FDA.reportPublic FDA data

NDC 63323-360-05 - 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
63323-360-05
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 6 of 11 · 213 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
STERILE WATERSTERILE WATERHF Acquisition Co LLC, DBA HealthFirst7610bf80-61b7-982f-e053-2a91aa0ac1bb2025-01-09Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
T-27WATERDNA Labs, Inc.f0e9afd7-64a4-4b85-9c5f-4bf07ba4b4812025-01-09WarningsExact identifier
unii: 059QF0KO0R
Sterile WaterSTERILE WATER FOR INJECTIONMedefil, Inc.99e99a50-82d5-aff6-e053-2a95a90a8c562025-01-08Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
BACTERIOSTATIC WATERBACTERIOSTATIC WATERHF Acquisition Co LLC, DBA HealthFirst99b0ef9b-600a-40dc-e053-2a95a90aa07e2025-01-08Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
STERILE WATERSTERILE WATERHF Acquisition Co LLC, DBA HealthFirst99b1cb12-0b2d-0c0f-e053-2a95a90ac3b62025-01-08Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Stress Away Anxiety ReliefACONITUM NAP, ALFALFA, AVENA, CHAMOMILLA, GELSEMIUM, HUMULUS IUPULUS, IGNATIA, KALI ARS, KALI PHOS, MURIATICUM AC, NAT PHOS, PASSIFLORA, PHOSPHORUS, STAPHYSAGRIA, STRAMONIUMSilver Star Brands05e04129-e7c1-4e11-e063-6394a90a09ca2025-01-01WarningsExact identifier
unii: QTT17582CB
Fendall Pure FlowPURIFIED WATERHoneywell Safety Products USA, Inc.afda6fc3-7615-b0be-e053-2995a90a62082024-12-10WarningsExact identifier
unii: 059QF0KO0R
Stress Away Anxiety ReliefACONITUM NAP, ALFALFA, AVENA, CHAMOMILLA, GELSEMIUM, HUMULUS LUPULUS, IGNATIA, KALI ARS, KALI PHOS, MURIATICUM AC, NAT PHOS, PASSIFLORA, PHOS, STAPHYSAG, STRAMONIUMSilver Star Brands9d75666e-3214-2bab-e053-2a95a90af7192024-12-03WarningsExact identifier
unii: QTT17582CB
PhysiciansCare Ophthalmic Solution Eyewash Purified Water, 98.3%PURIFIED WATER 98.3%Acme United Corporation9248ee71-2d47-620d-e053-2995a90af5c82024-11-26WarningsExact identifier
unii: 059QF0KO0R
PhysiciansCare Ophthalmic Solution EyewashPURIFIED WATER 98.3%Acme United Corporationcca454e0-b2bd-4215-bc06-426fcc3f7bd62024-11-26WarningsExact identifier
unii: 059QF0KO0R
PhysiciansCare Ophthalmic Solution EyewashPURIFIED WATER 98.3%Acme United Corporationd3812fa3-9334-464d-b50c-98548ff767272024-11-26WarningsExact identifier
unii: 059QF0KO0R
DANGTTEOLMINERAL WATERAQBC CO., LTD27db14a9-3812-433f-e063-6394a90a11e72024-11-26WarningsExact identifier
unii: 059QF0KO0R
Crane Safety Eye WashWATER SOLUTIONCrane Safety LLC96d8dda9-6cd6-3f68-e053-2995a90a0da22024-11-08WarningsExact identifier
unii: 059QF0KO0R
RUGBY EYE WASHWATER, PURIFIEDA-S Medication Solutions0773e558-2f46-494c-888a-3bc517202b652024-11-08WarningsExact identifier
unii: 059QF0KO0R
EyS Eye WashWATEREyes-Plus LLC1443f6bf-3a77-4a19-8585-0ec58efe042f2024-10-15WarningsExact identifier
unii: 059QF0KO0R
Eye WashWATER SOLUTIONKroger Company354402ad-581d-47e7-9fd3-933bef281ff42024-10-11WarningsExact identifier
unii: 059QF0KO0R
Eye WashWATERHubei Changjian Medical Products Co., Ltd.d57e1c5b-1edc-4a94-88bc-f9ecf347b7ea2024-10-11WarningsExact identifier
unii: 059QF0KO0R
Calcium GluconateCALCIUM GLUCONATEFresenius Kabi USA, LLC1aaf5c76-e526-4d8b-887e-cc3c4f39cc8b2024-08-21Warnings, Adverse reactionsExact identifier
application number: NDA208418
rxcui: 1668250
unii: CZN0MI5R31
EmpathyAETHUSA CYNAPIUM, AMBRA GRISEA, ARGEMONE MEXICANA, CANDIDA ALBICANS, CARLSBAD AQUA, CEREBRUM SUIS, COCCULUS INDICUS, COFFEA TOSTA, CROCUS SATIVUS, CYCLAMEN EUROPAEUM, MAGNESIA CARBONICA, NATRUM CARBONICUM, NUPHAR LUTEUM, NUX MOSCHATA, PHOSPHORUS, PLACENTA TOTALIS SUIS, ROSA DAMASCENA, SUCCINUM, VIOLA ODORATADeseret Biologicals, Inc.a89067c1-ef12-49da-8fa6-e65ff664f4972024-08-13WarningsExact identifier
unii: 059QF0KO0R
Thompson Safety EyewashWATERThompson Safety1d0e96cf-245b-cfb7-e063-6294a90a4ced2024-07-12WarningsExact identifier
unii: 059QF0KO0R

Reported adverse events (FAERS/openFDA)#

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