FDA.reportPublic FDA data

Potassium Chloride

Product NDC
64380-861
11-digit product format
643800861
Labeler code
64380
Product ID
64380-861_a74390de-64e9-482d-8630-d1a2452324fe
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Potassium Chloride
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Strides Pharma Science Limited
Application
ANDA210733
Marketing category
ANDA
Marketing start
2018-11-27
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

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
POTASSIUM CHLORIDE750 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii660YQ98I10
Rxcui312529, 628953

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
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
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
64380-861-062025-03-28C16284748780-12cef2736-7f6f-d83d-e063-dadaa90ab31fThese highlights do not include all the information needed to use Potassium Chloride Extended-release Tablets, USP safely and effectively. See full prescribing information for Potassium Chloride Extended-release Tablets, USP. Potassium Chloride Extended-release Tablets, USP for oral use. Initial U.S. Approval: 1948
64380-861-072025-03-28C16284748780-12cef2736-7f6f-d83d-e063-dadaa90ab31fThese highlights do not include all the information needed to use Potassium Chloride Extended-release Tablets, USP safely and effectively. See full prescribing information for Potassium Chloride Extended-release Tablets, USP. Potassium Chloride Extended-release Tablets, USP for oral use. Initial U.S. Approval: 1948
64380-861-082025-03-28C16284748780-12cef2736-7f6f-d83d-e063-dadaa90ab31fThese highlights do not include all the information needed to use Potassium Chloride Extended-release Tablets, USP safely and effectively. See full prescribing information for Potassium Chloride Extended-release Tablets, USP. Potassium Chloride Extended-release Tablets, USP for oral use. Initial U.S. Approval: 1948
64380-861-062025-01-30C16284748780-12cef2736-7f6f-d83d-e063-dadaa90ab31fThese highlights do not include all the information needed to use Potassium Chloride Extended-release Tablets, USP safely and effectively. See full prescribing information for Potassium Chloride Extended-release Tablets, USP. Potassium Chloride Extended-release Tablets, USP for oral use. Initial U.S. Approval: 1948
64380-861-072025-01-30C16284748780-12cef2736-7f6f-d83d-e063-dadaa90ab31fThese highlights do not include all the information needed to use Potassium Chloride Extended-release Tablets, USP safely and effectively. See full prescribing information for Potassium Chloride Extended-release Tablets, USP. Potassium Chloride Extended-release Tablets, USP for oral use. Initial U.S. Approval: 1948
64380-861-082025-01-30C16284748780-12cef2736-7f6f-d83d-e063-dadaa90ab31fThese highlights do not include all the information needed to use Potassium Chloride Extended-release Tablets, USP safely and effectively. See full prescribing information for Potassium Chloride Extended-release Tablets, USP. Potassium Chloride Extended-release Tablets, USP for oral use. Initial U.S. Approval: 1948

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
64380-861-06Potassium Chloride100 in 1 BOTTLETABLET, EXTENDED RELEASE1007
64380-861-07Potassium Chloride500 in 1 BOTTLETABLET, EXTENDED RELEASE5007
64380-861-08Potassium Chloride1000 in 1 BOTTLETABLET, EXTENDED RELEASE10007

