FDA.reportPublic FDA data

Potassium Chloride Extended-Release

Product NDC
63304-076
11-digit product format
633040076
Labeler code
63304
Product ID
63304-076_0e924cf6-53b8-28c4-e063-6294a90a4ac4
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Potassium Chloride
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Sun Pharmaceutical Industries, Inc.
Application
ANDA076368
Marketing category
ANDA
Marketing start
2019-11-20
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 Extended-Release
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
POTASSIUM CHLORIDE750 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii660YQ98I10
Rxcui1801298

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63304-076-01Potassium Chloride Extended-Release100 in 1 BOTTLETABLET, EXTENDED RELEASE1006
63304-076-05Potassium Chloride Extended-Release500 in 1 BOTTLETABLET, EXTENDED RELEASE5006
63304-076-10Potassium Chloride Extended-Release1000 in 1 BOTTLETABLET, EXTENDED RELEASE10006

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63304-076-01EA - Each63304-076da9d1afe-6ead-453d-ba9a-7e229b7cc72e12019-12-10
63304-076-05EA - Each63304-0762fb65909-8c50-4b8f-9a91-d26c0f090e1012019-12-10
63304-076-10EA - Each63304-0766d96192b-8871-4d9c-99a3-489eb1af517512019-12-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63304-076POTASSIUM CHLORIDE EXTENDED-RELEASE (POTASSIUM CHLORIDE) TABLET, EXTENDED RELEASE [SUN PHARMACEUTICAL INDUSTRIES, INC.]6Current NDC, Legacy NDC, 3 package rows20240110_8ed8ea55-8b15-f718-e053-2a95a90a587a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1801298potassium chloride 10 MEQ Microencapsulated Extended Release Oral TabletPSN863e6980-4a66-48a5-a14f-828a00480c93106
1801298Microencapsulated potassium chloride 10 MEQ Extended Release Oral TabletSCD863e6980-4a66-48a5-a14f-828a00480c93106
1801298Microencapsulated K+ Chloride 10 MEQ Extended Release Oral TabletSY863e6980-4a66-48a5-a14f-828a00480c93106
1801298Microencapsulated Pot Chloride 10 MEQ Extended Release Oral TabletSY863e6980-4a66-48a5-a14f-828a00480c93106
1801298potassium chloride 10 MEQ Microencapsulated Extended Release Oral TabletSY863e6980-4a66-48a5-a14f-828a00480c93106
1801298potassium chloride 750 MG Microencapsulated Extended Release OralSY863e6980-4a66-48a5-a14f-828a00480c93106
1801298potassium chloride 10 MEQ Microencapsulated Extended Release Oral TabletPSNb5a6b6f2-d073-4bd3-a66c-bf34ccabfe51103
1801298Microencapsulated potassium chloride 10 MEQ Extended Release Oral TabletSCDb5a6b6f2-d073-4bd3-a66c-bf34ccabfe51103
1801298Microencapsulated K+ Chloride 10 MEQ Extended Release Oral TabletSYb5a6b6f2-d073-4bd3-a66c-bf34ccabfe51103
1801298Microencapsulated Pot Chloride 10 MEQ Extended Release Oral TabletSYb5a6b6f2-d073-4bd3-a66c-bf34ccabfe51103
1801298potassium chloride 10 MEQ Microencapsulated Extended Release Oral TabletSYb5a6b6f2-d073-4bd3-a66c-bf34ccabfe51103
1801298potassium chloride 750 MG Microencapsulated Extended Release OralSYb5a6b6f2-d073-4bd3-a66c-bf34ccabfe51103
1801298potassium chloride 10 MEQ Microencapsulated Extended Release Oral TabletPSN1b64b0c9-31a2-4ee7-8818-66de906ebeda100
1801298potassium chloride 10 MEQ Microencapsulated Extended Release Oral TabletPSN6fc9eef0-3dfc-4344-85c7-9f11d9b99b65100
1801298potassium chloride 10 MEQ Microencapsulated Extended Release Oral TabletPSNff44dcd5-b255-4d80-83ee-3c8f922c99eb100
1801298potassium chloride 10 MEQ Microencapsulated Extended Release Oral TabletPSN2feda15e-f325-41fe-a442-41a8cc62b855100
1801298Microencapsulated potassium chloride 10 MEQ Extended Release Oral TabletSCD2feda15e-f325-41fe-a442-41a8cc62b855100
1801298Microencapsulated potassium chloride 10 MEQ Extended Release Oral TabletSCDff44dcd5-b255-4d80-83ee-3c8f922c99eb100
