FDA.reportPublic FDA data

POTASSIUM CHLORIDE

Product NDC
71656-021
11-digit product format
716560021
Labeler code
71656
Product ID
71656-021_4872fd4b-ae1d-9c4c-e063-6294a90a7fc6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
POTASSIUM CHLORIDE ORAL
Dosage form
SOLUTION
Route
ORAL
Labeler
Saptalis Pharmaceuticals, LLC
Application
ANDA211648
Marketing category
ANDA
Marketing start
2023-10-05
Substance
POTASSIUM CHLORIDE
Active strength
1.5 g/15mL
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
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
POTASSIUM CHLORIDE1.5 g/15mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii660YQ98I10
Rxcui312515, 314182

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
71656-021-01POTASSIUM CHLORIDE10 in 1 TRAYSOLUTION105
71656-021-01POTASSIUM CHLORIDE10 in 1 CASESOLUTION105
71656-021-02POTASSIUM CHLORIDE10 in 1 CASESOLUTION105
71656-021-02POTASSIUM CHLORIDE10 in 1 TRAYSOLUTION105
71656-021-15POTASSIUM CHLORIDE15 mL in 1 CUP, UNIT-DOSESOLUTION155
71656-021-16POTASSIUM CHLORIDE473 mL in 1 BOTTLESOLUTION4735
71656-021-30POTASSIUM CHLORIDE30 mL in 1 CUP, UNIT-DOSESOLUTION305
71656-021-50POTASSIUM CHLORIDE5 in 1 CASESOLUTION55
71656-021-50POTASSIUM CHLORIDE10 in 1 TRAYSOLUTION105
71656-021-51POTASSIUM CHLORIDE10 in 1 TRAYSOLUTION105
71656-021-51POTASSIUM CHLORIDE5 in 1 CASESOLUTION55

