FDA.reportPublic FDA data

50 ML calcium gluconate 100 MG/ML Injection

RxCUI
1668248
RxNorm name
50 ML calcium gluconate 100 MG/ML Injection
Display name
Calcium gluconate (Injectable)
Full name
50 ML calcium gluconate 100 MG/ML Injection
Term type
SCD
Status
Active
Strength
100 mg/ml
Dose form
Injection 50 ml
Route
Injectable
Updated
2026-10-30 15:31:12

RxNorm Status History#

Status
Active
Source
RXNORM
Current
YES
Release start
112015
Active start
112015
Multiple ingredient
NO
Branded
NO

Ingredients And Strength#

Ingredient, Strength, Base table
IngredientStrengthBaseBasis of strength
calcium gluconate100 MG / 1 MLcalcium gluconatecalcium gluconate

Dose Form Concepts#

Dose form, RxCUI table
Dose formRxCUI
Injection1649574

Derived Ingredient Concepts#

Ingredient, RxCUI table
IngredientRxCUI
calcium gluconate1908

Source Vocabulary Codes#

Code type, Values, Count table
Code typeValuesCountCategory
PRESCRIBABLEY1ATTRIBUTES
RXNAV_STR50 ML calcium gluconate 100 MG/ML Injection1NAMES
RxNorm Name50 ML calcium gluconate 100 MG/ML Injection1NAMES
RxNorm Synonymcalcium gluconate 10 % per 50 ML Injection1NAMES
TTYSCD1ATTRIBUTES
SPL_SET_ID
8 linked values
8CODES
RxCUI16682481CODES
MMSL_CODEMTH_RXN_BD35561CODES

FDA NDC Products And Packages#

Package NDC, Product NDC, Name table
Package NDCProduct NDCNameLabelerApplication
0143-9184-250143-9184calcium gluconate calcium gluconateHikma Pharmaceuticals USA Inc.ANDA213071
51662-1347-151662-1347CALCIUM GLUCONATE CALCIUM GLUCONATEHF Acquisition Co LLC, DBA HealthFirstNDA208418
63323-360-5963323-360Calcium Gluconate Calcium GluconateFresenius Kabi USA, LLCNDA208418
65145-171-2565145-171Calcium Gluconate Calcium GluconateCaplin Steriles LimitedANDA218840
68462-790-2568462-790Calcium Gluconate Calcium GluconateGLENMARK PHARMACEUTICALS INC., USAANDA218840
70069-727-1070069-727CALCIUM GLUCONATE CALCIUM GLUCONATESomerset Therapeutics, LLCANDA217689
70069-727-2570069-727CALCIUM GLUCONATE CALCIUM GLUCONATESomerset Therapeutics, LLCANDA217689
80830-1673-280830-1673calcium gluconate calcium gluconateAmneal Pharmaceuticals Private LimitedANDA216611
80830-1673-480830-1673calcium gluconate calcium gluconateAmneal Pharmaceuticals Private LimitedANDA216611
80830-1673-580830-1673calcium gluconate calcium gluconateAmneal Pharmaceuticals Private LimitedANDA216611

Drugs@FDA Applications#

Application, NDC, Name table
ApplicationNDCNameMarketing categoryLabeler
ANDA2130710143-9184calcium gluconate calcium gluconateANDAHikma Pharmaceuticals USA Inc.
NDA20841851662-1347CALCIUM GLUCONATE CALCIUM GLUCONATENDAHF Acquisition Co LLC, DBA HealthFirst
ANDA21884065145-171Calcium Gluconate Calcium GluconateANDACaplin Steriles Limited
ANDA21768970069-727CALCIUM GLUCONATE CALCIUM GLUCONATEANDASomerset Therapeutics, LLC
ANDA21661180830-1673calcium gluconate calcium gluconateANDAAmneal Pharmaceuticals Private Limited

RxNav Current And Historical NDCs#

RxNav current and historical NDC rows page 1 of 1 · 23 matching rows.