1801298Microencapsulated potassium chloride 10 MEQ Extended Release Oral TabletSCD1b64b0c9-31a2-4ee7-8818-66de906ebeda100
1801298Microencapsulated potassium chloride 10 MEQ Extended Release Oral TabletSCD6fc9eef0-3dfc-4344-85c7-9f11d9b99b65100
1801298Microencapsulated K+ Chloride 10 MEQ Extended Release Oral TabletSY2feda15e-f325-41fe-a442-41a8cc62b855100
1801298Microencapsulated K+ Chloride 10 MEQ Extended Release Oral TabletSYff44dcd5-b255-4d80-83ee-3c8f922c99eb100
1801298Microencapsulated K+ Chloride 10 MEQ Extended Release Oral TabletSY1b64b0c9-31a2-4ee7-8818-66de906ebeda100
1801298Microencapsulated K+ Chloride 10 MEQ Extended Release Oral TabletSY6fc9eef0-3dfc-4344-85c7-9f11d9b99b65100
1801298Microencapsulated Pot Chloride 10 MEQ Extended Release Oral TabletSYff44dcd5-b255-4d80-83ee-3c8f922c99eb100
1801298Microencapsulated Pot Chloride 10 MEQ Extended Release Oral TabletSY1b64b0c9-31a2-4ee7-8818-66de906ebeda100
1801298Microencapsulated Pot Chloride 10 MEQ Extended Release Oral TabletSY6fc9eef0-3dfc-4344-85c7-9f11d9b99b65100
1801298Microencapsulated Pot Chloride 10 MEQ Extended Release Oral TabletSY2feda15e-f325-41fe-a442-41a8cc62b855100
1801298potassium chloride 10 MEQ Microencapsulated Extended Release Oral TabletSY6fc9eef0-3dfc-4344-85c7-9f11d9b99b65100
1801298potassium chloride 10 MEQ Microencapsulated Extended Release Oral TabletSYff44dcd5-b255-4d80-83ee-3c8f922c99eb100
1801298potassium chloride 10 MEQ Microencapsulated Extended Release Oral TabletSY1b64b0c9-31a2-4ee7-8818-66de906ebeda100
1801298potassium chloride 10 MEQ Microencapsulated Extended Release Oral TabletSY2feda15e-f325-41fe-a442-41a8cc62b855100
1801298potassium chloride 750 MG Microencapsulated Extended Release OralSY1b64b0c9-31a2-4ee7-8818-66de906ebeda100
1801298potassium chloride 750 MG Microencapsulated Extended Release OralSY6fc9eef0-3dfc-4344-85c7-9f11d9b99b65100
1801298potassium chloride 750 MG Microencapsulated Extended Release OralSY2feda15e-f325-41fe-a442-41a8cc62b855100
1801298potassium chloride 750 MG Microencapsulated Extended Release OralSYff44dcd5-b255-4d80-83ee-3c8f922c99eb100
1801298potassium chloride 10 MEQ Microencapsulated Extended Release Oral TabletPSN7427c29e-55c1-4c30-b091-058c8bec592f8
1801298potassium chloride 10 MEQ Microencapsulated Extended Release Oral TabletPSN80dd5de2-5066-472b-b1f8-88070a5c73888
1801298potassium chloride 10 MEQ Microencapsulated Extended Release Oral TabletPSN473369cb-3a9b-437c-b08e-8fb38034c5078
1801298Microencapsulated potassium chloride 10 MEQ Extended Release Oral TabletSCD80dd5de2-5066-472b-b1f8-88070a5c73888
1801298Microencapsulated potassium chloride 10 MEQ Extended Release Oral TabletSCD473369cb-3a9b-437c-b08e-8fb38034c5078
1801298Microencapsulated potassium chloride 10 MEQ Extended Release Oral TabletSCD7427c29e-55c1-4c30-b091-058c8bec592f8
1801298Microencapsulated K+ Chloride 10 MEQ Extended Release Oral TabletSY7427c29e-55c1-4c30-b091-058c8bec592f8
1801298Microencapsulated K+ Chloride 10 MEQ Extended Release Oral TabletSY80dd5de2-5066-472b-b1f8-88070a5c73888
1801298Microencapsulated K+ Chloride 10 MEQ Extended Release Oral TabletSY473369cb-3a9b-437c-b08e-8fb38034c5078
1801298Microencapsulated Pot Chloride 10 MEQ Extended Release Oral TabletSY473369cb-3a9b-437c-b08e-8fb38034c5078
1801298Microencapsulated Pot Chloride 10 MEQ Extended Release Oral TabletSY80dd5de2-5066-472b-b1f8-88070a5c73888
1801298Microencapsulated Pot Chloride 10 MEQ Extended Release Oral TabletSY7427c29e-55c1-4c30-b091-058c8bec592f8
1801298potassium chloride 10 MEQ Microencapsulated Extended Release Oral TabletSY473369cb-3a9b-437c-b08e-8fb38034c5078
1801298potassium chloride 10 MEQ Microencapsulated Extended Release Oral TabletSY80dd5de2-5066-472b-b1f8-88070a5c73888
1801298potassium chloride 10 MEQ Microencapsulated Extended Release Oral TabletSY7427c29e-55c1-4c30-b091-058c8bec592f8
