FDA.reportPublic FDA data

Potassium Chloride

Product NDC
53746-542
11-digit product format
537460542
Labeler code
53746
Product ID
53746-542_39798c58-3f69-43f2-b103-9da28abbeeba
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Potassium Chloride
Dosage form
CAPSULE, EXTENDED RELEASE
Route
ORAL
Labeler
Amneal Pharmaceuticals of New York LLC
Application
ANDA202128
Marketing category
ANDA
Marketing start
2013-02-22
Substance
POTASSIUM CHLORIDE
Active strength
750 mg/1
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

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
53746-542-012021-02-04C16284748780-1ba0f9c33-2698-a910-e053-dadaa90a0b85These highlights do not include all the information needed to use POTASSIUM CHLORIDE EXTENDED-RELEASE CAPSULES safely and effectively. See full prescribing information for POTASSIUM CHLORIDE EXTENDED-RELEASE CAPSULES. POTASSIUM CHLORIDE extended-release capsules, for oral use Initial U.S. Approval: 1948
53746-542-012021-02-04C16284748780-1ba0f9c33-2698-a910-e053-dadaa90a0b85These highlights do not include all the information needed to use POTASSIUM CHLORIDE EXTENDED-RELEASE CAPSULES safely and effectively. See full prescribing information for POTASSIUM CHLORIDE EXTENDED-RELEASE CAPSULES. POTASSIUM CHLORIDE extended-release capsules, for oral use Initial U.S. Approval: 1948
53746-542-052021-02-04C16284748780-1ba0f9c33-2698-a910-e053-dadaa90a0b85These highlights do not include all the information needed to use POTASSIUM CHLORIDE EXTENDED-RELEASE CAPSULES safely and effectively. See full prescribing information for POTASSIUM CHLORIDE EXTENDED-RELEASE CAPSULES. POTASSIUM CHLORIDE extended-release capsules, for oral use Initial U.S. Approval: 1948
53746-542-052021-02-04C16284748780-1ba0f9c33-2698-a910-e053-dadaa90a0b85These highlights do not include all the information needed to use POTASSIUM CHLORIDE EXTENDED-RELEASE CAPSULES safely and effectively. See full prescribing information for POTASSIUM CHLORIDE EXTENDED-RELEASE CAPSULES. POTASSIUM CHLORIDE extended-release capsules, for oral use Initial U.S. Approval: 1948
53746-542-102021-02-04C16284748780-1ba0f9c33-2698-a910-e053-dadaa90a0b85These highlights do not include all the information needed to use POTASSIUM CHLORIDE EXTENDED-RELEASE CAPSULES safely and effectively. See full prescribing information for POTASSIUM CHLORIDE EXTENDED-RELEASE CAPSULES. POTASSIUM CHLORIDE extended-release capsules, for oral use Initial U.S. Approval: 1948
53746-542-102021-02-04C16284748780-1ba0f9c33-2698-a910-e053-dadaa90a0b85These highlights do not include all the information needed to use POTASSIUM CHLORIDE EXTENDED-RELEASE CAPSULES safely and effectively. See full prescribing information for POTASSIUM CHLORIDE EXTENDED-RELEASE CAPSULES. POTASSIUM CHLORIDE extended-release capsules, for oral use Initial U.S. Approval: 1948
53746-542-012021-01-29C16284748780-1ba0f9c33-2698-a910-e053-dadaa90a0b85These highlights do not include all the information needed to use POTASSIUM CHLORIDE EXTENDED-RELEASE CAPSULES safely and effectively. See full prescribing information for POTASSIUM CHLORIDE EXTENDED-RELEASE CAPSULES. POTASSIUM CHLORIDE extended-release capsules, for oral use Initial U.S. Approval: 1948
53746-542-012021-01-29C16284748780-1ba0f9c33-2698-a910-e053-dadaa90a0b85These highlights do not include all the information needed to use POTASSIUM CHLORIDE EXTENDED-RELEASE CAPSULES safely and effectively. See full prescribing information for POTASSIUM CHLORIDE EXTENDED-RELEASE CAPSULES. POTASSIUM CHLORIDE extended-release capsules, for oral use Initial U.S. Approval: 1948
53746-542-052021-01-29C16284748780-1ba0f9c33-2698-a910-e053-dadaa90a0b85These highlights do not include all the information needed to use POTASSIUM CHLORIDE EXTENDED-RELEASE CAPSULES safely and effectively. See full prescribing information for POTASSIUM CHLORIDE EXTENDED-RELEASE CAPSULES. POTASSIUM CHLORIDE extended-release capsules, for oral use Initial U.S. Approval: 1948
53746-542-052021-01-29C16284748780-1ba0f9c33-2698-a910-e053-dadaa90a0b85These highlights do not include all the information needed to use POTASSIUM CHLORIDE EXTENDED-RELEASE CAPSULES safely and effectively. See full prescribing information for POTASSIUM CHLORIDE EXTENDED-RELEASE CAPSULES. POTASSIUM CHLORIDE extended-release capsules, for oral use Initial U.S. Approval: 1948
53746-542-102021-01-29C16284748780-1ba0f9c33-2698-a910-e053-dadaa90a0b85These highlights do not include all the information needed to use POTASSIUM CHLORIDE EXTENDED-RELEASE CAPSULES safely and effectively. See full prescribing information for POTASSIUM CHLORIDE EXTENDED-RELEASE CAPSULES. POTASSIUM CHLORIDE extended-release capsules, for oral use Initial U.S. Approval: 1948
53746-542-102021-01-29C16284748780-1ba0f9c33-2698-a910-e053-dadaa90a0b85These highlights do not include all the information needed to use POTASSIUM CHLORIDE EXTENDED-RELEASE CAPSULES safely and effectively. See full prescribing information for POTASSIUM CHLORIDE EXTENDED-RELEASE CAPSULES. POTASSIUM CHLORIDE extended-release capsules, for oral use Initial U.S. Approval: 1948

