FDA.reportPublic FDA data

Potassium Chloride

Product NDC
65162-542
11-digit product format
651620542
Labeler code
65162
Product ID
65162-542_e58924cd-e819-4527-9101-d181aa4882f0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Potassium Chloride
Dosage form
CAPSULE, EXTENDED RELEASE
Route
ORAL
Labeler
Amneal Pharmaceuticals
Application
ANDA202128
Marketing category
ANDA
Marketing start
2013-02-22
Marketing end
0000-00-00
Substance
POTASSIUM CHLORIDE
Active strength
750 mg/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
E
Listing certified through
2017-12-31
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
65162-542-102019-11-27C16284748780-19855d018-d961-cd31-e053-dbdaa90ab51aPOTASSIUM CHLORIDE EXTENDED-RELEASE CAPSULES, USP, 10 mEq
65162-542-112019-11-27C16284748780-19855d018-d961-cd31-e053-dbdaa90ab51aPOTASSIUM CHLORIDE EXTENDED-RELEASE CAPSULES, USP, 10 mEq
65162-542-502019-11-27C16284748780-19855d018-d961-cd31-e053-dbdaa90ab51aPOTASSIUM CHLORIDE EXTENDED-RELEASE CAPSULES, USP, 10 mEq

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
65162-542-10Potassium Chloride100 in 1 BOTTLECAPSULE, EXTENDED RELEASE1003
65162-542-11Potassium Chloride1000 in 1 BOTTLECAPSULE, EXTENDED RELEASE10003
65162-542-50Potassium Chloride500 in 1 BOTTLECAPSULE, EXTENDED RELEASE5003

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
65162-542-10EA - Each65162-5425c1bee68-01ac-4d4d-af92-fa5eaf1f9c3212013-04-01
65162-542-11EA - Each65162-542c8424bd8-2f82-4c14-8e60-cf7f389b78b212013-04-01
65162-542-50EA - Each65162-542174e23a5-54a2-46ed-a904-7523afe1a46812013-04-01

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
POTASSIUM CHLORIDEACTIVE INGREDIENT660YQ98I10POTASSIUM CHLORIDE CAPSULE, EXTENDED RELEASE [AMNEAL PHARMACEUTICALS]3
POTASSIUM CATIONACTIVE MOIETY295O53K152POTASSIUM CHLORIDE CAPSULE, EXTENDED RELEASE [AMNEAL PHARMACEUTICALS]3
ETHYLCELLULOSESINACTIVE INGREDIENT7Z8S9VYZ4BPOTASSIUM CHLORIDE CAPSULE, EXTENDED RELEASE [AMNEAL PHARMACEUTICALS]3
GELATININACTIVE INGREDIENT2G86QN327LPOTASSIUM CHLORIDE CAPSULE, EXTENDED RELEASE [AMNEAL PHARMACEUTICALS]3
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JPOTASSIUM CHLORIDE CAPSULE, EXTENDED RELEASE [AMNEAL PHARMACEUTICALS]3
TRIETHYL CITRATEINACTIVE INGREDIENT8Z96QXD6UMPOTASSIUM CHLORIDE CAPSULE, EXTENDED RELEASE [AMNEAL PHARMACEUTICALS]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65162-542POTASSIUM CHLORIDE CAPSULE, EXTENDED RELEASE [AMNEAL PHARMACEUTICALS]3Legacy NDC, 3 package rows20130225_94c1c765-7ede-419a-ad5a-fcaac8f67a8a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312504potassium chloride 10 MEQ Extended Release Oral CapsulePSN94c1c765-7ede-419a-ad5a-fcaac8f67a8a3
312504potassium chloride 10 MEQ Extended Release Oral CapsuleSCD94c1c765-7ede-419a-ad5a-fcaac8f67a8a3
312504K+ Chloride 10 MEQ Extended Release Oral CapsuleSY94c1c765-7ede-419a-ad5a-fcaac8f67a8a3
312504Pot Chloride 10 MEQ Extended Release Oral CapsuleSY94c1c765-7ede-419a-ad5a-fcaac8f67a8a3
312504potassium chloride 750 MG Extended Release Oral CapsuleSY94c1c765-7ede-419a-ad5a-fcaac8f67a8a3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
65162-542-1065162054210100 in 1 BOTTLEHistorical
65162-542-11651620542111000 in 1 BOTTLEHistorical
65162-542-5065162054250500 in 1 BOTTLEHistorical