FDA.reportPublic FDA data

Potassium Chloride

Product NDC
71610-349
11-digit product format
716100349
Labeler code
71610
Product ID
71610-349_2b497b8f-a0e3-9ff7-e063-6394a90a3800
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Potassium Chloride
Dosage form
TABLET, FILM COATED, EXTENDED RELEASE
Route
ORAL
Labeler
Aphena Pharma Solutions - Tennessee, LLC
Application
NDA019123
Marketing category
NDA
Marketing start
2019-06-21
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
Rxcui628953

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
71610-349-15Potassium Chloride15 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE153
71610-349-30Potassium Chloride30 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE303
71610-349-45Potassium Chloride45 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE453
71610-349-53Potassium Chloride60 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE603
71610-349-60Potassium Chloride90 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE903
71610-349-70Potassium Chloride120 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE1203
71610-349-80Potassium Chloride180 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE1803
71610-349-85Potassium Chloride200 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE2003
71610-349-92Potassium Chloride270 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE2703
71610-349-94Potassium Chloride360 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE3603
71610-349-98Potassium Chloride540 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE5403

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71610-349-15EA - Each71610-349715115fe-fd3a-44db-b846-82e23dff169712022-04-06
71610-349-30EA - Each71610-3493ef90426-b22c-42e4-93c6-ce0449038dc012019-12-10
71610-349-45EA - Each71610-349cdd6fadc-ef2f-4476-a2e3-edb3fa59c92112022-04-06
71610-349-53EA - Each71610-349e8b9fd87-4620-4627-8e68-18ab2df1fc0812019-12-10
71610-349-60EA - Each71610-349244d197e-cf43-4a95-bb63-76ad475f04a012019-12-10
71610-349-70EA - Each71610-34962d1c762-6b2d-42ef-afe2-3c486eb9306412019-12-10
71610-349-80EA - Each71610-3492bf89b3c-134f-4e34-aa6c-06c4a494b0bd12019-12-10
71610-349-85EA - Each71610-3491e0996b4-238a-49d2-b3ff-7a1f4b022fc212019-12-10
71610-349-92EA - Each71610-34913ac5b45-8212-42a3-9ece-0941e2ee60ce12019-12-10
71610-349-94EA - Each71610-34989260239-75e9-4ed4-86bc-0756673c968c12019-12-10
71610-349-98EA - Each71610-349610aeaac-253e-4cbe-bfcf-9e3c0e3d4f3212022-04-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71610-349POTASSIUM CHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]3Current NDC, Legacy NDC, 11 package rows20250129_81a53ecd-2612-4efe-9491-415fff3f86e5.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
628953potassium chloride 10 MEQ (750 MG) Extended Release Oral TabletPSN81a53ecd-2612-4efe-9491-415fff3f86e53
628953potassium chloride 10 MEQ Extended Release Oral TabletSCD81a53ecd-2612-4efe-9491-415fff3f86e53
628953K+ Chloride 10 MEQ Extended Release Oral TabletSY81a53ecd-2612-4efe-9491-415fff3f86e53
628953Pot Chloride 10 MEQ Extended Release Oral TabletSY81a53ecd-2612-4efe-9491-415fff3f86e53
628953potassium chloride 750 MG (potassium 10 mEq) Extended Release Oral TabletSY81a53ecd-2612-4efe-9491-415fff3f86e53
628953potassium chloride 750 MG Extended Release Oral TabletSY81a53ecd-2612-4efe-9491-415fff3f86e53

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71610-349-157161003491515 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (71610-349-15) 2022-02-080000-00-00NoNoCurrent
71610-349-307161003493030 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (71610-349-30) 2019-10-160000-00-00NoNoCurrent
71610-349-457161003494545 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (71610-349-45) 2022-02-080000-00-00NoNoCurrent
71610-349-537161003495360 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (71610-349-53) 2019-10-160000-00-00NoNoCurrent
71610-349-607161003496090 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (71610-349-60) 2019-10-160000-00-00NoNoCurrent
71610-349-7071610034970120 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (71610-349-70) 2019-10-160000-00-00NoNoCurrent
71610-349-8071610034980180 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (71610-349-80) 2019-10-160000-00-00NoNoCurrent
71610-349-8571610034985200 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (71610-349-85) 2019-10-160000-00-00NoNoCurrent
71610-349-9271610034992270 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (71610-349-92) 2019-10-160000-00-00NoNoCurrent
71610-349-9471610034994360 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (71610-349-94) 2019-10-160000-00-00NoNoCurrent
71610-349-9871610034998540 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (71610-349-98) 2022-02-080000-00-00NoNoCurrent