FDA.reportPublic FDA data

NDC 63323-360-01 - Calcium Gluconate

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC
63323-360
Requested NDC
63323-360-01
Package NDCs from labels
63323-360-01, 63323-360-19, 63323-360-03, 63323-360-59, 63323-360-05, 63323-360-61
Manufacturer
Fresenius Kabi USA, LLC
Effective date
2026-05-18
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Calcium Gluconate - Fresenius Kabi USA, LLCFresenius Kabi USA, LLC2026-05-18HUMAN PRESCRIPTION DRUG LABEL
Calcium Gluconate - Henry Schein, Inc.Henry Schein, Inc.2025-11-03HUMAN PRESCRIPTION DRUG LABEL
Calcium Gluconate - REMEDYREPACK INC.REMEDYREPACK INC.2025-09-29HUMAN PRESCRIPTION DRUG LABEL
Calcium Gluconate - ProPharma DistributionProPharma Distribution2025-07-18HUMAN PRESCRIPTION DRUG LABEL
CALCIUM GLUCONATE - HF Acquisition Co LLC, DBA HealthFirstHF Acquisition Co LLC, DBA HealthFirst2024-02-01HUMAN PRESCRIPTION DRUG LABEL
Calcium Gluconate - Medical Purchasing Solutions, LLCMedical Purchasing Solutions, LLC2023-05-04HUMAN PRESCRIPTION DRUG LABEL
Calcium Gluconate - General Injectables and Vaccines, Inc.General Injectables and Vaccines, Inc.2022-12-13HUMAN PRESCRIPTION DRUG LABEL
CALCIUM GLUCONATE - HF Acquisition Co LLC, DBA HealthFirstHF Acquisition Co LLC, DBA HealthFirst2022-12-10HUMAN PRESCRIPTION DRUG LABEL
Calcium Gluconate - A-S Medication SolutionsA-S Medication Solutions2018-10-09Human Prescription Drug Label

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63323-360-01Calcium Gluconate10 mL in 1 VIAL, PLASTICINJECTION, SOLUTION106
63323-360-03Calcium Gluconate50 mL in 1 VIAL, PLASTICINJECTION, SOLUTION506
63323-360-05Calcium Gluconate100 mL in 1 VIAL, PLASTICINJECTION, SOLUTION1006
63323-360-19Calcium Gluconate25 in 1 TRAYINJECTION, SOLUTION256
63323-360-59Calcium Gluconate25 in 1 TRAYINJECTION, SOLUTION256
63323-360-61Calcium Gluconate20 in 1 TRAYINJECTION, SOLUTION206

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63323-360CALCIUM GLUCONATE (CALCIUM GLUCONATE) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC ]6Current NDC, Legacy NDC, 6 package rows20230808_8b77c3d2-992d-4261-8421-9cfd07328fbf.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63323-360-01ML - Milliliter63323-3601d434d18-2915-46fe-a4fd-26c3adca017612017-10-13
63323-360-03ML - Milliliter63323-3605cc8d670-ba3a-4eec-b5dc-bec4a770a71c12017-10-13
63323-360-05ML - Milliliter63323-360353fb39c-9d1e-4a17-b179-6ab94782731912017-10-13
63323-360-19ML - Milliliter63323-360faa54ab9-88fe-45ad-998c-b85cd78b698612017-10-13
63323-360-59ML - Milliliter63323-360fa4b02da-a263-415b-aa3c-c0eb1618003d12017-10-13
63323-360-61ML - Milliliter63323-360322c87e1-c87a-4ced-b4cf-499d1c46841b12017-10-13