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71656-021-01ML - Milliliter71656-0216bd0ebbf-a7a4-40f2-b463-9f94ddbce7be12024-06-10
71656-021-15ML - Milliliter71656-021c27304b6-be2d-4797-aac3-a530ab28e3ba12024-06-10
71656-021-16ML - Milliliter71656-02199d9cda5-bc17-4912-b16e-3b4dd995bd1412024-08-12
71656-021-30ML - Milliliter71656-0210b65870e-cf13-427b-af5f-c812d5eb9e9c12025-05-14
71656-021-50ML - Milliliter71656-021b55652f8-ada5-4d3a-a114-b9e2fbac018c12023-12-05
71656-021-51ML - Milliliter71656-0215d529fbd-3765-4e17-9818-571896c812e312023-12-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71656-021POTASSIUM CHLORIDE (POTASSIUM CHLORIDE ORAL) SOLUTION POTASSIUM CHLORIDE SOLUTION [SAPTALIS PHARMACEUTICALS, LLC]4Current NDC, 11 package rows20241228_483f338e-a164-4c1f-a34e-fef3312cb7ec.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312515potassium chloride 20 MEQ in 15 mL Oral SolutionPSN483f338e-a164-4c1f-a34e-fef3312cb7ec5
314182potassium chloride 40 MEQ in 15 mL Oral SolutionPSN483f338e-a164-4c1f-a34e-fef3312cb7ec5
312515potassium chloride 1.33 MEQ/ML Oral SolutionSCD483f338e-a164-4c1f-a34e-fef3312cb7ec5
314182potassium chloride 2.67 MEQ/ML Oral SolutionSCD483f338e-a164-4c1f-a34e-fef3312cb7ec5
312515K+ Chloride 1.33 MEQ/ML Oral SolutionSY483f338e-a164-4c1f-a34e-fef3312cb7ec5
314182K+ Chloride 2.67 MEQ/ML Oral SolutionSY483f338e-a164-4c1f-a34e-fef3312cb7ec5
312515Pot Chloride 1.33 MEQ/ML Oral SolutionSY483f338e-a164-4c1f-a34e-fef3312cb7ec5
314182Pot Chloride 2.67 MEQ/ML Oral SolutionSY483f338e-a164-4c1f-a34e-fef3312cb7ec5
312515potassium chloride 1.5 GM per 15 ML Oral SolutionSY483f338e-a164-4c1f-a34e-fef3312cb7ec5
312515potassium chloride 10 % Oral SolutionSY483f338e-a164-4c1f-a34e-fef3312cb7ec5
314182potassium chloride 20 % Oral SolutionSY483f338e-a164-4c1f-a34e-fef3312cb7ec5
312515potassium chloride 20 MEQ per 15 ML Oral SolutionSY483f338e-a164-4c1f-a34e-fef3312cb7ec5
314182potassium chloride 20 MEQ per 30 ML Oral SolutionSY483f338e-a164-4c1f-a34e-fef3312cb7ec5
314182potassium chloride 3 GM per 15 ML Oral SolutionSY483f338e-a164-4c1f-a34e-fef3312cb7ec5
314182potassium chloride 40 MEQ per 15 ML Oral SolutionSY483f338e-a164-4c1f-a34e-fef3312cb7ec5
312515potassium chloride 40 MEQ per 30 ML Oral SolutionSY483f338e-a164-4c1f-a34e-fef3312cb7ec5
312515potassium chloride 20 MEQ in 15 mL Oral SolutionPSNdc55474c-cc51-4f17-8cb3-0f34b3e68a553
312515potassium chloride 20 MEQ in 15 mL Oral SolutionPSN7c8dd5b0-db93-430f-8bf8-0318504f744c3
312515potassium chloride 1.33 MEQ/ML Oral SolutionSCDdc55474c-cc51-4f17-8cb3-0f34b3e68a553
312515potassium chloride 1.33 MEQ/ML Oral SolutionSCD7c8dd5b0-db93-430f-8bf8-0318504f744c3
312515K+ Chloride 1.33 MEQ/ML Oral SolutionSYdc55474c-cc51-4f17-8cb3-0f34b3e68a553
312515K+ Chloride 1.33 MEQ/ML Oral SolutionSY7c8dd5b0-db93-430f-8bf8-0318504f744c3
312515Pot Chloride 1.33 MEQ/ML Oral SolutionSYdc55474c-cc51-4f17-8cb3-0f34b3e68a553
312515Pot Chloride 1.33 MEQ/ML Oral SolutionSY7c8dd5b0-db93-430f-8bf8-0318504f744c3
312515potassium chloride 1.5 GM per 15 ML Oral SolutionSY7c8dd5b0-db93-430f-8bf8-0318504f744c3
312515potassium chloride 1.5 GM per 15 ML Oral SolutionSYdc55474c-cc51-4f17-8cb3-0f34b3e68a553
312515potassium chloride 10 % Oral SolutionSYdc55474c-cc51-4f17-8cb3-0f34b3e68a553
312515potassium chloride 10 % Oral SolutionSY7c8dd5b0-db93-430f-8bf8-0318504f744c3
312515potassium chloride 20 MEQ per 15 ML Oral SolutionSYdc55474c-cc51-4f17-8cb3-0f34b3e68a553
312515potassium chloride 20 MEQ per 15 ML Oral SolutionSY7c8dd5b0-db93-430f-8bf8-0318504f744c3
312515potassium chloride 40 MEQ per 30 ML Oral SolutionSYdc55474c-cc51-4f17-8cb3-0f34b3e68a553
312515potassium chloride 40 MEQ per 30 ML Oral SolutionSY7c8dd5b0-db93-430f-8bf8-0318504f744c3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
71656-021-017165600210110 TRAY in 1 CASE (71656-021-01) / 10 CUP, UNIT-DOSE in 1 TRAY / 15 mL in 1 CUP, UNIT-DOSE (71656-021-15) 10 tray2023-10-05NoNoCurrent
71656-021-027165600210210 TRAY in 1 CASE (71656-021-02) / 10 CUP, UNIT-DOSE in 1 TRAY / 30 mL in 1 CUP, UNIT-DOSE (71656-021-30) 10 tray2023-10-05NoNoCurrent
71656-021-157165600211515 mL in 1 CUP, UNIT-DOSE15 mlHistorical
71656-021-1671656002116473 mL in 1 BOTTLE (71656-021-16) 473 ml2023-10-05NoNoCurrent
71656-021-307165600213030 mL in 1 CUP, UNIT-DOSE30 mlHistorical
71656-021-50716560021505 TRAY in 1 CASE (71656-021-50) / 10 CUP, UNIT-DOSE in 1 TRAY / 15 mL in 1 CUP, UNIT-DOSE (71656-021-15) 5 tray2023-10-05NoNoCurrent
71656-021-51716560021515 TRAY in 1 CASE (71656-021-51) / 10 CUP, UNIT-DOSE in 1 TRAY / 30 mL in 1 CUP, UNIT-DOSE (71656-021-30) 5 tray2023-10-05NoNoCurrent