FDA.reportPublic FDA data

NDC 64950-321-20 - 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
64950-321
Requested NDC
64950-321-20
Package NDCs from labels
64950-321-20, 64950-321-30, 64950-321-01
Manufacturer
Genus Lifesciences Inc.
Effective date
2020-04-28
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Potassium Chloride - Genus Lifesciences Inc.Genus Lifesciences Inc.2020-04-28HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
64950-321-01Potassium Chloride100 in 1 CARTONPOWDER, FOR SOLUTION1004
64950-321-20Potassium Chloride1.58 g in 1 POUCHPOWDER, FOR SOLUTION1.584
64950-321-30Potassium Chloride30 in 1 CARTONPOWDER, FOR SOLUTION304

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
64950-321POTASSIUM CHLORIDE POWDER, FOR SOLUTION [GENUS LIFESCIENCES INC.]4Current NDC, Legacy NDC, 3 package rows20200501_23d818e7-c076-40de-8dc1-0b51ba4be96a.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
64950-321-01EA - Each64950-321c5e92e5b-e37c-49a4-9708-1b13e82e99b612015-10-02
64950-321-20EA - Each64950-32155e3c502-dd39-482f-be05-d78e90deaa1f12015-10-02
64950-321-30EA - Each64950-3218b587b55-0edf-4bd0-8232-2a78a4cfa09f12015-10-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Potassium ChlorideACTIVE INGREDIENT660YQ98I10POTASSIUM CHLORIDE POWDER, FOR SOLUTION [LEHIGH VALLEY TECHNOLOGIES, INC.]1
Chloride IonACTIVE MOIETYQ32ZN48698POTASSIUM CHLORIDE POWDER, FOR SOLUTION [LEHIGH VALLEY TECHNOLOGIES, INC.]1
Anhydrous Citric AcidINACTIVE INGREDIENTXF417D3PSLPOTASSIUM CHLORIDE POWDER, FOR SOLUTION [LEHIGH VALLEY TECHNOLOGIES, INC.]1
FD&C Yellow No. 6INACTIVE INGREDIENTH77VEI93A8POTASSIUM CHLORIDE POWDER, FOR SOLUTION [LEHIGH VALLEY TECHNOLOGIES, INC.]1
Silicon DioxideINACTIVE INGREDIENTETJ7Z6XBU4POTASSIUM CHLORIDE POWDER, FOR SOLUTION [LEHIGH VALLEY TECHNOLOGIES, INC.]1
SucraloseINACTIVE INGREDIENT96K6UQ3ZD4POTASSIUM CHLORIDE POWDER, FOR SOLUTION [LEHIGH VALLEY TECHNOLOGIES, INC.]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 54 of 56 · 1,111 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Isolyte SSODIUM CHLORIDE, SODIUM GLUCONATE, SODIUM ACETATE, POTASSIUM CHLORIDE, AND MAGNESIUM CHLORIDEB. Braun Medical Inc.7e8fe27f-ff82-48c1-9bf6-3c589c8e985d2020-05-14Warnings, Adverse reactionsExact identifier
unii: 660YQ98I10
Potassium ChloridePOTASSIUM CHLORIDEGenus Lifesciences Inc.23d818e7-c076-40de-8dc1-0b51ba4be96a2020-04-28Warnings, Adverse reactionsExact identifier
application number: NDA208019
ndc (package): 64950-321-01
ndc (package): 64950-321-30
ndc (package): 64950-321-20
ndc (product): 64950-321
ndc11 (package): 64950032120
rxcui: 1867544
spl id: 015c512b-8162-47af-9181-69065eef98fa
