FDA.reportPublic FDA data

NDC 63323-965-01 - Potassium Chloride

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
63323-965
Requested NDC
63323-965-01
Package NDCs from labels
63323-965-01, 63323-965-05, 63323-965-03, 63323-965-10, 63323-965-02, 63323-965-20
Manufacturer
Henry Schein, Inc.
Effective date
2025-08-12
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
POTASSIUM CHLORIDE FOR INJECTION CONCENTRATE, USPHenry Schein, Inc.2025-08-12HUMAN PRESCRIPTION DRUG LABEL
Potassium Chloride - Fresenius Kabi USA, LLCFresenius Kabi USA, LLC2023-02-27HUMAN PRESCRIPTION DRUG LABEL
Potassium Chloride - General Injectables & Vaccines, IncGeneral Injectables & Vaccines, Inc2022-12-29HUMAN PRESCRIPTION DRUG LABEL
POTASSIUM CHLORIDE - General Injectables & Vaccines, Inc.General Injectables & Vaccines, Inc.2022-12-29HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63323-965-01Potassium Chloride5 mL in 1 VIAL, SINGLE-DOSEINJECTION, SOLUTION, CONCENTRATE55
63323-965-02Potassium Chloride20 mL in 1 VIAL, SINGLE-DOSEINJECTION, SOLUTION, CONCENTRATE205
63323-965-03Potassium Chloride10 mL in 1 VIAL, SINGLE-DOSEINJECTION, SOLUTION, CONCENTRATE105
63323-965-05Potassium Chloride25 in 1 TRAYINJECTION, SOLUTION, CONCENTRATE255
63323-965-10Potassium Chloride25 in 1 TRAYINJECTION, SOLUTION, CONCENTRATE255
63323-965-20Potassium Chloride25 in 1 TRAYINJECTION, SOLUTION, CONCENTRATE255

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63323-965POTASSIUM CHLORIDE INJECTION, SOLUTION, CONCENTRATE [FRESENIUS KABI USA, LLC]5Current NDC, Legacy NDC, 6 package rows20230316_fcd4f458-ce27-417e-9bb6-de1cc49d44b9.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63323-965-01ML - Milliliter63323-9651bbfa031-5c7d-4660-bfc1-4d4f0c7b404912019-10-07
63323-965-02ML - Milliliter63323-965eb59be88-d60b-48d6-ae5b-4790007c02c512019-09-05
63323-965-03ML - Milliliter63323-965f645fe1e-bd3d-4cdc-99db-7744f42ecbab12019-10-07
63323-965-05ML - Milliliter63323-9651908bab0-016a-48b3-93bc-249396e92c0712012-07-24
63323-965-10ML - Milliliter63323-9658be2fd64-e5a7-4231-b851-2399e724fac712012-07-24
63323-965-20ML - Milliliter63323-965346766e4-da06-4c17-94c3-4ef8fe05b96e12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Potassium ChlorideACTIVE INGREDIENT660YQ98I10POTASSIUM CHLORIDE INJECTION, SOLUTION [GENERAL INJECTABLES & VACCINES, INC]4
Potassium CationACTIVE MOIETY295O53K152POTASSIUM CHLORIDE INJECTION, SOLUTION [GENERAL INJECTABLES & VACCINES, INC]4
POTASSIUM CHLORIDEACTIVE INGREDIENT660YQ98I10POTASSIUM CHLORIDE INJECTION, SOLUTION, CONCENTRATE [APP PHARMACEUTICALS, LLC]1
POTASSIUM CATIONACTIVE MOIETY295O53K152POTASSIUM CHLORIDE INJECTION, SOLUTION, CONCENTRATE [APP PHARMACEUTICALS, LLC]1
HYDROCHLORIC ACIDINACTIVE INGREDIENTQTT17582CBPOTASSIUM CHLORIDE INJECTION, SOLUTION, CONCENTRATE [APP PHARMACEUTICALS, LLC]1
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TPOTASSIUM CHLORIDE INJECTION, SOLUTION, CONCENTRATE [APP PHARMACEUTICALS, LLC]1
POTASSIUM HYDROXIDEINACTIVE INGREDIENTWZH3C48M4TPOTASSIUM CHLORIDE INJECTION, SOLUTION, CONCENTRATE [APP PHARMACEUTICALS, LLC]1
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHPOTASSIUM CHLORIDE INJECTION, SOLUTION, CONCENTRATE [APP PHARMACEUTICALS, LLC]1

