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 10 of 11 · 215 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
calcium gluconateCALCIUM GLUCONATEHikma Pharmaceuticals USA Inc.313a4ea9-178b-495e-9bc7-af1860fa65012023-05-26Warnings, Adverse reactionsExact identifier
rxcui: 1668250
unii: CZN0MI5R31
Bacteriostatic WaterWATERMedical Purchasing Solutions, LLC69485218-9343-952d-e053-2a91aa0ad4e82023-05-22Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Sterile WaterSTERILE WATERHikma Pharmaceuticals USA Inc.b20a28b0-7dfa-42eb-9177-ec256d5a5ef72023-05-08Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Calcium GluconateCALCIUM GLUCONATEMedical Purchasing Solutions, LLCb6226367-b061-eec5-e053-2a95a90a617d2023-05-04Warnings, Adverse reactionsExact identifier
application number: NDA208418
ndc (package): 71872-7222-1
ndc (product): 71872-7222
rxcui: 1668250
spl id: fadf4e81-eac7-e407-e053-6394a90a4932
spl set id: b6226367-b061-eec5-e053-2a95a90a617d
unii: CZN0MI5R31
Calcium GluconateCALCIUM GLUCONATEB. Braun Medical Inc.af362bcb-7010-4eb5-b8c4-42aa3b0cdcde2023-04-28Warnings, Adverse reactionsExact identifier
unii: CZN0MI5R31
Sterile WaterWATERCivica, Inc.3f49eedf-5bf5-4a95-b704-c956d860ca042023-04-07Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
TreprostinilTREPROSTINILSandoz Inc473297ca-a872-4052-a053-87dc8f0d3c132023-04-06Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
NOVOLOGINSULIN ASPARTNovo Nordisk3a1e73a2-3009-40d0-876c-b4cb2be56fc52023-02-28Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Acidum MuriaticumACIDUM MURIATICUMHahnemann Laboratories, INC.f2aad04c-5151-6cab-e053-2a95a90ad3a72023-01-19Exact identifier
unii: QTT17582CB
RehydrateAVENA SATIVA, EQUISETUM HYEMALE, HYPERICUM PERFORATUM, ULMUS FULVA, GLYCYRRHIZA GLABRA, SILICEA, PUERARIA LOBATA, CARLSBAD AQUA, ADENOSINUM TRIPHOSPHORICUM DINATRUM, GERMANIUM SESQUIOXIDE, HYDROGEN, OXYGEN, WIESBADENParaDocs All Natural, Inc.648fab10-c46b-420f-a42c-6642009d83fb2023-01-10WarningsExact identifier
unii: 059QF0KO0R
247dc1e8-daa7-40ac-a7ec-335b62cf6d8622a5b168-acc0-43ea-a2b2-f3a1d220ac062022-12-13Warnings, Adverse reactionsExact identifier
spl id: 247dc1e8-daa7-40ac-a7ec-335b62cf6d86
spl set id: 22a5b168-acc0-43ea-a2b2-f3a1d220ac06
CALCIUM GLUCONATECALCIUM GLUCONATEHF Acquisition Co LLC, DBA HealthFirst7d93251a-b555-0be0-e053-2991aa0ad7642022-12-10Warnings, Adverse reactionsExact identifier
application number: NDA208418
ndc (package): 51662-1347-1
ndc (product): 51662-1347
rxcui: 1668248
spl id: ef7bd5a0-02a5-7b66-e053-2995a90a8ffa
spl set id: 7d93251a-b555-0be0-e053-2991aa0ad764
unii: CZN0MI5R31
Sterile WaterWATERFresenius Kabi USA, LLCb45e9f1d-9c48-4b46-8541-d846b89540df2022-10-26Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Eye washPURIFIED WATERMcKessonbd089fde-24ba-4de5-e053-2995a90a39bb2022-10-18WarningsExact identifier
unii: 059QF0KO0R
Bach Original Flower Remedies Rock WaterWATERNelson Bach USA Limitedea242559-1618-3354-e053-2a95a90a1a952022-10-03WarningsExact identifier
unii: 059QF0KO0R
Sterile WaterWATERMedical Purchasing Solutions, LLCe90b47e3-9636-b9ee-e053-2a95a90ad48c2022-09-19Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Sterile WaterWATERFresenius Kabi USA, LLCf42ac50f-0ec5-4713-a4c8-99d972d90bed2022-06-22Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Sterile WaterWATERFresenius Kabi USA, LLCe71c6c83-d518-496c-b2ab-efd5987e47832022-06-09Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Sterile WaterWATERAmerican Regent, Inc.78b35864-4bbc-4759-a5c1-7e4f25e229322022-01-31Boxed warningExact identifier
unii: 059QF0KO0R
BHI HemorrhoidHORSE CHESTNUT, ALOE, COLLINSONIA CANADENSIS ROOT, VERONICASTRUM VIRGINICUM ROOT, HYDROCHLORIC ACID, STRYCHNOS NUX-VOMICA SEED, PAEONIA OFFICINALIS ROOT, AND SULFURMediNatura Incd7df7d3e-48ad-4f58-aef5-a7bd48d2f1912022-01-05WarningsExact identifier
unii: QTT17582CB

Reported adverse events (FAERS/openFDA)#

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