spl set id: 23d818e7-c076-40de-8dc1-0b51ba4be96a
unii: 660YQ98I10
Potassium ChloridePOTASSIUM CHLORIDELupin Pharmaceuticals,Inc.1bbacdbb-91fa-4897-a00c-1b293de27b832020-04-27Warnings, Adverse reactionsExact identifier
rxcui: 1867544
unii: 660YQ98I10
Potassium ChloridePOTASSIUM CHLORIDEMylan Pharmaceuticals Inc.c64ed4c0-1e27-42b3-9625-fb4e0d31e2712020-04-15Warnings, Adverse reactionsExact identifier
unii: 660YQ98I10
Dextrose and Electrolyte No. 48SODIUM LACTATE, POTASSIUM CHLORIDE, MAGNESIUM CHLORIDE, MONOBASIC POTASSIUM PHOSPHATE, SODIUM CHLORIDE AND DEXTROSE MONOHYDRATEBaxter Healthcare Companyb283a454-0c20-4fbf-92d3-dae1f3cd3cad2020-02-13Warnings, Adverse reactionsExact identifier
unii: 660YQ98I10
RenacidinCITRIC ACID, GLUCONOLACTONE AND MAGNESIUM CARBONATEUnited-Guardian, Inc.13a9bbba-db21-4cba-991c-5d8afaf2ed742019-12-17Warnings, Adverse reactionsExact identifier
unii: XF417D3PSL
CPDA-1ANTICOAGULANT CITRATE PHOSPHATE DEXTROSE ADENINEFenwal, Inc.e41adb4e-06fb-4141-ba55-50b043f3c9da2019-11-19Exact identifier
unii: XF417D3PSL
CPDA-1ANTICOAGULANT CITRATE PHOSPHATE DEXTROSE ADENINEFenwal, Inc.14445dfd-6041-40cd-a043-3f4da6bcb9c12019-11-18Exact identifier
unii: XF417D3PSL
CPDA-1ANTICOAGULANT CITRATE PHOSPHATE DEXTROSE ADENINEFenwal, Inc.2557199a-5f60-49d8-b093-1e07002112432019-11-18Exact identifier
unii: XF417D3PSL
CPDA-1ANTICOAGULANT CITRATE PHOSPHATE DEXTROSE ADENINEFenwal, Inc.794f724c-87f0-49c1-9b26-c9e4919783132019-11-18Exact identifier
unii: XF417D3PSL
CPDA-1ANTICOAGULANT CITRATE PHOSPHATE DEXTROSE ADENINEFenwal, Inc.5c7d3287-883a-459b-9214-074a583c8a592019-11-18Exact identifier
unii: XF417D3PSL
CPDA-1ANTICOAGULANT CITRATE PHOSPHATE DEXTROSE ADENINEFenwal, Inc.448a1dc5-7a98-4b2f-82af-4b92de05cfc32019-11-18Exact identifier
unii: XF417D3PSL
Plasma-Lyte ASODIUM CHLORIDE, SODIUM GLUCONATE, SODIUM ACETATE, POTASSIUM CHLORIDE AND MAGNESIUM CHLORIDEBaxter Healthcare Corporation6ec9e61c-2c26-402f-8604-f446b2e340582019-08-05Warnings, Adverse reactionsExact identifier
unii: 660YQ98I10
Potassium Chloride in DextrosePOTASSIUM CHLORIDE AND DEXTROSE MONOHYDRATEBaxter Healthcare Company45de5402-5e61-4bbd-8bbc-5e3392c9920e2019-07-15Warnings, Adverse reactionsExact identifier
unii: 660YQ98I10
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
Skin Klear Acne ReliefTRIBASIC CALCIUM PHOSPHATE, FUMARIA OFFICINALIS FLOWERING TOP, ARCTIUM LAPPA ROOT, SODIUM CHLORIDE, SAPONARIA OFFICINALIS ROOT, SILICON DIOXIDE, SOLIDAGO VIRGAUREA FLOWERING TOP, SULFUR, VIOLA TRICOLORHomeocare Laboratories65afbc20-611b-4bc4-a151-c633bec66a822018-12-31WarningsExact identifier
unii: ETJ7Z6XBU4

Reported adverse events (FAERS/openFDA)#

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