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 15 of 32 · 639 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Sterile WaterSTERILE WATERNephron Pharmaceuticals Corporationbc04a883-babc-87a6-e053-2995a90a3dfd2025-07-11Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
POTASSIUM CHLORIDE IN SODIUM CHLORIDESODIUM CHLORIDE AND POTASSIUM CHLORIDEB. Braun Medical Inc.ecc38772-246a-46c4-b42a-b9b81124f27f2025-07-11Warnings, Adverse reactionsExact identifier
unii: 660YQ98I10
Potassium ChloridePOTASSIUM CHLORIDEUpsher-SmithLaboratories, LLCad584ce4-a64d-4851-80e9-0eeedc0b9d062025-07-10Warnings, Adverse reactionsExact identifier
unii: 660YQ98I10
Schuessler Tissue Salts Kali Mur Glandular Tonic 5KALI MURIATICUMMartin & Pleasance Pty Ltd4b2d8d03-c829-4292-ad94-993376d81b8f2025-07-01WarningsExact identifier
unii: 660YQ98I10
Potassium ChloridePOTASSIUM CHLORIDEAmerican Health Packagingb165ad93-1dc1-4863-9f0b-d7b97c42c94c2025-06-23Warnings, Adverse reactionsExact identifier
unii: 660YQ98I10
Plaque identifyingPLAQUE IDENTIFYINGShenzhen Yagao Technology Co., Ltd.37eeb656-22f1-7372-e063-6394a90ad0412025-06-19WarningsExact identifier
unii: 059QF0KO0R
Potassium Chloride ERPOTASSIUM CHLORIDE ERDirect_Rx377854ff-8034-c7ac-e063-6294a90a08172025-06-13Warnings, Adverse reactionsExact identifier
unii: 660YQ98I10
PRISMASOL BGK2/0MAGNESIUM CHLORIDE, DEXTROSE ANHYDROUS, LACTIC ACID, SODIUM CHLORIDE, SODIUM BICARBONATE, AND POTASSIUM CHLORIDEVantive US Healthcare LLC7f675fee-8940-4ece-bb0c-75ac79d8708c2025-05-31Warnings, Adverse reactionsExact identifier
unii: 660YQ98I10
Sterile WaterWATERHenry Schein, Inc.88403fcf-a276-42c0-88b6-bd84a720b5642025-05-29Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Insecticides/Pest/Food Additives DetoxBOLDO, CARDUUS MARIANUS, CHELIDONIUM MAJUS, PETROSELINUM SATIVUM, TARAXACUM OFFICINALE, ARSENICUM ALBUM, BISPHENOL A, COBALTUM METALLICUM, CUPRUM METALLICUM, GLYPHOSATE, IODIUM, LYCOPODIUM CLAVATUM, PHOSPHORICUM ACIDUM, SELENIUM METALLICUM, ZINCUM METALLICUM, ASPARTAME, BENZALKONIUM CHLORIDE, FORMALINUM, METHYLENE CHLORIDE, METHYLPARABEN, PROPYLPARABEN, SODIUM BENZOATE, SODIUM CITRATE, TITANIUM DIOXIDE, ZINCUM OXYDATUMDr. Donna Restivo DCb5778211-0e3e-44ef-bd65-a76a68cf15042025-05-23WarningsExact identifier
unii: Z8IX2SC1OH
unii: A2I8C7HI9T
Eyesaline Emergency EyewashSTERILE EYESALINE EYEWASHHoneywell Safety Products USA, Inc.2d567518-4c54-7448-e063-6294a90a3e642025-05-14WarningsExact identifier
unii: 059QF0KO0R
Potassium ChloridePOTASSIUM CHLORIDEUpsher-Smith Laboratories, LLCa230185f-5493-487d-892a-5219869b4e472025-05-05Warnings, Adverse reactionsExact identifier
unii: 660YQ98I10
