FDA.reportPublic FDA data

Potassium Chloride

Product NDC
0121-1680
11-digit product format
001211680
Labeler code
0121
Product ID
0121-1680_cd3a937e-3347-6368-e053-2a95a90abe56
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
POTASSIUM CHLORIDE
Dosage form
SOLUTION
Route
ORAL
Labeler
Pharmaceutical Associates, Inc.
Application
ANDA210766
Marketing category
ANDA
Marketing start
2019-04-02
Marketing end
0000-00-00
Substance
POTASSIUM CHLORIDE
Active strength
20 meq/15mL
Pharmacologic classes
Potassium Compounds [CS],Potassium Salt [EPC],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA]
NDC exclude flag
No
Listing certified through
2022-12-31
Current FDA listing
Historical FDA.report record

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 Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0121-1680-00ML - Milliliter0121-16808cd3656d-3ffd-4eb3-bd92-e8b0b94509e412020-02-13
0121-1680-15ML - Milliliter0121-16802aacf374-9b72-4c17-920a-76c698dc39f512019-05-02
0121-1680-16ML - Milliliter0121-1680df3c5369-ffdf-44f3-bfbf-afe05b80b7be12019-06-19
0121-1680-30ML - Milliliter0121-1680758403ac-1ef0-489e-82a2-add23892eb0912020-05-08
0121-1680-40ML - Milliliter0121-168084681f1f-b724-4612-9ca0-a5b92ba71f7a12020-02-13
0121-1680-50ML - Milliliter0121-1680f147bb7a-2558-4d92-9072-f9ad44d1204312020-05-08
0121-1680-80ML - Milliliter0121-1680a452ee6d-d8b2-4bf9-88e3-c227dc15deeb12020-05-08

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312515potassium chloride 20 MEQ in 15 mL Oral SolutionPSN84c8c63e-d3b0-4b61-ba32-b8161efa185d2
312515potassium chloride 1.33 MEQ/ML Oral SolutionSCD84c8c63e-d3b0-4b61-ba32-b8161efa185d2
312515K+ Chloride 1.33 MEQ/ML Oral SolutionSY84c8c63e-d3b0-4b61-ba32-b8161efa185d2
312515Pot Chloride 1.33 MEQ/ML Oral SolutionSY84c8c63e-d3b0-4b61-ba32-b8161efa185d2
312515potassium chloride 1.5 GM per 15 ML Oral SolutionSY84c8c63e-d3b0-4b61-ba32-b8161efa185d2
312515potassium chloride 10 % Oral SolutionSY84c8c63e-d3b0-4b61-ba32-b8161efa185d2
312515potassium chloride 20 MEQ per 15 ML Oral SolutionSY84c8c63e-d3b0-4b61-ba32-b8161efa185d2
312515potassium chloride 40 MEQ per 30 ML Oral SolutionSY84c8c63e-d3b0-4b61-ba32-b8161efa185d2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0121-1680-000012116800010 TRAY in 1 CASE (0121-1680-00) > 10 CUP, UNIT-DOSE in 1 TRAY > 15 mL in 1 CUP, UNIT-DOSE10 tray2019-04-190000-00-00NoNoCurrent
0121-1680-150012116801510 TRAY in 1 CASE (0121-1680-15) > 10 CUP, UNIT-DOSE in 1 TRAY > 15 mL in 1 CUP, UNIT-DOSE10 tray2019-04-020000-00-00NoNoCurrent
0121-1680-1600121168016473 mL in 1 BOTTLE (0121-1680-16) 473 ml2019-05-130000-00-00NoNoCurrent
0121-1680-30001211680303 TRAY in 1 CASE (0121-1680-30) > 10 CUP, UNIT-DOSE in 1 TRAY > 15 mL in 1 CUP, UNIT-DOSE3 tray2020-04-200000-00-00NoNoCurrent
0121-1680-40001211680404 TRAY in 1 CASE (0121-1680-40) > 10 CUP, UNIT-DOSE in 1 TRAY > 15 mL in 1 CUP, UNIT-DOSE4 tray2020-04-200000-00-00NoNoCurrent
0121-1680-50001211680505 TRAY in 1 CASE (0121-1680-50) > 10 CUP, UNIT-DOSE in 1 TRAY > 15 mL in 1 CUP, UNIT-DOSE5 tray2020-04-200000-00-00NoNoCurrent
0121-1680-80001211680808 TRAY in 1 CASE (0121-1680-80) > 10 CUP, UNIT-DOSE in 1 TRAY > 15 mL in 1 CUP, UNIT-DOSE8 tray2020-04-200000-00-00NoNoCurrent