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 32 of 32 · 639 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Potassium ChloridePOTASSIUM CHLORIDEBluePoint Laboratories431ff2ef-567c-4b60-af43-f4da61febaad2019-07-03Warnings, Adverse reactionsExact identifier
unii: 660YQ98I10
POTASSIUM CHLORIDEPOTASSIUM CHLORIDE EXTENDED-RELEASESolco Healthcare LLCf704b746-ab75-4484-8704-5baa94a077502019-04-30Warnings, Adverse reactionsExact identifier
unii: 660YQ98I10
Tinnitus ReliefCINCHONA OFFICINALIS BARK,SALICYLIC ACID,QUININE SULFATE,FERRUM PHOSPHORICUM,POTASSIUM CHLORIDE,CALOMEL,ALLYLTHIOUREA,.Homeocare Laboratories30d67273-b9ec-4f3e-ace6-87a68325aaf12019-02-28WarningsExact identifier
unii: 660YQ98I10
Potassium Chloride in Dextrose and Sodium ChloridePOTASSIUM CHLORIDE, DEXTROSE MONOHYDRATE AND SODIUM CHLORIDEBaxter Healthcare Companyc553fed1-3de5-4826-8eff-633b5923bf0b2019-02-21Warnings, Adverse reactionsExact identifier
unii: 660YQ98I10
Potassium Chloride in Sodium ChloridePOTASSIUM CHLORIDE AND SODIUM CHLORIDEBaxter Healthcare Companybecc7410-0a25-49f5-b0c3-240078479dc82019-01-11Warnings, Adverse reactionsExact identifier
unii: 660YQ98I10
Dynamic Eyewash with EyecupWATERDynamic Safety International7d3af0f4-0e1f-9ea5-e053-2991aa0af7a22018-12-17WarningsExact identifier
unii: 059QF0KO0R
Potassium ChloridePOTASSIUM CHLORIDENovel Laboratories, Inc.ce4d4d39-8551-4789-8347-af763635922c2018-11-28Warnings, Adverse reactionsExact identifier
unii: 660YQ98I10
Bio Rock WaterROCK WATERBioActive Nutritional, Inc.178bd16d-0d4f-49d8-866b-8ab3a3c6889d2018-07-30WarningsExact identifier
unii: 059QF0KO0R
AdditoxTRIFOLIUM PRATENSE, XANTHOXYLUM FRAXINEUM, PHYTOLACCA DECANDRA, ARSENICUM ALBUM, BELLADONNA, CHELIDONIUM MAJUS, LYCOPODIUM CLAVATUM, PHOSPHORICUM ACIDUM, ASPARTAME, BENZALKONIUM CHLORIDE, FORMALINUM, METHYLENE CHLORIDE, METHYLPARABEN, PROPYLPARABEN, SODIUM BENZOATE, SODIUM CITRATE, TITANIUM DIOXIDE, ZINCUM OXYDATUMBioActive Nutritional, Inc.319ee2fe-58e3-495e-bf0d-df201f6fbb1c2018-07-18WarningsExact identifier
unii: Z8IX2SC1OH
unii: A2I8C7HI9T
Potassium ChloridePOTASSIUM CHLORIDENorthstar Rx LLCdded25a9-3df4-463a-8685-d2bc03ea4edb2018-07-16Warnings, Adverse reactionsExact identifier
unii: 660YQ98I10
Lactated RingersSODIUM CHLORIDE, SOLDIUM LACTATE, POTASSIUM CHLORIDE AND CALCIUM CHLORIDEBaxter Healthcare Company5215ec33-8cfe-4885-ae92-e6a12100bd272018-01-02Warnings, Adverse reactionsExact identifier
unii: 660YQ98I10
Homeoplex FECHINACEA (ANGUSTIFOLIA), PHYTOLACCA DECANDRA, LYMPH NODE (SUIS), CONIUM MACULATUM, FERRUM IODATUM, HEPAR SULPHURIS CALCAREUM, KALI MURIATICUM, LACHESIS MUTUS, SILICEASupplement Clinic, LLC.a1872d34-7298-4016-b7b3-830ac11491262017-11-01WarningsExact identifier
unii: 660YQ98I10
Sterile WaterWATERBaxter Healthcare Corporationef3e79c5-3f58-4b36-a296-64b7d9a651c12017-10-17Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Cardio TonicKALI MURIATICUM, KALI PHOSPHORICUM, PLANTAGO MAJOR, CACTUS GRANDIFLORUS, DIGITALIS PURPUREA, HEART (BOVINE), L-CARNITINE, L-VALINE, THYROIDINUM (SUIS), ABROTANUM (ARTEMISIA ABROTANUM), IODIUM, LECITHIN, SPIGELIA ANTHELMIABioActive Nutritional, Inc.2c252ba6-f147-4c22-b432-cd603a9623ac2017-08-14WarningsExact identifier
unii: 660YQ98I10
Eye WashWATERCVS Pharmacy049cee29-7ec2-4d5b-8308-f522acde43a72017-03-29WarningsExact identifier
unii: 059QF0KO0R
Sterile WaterWATERBaxter Healthcare Company210dc9ab-d6ca-4552-ac19-1be17792d2902016-05-31Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
TIS-U-SOLSODIUM CHLORIDE, POTASSIUM CHLORIDE, MAGNESIUM SULFATE, SODIUM PHOSPHATE, AND POTASSIUM PHOSPHATEBaxter Healthcare Corporation9da4121f-d62d-4da4-8dfb-0494da16015f2014-02-21Exact identifier
unii: 660YQ98I10
RingersSODIUM CHLORIDE, CALCIUM CHLORIDE, POTASSIUM CHLORIDE,Baxter Healthcare Corporatione1953d54-818d-46a6-8532-518ebae6d84e2012-06-13Exact identifier
unii: 660YQ98I10
Lactated RingersSODIUM CHLORIDE, SODIUM LACTATE, POTASSIUM CHLORIDE, CALCIUM CHLORIDEBaxter Healthcare Corporationf09f80bf-2f8b-4420-865d-aec2d5e5cd4d2012-06-12Exact identifier
unii: 660YQ98I10

Reported adverse events (FAERS/openFDA)#

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