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
64380-861-06EA - Each64380-861ebf6f44f-41e0-4928-a9e8-bf45016e8ce812018-12-13
64380-861-07EA - Each64380-86151b8ec68-4026-4ce5-bcdb-71ef8753028612018-12-13
64380-861-08EA - Each64380-861c4fad470-d472-4b17-81d3-34f8fac779df12018-12-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
64380-861POTASSIUM CHLORIDE TABLET, EXTENDED RELEASE [STRIDES PHARMA SCIENCE LIMITED]7Current NDC, Legacy NDC, 3 package rows20250330_0224e5b3-3c49-4e6e-aa78-1abcc6969246.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
628953potassium chloride 10 MEQ (750 MG) Extended Release Oral TabletPSN0224e5b3-3c49-4e6e-aa78-1abcc69692467
312529potassium chloride 8 MEQ (600 MG) Extended Release Oral TabletPSN0224e5b3-3c49-4e6e-aa78-1abcc69692467
628953potassium chloride 10 MEQ Extended Release Oral TabletSCD0224e5b3-3c49-4e6e-aa78-1abcc69692467
312529potassium chloride 8 MEQ Extended Release Oral TabletSCD0224e5b3-3c49-4e6e-aa78-1abcc69692467
628953K+ Chloride 10 MEQ Extended Release Oral TabletSY0224e5b3-3c49-4e6e-aa78-1abcc69692467
312529K+ Chloride 8 MEQ Extended Release Oral TabletSY0224e5b3-3c49-4e6e-aa78-1abcc69692467
628953Pot Chloride 10 MEQ Extended Release Oral TabletSY0224e5b3-3c49-4e6e-aa78-1abcc69692467
312529Pot Chloride 8 MEQ Extended Release Oral TabletSY0224e5b3-3c49-4e6e-aa78-1abcc69692467
312529potassium chloride 600 MG Extended Release Oral TabletSY0224e5b3-3c49-4e6e-aa78-1abcc69692467
628953potassium chloride 750 MG (potassium 10 mEq) Extended Release Oral TabletSY0224e5b3-3c49-4e6e-aa78-1abcc69692467
628953potassium chloride 750 MG Extended Release Oral TabletSY0224e5b3-3c49-4e6e-aa78-1abcc69692467
628953potassium chloride 10 MEQ (750 MG) Extended Release Oral TabletPSN946b9568-671d-172a-e053-2a95a90ac8276
628953potassium chloride 10 MEQ Extended Release Oral TabletSCD946b9568-671d-172a-e053-2a95a90ac8276
628953K+ Chloride 10 MEQ Extended Release Oral TabletSY946b9568-671d-172a-e053-2a95a90ac8276
628953Pot Chloride 10 MEQ Extended Release Oral TabletSY946b9568-671d-172a-e053-2a95a90ac8276
628953potassium chloride 750 MG (potassium 10 mEq) Extended Release Oral TabletSY946b9568-671d-172a-e053-2a95a90ac8276
628953potassium chloride 750 MG Extended Release Oral TabletSY946b9568-671d-172a-e053-2a95a90ac8276
628953potassium chloride 10 MEQ (750 MG) Extended Release Oral TabletPSNa344a6e7-77e4-4a78-e053-2995a90a03925
628953potassium chloride 10 MEQ Extended Release Oral TabletSCDa344a6e7-77e4-4a78-e053-2995a90a03925
628953K+ Chloride 10 MEQ Extended Release Oral TabletSYa344a6e7-77e4-4a78-e053-2995a90a03925
628953Pot Chloride 10 MEQ Extended Release Oral TabletSYa344a6e7-77e4-4a78-e053-2995a90a03925
628953potassium chloride 750 MG (potassium 10 mEq) Extended Release Oral TabletSYa344a6e7-77e4-4a78-e053-2995a90a03925
628953potassium chloride 750 MG Extended Release Oral TabletSYa344a6e7-77e4-4a78-e053-2995a90a03925
628953potassium chloride 10 MEQ (750 MG) Extended Release Oral TabletPSNab147ac2-d7d5-46d1-a2de-d866219197c14
628953potassium chloride 10 MEQ Extended Release Oral TabletSCDab147ac2-d7d5-46d1-a2de-d866219197c14
628953K+ Chloride 10 MEQ Extended Release Oral TabletSYab147ac2-d7d5-46d1-a2de-d866219197c14
628953Pot Chloride 10 MEQ Extended Release Oral TabletSYab147ac2-d7d5-46d1-a2de-d866219197c14
628953potassium chloride 750 MG (potassium 10 mEq) Extended Release Oral TabletSYab147ac2-d7d5-46d1-a2de-d866219197c14
628953potassium chloride 750 MG Extended Release Oral TabletSYab147ac2-d7d5-46d1-a2de-d866219197c14
628953potassium chloride 10 MEQ (750 MG) Extended Release Oral TabletPSNdb4dc4ab-e0d4-7dc7-e053-2995a90ac46e2
628953potassium chloride 10 MEQ Extended Release Oral TabletSCDdb4dc4ab-e0d4-7dc7-e053-2995a90ac46e2
628953K+ Chloride 10 MEQ Extended Release Oral TabletSYdb4dc4ab-e0d4-7dc7-e053-2995a90ac46e2
628953Pot Chloride 10 MEQ Extended Release Oral TabletSYdb4dc4ab-e0d4-7dc7-e053-2995a90ac46e2
628953potassium chloride 750 MG (potassium 10 mEq) Extended Release Oral TabletSYdb4dc4ab-e0d4-7dc7-e053-2995a90ac46e2
628953potassium chloride 750 MG Extended Release Oral TabletSYdb4dc4ab-e0d4-7dc7-e053-2995a90ac46e2
628953potassium chloride 10 MEQ (750 MG) Extended Release Oral TabletPSN495e8de7-41c1-40fc-8af5-3c54807161191
628953potassium chloride 10 MEQ Extended Release Oral TabletSCD495e8de7-41c1-40fc-8af5-3c54807161191
628953K+ Chloride 10 MEQ Extended Release Oral TabletSY495e8de7-41c1-40fc-8af5-3c54807161191
628953Pot Chloride 10 MEQ Extended Release Oral TabletSY495e8de7-41c1-40fc-8af5-3c54807161191
628953potassium chloride 750 MG (potassium 10 mEq) Extended Release Oral TabletSY495e8de7-41c1-40fc-8af5-3c54807161191
628953potassium chloride 750 MG Extended Release Oral TabletSY495e8de7-41c1-40fc-8af5-3c54807161191

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
64380-861-0664380086106100 TABLET, EXTENDED RELEASE in 1 BOTTLE (64380-861-06) 2018-11-270000-00-00NoNoCurrent
64380-861-0764380086107500 TABLET, EXTENDED RELEASE in 1 BOTTLE (64380-861-07) 2018-11-270000-00-00NoNoCurrent
64380-861-08643800861081000 TABLET, EXTENDED RELEASE in 1 BOTTLE (64380-861-08) 2018-11-270000-00-00NoNoCurrent