FDA.reportPublic FDA data

NDC 65219-258-01 - Cardioplegic Solution

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
65219-258
Requested NDC
65219-258-01
Package NDCs from labels
65219-258-01, 65219-258-10
Manufacturer
Fresenius Kabi, USA, LLC | Fresenius Kabi Deutschland GmbH
Effective date
2022-05-27
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
POTASSIUM CHLORIDE - Fresenius Kabi, USA, LLC | Fresenius Kabi Deutschland GmbHFresenius Kabi, USA, LLC | Fresenius Kabi Deutschland GmbH2022-05-27HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
65219-258-01Cardioplegic Solution1000 mL in 1 BAGINJECTION, SOLUTION10004
65219-258-10Cardioplegic Solution10 in 1 CASEINJECTION, SOLUTION104
65219-258-10Cardioplegic Solution1 in 1 POUCHINJECTION, SOLUTION14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65219-258CARDIOPLEGIC SOLUTION (POTASSIUM CHLORIDE, SODIUM CHLORIDE, CALCIUM CHLORIDE, AND MAGNESIUM CHLORIDE) INJECTION, SOLUTION [FRESENIUS KABI, USA, LLC]4Current NDC, Legacy NDC, 3 package rows20220606_eb360dc4-88d6-4b28-9b61-bc359e16bd22.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
65219-258-01ML - Milliliter65219-2581a70cebb-a2a2-4fc7-aba7-e3d33dc3ee0a12023-06-06
65219-258-10ML - Milliliter65219-2586f993564-0dbf-4777-a20d-6b46dfd7b2c612023-06-06

