FDA.reportPublic FDA data

Potassium Chloride

Product NDC
63323-965
11-digit product format
633230965
Labeler code
63323
Product ID
63323-965_a1b31b46-2bb4-457e-a30b-e7dab47a2c54
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
POTASSIUM CHLORIDE
Dosage form
INJECTION, SOLUTION, CONCENTRATE
Route
INTRAVENOUS
Labeler
Fresenius Kabi USA, LLC
Application
ANDA088901
Marketing category
ANDA
Marketing start
1999-09-27
Substance
POTASSIUM CHLORIDE
Active strength
2 meq/mL
Pharmacologic classes
Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Osmotic Activity [MoA], Osmotic Laxative [EPC], Potassium Compounds [CS], Potassium Salt [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Potassium Chloride
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
POTASSIUM CHLORIDE2 meq/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii660YQ98I10
Rxcui204520, 1860132, 1860136, 1860139

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
9e37788c-b1bf-42ae-aac9-b60601606144Product name820260122
95250459-30e4-45c1-b08a-993044f49109Product name220250805
d9771140-739b-484b-ae64-b79528ff1211Product name320250801
efd58dcf-540a-4531-8766-e713129ca6f2Product name120250307
1527ac37-808d-43be-a63e-74e1258dbe46Product name920250219
bed0530e-f939-4541-956b-6928a2f6404fProduct name120241008
cefa60e2-a5b5-493e-9c54-24735b7dc509Product name620240814
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
9fcb7a91-de07-4f00-aabf-e4d6fda403d5Product name820230322
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
9badc7be-250a-44ab-aa36-926af3f02679Product name120210527
0ec3537a-6c9b-432a-896c-b9ea8723049aProduct name920200701
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
7916de40-e296-41f0-b811-6d0df1a33e2cProduct name920180627
cefa60e2-a5b5-493e-9c54-24735b7dc509Product name220171212
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
26acd337-b838-40ac-bcbc-05c3b81c8712Product name120170323
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
5668b646-cd56-c3c7-bdea-3f6b1a8840dbProduct name120140508
810ab97e-f109-f41c-7c83-6a652a9cbf43Product name120140508
87711080-88eb-65c5-b2dd-bf99e700a372Product name120140508
8dbefedf-0a0d-a224-5a3c-66dc9e11c2ddProduct name120140508
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

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 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, 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