Potassium ChloridePOTASSIUM CHLORIDEBryant Ranch Prepackab147ac2-d7d5-46d1-a2de-d866219197c12025-04-28Warnings, Adverse reactionsExact identifier
unii: 660YQ98I10
Eye WashWATERCMC Group Inc.6158a1f5-a6bc-4a3e-9d1d-0a310d9dc5612025-04-02WarningsExact identifier
unii: 059QF0KO0R
Potassium ChloridePOTASSIUM CHLORIDEEndo USA, Inc.a64d7151-09a6-474c-83fc-36c7cf582d322025-03-26Warnings, Adverse reactionsExact identifier
unii: 660YQ98I10
Bestmade Natural Products BM60CIMICIFUGAD6, DROSERAD6, FORMICA RUFAD6, FULIGOD6, INULA HELD6, KALI MURD6, LAPIS ALBUSD6, SILICEAD6Bestmade Natural Products29912fb7-8712-18d9-e063-6394a90a82f72025-03-25WarningsExact identifier
unii: 660YQ98I10
RenotoxTRITICUM AESTIVUM, ASPARAGUS OFFICINALIS, BERBERIS VULGARIS, ECHINACEA (ANGUSTIFOLIA), KALI MURIATICUM, PETROSELINUM SATIVUM, SABAL SERRULATA, SOLIDAGO VIRGAUREA, TARAXACUM OFFICINALE, UVA-URSI, BAROSMA (BETULINA), EUPATORIUM PURPUREUM, KIDNEY (SUIS), BRYONIA (ALBA), MERCURIUS CORROSIVUS, ALUMINUM METALLICUM, ANTIMONIUM CRUDUM, ARGENTUM METALLICUM, ARSENICUM ALBUM, AURUM METALLICUM, BARYTA CARBONICA, BERYLLIUM METALLICUM, BISMUTHUM METALLICUM, BORON, BROMIUM, CADMIUM METALLICUM, CERIUM METALLICUM,BioActive Nutritional, Inc.f2b9cc0d-e146-47f7-b1b8-3e4d1cf6d0e92025-03-20WarningsExact identifier
unii: 660YQ98I10
RenotoxTRITICUM AESTIVUM, ASPARAGUS OFFICINALIS, BERBERIS VULGARIS, ECHINACEA (ANGUSTIFOLIA), KALI MURIATICUM, PETROSELINUM SATIVUM, SABAL SERRULATA, SOLIDAGO VIRGAUREA, TARAXACUM OFFICINALE, UVA-URSI, BAROSMA (BETULINA), EUPATORIUM PURPUREUM, KIDNEY (SUIS), BRYONIA (ALBA), MERCURIUS CORROSIVUS, ALUMINUM METALLICUM, ANTIMONIUM CRUDUM, ARGENTUM METALLICUM, ARSENICUM ALBUM, AURUM METALLICUM, BARYTA CARBONICA, BERYLLIUM METALLICUM, BISMUTHUM METALLICUM, BORON, BROMIUM, CADMIUM METALLICUM, CERIUM METALLICUM,BioActive Nutritional, Inc.2b691b17-296b-49d2-924e-c62522d4b9a72025-03-20WarningsExact identifier
unii: 660YQ98I10
AddiclenzASPARTAME, BENZALKONIUM CHLORIDE, FORMALINUM, METHYLENE CHLORIDE, METHYLPARABEN, PROPYLPARABEN, SODIUM BENZOATE, SODIUM CITRATE, TITANIUM DIOXIDE, ZINCUM OXYDATUM, ARSENICUM ALBUM, BETA VULGARIS, BISPHENOL A, BOLDO, CHELIDONIUM MAJUS, COBALTUM METALLICUM, CUPRUM METALLICUM, GLYPHOSATE, IODIUM, LYCOPODIUM CLAVATUM, PETROSELINUM SATIVUM, PHOSPHORICUM ACIDUM, SELENIUM METALLICUM, TARAXACUM OFFICINALE, ZINCUM METALLICUMDeseret Biologicals, Inc.25036c26-1c21-4e5a-b4db-b8e1774583412025-03-11WarningsExact identifier
unii: Z8IX2SC1OH
unii: A2I8C7HI9T
Bestmade Natural Products BM253CALC FLUOR, CALC PHOS, FERR PHOS, KALI MUR, KALI PHOS, MAG PHOS, NAT MURBestmade Natural Products2fa9913f-0593-f77b-e063-6394a90ab6b22025-03-06WarningsExact identifier
unii: 660YQ98I10

Reported adverse events (FAERS/openFDA)#

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