FDA.reportPublic FDA data

Potassium Chloride Extended-release

Product NDC
70010-135
11-digit product format
700100135
Labeler code
70010
Product ID
70010-135_495d2e0b-e6b6-958e-e063-6394a90ac328
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Potassium Chloride Extended-release
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Granules Pharmaceuticals Inc.
Application
ANDA214452
Marketing category
ANDA
Marketing start
2021-01-30
Substance
POTASSIUM CHLORIDE
Active strength
1500 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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Potassium Chloride Extended-release
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
POTASSIUM CHLORIDE1500 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii660YQ98I10
Rxcui1801294, 1801298

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
70010-135-01Potassium Chloride Extended-release100 in 1 BOTTLETABLET, EXTENDED RELEASE1008
70010-135-05Potassium Chloride Extended-release500 in 1 BOTTLETABLET, EXTENDED RELEASE5008
70010-135-10Potassium Chloride Extended-release1000 in 1 BOTTLETABLET, EXTENDED RELEASE10008

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70010-135-01EA - Each70010-1350e3c8490-d3bf-41a9-8b91-37cc89c2f4e112021-04-08
70010-135-05EA - Each70010-135ece152fc-5417-4497-9878-ba67b5a1a3fb12021-04-08
70010-135-10EA - Each70010-13500f2046d-933a-4c8a-bce8-ebc28d0658ec12022-09-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70010-135POTASSIUM CHLORIDE EXTENDED-RELEASE TABLET, EXTENDED RELEASE [GRANULES PHARMACEUTICALS INC.]6Current NDC, Legacy NDC, 3 package rows20240125_b3d4d5b5-2898-ae3d-e053-2a95a90a6d04.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1801294potassium chloride 20 MEQ Microencapsulated Extended Release Oral TabletPSN7b8e7a4f-0d44-46b2-9565-7b4c294e9fcb102
1801294Microencapsulated potassium chloride 20 MEQ Extended Release Oral TabletSCD7b8e7a4f-0d44-46b2-9565-7b4c294e9fcb102
1801294Microencapsulated K+ Chloride 20 MEQ Extended Release Oral TabletSY7b8e7a4f-0d44-46b2-9565-7b4c294e9fcb102
1801294Microencapsulated Pot Chloride 20 MEQ Extended Release Oral TabletSY7b8e7a4f-0d44-46b2-9565-7b4c294e9fcb102
1801294potassium chloride 1500 MG Microencapsulated Extended Release Oral TabletSY7b8e7a4f-0d44-46b2-9565-7b4c294e9fcb102
1801294potassium chloride 20 MEQ Microencapsulated Extended Release Oral TabletSY7b8e7a4f-0d44-46b2-9565-7b4c294e9fcb102
1801298potassium chloride 10 MEQ Microencapsulated Extended Release Oral TabletPSNc684758c-16f0-4bd9-b719-1aae64b7907f18
1801294potassium chloride 20 MEQ Microencapsulated Extended Release Oral TabletPSNc684758c-16f0-4bd9-b719-1aae64b7907f18
1801298Microencapsulated potassium chloride 10 MEQ Extended Release Oral TabletSCDc684758c-16f0-4bd9-b719-1aae64b7907f18
1801294Microencapsulated potassium chloride 20 MEQ Extended Release Oral TabletSCDc684758c-16f0-4bd9-b719-1aae64b7907f18
1801298Microencapsulated K+ Chloride 10 MEQ Extended Release Oral TabletSYc684758c-16f0-4bd9-b719-1aae64b7907f18
1801294Microencapsulated K+ Chloride 20 MEQ Extended Release Oral TabletSYc684758c-16f0-4bd9-b719-1aae64b7907f18
1801298Microencapsulated Pot Chloride 10 MEQ Extended Release Oral TabletSYc684758c-16f0-4bd9-b719-1aae64b7907f18
1801294Microencapsulated Pot Chloride 20 MEQ Extended Release Oral TabletSYc684758c-16f0-4bd9-b719-1aae64b7907f18
1801298potassium chloride 10 MEQ Microencapsulated Extended Release Oral TabletSYc684758c-16f0-4bd9-b719-1aae64b7907f18
1801294potassium chloride 1500 MG Microencapsulated Extended Release Oral TabletSYc684758c-16f0-4bd9-b719-1aae64b7907f18
1801294potassium chloride 20 MEQ Microencapsulated Extended Release Oral TabletSYc684758c-16f0-4bd9-b719-1aae64b7907f18
1801298potassium chloride 750 MG Microencapsulated Extended Release OralSYc684758c-16f0-4bd9-b719-1aae64b7907f18
