FDA.reportPublic FDA data

Potassium Chloride

Product NDC
65862-987
11-digit product format
658620987
Labeler code
65862
Product ID
65862-987_43cc6b36-fcf7-4e43-b66a-00eecc48d0a7
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Potassium Chloride
Dosage form
TABLET, FILM COATED, EXTENDED RELEASE
Route
ORAL
Labeler
Aurobindo Pharma Limited
Application
ANDA210921
Marketing category
ANDA
Marketing start
2018-12-19
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
65862-987-01Potassium Chloride100 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE1004
65862-987-04Potassium Chloride4 in 1 BLISTER PACKTABLET, FILM COATED, EXTENDED RE44
65862-987-06Potassium Chloride6 in 1 BLISTER PACKTABLET, FILM COATED, EXTENDED RE64
65862-987-12Potassium Chloride120 in 1 CARTONTABLET, FILM COATED, EXTENDED RE1204
65862-987-80Potassium Chloride80 in 1 CARTONTABLET, FILM COATED, EXTENDED RE804
65862-987-99Potassium Chloride1000 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE10004

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65862-987POTASSIUM CHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [AUROBINDO PHARMA LIMITED]4Current NDC, Legacy NDC, 6 package rows20210501_d43beabe-b801-4319-ad36-9a80856b94bd.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
628953potassium chloride 10 MEQ (750 MG) Extended Release Oral TabletPSN16c775e4-0dd8-4e9f-b2bf-dd2b639374cf12
628953potassium chloride 10 MEQ Extended Release Oral TabletSCD16c775e4-0dd8-4e9f-b2bf-dd2b639374cf12
628953K+ Chloride 10 MEQ Extended Release Oral TabletSY16c775e4-0dd8-4e9f-b2bf-dd2b639374cf12
628953Pot Chloride 10 MEQ Extended Release Oral TabletSY16c775e4-0dd8-4e9f-b2bf-dd2b639374cf12
628953potassium chloride 750 MG (potassium 10 mEq) Extended Release Oral TabletSY16c775e4-0dd8-4e9f-b2bf-dd2b639374cf12
628953potassium chloride 750 MG Extended Release Oral TabletSY16c775e4-0dd8-4e9f-b2bf-dd2b639374cf12
628953potassium chloride 10 MEQ (750 MG) Extended Release Oral TabletPSNe1670127-c551-441b-bac4-39f10a6d156f9
628953potassium chloride 10 MEQ Extended Release Oral TabletSCDe1670127-c551-441b-bac4-39f10a6d156f9
628953K+ Chloride 10 MEQ Extended Release Oral TabletSYe1670127-c551-441b-bac4-39f10a6d156f9
628953Pot Chloride 10 MEQ Extended Release Oral TabletSYe1670127-c551-441b-bac4-39f10a6d156f9
628953potassium chloride 750 MG (potassium 10 mEq) Extended Release Oral TabletSYe1670127-c551-441b-bac4-39f10a6d156f9
628953potassium chloride 750 MG Extended Release Oral TabletSYe1670127-c551-441b-bac4-39f10a6d156f9
628953potassium chloride 10 MEQ (750 MG) Extended Release Oral TabletPSNa9d68a40-75e3-4c5c-b5d7-1d6160527fa74
628953potassium chloride 10 MEQ (750 MG) Extended Release Oral TabletPSNd43beabe-b801-4319-ad36-9a80856b94bd4
628953potassium chloride 10 MEQ (750 MG) Extended Release Oral TabletPSN3f19ed0e-6c73-482c-94d6-d3205318fd6f4
312529potassium chloride 8 MEQ (600 MG) Extended Release Oral TabletPSNd43beabe-b801-4319-ad36-9a80856b94bd4
628953potassium chloride 10 MEQ Extended Release Oral TabletSCD3f19ed0e-6c73-482c-94d6-d3205318fd6f4
628953potassium chloride 10 MEQ Extended Release Oral TabletSCDd43beabe-b801-4319-ad36-9a80856b94bd4
628953potassium chloride 10 MEQ Extended Release Oral TabletSCDa9d68a40-75e3-4c5c-b5d7-1d6160527fa74
312529potassium chloride 8 MEQ Extended Release Oral TabletSCDd43beabe-b801-4319-ad36-9a80856b94bd4
628953K+ Chloride 10 MEQ Extended Release Oral TabletSY3f19ed0e-6c73-482c-94d6-d3205318fd6f4
628953K+ Chloride 10 MEQ Extended Release Oral TabletSYd43beabe-b801-4319-ad36-9a80856b94bd4
628953K+ Chloride 10 MEQ Extended Release Oral TabletSYa9d68a40-75e3-4c5c-b5d7-1d6160527fa74
312529K+ Chloride 8 MEQ Extended Release Oral TabletSYd43beabe-b801-4319-ad36-9a80856b94bd4
