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 45 of 70 · 1,386 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Potassium Chloride Extended-ReleasePOTASSIUM CHLORIDEBryant Ranch Prepack863e6980-4a66-48a5-a14f-828a00480c932024-08-23Warnings, Adverse reactionsExact identifier
unii: 660YQ98I10
Upper Respiratory SupportALLIUM CEPA, ECHINACEA (ANGUSTIFOLIA), EUCALYPTUS GLOBULUS, SALVIA OFFICINALIS, DULCAMARA, EUPHRASIA OFFICINALIS, HYDRASTIS CANADENSIS, NATRUM MURIATICUM, SABADILLA, VISCUM ALBUM, MUCOSA NASALIS SUIS, ACONITUM NAPELLUS, AMMONIUM CARBONICUM, ARSENICUM IODATUM, BRYONIA (ALBA), GELSEMIUM SEMPERVIRENS, KALI BICHROMICUM, MERCURIUS VIVUS, NUX VOMICA, PULSATILLA (PRATENSIS), RHUS TOXDeseret Biologicals, Inc.882a284f-aa25-40cf-8aff-fe4c38ff3f0a2024-08-23WarningsExact identifier
unii: 451W47IQ8X
Potassium Chloride Extended-ReleasePOTASSIUM CHLORIDEAmerican Health Packaging8c12c5f8-5950-44e3-9473-a0b95187b43c2024-08-22Warnings, Adverse reactionsExact identifier
unii: 660YQ98I10
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
POTASSIUM CHLORIDEPOTASSIUM CHLORIDEEpic Pharma, LLC1373321f-533a-4ab4-8bcd-8bde15371a092024-08-13Warnings, Adverse reactionsExact identifier
unii: 660YQ98I10
Potassium Chloride Extended-ReleasePOTASSIUM CHLORIDEBryant Ranch Prepack7427c29e-55c1-4c30-b091-058c8bec592f2024-08-12Warnings, Adverse reactionsExact identifier
unii: 660YQ98I10
Potassium ChloridePOTASSIUM CHLORIDENCS HealthCare of KY, LLC dba Vangard Labsf1791d4f-029a-487f-aee1-fc5be246d0bc2024-08-09Warnings, Adverse reactionsExact identifier
unii: 660YQ98I10
Potassium Chloride Extended-ReleasePOTASSIUM CHLORIDEBryant Ranch Prepack80dd5de2-5066-472b-b1f8-88070a5c73882024-08-05Warnings, Adverse reactionsExact identifier
unii: 660YQ98I10
Lymph/Spleen ComboADENOSINUM TRIPHOSPHORICUM DINATRUM, APIS MELLIFICA, CASTANEA VESCA, CEANOTHUS AMERICANUS, CHININUM ARSENICOSUM, FERRUM METALLICUM, HELIANTHUS ANNUUS, JUNIPERUS COMMUNIS, LYMPH NODE (SUIS), MYOSOTIS ARVENSIS, NATRUM MURIATICUM, NATRUM SULPHURICUM, PHYTOLACCA DECANDRA, QUERCUS GLANDIUM SPIRITUS, SPLEEN (SUIS), SUCCINUM, THYMUS (SUIS), UBIDECARENONUMDeseret Biologicals, Inc.afce86e2-cbfa-44d4-b803-bc2ad50533572024-07-31WarningsExact identifier
unii: 451W47IQ8X
DrainageECHINACEA (ANGUSTIFOLIA), TRIFOLIUM PRATENSE, PHYTOLACCA DECANDRA, CALCAREA IODATA, KALI MURIATICUM, NITRICUM ACIDUM, PHOSPHORICUM ACIDUM, SULPHUR IODATUMBioActive Nutritional, Inc.7920e8f6-be48-4402-9085-9673779db5a22024-07-31WarningsExact identifier
unii: 660YQ98I10
Lymph/Spleen ComboJUNIPERUS COMMUNIS, QUERCUS GLANDIUM SPIRITUS, MYOSOTIS ARVENSIS, NATRUM SULPHURICUM, CEANOTHUS AMERICANUS, HELIANTHUS ANNUUS, NATRUM MURIATICUM, PHYTOLACCA DECANDRA, LYMPH NODE (SUIS), SPLEEN (SUIS), THYMUS (SUIS), CHININUM ARSENICOSUM, ADENOSINUM TRIPHOSPHORICUM DINATRUM, UBIDECARENONUM, FERRUM METALLICUM, SUCCINUM, CASTANEA VESCA, APIS MELLIFICADeseret Biologicals, Inc.b55787b5-5e35-4342-8f00-ef202c3538772024-07-31WarningsExact identifier
unii: 451W47IQ8X
AdrenaparARALIA QUINQUEFOLIA, AVENA SATIVA, GLANDULA SUPRARENALIS SUIS, HYPOTHALAMUS SUIS, ARSENICUM IODATUM, CALCAREA CARBONICA, IGNATIA AMARA, LYCOPODIUM CLAVATUM, NATRUM MURIATICUM, NUX VOMICA, PHOSPHORICUM ACIDUM, PHOSPHORUS, ZINCUM METALLICUMEnergique, Inc.4080fcfb-7ef2-45f5-8c3b-592d3b66a1202024-07-29WarningsExact identifier
unii: 451W47IQ8X
Pineal LiquescenceVALERIANA OFFICINALIS, HYDROCOTYLE ASIATICA, MELATONIN, CEREBRUM SUIS, HYPOTHALAMUS SUIS, PINEAL GLAND (SUIS), SCUTELLARIA LATERIFLORA, STELLARIA MEDIA, CALCAREA CARBONICA, ZINCUM METALLICUM, AURUM METALLICUM, DOPAMINE (HYDROCHLORIDE), SEROTONIN (HYDROCHLORIDE), MAGNESIA MURIATICANutritional Specialties, Inc.ccaf3166-5e2f-4c7f-80a8-ee722bdf0c5b2024-07-24WarningsExact identifier
unii: 02F3473H9O
Sodium ChlorideSODIUM CHLORIDEBaxter Healthcare Corporationf55bd888-5e01-474d-871b-24654c0701782024-07-24Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
POTASSIUM CHLORIDEPOTASSIUM CHLORIDEFresenius Kabi USA, LLC3849b89c-c309-46fb-a1e2-53ff0c65077f2024-07-23Warnings, Adverse reactionsExact identifier
unii: 660YQ98I10
Sodium chlorideSODIUM CHLORIDEFresenius Kabi USA, LLC83994d0c-8484-4505-abb5-8a384ed122882024-07-22Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
Potassium Chloride Extended-releasePOTASSIUM CHLORIDE EXTENDED-RELEASEBryant Ranch Prepack7b8e7a4f-0d44-46b2-9565-7b4c294e9fcb2024-07-18Warnings, Adverse reactionsExact identifier
unii: 660YQ98I10
Potassium Chloride Extended-ReleasePOTASSIUM CHLORIDEBryant Ranch Prepackb5a6b6f2-d073-4bd3-a66c-bf34ccabfe512024-07-18Warnings, Adverse reactionsExact identifier
unii: 660YQ98I10
sodium chlorideSODIUM CHLORIDEBecton Dickinson and Company8df7dcf6-8714-6caf-e053-2995a90ab8cc2024-07-15Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
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.