NDC11, Source, Active table
NDC11SourceActive
00143918401rxnav_ndcsyes
00143918425rxnav_ndcsyes
51662134701rxnav_ndcsyes
63323036003rxnav_ndcsyes
63323036059rxnav_ndcsyes
65145017101rxnav_ndcsyes
65145017125rxnav_ndcsyes
68462079025rxnav_ndcsyes
68462079050rxnav_ndcsyes
70069072701rxnav_ndcsyes
70069072710rxnav_ndcsyes
70069072725rxnav_ndcsyes
80830167301rxnav_ndcsyes
80830167302rxnav_ndcsyes
80830167304rxnav_ndcsyes
80830167305rxnav_ndcsyes
00517395025rxnav_historical
52584031150rxnav_historical
52584031159rxnav_historical
52584036003rxnav_historical
52584095025rxnav_historical
63323031150rxnav_historical
63323031159rxnav_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 · 8 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
calcium gluconateCALCIUM GLUCONATEAmneal Pharmaceuticals Private Limited787603c6-3f50-473a-8e3b-71dcf6d869642026-06-23Warnings, Adverse reactionsExact identifier
ndc (package): 80830-1673-4
ndc (product): 80830-1673
ndc11 (package): 80830167304
rxcui: 1668248
Calcium GluconateCALCIUM GLUCONATEGLENMARK PHARMACEUTICALS INC., USAb2470072-f443-4596-ae33-1b8b0d05bc9d2026-06-11Warnings, Adverse reactionsExact identifier
ndc (package): 68462-790-25
ndc (product): 68462-790
ndc11 (package): 68462079050
ndc11 (package): 68462079025
rxcui: 1668248
Calcium GluconateCALCIUM GLUCONATEFresenius Kabi USA, LLC8b77c3d2-992d-4261-8421-9cfd07328fbf2026-05-18Warnings, Adverse reactionsExact identifier
ndc (package): 63323-360-59
ndc (product): 63323-360
ndc11 (package): 63323036059
ndc11 (package): 63323036003
rxcui: 1668248
Calcium GluconateCALCIUM GLUCONATECaplin Steriles Limitedf28e9871-d546-4b48-ac3d-aead0d4c04492026-05-13Warnings, Adverse reactionsExact identifier
ndc (package): 65145-171-25
ndc (product): 65145-171
ndc11 (package): 65145017125
ndc11 (package): 65145017101
rxcui: 1668248
calcium gluconateCALCIUM GLUCONATEAmneal Pharmaceuticals Private Limited13d7cfc9-ff7a-437e-8c21-d9709ac07d482026-05-12Warnings, Adverse reactionsExact identifier
ndc (package): 80830-1673-5
ndc (package): 80830-1673-2
ndc (product): 80830-1673
ndc11 (package): 80830167302
ndc11 (package): 80830167305
ndc11 (package): 80830167301
rxcui: 1668248
CALCIUM GLUCONATECALCIUM GLUCONATESomerset Therapeutics, LLCfb40eba7-04e5-40dc-8a95-5f45e7bd70bc2025-02-06Warnings, Adverse reactionsExact identifier
ndc (package): 70069-727-10
ndc (package): 70069-727-25
ndc (product): 70069-727
ndc11 (package): 70069072725
ndc11 (package): 70069072710
ndc11 (package): 70069072701
rxcui: 1668248
calcium gluconateCALCIUM GLUCONATEHikma Pharmaceuticals USA Inc.ce7becd8-cf59-4470-aac8-82761a24ebd72023-09-01Warnings, Adverse reactionsExact identifier
ndc (package): 0143-9184-25
ndc (product): 0143-9184
ndc11 (package): 00143918401
ndc11 (package): 00143918425
rxcui: 1668248
CALCIUM GLUCONATECALCIUM GLUCONATEHF Acquisition Co LLC, DBA HealthFirst7d93251a-b555-0be0-e053-2991aa0ad7642022-12-10Warnings, Adverse reactionsExact identifier
ndc (package): 51662-1347-1
ndc (product): 51662-1347
ndc11 (package): 51662134701
rxcui: 1668248

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 · 4 matching rows.

