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 2 of 34 · 672 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Potassium Chloride Extended-ReleasePOTASSIUM CHLORIDEUpsher-Smith Laboratories, LLC02707146-331f-4511-a187-0152fc8bca852026-07-24Warnings, Adverse reactionsExact identifier
unii: 660YQ98I10
PEG 3350 and ElectrolytesPOLYETHYLENE GLYCOL 3350, SODIUM SULFATE ANHYDROUS, SODIUM BICARBONATE, SODIUM CHLORIDE, POTASSIUM CHLORIDEA-S Medication Solutions19daf830-7270-4661-81b1-ded38f867f282026-07-24Warnings, Adverse reactionsExact identifier
unii: 660YQ98I10
Sterile WaterWATERCardinal Health 107, LLC9655cd02-82b5-4a75-813b-854b195514812026-07-21Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Potassium ChloridePOTASSIUM CHLORIDEMajor Pharmaceuticals6c080e51-4eb7-4e96-b29f-eb1cce3813042026-07-14Warnings, Adverse reactionsExact identifier
unii: 660YQ98I10
Potassium ChloridePOTASSIUM CHLORIDEATLANTIC BIOLOGICALS CORP.104ccc91-2aaf-4bb7-bb64-77c29413f60e2026-07-10Warnings, Adverse reactionsExact identifier
unii: 660YQ98I10
Dr. Drop NMN Vital Balance (Drop No.1 Cream 90g)NMN (NICOTINAMIDE MONONUCLEOTIDE), ECTOIN (ECTOINE)Reedfresh Co., LTD55d703ca-ff9d-0dbc-e063-6294a90ab6b12026-07-05WarningsExact identifier
unii: 059QF0KO0R
Eyesaline Eyewash ConcentratePURIFIED WATERProtective Industrial Products, Inc.558e5926-9027-d3f6-e063-6294a90ab1212026-07-02WarningsExact identifier
unii: 059QF0KO0R
Fendall 2000 Pure FlowPURIFIED WATERProtective Industrial Products, Inc.55a1d07e-0006-0c75-e063-6394a90a7acc2026-07-02WarningsExact identifier
unii: 059QF0KO0R
Fendall 1000 Pure FlowPURIFIED WATERProtective Industrial Products, Inc.55a2f4da-bb1e-8ead-e063-6394a90af72e2026-07-02WarningsExact identifier
unii: 059QF0KO0R
Sterile Eyesaline EyewashSTERILE EYESALINE EYEWASHProtective Industrial Products, Inc.55a290e8-8310-8be4-e063-6394a90abdce2026-07-02WarningsExact identifier
unii: 059QF0KO0R
Eyesaline Emergency EyewashPURIFIED WATERProtective Industrial Products, Inc.55a261c2-725d-6765-e063-6294a90a32602026-07-02WarningsExact identifier
unii: 059QF0KO0R
RemodulinTREPROSTINILUnited Therapeutics Corporation6c80bb38-e8db-4138-9f0d-dbbf9c6731852026-07-02Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
The Cell Salt Co. Daily Blend 12 in 1CALC FLUOR, CALC PHOS, CALC SULPH, FERRUM PHOS, KALI MUR, KALI PHOS, KALI SULPH, MAG PHOS, NAT MUR, NAT PHOS, NAT SULPH, SILICEAThe Cell Salt Company LLC55826f59-acf4-7370-e063-6394a90afed72026-07-01WarningsExact identifier
unii: 660YQ98I10
POTASSIUM CHLORIDEPOTASSIUM CHLORIDEHospira, Inc.559a0a8c-a8fe-40a5-b196-21f9308780ab2026-07-01Warnings, Adverse reactionsExact identifier
rxcui: 1860139
rxcui: 1860136
rxcui: 1860132
unii: 660YQ98I10
Potassium ChloridePOTASSIUM CHLORIDEA-S Medication Solutions30527e49-6648-44f3-97b2-9c51783ac0032026-07-01Warnings, Adverse reactionsExact identifier
unii: 660YQ98I10
Potassium ChloridePOTASSIUM CHLORIDEAmneal Pharmaceuticals NY LLC590dd25c-c4cb-489a-a09b-eccbf1d37c1f2026-07-01Warnings, Adverse reactionsExact identifier
unii: 660YQ98I10
Fendall 2000 Pure FlowPURIFIED WATERHoneywell Safety Products USA, Inc.37dead3e-60cb-88ae-e063-6294a90a8f702026-06-24WarningsExact identifier
unii: 059QF0KO0R
Bacteriostatic WaterBACTERIOSTATIC WATERFujian Genohope Biotech Ltd.54f66b82-c9e5-a2bc-e063-6394a90adbbc2026-06-23Exact identifier
unii: 059QF0KO0R
Potassium ChloridePOTASSIUM CHLORIDESt. Mary's Medical Park Pharmacy549c9d28-bf8b-2dc2-e063-6294a90abe7b2026-06-19Warnings, Adverse reactionsExact identifier
unii: 660YQ98I10
HumalogINSULIN LISPROEli Lilly and Companyc8ecbd7a-0e22-4fc7-a503-faa58c1b6f3f2026-06-16Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R

Reported adverse events (FAERS/openFDA)#

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