FDA.reportPublic FDA data

Potassium Chloride

Product NDC
43353-215
11-digit product format
433530215
Labeler code
43353
Product ID
43353-215_781c4c71-059d-40d0-bcd3-0867dcb550f3
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
potassium chloride
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Aphena Pharma Solutions - Tennessee, LLC
Application
ANDA076368
Marketing category
ANDA
Marketing start
2004-08-18
Marketing end
0000-00-00
Substance
POTASSIUM CHLORIDE
Active strength
20 meq/1
Pharmacologic classes
Potassium Compounds [CS],Potassium Salt [EPC],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA]
NDC exclude flag
No
Listing certified through
2019-12-31
Current FDA listing
Historical FDA.report record

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
43353-215-302020-01-31C16284748780-19d75b9d0-d339-f424-e053-dadaa90a57cePOTASSIUM CHLORIDE EXTENDED RELEASE TABLETS USP 20 mEq K Rx Only 173714
43353-215-452020-01-31C16284748780-19d75b9d0-d339-f424-e053-dadaa90a57cePOTASSIUM CHLORIDE EXTENDED RELEASE TABLETS USP 20 mEq K Rx Only 173714
43353-215-532020-01-31C16284748780-19d75b9d0-d339-f424-e053-dadaa90a57cePOTASSIUM CHLORIDE EXTENDED RELEASE TABLETS USP 20 mEq K Rx Only 173714
43353-215-602020-01-31C16284748780-19d75b9d0-d339-f424-e053-dadaa90a57cePOTASSIUM CHLORIDE EXTENDED RELEASE TABLETS USP 20 mEq K Rx Only 173714
43353-215-702020-01-31C16284748780-19d75b9d0-d339-f424-e053-dadaa90a57cePOTASSIUM CHLORIDE EXTENDED RELEASE TABLETS USP 20 mEq K Rx Only 173714
43353-215-732020-01-31C16284748780-19d75b9d0-d339-f424-e053-dadaa90a57cePOTASSIUM CHLORIDE EXTENDED RELEASE TABLETS USP 20 mEq K Rx Only 173714
43353-215-802020-01-31C16284748780-19d75b9d0-d339-f424-e053-dadaa90a57cePOTASSIUM CHLORIDE EXTENDED RELEASE TABLETS USP 20 mEq K Rx Only 173714
43353-215-922020-01-31C16284748780-19d75b9d0-d339-f424-e053-dadaa90a57cePOTASSIUM CHLORIDE EXTENDED RELEASE TABLETS USP 20 mEq K Rx Only 173714

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
43353-215-30Potassium Chloride30 in 1 BOTTLE, PLASTICTABLET, EXTENDED RELEASE302
43353-215-45Potassium Chloride45 in 1 BOTTLE, PLASTICTABLET, EXTENDED RELEASE452
43353-215-53Potassium Chloride60 in 1 BOTTLE, PLASTICTABLET, EXTENDED RELEASE602
43353-215-60Potassium Chloride90 in 1 BOTTLE, PLASTICTABLET, EXTENDED RELEASE902
43353-215-70Potassium Chloride120 in 1 BOTTLE, PLASTICTABLET, EXTENDED RELEASE1202
43353-215-73Potassium Chloride135 in 1 BOTTLE, PLASTICTABLET, EXTENDED RELEASE1352
43353-215-80Potassium Chloride180 in 1 BOTTLE, PLASTICTABLET, EXTENDED RELEASE1802
43353-215-92Potassium Chloride270 in 1 BOTTLE, PLASTICTABLET, EXTENDED RELEASE2702

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43353-215POTASSIUM CHLORIDE TABLET, EXTENDED RELEASE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]2Legacy NDC, 8 package rows20140507_f11e34a4-3206-4b2b-ba87-0312785d829b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1801294potassium chloride 20 MEQ Microencapsulated Extended Release Oral TabletPSNf11e34a4-3206-4b2b-ba87-0312785d829b2
1801294Microencapsulated potassium chloride 20 MEQ Extended Release Oral TabletSCDf11e34a4-3206-4b2b-ba87-0312785d829b2
1801294Microencapsulated K+ Chloride 20 MEQ Extended Release Oral TabletSYf11e34a4-3206-4b2b-ba87-0312785d829b2
1801294Microencapsulated Pot Chloride 20 MEQ Extended Release Oral TabletSYf11e34a4-3206-4b2b-ba87-0312785d829b2
1801294potassium chloride 1500 MG Microencapsulated Extended Release Oral TabletSYf11e34a4-3206-4b2b-ba87-0312785d829b2
1801294potassium chloride 20 MEQ Microencapsulated Extended Release Oral TabletSYf11e34a4-3206-4b2b-ba87-0312785d829b2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
43353-215-304335302153030 in 1 BOTTLE, PLASTICHistorical
43353-215-454335302154545 in 1 BOTTLE, PLASTICHistorical
43353-215-534335302155360 in 1 BOTTLE, PLASTICHistorical
43353-215-604335302156090 in 1 BOTTLE, PLASTICHistorical
43353-215-7043353021570120 in 1 BOTTLE, PLASTICHistorical
43353-215-7343353021573135 in 1 BOTTLE, PLASTICHistorical
43353-215-8043353021580180 in 1 BOTTLE, PLASTICHistorical
43353-215-9243353021592270 in 1 BOTTLE, PLASTICHistorical