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 RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1860132potassium chloride 10 MEQ in 5 ML InjectionPSNfcd4f458-ce27-417e-9bb6-de1cc49d44b95
1860132potassium chloride 10 MEQ in 5 ML InjectionPSNbf8e8ac7-e6a8-4571-a0ea-7bcab89290f65
204520potassium chloride 2 MEQ/mL Injectable SolutionPSNfcd4f458-ce27-417e-9bb6-de1cc49d44b95
1860136potassium chloride 20 MEQ in 10 ML InjectionPSNfcd4f458-ce27-417e-9bb6-de1cc49d44b95
1860139potassium chloride 40 MEQ in 20 ML InjectionPSNfcd4f458-ce27-417e-9bb6-de1cc49d44b95
1860139potassium chloride 40 MEQ in 20 ML InjectionPSNbf8e8ac7-e6a8-4571-a0ea-7bcab89290f65
186013610 ML potassium chloride 2 MEQ/ML InjectionSCDfcd4f458-ce27-417e-9bb6-de1cc49d44b95
186013920 ML potassium chloride 2 MEQ/ML InjectionSCDfcd4f458-ce27-417e-9bb6-de1cc49d44b95
186013920 ML potassium chloride 2 MEQ/ML InjectionSCDbf8e8ac7-e6a8-4571-a0ea-7bcab89290f65
18601325 ML potassium chloride 2 MEQ/ML InjectionSCDbf8e8ac7-e6a8-4571-a0ea-7bcab89290f65
18601325 ML potassium chloride 2 MEQ/ML InjectionSCDfcd4f458-ce27-417e-9bb6-de1cc49d44b95
204520potassium chloride 2 MEQ/ML Injectable SolutionSCDfcd4f458-ce27-417e-9bb6-de1cc49d44b95
186013610 ML K+ Chloride 2 MEQ/ML InjectionSYfcd4f458-ce27-417e-9bb6-de1cc49d44b95
186013610 ML Pot Chloride 2 MEQ/ML InjectionSYfcd4f458-ce27-417e-9bb6-de1cc49d44b95
186013920 ML K+ Chloride 2 MEQ/ML InjectionSYbf8e8ac7-e6a8-4571-a0ea-7bcab89290f65
186013920 ML K+ Chloride 2 MEQ/ML InjectionSYfcd4f458-ce27-417e-9bb6-de1cc49d44b95
186013920 ML Pot Chloride 2 MEQ/ML InjectionSYfcd4f458-ce27-417e-9bb6-de1cc49d44b95
186013920 ML Pot Chloride 2 MEQ/ML InjectionSYbf8e8ac7-e6a8-4571-a0ea-7bcab89290f65
18601325 ML K+ Chloride 2 MEQ/ML InjectionSYfcd4f458-ce27-417e-9bb6-de1cc49d44b95
18601325 ML K+ Chloride 2 MEQ/ML InjectionSYbf8e8ac7-e6a8-4571-a0ea-7bcab89290f65
18601325 ML Pot Chloride 2 MEQ/ML InjectionSYfcd4f458-ce27-417e-9bb6-de1cc49d44b95
18601325 ML Pot Chloride 2 MEQ/ML InjectionSYbf8e8ac7-e6a8-4571-a0ea-7bcab89290f65
204520K+ Chloride 2 MEQ/ML Injectable SolutionSYfcd4f458-ce27-417e-9bb6-de1cc49d44b95
204520Pot Chloride 2 MEQ/ML Injectable SolutionSYfcd4f458-ce27-417e-9bb6-de1cc49d44b95
1860132potassium chloride 10 MEQ per 5 ML InjectionSYbf8e8ac7-e6a8-4571-a0ea-7bcab89290f65
1860132potassium chloride 10 MEQ per 5 ML InjectionSYfcd4f458-ce27-417e-9bb6-de1cc49d44b95
1860136potassium chloride 14.9 % per 10 ML InjectionSYfcd4f458-ce27-417e-9bb6-de1cc49d44b95
1860139potassium chloride 14.9 % per 20 ML InjectionSYbf8e8ac7-e6a8-4571-a0ea-7bcab89290f65
1860139potassium chloride 14.9 % per 20 ML InjectionSYfcd4f458-ce27-417e-9bb6-de1cc49d44b95
1860132potassium chloride 14.9 % per 5 ML InjectionSYfcd4f458-ce27-417e-9bb6-de1cc49d44b95
1860132potassium chloride 14.9 % per 5 ML InjectionSYbf8e8ac7-e6a8-4571-a0ea-7bcab89290f65
204520potassium chloride 15 % Injectable SolutionSYfcd4f458-ce27-417e-9bb6-de1cc49d44b95
1860136potassium chloride 20 MEQ per 10 ML InjectionSYfcd4f458-ce27-417e-9bb6-de1cc49d44b95
1860139potassium chloride 40 MEQ per 20 ML InjectionSYfcd4f458-ce27-417e-9bb6-de1cc49d44b95
1860139potassium chloride 40 MEQ per 20 ML InjectionSYbf8e8ac7-e6a8-4571-a0ea-7bcab89290f65

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63323-965-01633230965015 mL in 1 VIAL, SINGLE-DOSE5 mlHistorical
63323-965-026332309650220 mL in 1 VIAL, SINGLE-DOSE20 mlHistorical
63323-965-036332309650310 mL in 1 VIAL, SINGLE-DOSE10 mlHistorical
63323-965-056332309650525 VIAL, SINGLE-DOSE in 1 TRAY (63323-965-05) / 5 mL in 1 VIAL, SINGLE-DOSE (63323-965-01) 1999-09-270000-00-00NoNoCurrent
63323-965-106332309651025 VIAL, SINGLE-DOSE in 1 TRAY (63323-965-10) / 10 mL in 1 VIAL, SINGLE-DOSE (63323-965-03) 1999-09-270000-00-00NoNoCurrent
63323-965-206332309652025 VIAL, SINGLE-DOSE in 1 TRAY (63323-965-20) / 20 mL in 1 VIAL, SINGLE-DOSE (63323-965-02) 1999-09-270000-00-00NoNoCurrent