FDA.reportPublic FDA data

Potassium Chloride for Oral Solution

Product NDC
10135-807
11-digit product format
101350807
Labeler code
10135
Product ID
10135-807_3e8a7f18-164c-7766-e063-6394a90acbca
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Potassium Chloride for Oral Solution
Dosage form
POWDER, FOR SOLUTION
Route
ORAL
Labeler
Marlex Pharmaceuticals, Inc.
Application
ANDA212183
Marketing category
ANDA
Marketing start
2025-08-01
Substance
POTASSIUM CHLORIDE
Active strength
1.5 g/1.58g
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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A212183-001POTASSIUM CHLORIDEPOTASSIUM CHLORIDE20MEQFOR SOLUTION / ORALAA2019-05-06

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-productTE code
A212183-001AA

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A212183-001POTASSIUM CHLORIDE20MEQFOR SOLUTION / ORALAA2019-05-06caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A212183-001POTASSIUM CHLORIDE20MEQFOR SOLUTION / ORALAA2019-05-06011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A212183-001POTASSIUM CHLORIDE20MEQFOR SOLUTION / ORALAA2019-05-0631067a03dcf5…
2025-08-23 18:47 UTC2025-08A212183-001POTASSIUM CHLORIDE20MEQFOR SOLUTION / ORALAA2019-05-066a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A212183-001POTASSIUM CHLORIDE20MEQFOR SOLUTION / ORALAA2019-05-06fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A212183-001POTASSIUM CHLORIDE20MEQFOR SOLUTION / ORALAA2019-05-06b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A212183-001POTASSIUM CHLORIDE20MEQFOR SOLUTION / ORALAA2019-05-0603ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A212183-001POTASSIUM CHLORIDE20MEQFOR SOLUTION / ORALAA2019-05-062680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A212183-001POTASSIUM CHLORIDE20MEQFOR SOLUTION / ORALAA2019-05-065bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A212183-001POTASSIUM CHLORIDE20MEQFOR SOLUTION / ORALAA2019-05-06d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A212183-001POTASSIUM CHLORIDE20MEQFOR SOLUTION / ORALAA2019-05-06d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A212183-001POTASSIUM CHLORIDE20MEQFOR SOLUTION / ORALAA2019-05-0679d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A212183-001POTASSIUM CHLORIDE20MEQFOR SOLUTION / ORALAA2019-05-06301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A212183-001POTASSIUM CHLORIDE20MEQFOR SOLUTION / ORALAA2019-05-061e350fbaab3a…
2024-05-31 18:47 UTC2024-05A212183-001POTASSIUM CHLORIDE20MEQFOR SOLUTION / ORALAA2019-05-068072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A212183-001POTASSIUM CHLORIDE20MEQFOR SOLUTION / ORALAA2019-05-065c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A212183-001POTASSIUM CHLORIDE20MEQFOR SOLUTION / ORALAA2019-05-065d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A212183-001POTASSIUM CHLORIDE20MEQFOR SOLUTION / ORALAA2019-05-064b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A212183-001POTASSIUM CHLORIDE20MEQFOR SOLUTION / ORALAA2019-05-0674a2ff9319b5…
2022-03-09 01:35 UTC2022-03A212183-001POTASSIUM CHLORIDE20MEQFOR SOLUTION / ORALAA2019-05-06bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A212183-001POTASSIUM CHLORIDE20MEQFOR SOLUTION / ORALAA2019-05-06782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A212183-001POTASSIUM CHLORIDE20MEQFOR SOLUTION / ORALAA2019-05-0687673890dc5c…
2021-03-12 10:30 UTC2021-03A212183-001POTASSIUM CHLORIDE20MEQFOR SOLUTION / ORALAA2019-05-065aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A212183-001POTASSIUM CHLORIDE20MEQFOR SOLUTION / ORALAA2019-05-068869cabd3fbd…
2020-11-12 02:37 UTC2020-11A212183-001POTASSIUM CHLORIDE20MEQFOR SOLUTION / ORALAA2019-05-06c0c555d07b60…
2019-12-14 00:12 UTC2019-12A212183-001POTASSIUM CHLORIDE20MEQFOR SOLUTION / ORALAA2019-05-063f01610625f2…
2019-09-15 20:21 UTC2019-09A212183-001POTASSIUM CHLORIDE20MEQFOR SOLUTION / ORALAA2019-05-06b00525d2431f…
2019-07-19 19:46 UTC2019-07A212183-001POTASSIUM CHLORIDE20MEQFOR SOLUTION / ORALAA2019-05-06ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A212183-001POTASSIUM CHLORIDE20MEQFOR SOLUTION / ORALAA2019-05-066a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A212183-001POTASSIUM CHLORIDE20MEQFOR SOLUTION / ORALAA2019-05-061c564ffb4f44…
2023-12-20 04:57 UTC2023-12A212183-001POTASSIUM CHLORIDE20MEQFOR SOLUTION / ORALAA2019-05-06ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A212183-001POTASSIUM CHLORIDE20MEQFOR SOLUTION / ORALAA2019-05-06a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A212183-001POTASSIUM CHLORIDE20MEQFOR SOLUTION / ORALAA2019-05-069b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A212183-001POTASSIUM CHLORIDE20MEQFOR SOLUTION / ORALAA2019-05-06a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A212183-001POTASSIUM CHLORIDE20MEQFOR SOLUTION / ORALAA2019-05-063f0d92c62455…
2023-05-13 08:27 UTC2023-05A212183-001POTASSIUM CHLORIDE20MEQFOR SOLUTION / ORALAA2019-05-06053a50430f4f…
2023-01-26 05:58 UTC2023-01A212183-001POTASSIUM CHLORIDE20MEQFOR SOLUTION / ORALAA2019-05-063bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A212183-001POTASSIUM CHLORIDE20MEQFOR SOLUTION / ORALAA2019-05-063a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A212183-001POTASSIUM CHLORIDE20MEQFOR SOLUTION / ORALAA2019-05-06f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A212183-001POTASSIUM CHLORIDE20MEQFOR SOLUTION / ORALAA2019-05-06e64feba35796…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A212183-001AA1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A212183-001AA1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A212183-001AA131067a03dcf5…
2025-08-23 18:47 UTC2025-08A212183-001AA16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A212183-001AA1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A212183-001AA1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A212183-001AA103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A212183-001AA12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A212183-001AA15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A212183-001AA1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A212183-001AA1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A212183-001AA179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A212183-001AA1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A212183-001AA11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A212183-001AA18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A212183-001AA15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A212183-001AA15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A212183-001AA14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A212183-001AA174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A212183-001AA1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A212183-001AA1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A212183-001AA187673890dc5c…
2021-03-12 10:30 UTC2021-03A212183-001AA15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A212183-001AA18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A212183-001AA1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A212183-001AA13f01610625f2…
2019-09-15 20:21 UTC2019-09A212183-001AA1b00525d2431f…
2019-07-19 19:46 UTC2019-07A212183-001AA1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A212183-001AA16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A212183-001AA11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A212183-001AA1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A212183-001AA1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A212183-001AA19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A212183-001AA1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A212183-001AA13f0d92c62455…
2023-05-13 08:27 UTC2023-05A212183-001AA1053a50430f4f…
2023-01-26 05:58 UTC2023-01A212183-001AA13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A212183-001AA13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A212183-001AA1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A212183-001AA1e64feba35796…