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 2 of 11 · 215 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
BM BM182 DROPSHEPAR SULF, GRAPHITES, MERC SOL, MURIATIC ACIDBM Private Limited540d11e3-e4a1-0ca2-e063-6394a90a3c262026-06-12WarningsExact identifier
unii: QTT17582CB
BM BM70 DROPSANTIM CURD, FERR MET, PHOSPHORUS, SULPHUR, WIESBADEN, THUJA, VERATRUM ALBTotal Operations Management LLC DBA:Bestmade Natural Products Micro54113d1f-e8e7-6b4c-e063-6394a90a0edf2026-06-12WarningsExact identifier
unii: 059QF0KO0R
BM BM70 DROPSANTIM CURD, FERR MET, PHOSPHORUS, SULPHUR, WIESBADEN, THUJA, VERATRUM ALBBM Private Limited53fa21d9-1f80-2e69-e063-6394a90ab9f32026-06-11WarningsExact identifier
unii: 059QF0KO0R
Calcium GluconateCALCIUM GLUCONATEGLENMARK PHARMACEUTICALS INC., USAb2470072-f443-4596-ae33-1b8b0d05bc9d2026-06-11Warnings, Adverse reactionsExact identifier
rxcui: 197435
rxcui: 1668248
rxcui: 1668250
unii: CZN0MI5R31
XIMONTH Fungi Free Bee Venom Nail Soothing SerumGLYCERINShantou Ximonth Biotechnology Co., Ltd.53bab969-8407-6334-e063-6294a90aa5d12026-06-08WarningsExact identifier
unii: 059QF0KO0R
Bacteriostatic WaterBACTERIOSTATIC WATERHospira, Inc.87d6e9dc-fe3b-4593-ac9a-d7493d1959c72026-05-22Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
WHITENING SUNSCREENANTI WRINKLEWHITENING SUNSCREENANTI WRINKLEShantou Oushiya Biotechnology Co.,Ltd524384e9-b3f8-4c13-e063-6394a90a89732026-05-20WarningsExact identifier
unii: 059QF0KO0R
Muriaticum acidumHYDROCHLORIC ACIDBoiron8643bc58-bb0e-5c79-e053-2991aa0a02ae2026-05-19WarningsExact identifier
unii: QTT17582CB
Calcium GluconateCALCIUM GLUCONATEFresenius Kabi USA, LLC8b77c3d2-992d-4261-8421-9cfd07328fbf2026-05-18Warnings, Adverse reactionsExact identifier
application number: NDA208418
ndc (package): 63323-360-19
ndc (package): 63323-360-01
ndc (package): 63323-360-59
ndc (package): 63323-360-61
ndc (package): 63323-360-05
ndc (package): 63323-360-03
ndc (product): 63323-360
ndc11 (package): 63323036001
rxcui: 197435
rxcui: 1668248
rxcui: 1668250
spl id: 661fc3fe-30e4-4d3e-a7a0-7405bfabe79f
spl set id: 8b77c3d2-992d-4261-8421-9cfd07328fbf
unii: CZN0MI5R31
Calcium GluconateCALCIUM GLUCONATECaplin Steriles Limitedf28e9871-d546-4b48-ac3d-aead0d4c04492026-05-13Warnings, Adverse reactionsExact identifier
rxcui: 197435
rxcui: 1668248
rxcui: 1668250
unii: CZN0MI5R31
calcium gluconateCALCIUM GLUCONATEAmneal Pharmaceuticals Private Limited13d7cfc9-ff7a-437e-8c21-d9709ac07d482026-05-12Warnings, Adverse reactionsExact identifier
rxcui: 197435
rxcui: 1668248
rxcui: 1668250
unii: CZN0MI5R31
Sterile WaterWATERHospira, Inc.3a6422e1-feee-4095-8883-2b0837039e6e2026-05-07Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Multi FlowerAESCULUS CARNEA, FLOS, AESCULUS HIPPOCASTANUM, FLOS, AGRIMONIA EUPATORIA, FLOS, BROMUS RAMOSUS, FLOS, CALLUNA VULGARIS, FLOS, CARPINUS BETULUS , FLOS, CASTANEA SATIVA, FLOS, CENTAURIUM UMBELLATUM, FLOS, CERATOSTIGMA WILLMOTTIANUM, FLOS, CICHORIUM INTYBUS, FLOS, CLEMATIS VITALBA, FLOS, CLEMATIS VITALBA, FLOS, FAGUS SYLVATICA, FLOS, GENTIANELLA AMARELLA, FLOS, HELIANTHEMUM NUMMULARIUM, FLOS, ILEX AQUIFOLIUM, FLOS, IMPATIENS GLANDULIFERA, FLOS, LARIX DECIDUA, FLOS, LONICERA CAPRIFOLIUM, FLOSEnergique, Inc.09c059e7-f748-402c-8447-af5b61169c582026-05-06WarningsExact identifier
unii: 059QF0KO0R
KIDS TOOTHPASTE, FOR CAVITY PROTECTIONKIDS TOOTHPASTE FOR CAVITY PROTECTIONShulisa (Foshan) Daily ChemicalIndustry Co., Ltd4e8fab9e-f05c-5e2f-e063-6294a90aecf92026-04-03WarningsExact identifier
unii: 059QF0KO0R
Sterile WaterWATERHospira, Inc.2b9ea23a-f9e9-48a8-25b7-519e3bbd68282026-03-18Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
TINTED SUNSCREEN FOUNDATIONTINTED SUNSCREEN FOUNDATIONGuanghzou AiXin Biotech Co Ltd396393c4-b50c-3877-e063-6294a90a0e9b2026-03-17WarningsExact identifier
unii: 059QF0KO0R
Skin Irritations and Itch ReliefAGARICUS MUSCARIUS, ALUMINA, ANAGALLIS ARVENSIS, ANTIMONIUM TARTARICUM, APIS MELLIFICA, ARSENICUM ALBUM, ARSENICUM IODATUM, BOVISTA, CAUSTICUM, DOLICHOS PRURIENS, FAGOPYRUM ESCULENTUM, GRAPHITES, KALI MURIATICUM, MURIATICUM ACIDUM, OLEANDER, PETROLEUM, PIX LIQUIDA, RADIUM BROMATUM (12X, 30X, 1LM), RHUS TOX, SELENIUM METALLICUM, SULPHUR AND URTICA URENS.King Bio Inc.d139d2f1-0369-4963-9f3d-c4cc0f1ea2dd2026-03-10WarningsExact identifier
unii: QTT17582CB
2-Pack Facial Serum2-PACK FACIAL SERUMGuangzhou Ariel Biotech Co., Ltd.27c7f645-cfb3-6db1-e063-6394a90a42ff2026-03-06WarningsExact identifier
unii: 059QF0KO0R
INSULIN DILUTING MEDIUM FOR KirstyWATERBiocon Biologics Inc.3db1d482-7e1f-aec6-79ef-3f305b4d82772026-01-20Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Walgreens Sterile Soothing Eye WashPURIFIED WATERWalgreensa62e3294-abd6-48dc-81b1-62a809bdc9682026-01-14WarningsExact identifier
unii: 059QF0KO0R

Reported adverse events (FAERS/openFDA)#

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