FDA.reportPublic FDA data

Potassium Chloride

Product NDC
0121-4948
11-digit product format
001214948
Labeler code
0121
Product ID
0121-4948_f5027a39-0ab3-4d01-9f7a-3737c7e8e852
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
POTASSIUM CHLORIDE
Dosage form
SOLUTION
Route
ORAL
Labeler
PAI Holdings, LLC dba PAI Pharma
Application
ANDA210766
Marketing category
ANDA
Marketing start
2023-03-27
Substance
POTASSIUM CHLORIDE
Active strength
20 meq/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
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 CHLORIDE20 meq/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
30b0ac6e-02aa-0e5c-0d8b-cffdf3a282b2Product name520250304
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
f1e0dc7e-7d61-4625-b6d9-4894927679d7Product name220211025
9badc7be-250a-44ab-aa36-926af3f02679Product name120210527
e4870509-7e28-6f92-f0be-dd3dd889a9cfProduct name520200810
0ec3537a-6c9b-432a-896c-b9ea8723049aProduct name920200701
6e9d4a47-c464-b93e-aebc-ad7bffc9c4cdProduct name220190619
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
684ea482-2e8b-14af-5664-b98f1e402036Product name120140508
810ab97e-f109-f41c-7c83-6a652a9cbf43Product name120140508
87711080-88eb-65c5-b2dd-bf99e700a372Product name120140508
8dbefedf-0a0d-a224-5a3c-66dc9e11c2ddProduct name120140508
b060cc1a-fe47-856b-0b77-4448b5963de8Product 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
0121-4948-00Potassium Chloride10 in 1 CASESOLUTION107
0121-4948-00Potassium Chloride10 in 1 TRAYSOLUTION107
0121-4948-15Potassium Chloride15 mL in 1 CUP, UNIT-DOSESOLUTION157
0121-4948-40Potassium Chloride4 in 1 CASESOLUTION47
0121-4948-40Potassium Chloride10 in 1 TRAYSOLUTION107
0121-4948-50Potassium Chloride10 in 1 TRAYSOLUTION107
0121-4948-50Potassium Chloride5 in 1 CASESOLUTION57
0121-4948-80Potassium Chloride10 in 1 TRAYSOLUTION107
0121-4948-80Potassium Chloride8 in 1 CASESOLUTION87
0121-4948-94Potassium Chloride10 in 1 TRAYSOLUTION107
0121-4948-94Potassium Chloride3 in 1 CASESOLUTION37

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0121-4948-00ML - Milliliter0121-49483267b291-034c-4e51-be8f-a404e402639212023-04-07
0121-4948-15ML - Milliliter0121-4948f0be6465-29db-4e0f-bc8f-9f0a17b6ac5a12023-05-05
0121-4948-40ML - Milliliter0121-49487b526493-410d-4520-bc09-02459353892c12023-04-07
0121-4948-50ML - Milliliter0121-49483463271e-08c9-4a2d-b215-80c2fd3b6e3012023-05-05
0121-4948-80ML - Milliliter0121-4948679797ca-594c-44f5-9912-28db6a15254f12023-05-05
0121-4948-94ML - Milliliter0121-494809f6b55e-3c77-4961-831d-4af8887dfd7e12023-05-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0121-4948POTASSIUM CHLORIDE SOLUTION [PAI HOLDINGS, LLC DBA PAI PHARMA]7Current NDC, 11 package rows20241121_e848477f-b10d-4249-b322-b70cd6a062de.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312515potassium chloride 20 MEQ in 15 mL Oral SolutionPSNe848477f-b10d-4249-b322-b70cd6a062de7
314182potassium chloride 40 MEQ in 15 mL Oral SolutionPSNe848477f-b10d-4249-b322-b70cd6a062de7
312515potassium chloride 1.33 MEQ/ML Oral SolutionSCDe848477f-b10d-4249-b322-b70cd6a062de7
314182potassium chloride 2.67 MEQ/ML Oral SolutionSCDe848477f-b10d-4249-b322-b70cd6a062de7
312515K+ Chloride 1.33 MEQ/ML Oral SolutionSYe848477f-b10d-4249-b322-b70cd6a062de7
314182K+ Chloride 2.67 MEQ/ML Oral SolutionSYe848477f-b10d-4249-b322-b70cd6a062de7
312515Pot Chloride 1.33 MEQ/ML Oral SolutionSYe848477f-b10d-4249-b322-b70cd6a062de7
314182Pot Chloride 2.67 MEQ/ML Oral SolutionSYe848477f-b10d-4249-b322-b70cd6a062de7
312515potassium chloride 1.5 GM per 15 ML Oral SolutionSYe848477f-b10d-4249-b322-b70cd6a062de7
312515potassium chloride 10 % Oral SolutionSYe848477f-b10d-4249-b322-b70cd6a062de7
314182potassium chloride 20 % Oral SolutionSYe848477f-b10d-4249-b322-b70cd6a062de7
312515potassium chloride 20 MEQ per 15 ML Oral SolutionSYe848477f-b10d-4249-b322-b70cd6a062de7
314182potassium chloride 20 MEQ per 30 ML Oral SolutionSYe848477f-b10d-4249-b322-b70cd6a062de7
314182potassium chloride 3 GM per 15 ML Oral SolutionSYe848477f-b10d-4249-b322-b70cd6a062de7
314182potassium chloride 40 MEQ per 15 ML Oral SolutionSYe848477f-b10d-4249-b322-b70cd6a062de7
312515potassium chloride 40 MEQ per 30 ML Oral SolutionSYe848477f-b10d-4249-b322-b70cd6a062de7

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
0121-4948-000012149480010 TRAY in 1 CASE (0121-4948-00) / 10 CUP, UNIT-DOSE in 1 TRAY / 15 mL in 1 CUP, UNIT-DOSE (0121-4948-15) 10 tray2023-03-27NoNoHistorical
0121-4948-150012149481515 mL in 1 CUP, UNIT-DOSE15 mlHistorical
0121-4948-40001214948404 TRAY in 1 CASE (0121-4948-40) / 10 CUP, UNIT-DOSE in 1 TRAY / 15 mL in 1 CUP, UNIT-DOSE (0121-4948-15) 4 tray2023-03-27NoNoHistorical
0121-4948-50001214948505 TRAY in 1 CASE (0121-4948-50) / 10 CUP, UNIT-DOSE in 1 TRAY / 15 mL in 1 CUP, UNIT-DOSE (0121-4948-15) 5 tray2023-03-27NoNoHistorical
0121-4948-80001214948808 TRAY in 1 CASE (0121-4948-80) / 10 CUP, UNIT-DOSE in 1 TRAY / 15 mL in 1 CUP, UNIT-DOSE (0121-4948-15) 8 tray2023-03-27NoNoHistorical
0121-4948-94001214948943 TRAY in 1 CASE (0121-4948-94) / 10 CUP, UNIT-DOSE in 1 TRAY / 15 mL in 1 CUP, UNIT-DOSE (0121-4948-15) 3 tray2023-03-27NoNoHistorical