Set ID, RxNorm mappings, Terms table
Set IDRxNorm mappingsTermsSPL versionLabelEffective
fb40eba7-04e5-40dc-8a95-5f45e7bd70bccalcium gluconate 5 GM in 50 ML (10 % ) Injection [PSN] · 50 ML calcium gluconate 100 MG/ML Injection [SCD] · calcium gluconate 10 % per 50 ML Injection [SY]36These highlights do not include all the information needed to use CALCIUM GLUCONATE INJECTION safely and effectively. See full prescribing information for CALCIUM GLUCONATE INJECTION Initial U.S. Approval: 194120250206
7d93251a-b555-0be0-e053-2991aa0ad764calcium gluconate 5 GM in 50 ML (10 % ) Injection [PSN] · 50 ML calcium gluconate 100 MG/ML Injection [SCD] · calcium gluconate 10 % per 50 ML Injection [SY]34CALCIUM GLUCONATE INJECTION, USP 5,000mg PER 50mL (100mg/mL) 50mL VIAL20221210
f28e9871-d546-4b48-ac3d-aead0d4c0449calcium gluconate 5 GM in 50 ML (10 % ) Injection [PSN] · 50 ML calcium gluconate 100 MG/ML Injection [SCD] · calcium gluconate 10 % per 50 ML Injection [SY]31These highlights do not include all the information needed to use CALCIUM GLUCONATE INJECTION safely and effectively. See full prescribing information for CALCIUM GLUCONATE INJECTION CALCIUM GLUCONATE injection, for intravenous use Initial U.S. Approval: 194120260513
ce7becd8-cf59-4470-aac8-82761a24ebd7calcium gluconate 5 GM in 50 ML (10 % ) Injection [PSN] · 50 ML calcium gluconate 100 MG/ML Injection [SCD] · calcium gluconate 10 % per 50 ML Injection [SY]31These highlights do not include all the information needed to use CALCIUM GLUCONATE INJECTION safely and effectively. See full prescribing information for CALCIUM GLUCONATE INJECTION. CALCIUM GLUCONATE injection, for intravenous use Initial U.S. Approval: 194120230901

Recently Linked DailyMed Labels#

Set ID, Title, Manufacturer table
Set IDTitleManufacturerEffective
787603c6-3f50-473a-8e3b-71dcf6d86964These highlights do not include all the information needed to use CALCIUM GLUCONATE INJECTION safely and effectively. See full prescribing information for CALCIUM GLUCONATE INJECTION . CALCIUM GLUCONATE injection, for intravenous use Initial U.S. Approval: 1941Amneal Pharmaceuticals Private Limited20260623
b2470072-f443-4596-ae33-1b8b0d05bc9dThese highlights do not include all the information needed to use CALCIUM GLUCONATE INJECTION safely and effectively. See full prescribing information for CALCIUM GLUCONATE INJECTION CALCIUM GLUCONATE injection, for intravenous use Initial U.S. Approval: 1941GLENMARK PHARMACEUTICALS INC., USA | Caplin Steriles Limited20260611
8b77c3d2-992d-4261-8421-9cfd07328fbfThese highlights do not include all the information needed to use CALCIUM GLUCONATE INJECTION safely and effectively. See full prescribing information for CALCIUM GLUCONATE INJECTION. CALCIUM GLUCONATE injection, for intravenous use Initial U.S. Approval: 1941Fresenius Kabi USA, LLC20260518
f28e9871-d546-4b48-ac3d-aead0d4c0449These highlights do not include all the information needed to use CALCIUM GLUCONATE INJECTION safely and effectively. See full prescribing information for CALCIUM GLUCONATE INJECTION CALCIUM GLUCONATE injection, for intravenous use Initial U.S. Approval: 1941Caplin Steriles Limited20260513
13d7cfc9-ff7a-437e-8c21-d9709ac07d48These highlights do not include all the information needed to use CALCIUM GLUCONATE INJECTION safely and effectively. See full prescribing information for CALCIUM GLUCONATE INJECTION . CALCIUM GLUCONATE injection, for intravenous use Initial U.S. Approval: 1941Amneal Pharmaceuticals Private Limited | Amneal Pharmaceuticals of New York, LLC20260512
fb40eba7-04e5-40dc-8a95-5f45e7bd70bcThese highlights do not include all the information needed to use CALCIUM GLUCONATE INJECTION safely and effectively. See full prescribing information for CALCIUM GLUCONATE INJECTION Initial U.S. Approval: 1941Somerset Therapeutics, LLC | Maiva Pharma Private Limited20250206
13d7cfc9-ff7a-437e-8c21-d9709ac07d48These highlights do not include all the information needed to use CALCIUM GLUCONATE INJECTION safely and effectively. See full prescribing information for CALCIUM GLUCONATE INJECTION . CALCIUM GLUCONATE injection, for intravenous use Initial U.S. Approval: 1941Amneal Pharmaceuticals Private Limited | Amneal Pharmaceuticals of New York, LLC20231211
ce7becd8-cf59-4470-aac8-82761a24ebd7These highlights do not include all the information needed to use CALCIUM GLUCONATE INJECTION safely and effectively. See full prescribing information for CALCIUM GLUCONATE INJECTION. CALCIUM GLUCONATE injection, for intravenous use Initial U.S. Approval: 1941Hikma Pharmaceuticals USA Inc. | Nivagen Pharmaceuticals, Inc.20230901
8b77c3d2-992d-4261-8421-9cfd07328fbfThese highlights do not include all the information needed to use CALCIUM GLUCONATE INJECTION safely and effectively. See full prescribing information for CALCIUM GLUCONATE INJECTION. CALCIUM GLUCONATE injection, for intravenous use Initial U.S. Approval: 1941Fresenius Kabi USA, LLC20230628
22a5b168-acc0-43ea-a2b2-f3a1d220ac06Calcium Gluconate These highlights do not include all the information needed to use CALCIUM GLUCONATE INJECTION safely and effectively. See full prescribing information for CALCIUM GLUCONATE INJECTION.CALCIUM GLUCONATE injection, for intravenous use Initial U.S. Approval: 1941General Injectables and Vaccines, Inc.20221213
7d93251a-b555-0be0-e053-2991aa0ad764CALCIUM GLUCONATE INJECTION, USP 5,000mg PER 50mL (100mg/mL) 50mL VIALHF Acquisition Co LLC, DBA HealthFirst20221210
ab2e6c9e-974d-4990-88c6-9a7b45dd7509National Council for Prescription Drug Programs20120724
e1e31d78-5bf4-4694-9776-146e11f91165National Council for Prescription Drug Programs20120724
6843315b-d983-49fb-9b35-bda4718c0464CALCIUM GLUCONATE INJECTION, USP 10%American Regent, Inc.20110929