1801298potassium chloride 10 MEQ Microencapsulated Extended Release Oral TabletPSNb3d4d5b5-2898-ae3d-e053-2a95a90a6d048
1801294potassium chloride 20 MEQ Microencapsulated Extended Release Oral TabletPSNb3d4d5b5-2898-ae3d-e053-2a95a90a6d048
1801298Microencapsulated potassium chloride 10 MEQ Extended Release Oral TabletSCDb3d4d5b5-2898-ae3d-e053-2a95a90a6d048
1801294Microencapsulated potassium chloride 20 MEQ Extended Release Oral TabletSCDb3d4d5b5-2898-ae3d-e053-2a95a90a6d048
1801298Microencapsulated K+ Chloride 10 MEQ Extended Release Oral TabletSYb3d4d5b5-2898-ae3d-e053-2a95a90a6d048
1801294Microencapsulated K+ Chloride 20 MEQ Extended Release Oral TabletSYb3d4d5b5-2898-ae3d-e053-2a95a90a6d048
1801298Microencapsulated Pot Chloride 10 MEQ Extended Release Oral TabletSYb3d4d5b5-2898-ae3d-e053-2a95a90a6d048
1801294Microencapsulated Pot Chloride 20 MEQ Extended Release Oral TabletSYb3d4d5b5-2898-ae3d-e053-2a95a90a6d048
1801298potassium chloride 10 MEQ Microencapsulated Extended Release Oral TabletSYb3d4d5b5-2898-ae3d-e053-2a95a90a6d048
1801294potassium chloride 1500 MG Microencapsulated Extended Release Oral TabletSYb3d4d5b5-2898-ae3d-e053-2a95a90a6d048
1801294potassium chloride 20 MEQ Microencapsulated Extended Release Oral TabletSYb3d4d5b5-2898-ae3d-e053-2a95a90a6d048
1801298potassium chloride 750 MG Microencapsulated Extended Release OralSYb3d4d5b5-2898-ae3d-e053-2a95a90a6d048
1801294potassium chloride 20 MEQ Microencapsulated Extended Release Oral TabletPSNde335131-bb8a-44e5-89fa-1478edbcdc0e6
1801294potassium chloride 20 MEQ Microencapsulated Extended Release Oral TabletPSNedb6c987-e2c3-421f-8a8d-849c9e17ace86
1801294Microencapsulated potassium chloride 20 MEQ Extended Release Oral TabletSCDde335131-bb8a-44e5-89fa-1478edbcdc0e6
1801294Microencapsulated potassium chloride 20 MEQ Extended Release Oral TabletSCDedb6c987-e2c3-421f-8a8d-849c9e17ace86
1801294Microencapsulated K+ Chloride 20 MEQ Extended Release Oral TabletSYde335131-bb8a-44e5-89fa-1478edbcdc0e6
1801294Microencapsulated K+ Chloride 20 MEQ Extended Release Oral TabletSYedb6c987-e2c3-421f-8a8d-849c9e17ace86
1801294Microencapsulated Pot Chloride 20 MEQ Extended Release Oral TabletSYedb6c987-e2c3-421f-8a8d-849c9e17ace86
1801294Microencapsulated Pot Chloride 20 MEQ Extended Release Oral TabletSYde335131-bb8a-44e5-89fa-1478edbcdc0e6
1801294potassium chloride 1500 MG Microencapsulated Extended Release Oral TabletSYedb6c987-e2c3-421f-8a8d-849c9e17ace86
1801294potassium chloride 1500 MG Microencapsulated Extended Release Oral TabletSYde335131-bb8a-44e5-89fa-1478edbcdc0e6
1801294potassium chloride 20 MEQ Microencapsulated Extended Release Oral TabletSYedb6c987-e2c3-421f-8a8d-849c9e17ace86
1801294potassium chloride 20 MEQ Microencapsulated Extended Release Oral TabletSYde335131-bb8a-44e5-89fa-1478edbcdc0e6
1801294potassium chloride 20 MEQ Microencapsulated Extended Release Oral TabletPSN37455920-e408-5906-e063-6294a90a57ae4
1801294potassium chloride 20 MEQ Microencapsulated Extended Release Oral TabletPSN87f369cf-40e5-4f91-aa42-ae986fce65444
1801294Microencapsulated potassium chloride 20 MEQ Extended Release Oral TabletSCD87f369cf-40e5-4f91-aa42-ae986fce65444
1801294Microencapsulated potassium chloride 20 MEQ Extended Release Oral TabletSCD37455920-e408-5906-e063-6294a90a57ae4
1801294Microencapsulated K+ Chloride 20 MEQ Extended Release Oral TabletSY87f369cf-40e5-4f91-aa42-ae986fce65444
1801294Microencapsulated K+ Chloride 20 MEQ Extended Release Oral TabletSY37455920-e408-5906-e063-6294a90a57ae4
1801294Microencapsulated Pot Chloride 20 MEQ Extended Release Oral TabletSY87f369cf-40e5-4f91-aa42-ae986fce65444
1801294Microencapsulated Pot Chloride 20 MEQ Extended Release Oral TabletSY37455920-e408-5906-e063-6294a90a57ae4
1801294potassium chloride 1500 MG Microencapsulated Extended Release Oral TabletSY87f369cf-40e5-4f91-aa42-ae986fce65444
