FDA.reportPublic FDA data

Potassium Chloride

Product NDC
0338-0705
11-digit product format
003380705
Labeler code
0338
Product ID
0338-0705_4cf18d0e-1854-48fb-b711-49b2a3042ae4
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
POTASSIUM CHLORIDE
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
Baxter Healthcare Corporation
Application
NDA019904
Marketing category
NDA
Marketing start
1989-12-26
Substance
POTASSIUM CHLORIDE
Active strength
14.9 g/1000mL
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Potassium Chloride
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
POTASSIUM CHLORIDE14.9 g/1000mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii660YQ98I10
Rxcui312507, 1860239, 1860241, 1860463, 1860466

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
30b0ac6e-02aa-0e5c-0d8b-cffdf3a282b2Product name520250304
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
f1e0dc7e-7d61-4625-b6d9-4894927679d7Product name220211025
9badc7be-250a-44ab-aa36-926af3f02679Product name120210527
e4870509-7e28-6f92-f0be-dd3dd889a9cfProduct name520200810
0ec3537a-6c9b-432a-896c-b9ea8723049aProduct name920200701
6e9d4a47-c464-b93e-aebc-ad7bffc9c4cdProduct name220190619
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
684ea482-2e8b-14af-5664-b98f1e402036Product name120140508
810ab97e-f109-f41c-7c83-6a652a9cbf43Product name120140508
87711080-88eb-65c5-b2dd-bf99e700a372Product name120140508
8dbefedf-0a0d-a224-5a3c-66dc9e11c2ddProduct name120140508
b060cc1a-fe47-856b-0b77-4448b5963de8Product 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
0338-0705-41Potassium Chloride24 in 1 CARTONINJECTION, SOLUTION2415
0338-0705-41Potassium Chloride50 mL in 1 BAGINJECTION, SOLUTION5015
0338-0705-48Potassium Chloride24 in 1 CARTONINJECTION, SOLUTION2415
0338-0705-48Potassium Chloride100 mL in 1 BAGINJECTION, SOLUTION10015

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0338-0705-41ML - Milliliter0338-0705079fb808-7bf0-4726-8d4d-cb508c8c953112013-02-13
0338-0705-48ML - Milliliter0338-0705fd9c3a99-d373-46dd-adc7-3888e7d3172612013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
POTASSIUM CHLORIDEACTIVE INGREDIENT660YQ98I10POTASSIUM CHLORIDE INJECTION, SOLUTION [BAXTER HEALTHCARE CORPORATION]4
CHLORIDE IONACTIVE MOIETYQ32ZN48698POTASSIUM CHLORIDE INJECTION, SOLUTION [BAXTER HEALTHCARE CORPORATION]4
WATERINACTIVE INGREDIENT059QF0KO0RPOTASSIUM CHLORIDE INJECTION, SOLUTION [BAXTER HEALTHCARE CORPORATION]4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0338-0705POTASSIUM CHLORIDE INJECTION, SOLUTION [BAXTER HEALTHCARE CORPORATION]14Current NDC, Legacy NDC, 4 package rows20250315_092ddee4-572d-4771-8d95-880cea01097e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312507potassium chloride 10 MEQ in 100 ML InjectionPSN092ddee4-572d-4771-8d95-880cea01097e15
1860241potassium chloride 10 MEQ in 50 ML InjectionPSN092ddee4-572d-4771-8d95-880cea01097e15
1860239potassium chloride 20 MEQ in 100 ML InjectionPSN092ddee4-572d-4771-8d95-880cea01097e15
1860466potassium chloride 20 MEQ in 50 ML InjectionPSN092ddee4-572d-4771-8d95-880cea01097e15
1860463potassium chloride 40 MEQ in 100 ML InjectionPSN092ddee4-572d-4771-8d95-880cea01097e15
312507100 ML potassium chloride 0.1 MEQ/ML InjectionSCD092ddee4-572d-4771-8d95-880cea01097e15
1860239100 ML potassium chloride 0.2 MEQ/ML InjectionSCD092ddee4-572d-4771-8d95-880cea01097e15
1860463100 ML potassium chloride 0.4 MEQ/ML InjectionSCD092ddee4-572d-4771-8d95-880cea01097e15
186024150 ML potassium chloride 0.2 MEQ/ML InjectionSCD092ddee4-572d-4771-8d95-880cea01097e15
186046650 ML potassium chloride 0.4 MEQ/ML InjectionSCD092ddee4-572d-4771-8d95-880cea01097e15
312507100 ML K+ Chloride 0.1 MEQ/ML InjectionSY092ddee4-572d-4771-8d95-880cea01097e15
1860239100 ML K+ Chloride 0.2 MEQ/ML InjectionSY092ddee4-572d-4771-8d95-880cea01097e15
1860463100 ML K+ Chloride 0.4 MEQ/ML InjectionSY092ddee4-572d-4771-8d95-880cea01097e15
312507100 ML Pot Chloride 0.1 MEQ/ML InjectionSY092ddee4-572d-4771-8d95-880cea01097e15
1860239100 ML Pot Chloride 0.2 MEQ/ML InjectionSY092ddee4-572d-4771-8d95-880cea01097e15
1860463100 ML Pot Chloride 0.4 MEQ/ML InjectionSY092ddee4-572d-4771-8d95-880cea01097e15
186024150 ML K+ Chloride 0.2 MEQ/ML InjectionSY092ddee4-572d-4771-8d95-880cea01097e15
186046650 ML K+ Chloride 0.4 MEQ/ML InjectionSY092ddee4-572d-4771-8d95-880cea01097e15
186024150 ML Pot Chloride 0.2 MEQ/ML InjectionSY092ddee4-572d-4771-8d95-880cea01097e15
186046650 ML Pot Chloride 0.4 MEQ/ML InjectionSY092ddee4-572d-4771-8d95-880cea01097e15
312507potassium chloride 10 MEQ per 100 ML InjectionSY092ddee4-572d-4771-8d95-880cea01097e15
1860241potassium chloride 10 MEQ per 50 ML InjectionSY092ddee4-572d-4771-8d95-880cea01097e15
1860239potassium chloride 20 MEQ per 100 ML InjectionSY092ddee4-572d-4771-8d95-880cea01097e15
1860466potassium chloride 20 MEQ per 50 ML InjectionSY092ddee4-572d-4771-8d95-880cea01097e15
1860463potassium chloride 40 MEQ per 100 ML InjectionSY092ddee4-572d-4771-8d95-880cea01097e15

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0338-0705-410033807054124 BAG in 1 CARTON (0338-0705-41) / 50 mL in 1 BAG24 bag1989-12-260000-00-00NoNoCurrent
0338-0705-480033807054824 BAG in 1 CARTON (0338-0705-48) / 100 mL in 1 BAG24 bag1989-12-260000-00-00NoNoCurrent