FDA.reportPublic FDA data

calcium carbonate 497 MG / sodium bicarbonate 600 MG Oral Powder

RxCUI
1361708
RxNorm name
calcium carbonate 497 MG / sodium bicarbonate 600 MG Oral Powder
Term type
SCD
Status
Active
Updated
2026-10-29 06:02:59

RxNorm Status History#

Status
Active
Source
RXNORM
Current
YES
Release start
012013
Active start
012013
Multiple ingredient
YES
Branded
NO

Ingredients And Strength#

Ingredient, Strength, Base table
IngredientStrengthBaseBasis of strength
calcium carbonate497 MG / 1 EACHcalcium carbonatecalcium carbonate
sodium bicarbonate600 MG / 1 EACHsodium bicarbonatesodium bicarbonate

Dose Form Concepts#

Dose form, RxCUI table
Dose formRxCUI
Oral Powder346289

Derived Ingredient Concepts#

Ingredient, RxCUI table
IngredientRxCUI
calcium carbonate1897
sodium bicarbonate36676

Source Vocabulary Codes#

Code type, Values, Count table
Code typeValuesCountCategory
RXNAV_STRcalcium carbonate 497 MG / sodium bicarbonate 600 MG Oral Powder1NAMES
RxNorm Namecalcium carbonate 497 MG / sodium bicarbonate 600 MG Oral Powder1NAMES
RxNorm SynonymCalcium Carbonate 497 MG / NaHCO3 600 MG Oral Powder1NAMES
TTYSCD1ATTRIBUTES
SPL_SET_ID
2 linked values
2CODES
RxCUI13617081CODES

FDA NDC Products And Packages#

Package NDC, Product NDC, Name table
Package NDCProduct NDCNameLabelerApplication
49631-178-1349631-178OHTAS ISAN ANTACID calcium carbonate, sodium bicarbonateOHTA'S ISAN CO.,LTD.M001
49631-178-2149631-178OHTAS ISAN ANTACID calcium carbonate, sodium bicarbonateOHTA'S ISAN CO.,LTD.M001
49631-178-2249631-178OHTAS ISAN ANTACID calcium carbonate, sodium bicarbonateOHTA'S ISAN CO.,LTD.M001

Drugs@FDA Applications#

Application, NDC, Name table
ApplicationNDCNameMarketing categoryLabeler
M00149631-178OHTAS ISAN ANTACID calcium carbonate, sodium bicarbonateOTC MONOGRAPH DRUGOHTA'S ISAN CO.,LTD.

RxNav Current And Historical NDCs#

RxNav current and historical NDC rows page 1 of 1 · 5 matching rows.

NDC11, Source, Active table
NDC11SourceActive
49631017813rxnav_ndcsyes
49631017821rxnav_ndcsyes
49631017822rxnav_ndcsyes
49631017811rxnav_historical
49631017812rxnav_historical

UNII Substances#

UNII substance links page 1 of 1 · 0 matching rows.

No records found.

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
OHTAS ISAN ANTACIDCALCIUM CARBONATE, SODIUM BICARBONATEOHTA'S ISAN CO.,LTD.53380470-5748-6fa7-548e-7484ef204c0f2024-10-21WarningsExact identifier
ndc (package): 49631-178-22
ndc (package): 49631-178-21
ndc (product): 49631-178
ndc11 (package): 49631017822
ndc11 (package): 49631017821
rxcui: 1361708
OHTAS ISAN ANTACIDCALCIUM CARBONATE, SODIUM BICARBONATEOHTA'S ISAN CO.,LTD.8723fe90-8402-4511-b6c6-b71cf98513e32024-10-21WarningsExact identifier
ndc (package): 49631-178-13
ndc (product): 49631-178
ndc11 (package): 49631017813
rxcui: 1361708

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

DailyMed RxNorm Mappings#

unique DailyMed labels mapped to this RxNorm concept page 1 of 1 · 2 matching rows.

Set ID, RxNorm mappings, Terms table
Set IDRxNorm mappingsTermsSPL versionLabelEffective
53380470-5748-6fa7-548e-7484ef204c0fcalcium carbonate 497 MG / sodium bicarbonate 600 MG Oral Powder [PSN] · calcium carbonate 497 MG / sodium bicarbonate 600 MG Oral Powder [SCD] · Calcium Carbonate 497 MG / NaHCO3 600 MG Oral Powder [SY]3620241021
8723fe90-8402-4511-b6c6-b71cf98513e3calcium carbonate 497 MG / sodium bicarbonate 600 MG Oral Powder [PSN] · calcium carbonate 497 MG / sodium bicarbonate 600 MG Oral Powder [SCD] · Calcium Carbonate 497 MG / NaHCO3 600 MG Oral Powder [SY]3420241021