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 46 of 70 · 1,386 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
WINTER BLENDECHINACEA (ANGUSTIFOLIA), UVA-URSI, BAPTISIA TINCTORIA, CONVALLARIA MAJALIS, KALI MURIATICUM, PINUS SYLVESTRIS, THUJA OCCIDENTALIS, BRYONIA, CROTALUS HORRIDUS, LACHESIS MUTUS, SELENIUM METALLICUM, VISCUM ALBUMEnergique, Inc.ff696389-bad5-463a-be99-e92e86250e862024-07-12WarningsExact identifier
unii: 660YQ98I10
Isolyte P in DextroseDEXTROSE, SODIUM ACETATE, POTASSIUM CHLORIDE, MAGNESIUM CHLORIDE, AND POTASSIUM PHOSPHATE, DIBASICB. Braun Medical Inc.4ea4397c-2fa4-4670-91e6-21ae498c88f72024-06-24Warnings, Adverse reactionsExact identifier
unii: 02F3473H9O
unii: 660YQ98I10
Eyesaline Emergency EyewashPURIFIED WATERHoneywell Safety Products USA, Inc.ad42a7e3-84ea-390d-e053-2a95a90a3a322024-06-14WarningsExact identifier
unii: 059QF0KO0R
Derma Pain PlusCROTON TIGLIUM, NATRUM MURIATICUM, PLANTAGO MAJOR, RHUS TOXICODENDRON, SARSAPARILLA (SMILAX REGELII)Peaceful Mountain, Inc.6fa79c31-e48e-4c83-baa2-96cef22cfee12024-06-13WarningsExact identifier
unii: 451W47IQ8X
Cold Sore RescueBORAX, DULCAMARA, NATRUM MURIATICUM, RANUNCULUS BULBOSUS, SILICEAPeaceful Mountain, Inc.a7fe6ec7-a758-43cf-b46f-c327e0632fb82024-06-13WarningsExact identifier
unii: 451W47IQ8X
KALI MURKALI MURRxhomeo Private Limited d.b.a. Rxhomeo, Inc1a3522bc-3d43-ea96-e063-6394a90aa2cc2024-06-06WarningsExact identifier
unii: 660YQ98I10
Eyes Alive Eye WashWATERRIVIERA PHARMA INC081079f4-1c06-4054-b771-00fedaa666f62024-06-05WarningsExact identifier
unii: 059QF0KO0R
NATRUM MURNATRUM MURRxhomeo Private Limited d.b.a. Rxhomeo, Inc1a22655a-68f3-4f13-e063-6294a90ae52c2024-06-05WarningsExact identifier
unii: 451W47IQ8X
Potassium Chloride Extended-releasePOTASSIUM CHLORIDE EXTENDED-RELEASEProficient Rx LPc53d1db5-1c9e-4289-a2a2-961e0dd56f322024-06-01Warnings, Adverse reactionsExact identifier
unii: 660YQ98I10
Sterile WaterWATERBecton Dickinson and Company6e43c5a3-dad2-49ed-b500-964cb4563cc92024-05-31Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Mentox HPAURUM METALLICUM, BARYTA CARBONICA, CALCAREA CARBONICA, LACHESIS MUTUS, LYCOPODIUM CLAVATUM, NATRUM MURIATICUM, NUX VOMICA, PHOSPHORUSEnergique, Inc.ebb23637-4931-4563-ab30-99bea02765802024-05-28WarningsExact identifier
unii: 451W47IQ8X
POTASSIUM CHLORIDEPOTASSIUM CHLORIDEBryant Ranch Prepackd396477a-6b15-4782-9c85-b9663b83c4842024-05-23Warnings, Adverse reactionsExact identifier
unii: 660YQ98I10
Potassium Chloride in Lactated Ringers and DextrosePOTASSIUM CHLORIDE, SODIUM CHLORIDE, CALCIUM CHLORIDE, SODIUM LACTATE, AND DEXTROSE MONOHYDRATEFresenius Kabi USA, LLCdbed53b7-0109-4561-8342-0178ec8c64b02024-05-22Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
unii: 660YQ98I10
unii: M4I0D6VV5M
Lactated Ringers and DextroseSODIUM CHLORIDE, SODIUM LACTATE, POTASSIUM CHLORIDE, CALCIUM CHLORIDE, AND DEXTROSE MONOHYDRATEFresenius Kabi USA, LLC1b912c7e-f005-4af4-b683-0834409642492024-05-22Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
unii: 660YQ98I10
unii: M4I0D6VV5M
Sodium chlorideSODIUM CHLORIDEFresenius Kabi USA, LLC239a5af1-7498-480f-862c-ab7c3d89d1832024-05-21Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
Sodium chlorideSODIUM CHLORIDEBecton Dickinson and Companyebc8b008-a8b3-4c41-89e4-b413f7aab89f2024-05-21Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
POTASSIUM CHLORIDEPOTASSIUM CHLORIDEXLCare Pharmaceuticals, Inc.7fd82f08-8ad0-4ee2-8eb6-5c973f98baee2024-05-21Warnings, Adverse reactionsExact identifier
unii: 660YQ98I10
Potassium ChloridePOTASSIUM CHLORIDEBryant Ranch Prepack7a220e87-ff72-417b-bc45-90a37b7f2aa62024-05-21Warnings, Adverse reactionsExact identifier
unii: 660YQ98I10
AllergiesAPIS MELLIFICA, ECHINACEA, HYDRASTIS CANADENSIS, TARAXACUM OFFICINALE, ACONITUM NAPELLUS, AETHUSA CYNAPIUM, AGARICUS MUSCARIUS, ALETRIS FARINOSA, ALFALFA, ALLIUM CEPA, ALLIUM SATIVUM, AMBROSIA ARTEMISIAEFOLIA, ARSENICUM ALBUM, ARTEMISIA VULGARIS, ARUNDO MAURITANICA, AVENA SATIVA, BELLADONNA, BELLIS PERRENIS, BOVISTA, BROMIUM, BRYONIA, CAFFEINUM, CALCAREA CARBONICA, CALLUNA VULGARIS, FLOS, CAPSICUM ANNUUM, CAT HAIR, CHAMOMILLA, CHELIDONIUM MAJUS, CHENOPODIUM ANTHELMINTICUM, CINNAMOMUMNewton Laboratories, Inc.9d5dea47-5103-21a3-e053-2995a90aee782024-05-20WarningsExact identifier
unii: 451W47IQ8X
ColoparCOLON (SUIS), ARSENICUM ALBUM, CAUSTICUM, IGNATIA AMARA, LACHESIS MUTUS, LYCOPODIUM CLAVATUM, NATRUM MURIATICUM, NUX VOMICA, SEPIA, SILICEA, THUJA OCCIDENTALISEnergique, Inc.c47d7203-abcd-4ae5-bf9b-5df07e07d3c12024-05-20WarningsExact identifier
unii: 451W47IQ8X

Reported adverse events (FAERS/openFDA)#

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