1801294potassium chloride 1500 MG Microencapsulated Extended Release Oral TabletSY37455920-e408-5906-e063-6294a90a57ae4
1801294potassium chloride 20 MEQ Microencapsulated Extended Release Oral TabletSY87f369cf-40e5-4f91-aa42-ae986fce65444
1801294potassium chloride 20 MEQ Microencapsulated Extended Release Oral TabletSY37455920-e408-5906-e063-6294a90a57ae4
1801294potassium chloride 20 MEQ Microencapsulated Extended Release Oral TabletPSNace1eb11-b925-405a-b772-58c60b3ca7d43
1801294Microencapsulated potassium chloride 20 MEQ Extended Release Oral TabletSCDace1eb11-b925-405a-b772-58c60b3ca7d43
1801294Microencapsulated K+ Chloride 20 MEQ Extended Release Oral TabletSYace1eb11-b925-405a-b772-58c60b3ca7d43
1801294Microencapsulated Pot Chloride 20 MEQ Extended Release Oral TabletSYace1eb11-b925-405a-b772-58c60b3ca7d43
1801294potassium chloride 1500 MG Microencapsulated Extended Release Oral TabletSYace1eb11-b925-405a-b772-58c60b3ca7d43
1801294potassium chloride 20 MEQ Microencapsulated Extended Release Oral TabletSYace1eb11-b925-405a-b772-58c60b3ca7d43
1801294potassium chloride 20 MEQ Microencapsulated Extended Release Oral TabletPSNf191b15c-7959-4aa6-a2ef-617cde77c9182
1801294potassium chloride 20 MEQ Microencapsulated Extended Release Oral TabletPSN4d7ad5c6-2c18-dc29-e063-6394a90a621e2
1801294Microencapsulated potassium chloride 20 MEQ Extended Release Oral TabletSCD4d7ad5c6-2c18-dc29-e063-6394a90a621e2
1801294Microencapsulated potassium chloride 20 MEQ Extended Release Oral TabletSCDf191b15c-7959-4aa6-a2ef-617cde77c9182
1801294Microencapsulated K+ Chloride 20 MEQ Extended Release Oral TabletSY4d7ad5c6-2c18-dc29-e063-6394a90a621e2
1801294Microencapsulated K+ Chloride 20 MEQ Extended Release Oral TabletSYf191b15c-7959-4aa6-a2ef-617cde77c9182
1801294Microencapsulated Pot Chloride 20 MEQ Extended Release Oral TabletSY4d7ad5c6-2c18-dc29-e063-6394a90a621e2
1801294Microencapsulated Pot Chloride 20 MEQ Extended Release Oral TabletSYf191b15c-7959-4aa6-a2ef-617cde77c9182
1801294potassium chloride 1500 MG Microencapsulated Extended Release Oral TabletSY4d7ad5c6-2c18-dc29-e063-6394a90a621e2
1801294potassium chloride 1500 MG Microencapsulated Extended Release Oral TabletSYf191b15c-7959-4aa6-a2ef-617cde77c9182
1801294potassium chloride 20 MEQ Microencapsulated Extended Release Oral TabletSY4d7ad5c6-2c18-dc29-e063-6394a90a621e2
1801294potassium chloride 20 MEQ Microencapsulated Extended Release Oral TabletSYf191b15c-7959-4aa6-a2ef-617cde77c9182
1801294potassium chloride 20 MEQ Microencapsulated Extended Release Oral TabletPSN28d89ce5-0df3-806f-e063-6394a90a02a71
1801294potassium chloride 20 MEQ Microencapsulated Extended Release Oral TabletPSN377854ff-8034-c7ac-e063-6294a90a08171
1801294Microencapsulated potassium chloride 20 MEQ Extended Release Oral TabletSCD28d89ce5-0df3-806f-e063-6394a90a02a71
1801294Microencapsulated potassium chloride 20 MEQ Extended Release Oral TabletSCD377854ff-8034-c7ac-e063-6294a90a08171
1801294Microencapsulated K+ Chloride 20 MEQ Extended Release Oral TabletSY28d89ce5-0df3-806f-e063-6394a90a02a71
1801294Microencapsulated K+ Chloride 20 MEQ Extended Release Oral TabletSY377854ff-8034-c7ac-e063-6294a90a08171
1801294Microencapsulated Pot Chloride 20 MEQ Extended Release Oral TabletSY28d89ce5-0df3-806f-e063-6394a90a02a71
1801294Microencapsulated Pot Chloride 20 MEQ Extended Release Oral TabletSY377854ff-8034-c7ac-e063-6294a90a08171

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
70010-135-0170010013501100 TABLET, EXTENDED RELEASE in 1 BOTTLE (70010-135-01) 2021-01-300000-00-00NoNoCurrent
70010-135-0570010013505500 TABLET, EXTENDED RELEASE in 1 BOTTLE (70010-135-05) 2021-01-300000-00-00NoNoCurrent
70010-135-10700100135101000 TABLET, EXTENDED RELEASE in 1 BOTTLE (70010-135-10) 2021-01-300000-00-00NoNoCurrent