628953Pot Chloride 10 MEQ Extended Release Oral TabletSY3f19ed0e-6c73-482c-94d6-d3205318fd6f4
628953Pot Chloride 10 MEQ Extended Release Oral TabletSYd43beabe-b801-4319-ad36-9a80856b94bd4
628953Pot Chloride 10 MEQ Extended Release Oral TabletSYa9d68a40-75e3-4c5c-b5d7-1d6160527fa74
312529Pot Chloride 8 MEQ Extended Release Oral TabletSYd43beabe-b801-4319-ad36-9a80856b94bd4
312529potassium chloride 600 MG Extended Release Oral TabletSYd43beabe-b801-4319-ad36-9a80856b94bd4
628953potassium chloride 750 MG (potassium 10 mEq) Extended Release Oral TabletSYd43beabe-b801-4319-ad36-9a80856b94bd4
628953potassium chloride 750 MG (potassium 10 mEq) Extended Release Oral TabletSY3f19ed0e-6c73-482c-94d6-d3205318fd6f4
628953potassium chloride 750 MG (potassium 10 mEq) Extended Release Oral TabletSYa9d68a40-75e3-4c5c-b5d7-1d6160527fa74
628953potassium chloride 750 MG Extended Release Oral TabletSY3f19ed0e-6c73-482c-94d6-d3205318fd6f4
628953potassium chloride 750 MG Extended Release Oral TabletSYa9d68a40-75e3-4c5c-b5d7-1d6160527fa74
628953potassium chloride 750 MG Extended Release Oral TabletSYd43beabe-b801-4319-ad36-9a80856b94bd4
628953potassium chloride 10 MEQ (750 MG) Extended Release Oral TabletPSNf3081031-8234-5732-e053-2995a90aebeb2
628953potassium chloride 10 MEQ Extended Release Oral TabletSCDf3081031-8234-5732-e053-2995a90aebeb2
628953K+ Chloride 10 MEQ Extended Release Oral TabletSYf3081031-8234-5732-e053-2995a90aebeb2
628953Pot Chloride 10 MEQ Extended Release Oral TabletSYf3081031-8234-5732-e053-2995a90aebeb2
628953potassium chloride 750 MG (potassium 10 mEq) Extended Release Oral TabletSYf3081031-8234-5732-e053-2995a90aebeb2
628953potassium chloride 750 MG Extended Release Oral TabletSYf3081031-8234-5732-e053-2995a90aebeb2
628953potassium chloride 10 MEQ (750 MG) Extended Release Oral TabletPSNa67f5ba7-ac23-4bdc-9563-cb7fd049a9511
628953potassium chloride 10 MEQ (750 MG) Extended Release Oral TabletPSN3dfa63fc-f8de-f1e0-e063-6294a90a8d471
628953potassium chloride 10 MEQ Extended Release Oral TabletSCDa67f5ba7-ac23-4bdc-9563-cb7fd049a9511
628953potassium chloride 10 MEQ Extended Release Oral TabletSCD3dfa63fc-f8de-f1e0-e063-6294a90a8d471
628953K+ Chloride 10 MEQ Extended Release Oral TabletSYa67f5ba7-ac23-4bdc-9563-cb7fd049a9511
628953K+ Chloride 10 MEQ Extended Release Oral TabletSY3dfa63fc-f8de-f1e0-e063-6294a90a8d471
628953Pot Chloride 10 MEQ Extended Release Oral TabletSY3dfa63fc-f8de-f1e0-e063-6294a90a8d471
628953Pot Chloride 10 MEQ Extended Release Oral TabletSYa67f5ba7-ac23-4bdc-9563-cb7fd049a9511
628953potassium chloride 750 MG (potassium 10 mEq) Extended Release Oral TabletSY3dfa63fc-f8de-f1e0-e063-6294a90a8d471
628953potassium chloride 750 MG (potassium 10 mEq) Extended Release Oral TabletSYa67f5ba7-ac23-4bdc-9563-cb7fd049a9511
628953potassium chloride 750 MG Extended Release Oral TabletSYa67f5ba7-ac23-4bdc-9563-cb7fd049a9511
628953potassium chloride 750 MG Extended Release Oral TabletSY3dfa63fc-f8de-f1e0-e063-6294a90a8d471

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
65862-987-0165862098701100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (65862-987-01) 2018-12-190000-00-00NoNoCurrent
65862-987-04658620987044 in 1 BLISTER PACKHistorical
65862-987-06658620987066 in 1 BLISTER PACKHistorical
65862-987-1265862098712120 BLISTER PACK in 1 CARTON (65862-987-12) / 6 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK (65862-987-06) 120 blister pack2018-12-190000-00-00NoNoCurrent
65862-987-806586209878080 BLISTER PACK in 1 CARTON (65862-987-80) / 4 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK (65862-987-04) 80 blister pack2018-12-190000-00-00NoNoCurrent
65862-987-99658620987991000 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (65862-987-99) 2018-12-190000-00-00NoNoCurrent