1801298potassium chloride 750 MG Microencapsulated Extended Release OralSY473369cb-3a9b-437c-b08e-8fb38034c5078
1801298potassium chloride 750 MG Microencapsulated Extended Release OralSY80dd5de2-5066-472b-b1f8-88070a5c73888
1801298potassium chloride 750 MG Microencapsulated Extended Release OralSY7427c29e-55c1-4c30-b091-058c8bec592f8
1801298potassium chloride 10 MEQ Microencapsulated Extended Release Oral TabletPSN55747ef3-9437-4bdc-9ebd-a74d8e2de1cf7
1801298Microencapsulated potassium chloride 10 MEQ Extended Release Oral TabletSCD55747ef3-9437-4bdc-9ebd-a74d8e2de1cf7
1801298Microencapsulated K+ Chloride 10 MEQ Extended Release Oral TabletSY55747ef3-9437-4bdc-9ebd-a74d8e2de1cf7
1801298Microencapsulated Pot Chloride 10 MEQ Extended Release Oral TabletSY55747ef3-9437-4bdc-9ebd-a74d8e2de1cf7
1801298potassium chloride 10 MEQ Microencapsulated Extended Release Oral TabletSY55747ef3-9437-4bdc-9ebd-a74d8e2de1cf7
1801298potassium chloride 750 MG Microencapsulated Extended Release OralSY55747ef3-9437-4bdc-9ebd-a74d8e2de1cf7
1801298potassium chloride 10 MEQ Microencapsulated Extended Release Oral TabletPSN8ed8ea55-8b15-f718-e053-2a95a90a587a6
1801298Microencapsulated potassium chloride 10 MEQ Extended Release Oral TabletSCD8ed8ea55-8b15-f718-e053-2a95a90a587a6
1801298Microencapsulated K+ Chloride 10 MEQ Extended Release Oral TabletSY8ed8ea55-8b15-f718-e053-2a95a90a587a6
1801298Microencapsulated Pot Chloride 10 MEQ Extended Release Oral TabletSY8ed8ea55-8b15-f718-e053-2a95a90a587a6
1801298potassium chloride 10 MEQ Microencapsulated Extended Release Oral TabletSY8ed8ea55-8b15-f718-e053-2a95a90a587a6
1801298potassium chloride 750 MG Microencapsulated Extended Release OralSY8ed8ea55-8b15-f718-e053-2a95a90a587a6
1801298potassium chloride 10 MEQ Microencapsulated Extended Release Oral TabletPSN7ec22e8e-6643-44fe-804d-ca0b0b2666635
1801298Microencapsulated potassium chloride 10 MEQ Extended Release Oral TabletSCD7ec22e8e-6643-44fe-804d-ca0b0b2666635
1801298Microencapsulated K+ Chloride 10 MEQ Extended Release Oral TabletSY7ec22e8e-6643-44fe-804d-ca0b0b2666635
1801298Microencapsulated Pot Chloride 10 MEQ Extended Release Oral TabletSY7ec22e8e-6643-44fe-804d-ca0b0b2666635
1801298potassium chloride 10 MEQ Microencapsulated Extended Release Oral TabletSY7ec22e8e-6643-44fe-804d-ca0b0b2666635
1801298potassium chloride 750 MG Microencapsulated Extended Release OralSY7ec22e8e-6643-44fe-804d-ca0b0b2666635
1801298potassium chloride 10 MEQ Microencapsulated Extended Release Oral TabletPSN8c12c5f8-5950-44e3-9473-a0b95187b43c2
1801298Microencapsulated potassium chloride 10 MEQ Extended Release Oral TabletSCD8c12c5f8-5950-44e3-9473-a0b95187b43c2
1801298Microencapsulated K+ Chloride 10 MEQ Extended Release Oral TabletSY8c12c5f8-5950-44e3-9473-a0b95187b43c2
1801298Microencapsulated Pot Chloride 10 MEQ Extended Release Oral TabletSY8c12c5f8-5950-44e3-9473-a0b95187b43c2
1801298potassium chloride 10 MEQ Microencapsulated Extended Release Oral TabletSY8c12c5f8-5950-44e3-9473-a0b95187b43c2
1801298potassium chloride 750 MG Microencapsulated Extended Release OralSY8c12c5f8-5950-44e3-9473-a0b95187b43c2
1801298potassium chloride 10 MEQ Microencapsulated Extended Release Oral TabletPSN7d74652b-3513-4ebb-8b47-10b3603d04a71
1801298Microencapsulated potassium chloride 10 MEQ Extended Release Oral TabletSCD7d74652b-3513-4ebb-8b47-10b3603d04a71

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
63304-076-0163304007601100 TABLET, EXTENDED RELEASE in 1 BOTTLE (63304-076-01) 2019-11-200000-00-00NoNoCurrent
63304-076-0563304007605500 TABLET, EXTENDED RELEASE in 1 BOTTLE (63304-076-05) 2019-11-200000-00-00NoNoCurrent
63304-076-10633040076101000 TABLET, EXTENDED RELEASE in 1 BOTTLE (63304-076-10) 2019-11-200000-00-00NoNoCurrent