAVISCON DOUBLE ACTION LIQUID, SUSPENSION
SIN14016P
SUSPENSION
325MG/10ML
9/19/2011
OHTA'S ISAN ANTACID POWDER
SIN05820P
POWDER
497 mg/1.3 g
5/3/1991

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
OHTA'S ISAN POWDER
N/A
N/A
N/A
4/13/1987
STROCAIN TAB
N/A
N/A
N/A
9/6/1988
SPAGASTROL TAB
N/A
N/A
N/A
3/5/1987

Health Canada Drug Approvals

Approved Product
Company
DIN
Dosage Form
Strength
Market Date
R90 ANTI-ACIDE TAB
dr reckeweg canada
02001004
Tablet - Oral
300 MG / TAB
12/31/1993
R35 CHADONTIN LIQ
dr reckeweg and co
00864609
Drops - Oral
30 D / D
12/31/1989
ASPIRIN PLUS STOMACH GUARD TAB
sterling winthrop inc.
02078449
Tablet - Oral
160 MG / TAB
12/31/1994
R-57 DPS
dr reckeweg canada
02090384
Drops - Oral
30 D / 10 ML
12/31/1994
CALCIUM TAB 600MG
00722332
Tablet - Oral
1.5 G
12/31/1987
GRAPHITES HOMACCORD (GRAPHITE:10D,30D,200D/100ML)(CALCIUM CARBONATE:10D,30D,200D/100ML)
01988468
Liquid - Oral
10 D / 100 ML
12/31/1992
GRAMCAL EVT 1000MG
Sandoz Canada Inc
00259497
Tablet (Effervescent) - Oral
1.75 G / EVT
12/31/1972
CALMICID
melaleuca of canada inc.
02242772
Tablet - Oral
420 MG
1/8/2001
PEPCID COMPLETE
mcneil consumer healthcare division of johnson & johnson inc
02243053
Tablet (Chewable) - Oral
800 MG
5/14/2001
TUMS ASSORTED MINT TAB
smithkline beecham consumer healthcare, division of smithkline beecham inc.
02016613
Tablet - Oral
500 MG / TAB
12/31/1993

CIMA AEMPS Drug Approvals

Approved Product
Company
Registration Number
Pharmaceutical Form
Prescription Type
Status
IDEOS UNIDIA 1000 mg/880 UI GRANULADO EFERVESCENTE
68006
GRANULADO EFERVESCENTE
Medicamento Sujeto A Prescripción Médica
Commercialized
IDEOS 500 MG/400 UI COMPRIMIDOS MASTICABLES
61159
COMPRIMIDO MASTICABLE
Medicamento Sujeto A Prescripción Médica
Commercialized
RENNIE 680 MG/80 MG COMPRIMIDOS MASTICABLES CON SACAROSA
Bayer Hispania S.L.
52873
COMPRIMIDO MASTICABLE
Sin Receta
Commercialized
GAVISCON FORTE SUSPENSION ORAL EN SOBRES
Reckitt Benckiser Healthcare S.A.
79018
SUSPENSIÓN ORAL
Sin Receta
Commercialized
MASTICAL D SABOR LIMON 500 mg/400 UI COMPRIMIDOS MASTICABLES
67800
COMPRIMIDO MASTICABLE
Medicamento Sujeto A Prescripción Médica
Commercialized
CALCIO/VITAMINA D3 SANDOZ 1000 MG/ 880 UI COMPRIMIDOS MASTICABLES
Sandoz Farmaceutica S.A.
76617
COMPRIMIDO MASTICABLE
Medicamento Sujeto A Prescripción Médica
Commercialized
CALCIO/VITAMINA D3 ROVI 1000 MG/880 UI COMPRIMIDOS MASTICABLES
81988
COMPRIMIDO MASTICABLE
Medicamento Sujeto A Prescripción Médica
Commercialized
CALODIS 1000 mg/880 UI COMPRIMIDOS EFERVESCENTES
68295
COMPRIMIDO EFERVESCENTE
Medicamento Sujeto A Prescripción Médica
Commercialized
ADIAVAL 1.000 MG/880 UI COMPRIMIDOS MASTICABLES EFG
Lacer S.A.
81862
COMPRIMIDO MASTICABLE
Medicamento Sujeto A Prescripción Médica
Commercialized
TRIDEPOS 70 MG + 500 MG/800 UI COMPRIMIDOS
Meda Pharma S.L.
81769
COMPRIMIDO
Medicamento Sujeto A Prescripción Médica
Not Commercialized

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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