Drug Classes#

Source, Class ID, Class table
SourceClass IDClassTypeRelationshipDrug concept
ATCA12AACalciumATC1-4calcium gluconate
ATCB05XAElectrolyte solutionsATC1-4calcium gluconate
ATCD11AXOther dermatologicalsATC1-4calcium gluconate
MEDRTD002125Calcium GluconateCHEMhas_ingredientcalcium gluconate
MEDRTD004342Drug HypersensitivityDISEASEci_withcalcium gluconate
MEDRTD064420Drug-Related Side Effects and Adverse ReactionsDISEASEci_withcalcium gluconate
MEDRTD006323Heart ArrestDISEASEmay_treatcalcium gluconate
MEDRTD006934HypercalcemiaDISEASEci_withcalcium gluconate
MEDRTD006947HyperkalemiaDISEASEmay_treatcalcium gluconate
MEDRTD006996HypocalcemiaDISEASEmay_treatcalcium gluconate
MEDRTD007669Kidney CalculiDISEASEci_withcalcium gluconate
MEDRTD010024OsteoporosisDISEASEmay_preventcalcium gluconate
MEDRTD015663Osteoporosis, PostmenopausalDISEASEmay_treatcalcium gluconate
MEDRTD001098Spider BitesDISEASEmay_treatcalcium gluconate
MEDRTD013746TetanyDISEASEmay_treatcalcium gluconate
MEDRTD014693Ventricular FibrillationDISEASEci_withcalcium gluconate
MEDRTN0000008312Bone Resorption AlterationPEhas_pecalcium gluconate

Properties#

Category, Property, Value table
CategoryPropertyValue
ATTRIBUTESAVAILABLE_STRENGTH100 MG/ML
ATTRIBUTESGENERAL_CARDINALITYSINGLE
ATTRIBUTESHUMAN_DRUGUS
ATTRIBUTESQUANTITY50 ML
ATTRIBUTESRXNAV_HUMAN_DRUGUS
ATTRIBUTESSCHEDULE0
CODESANDAANDA213071
CODESANDAANDA216611
CODESANDAANDA217689
CODESANDAANDA218840
CODESNDANDA208418
CODESVUID4003490
NAMESPrescribable Synonymcalcium gluconate 5 GM in 50 ML (10 % ) Injection
SOURCESSourceGold Standard Alchemy
SOURCESSourceMetathesaurus FDA Structured Product Labels
SOURCESSourceMicromedex RED BOOK
SOURCESSourceMultum MediSource Lexicon
SOURCESSourceNational Drug Data File Plus Source Vocabulary
SOURCESSourceVeterans Health Administration National Drug File