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53746-542-01Potassium Chloride100 in 1 BOTTLECAPSULE, EXTENDED RELEASE10017
53746-542-05Potassium Chloride500 in 1 BOTTLECAPSULE, EXTENDED RELEASE50017
53746-542-10Potassium Chloride1000 in 1 BOTTLECAPSULE, EXTENDED RELEASE100017

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
53746-542-01EA - Each53746-5425107b9a9-d763-40da-8b8c-2e98a3d1132f12014-07-02
53746-542-05EA - Each53746-5426bba6f36-b3a0-4063-8ad0-ccf99bff6a4e12014-07-02
53746-542-10EA - Each53746-542ce74f1c6-4992-40ae-8bae-b6289379cf9c12014-07-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
POTASSIUM CHLORIDEACTIVE INGREDIENT660YQ98I10POTASSIUM CHLORIDE CAPSULE, EXTENDED RELEASE [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]10
POTASSIUM CATIONACTIVE MOIETY295O53K152POTASSIUM CHLORIDE CAPSULE, EXTENDED RELEASE [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]10
ETHYLCELLULOSESINACTIVE INGREDIENT7Z8S9VYZ4BPOTASSIUM CHLORIDE CAPSULE, EXTENDED RELEASE [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]10
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDPOTASSIUM CHLORIDE CAPSULE, EXTENDED RELEASE [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]10
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAPOTASSIUM CHLORIDE CAPSULE, EXTENDED RELEASE [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]10
GELATININACTIVE INGREDIENT2G86QN327LPOTASSIUM CHLORIDE CAPSULE, EXTENDED RELEASE [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]10
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JPOTASSIUM CHLORIDE CAPSULE, EXTENDED RELEASE [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]10
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPPOTASSIUM CHLORIDE CAPSULE, EXTENDED RELEASE [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]10
TRIETHYL CITRATEINACTIVE INGREDIENT8Z96QXD6UMPOTASSIUM CHLORIDE CAPSULE, EXTENDED RELEASE [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53746-542POTASSIUM CHLORIDE CAPSULE, EXTENDED RELEASE [AMNEAL PHARMACEUTICALS OF NEW YORK LLC]17Current NDC, Legacy NDC, 3 package rows20240413_cd56e147-92d6-46ce-ae00-63fac08d49b5.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312504potassium chloride 10 MEQ Extended Release Oral CapsulePSNcd56e147-92d6-46ce-ae00-63fac08d49b517
312504potassium chloride 10 MEQ Extended Release Oral CapsuleSCDcd56e147-92d6-46ce-ae00-63fac08d49b517
312504K+ Chloride 10 MEQ Extended Release Oral CapsuleSYcd56e147-92d6-46ce-ae00-63fac08d49b517
312504Pot Chloride 10 MEQ Extended Release Oral CapsuleSYcd56e147-92d6-46ce-ae00-63fac08d49b517
312504potassium chloride 750 MG Extended Release Oral CapsuleSYcd56e147-92d6-46ce-ae00-63fac08d49b517
312504potassium chloride 10 MEQ Extended Release Oral CapsulePSN6bb3f62d-79ce-cee6-8c6c-ee1eb6121f016
312504potassium chloride 10 MEQ Extended Release Oral CapsuleSCD6bb3f62d-79ce-cee6-8c6c-ee1eb6121f016
312504K+ Chloride 10 MEQ Extended Release Oral CapsuleSY6bb3f62d-79ce-cee6-8c6c-ee1eb6121f016
312504Pot Chloride 10 MEQ Extended Release Oral CapsuleSY6bb3f62d-79ce-cee6-8c6c-ee1eb6121f016
312504potassium chloride 750 MG Extended Release Oral CapsuleSY6bb3f62d-79ce-cee6-8c6c-ee1eb6121f016
312504potassium chloride 10 MEQ Extended Release Oral CapsulePSN6c080e51-4eb7-4e96-b29f-eb1cce3813041
312504potassium chloride 10 MEQ Extended Release Oral CapsuleSCD6c080e51-4eb7-4e96-b29f-eb1cce3813041
312504K+ Chloride 10 MEQ Extended Release Oral CapsuleSY6c080e51-4eb7-4e96-b29f-eb1cce3813041
312504Pot Chloride 10 MEQ Extended Release Oral CapsuleSY6c080e51-4eb7-4e96-b29f-eb1cce3813041
312504potassium chloride 750 MG Extended Release Oral CapsuleSY6c080e51-4eb7-4e96-b29f-eb1cce3813041

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
53746-542-0153746054201100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (53746-542-01) 2013-02-220000-00-00NoNoCurrent
53746-542-0553746054205500 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (53746-542-05) 2013-02-220000-00-00NoNoCurrent
53746-542-10537460542101000 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (53746-542-10) 2013-02-220000-00-00NoNoCurrent