Recently Linked DailyMed Labels#

Set ID, Title, Manufacturer table
Set IDTitleManufacturerEffective
53380470-5748-6fa7-548e-7484ef204c0fOHTA'S ISAN CO.,LTD.20241021
8723fe90-8402-4511-b6c6-b71cf98513e3OHTA'S ISAN CO.,LTD.20241021

Drug Classes#

Source, Class ID, Class table
SourceClass IDClassTypeRelationshipDrug concept
ATCA12AACalciumATC1-4calcium carbonate
ATCA02ACCalcium compoundsATC1-4calcium carbonate
ATCB05XAElectrolyte solutionsATC1-4sodium bicarbonate
ATCB05CBSalt solutionsATC1-4sodium bicarbonate
MEDRTD002119Calcium CarbonateCHEMhas_ingredientcalcium carbonate
MEDRTD017693Sodium BicarbonateCHEMhas_ingredientsodium bicarbonate
MEDRTD000141Acidosis, Renal TubularDISEASEmay_treatsodium bicarbonate
MEDRTD000471AlkalosisDISEASEci_withsodium bicarbonate
MEDRTD004342Drug HypersensitivityDISEASEci_withcalcium carbonate
MEDRTD004342Drug HypersensitivityDISEASEci_withsodium bicarbonate
MEDRTD062787Drug OverdoseDISEASEmay_treatsodium bicarbonate
MEDRTD064420Drug-Related Side Effects and Adverse ReactionsDISEASEmay_preventsodium bicarbonate
MEDRTD004381Duodenal UlcerDISEASEmay_treatcalcium carbonate
MEDRTD004415DyspepsiaDISEASEmay_treatcalcium carbonate
MEDRTD004415DyspepsiaDISEASEmay_treatsodium bicarbonate
MEDRTD004487EdemaDISEASEci_withsodium bicarbonate
MEDRTD004942Esophagitis, PepticDISEASEmay_treatcalcium carbonate
MEDRTD005764Gastroesophageal RefluxDISEASEmay_treatcalcium carbonate
MEDRTD005764Gastroesophageal RefluxDISEASEmay_treatsodium bicarbonate
MEDRTD006471Gastrointestinal HemorrhageDISEASEmay_preventcalcium carbonate
MEDRTD006471Gastrointestinal HemorrhageDISEASEmay_treatcalcium carbonate
MEDRTD006323Heart ArrestDISEASEmay_treatsodium bicarbonate
MEDRTD006356HeartburnDISEASEmay_treatsodium bicarbonate
MEDRTD006356HeartburnDISEASEmay_treatcalcium carbonate
MEDRTD006934HypercalcemiaDISEASEci_withcalcium carbonate
MEDRTD006947HyperkalemiaDISEASEmay_treatsodium bicarbonate
MEDRTD006955HypernatremiaDISEASEci_withsodium bicarbonate
MEDRTD006996HypocalcemiaDISEASEci_withsodium bicarbonate
MEDRTD006996HypocalcemiaDISEASEmay_treatcalcium carbonate
MEDRTD017674HypophosphatemiaDISEASEci_withcalcium carbonate
MEDRTD007669Kidney CalculiDISEASEci_withcalcium carbonate
MEDRTD007676Kidney Failure, ChronicDISEASEmay_treatcalcium carbonate
MEDRTD010024OsteoporosisDISEASEmay_preventcalcium carbonate
MEDRTD015663Osteoporosis, PostmenopausalDISEASEmay_treatcalcium carbonate
MEDRTD011654Pulmonary EdemaDISEASEci_withsodium bicarbonate
MEDRTD013276Stomach UlcerDISEASEmay_treatcalcium carbonate
MEDRTN0000000226Acid-Base ActivityMOAhas_moasodium bicarbonate
MEDRTN0000000226Acid-Base ActivityMOAhas_moacalcium carbonate
MEDRTN0000000220Electrolyte ActivityMOAhas_moacalcium carbonate
MEDRTN0000000220Electrolyte ActivityMOAhas_moasodium bicarbonate
MEDRTN0000008312Bone Resorption AlterationPEhas_pecalcium carbonate
MEDRTN0000009054Gastric Acid AlterationPEhas_pesodium bicarbonate
MEDRTN0000009054Gastric Acid AlterationPEhas_pecalcium carbonate
MEDRTN0000009549Increased Renal HCO3- ExcretionPEhas_pesodium bicarbonate
MEDRTN0000009557Increased Renal PO4-- ExcretionPEhas_pecalcium carbonate

Properties#

Category, Property, Value table
CategoryPropertyValue
ATTRIBUTESAVAILABLE_STRENGTH497 MG / 600 MG
ATTRIBUTESGENERAL_CARDINALITYMULTI
ATTRIBUTESHUMAN_DRUGUS
ATTRIBUTESRXNAV_HUMAN_DRUGUS
NAMESPrescribable Synonymcalcium carbonate 497 MG / sodium bicarbonate 600 MG Oral Powder
SOURCESSourceMetathesaurus FDA Structured Product Labels