Additional Listing Data#

Finished product
Yes
Brand name base
Potassium Chloride for Oral Solution
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
POTASSIUM CHLORIDE1.5 g/1.58g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
660YQ98I10Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1867544Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
3e8a6f61-44eb-4b5a-e063-6294a90a4b1bAvailable on FDA.report

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
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
f1e0dc7e-7d61-4625-b6d9-4894927679d7Product name220211025
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625
9badc7be-250a-44ab-aa36-926af3f02679Product name120210527
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
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
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
7916de40-e296-41f0-b811-6d0df1a33e2cProduct name920180627
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
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
10135-807-11Potassium Chloride for Oral Solution1.58 g in 1 POUCHPOWDER, FOR SOLUTION1.581
10135-807-13Potassium Chloride for Oral Solution100 in 1 CARTONPOWDER, FOR SOLUTION1001
10135-807-15Potassium Chloride for Oral Solution30 in 1 CARTONPOWDER, FOR SOLUTION301

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 4 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Potassium Chloride for Oral SolutionPOTASSIUM CHLORIDE FOR ORAL SOLUTIONBPI Labs LLC1ea4345e-f8bb-4d41-9003-c87b21169d7c2026-01-05Warnings, Adverse reactionsExact identifier
application applno (ANDA): 212183
application number: ANDA212183
Potassium Chloride for Oral SolutionPOTASSIUM CHLORIDE FOR ORAL SOLUTIONAjenat Pharmaceuticals LLCc62c5704-3667-4d4f-8230-3f7f5ed825b12025-12-29Warnings, Adverse reactionsExact identifier
application applno (ANDA): 212183
application number: ANDA212183
Potassium Chloride for Oral SolutionPOTASSIUM CHLORIDE FOR ORAL SOLUTIONMarlex Pharmaceuticals Inc3e78028d-21a0-ba0f-e063-6294a90aac492025-08-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 212183
application number: ANDA212183
Potassium Chloride for Oral SolutionPOTASSIUM CHLORIDE FOR ORAL SOLUTIONMarlex Pharmaceuticals, Inc.3e8a6f61-44eb-4b5a-e063-6294a90a4b1b2025-08-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 212183
application number: ANDA212183
ndc (product): 10135-807

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1867544potassium chloride 20 MEQ (1.5 GM) Powder for Oral SolutionPSN3e8a6f61-44eb-4b5a-e063-6294a90a4b1b1
1867544potassium chloride 20 MEQ Powder for Oral SolutionSCD3e8a6f61-44eb-4b5a-e063-6294a90a4b1b1
1867544K+ Chloride 20 MEQ Powder for Oral SolutionSY3e8a6f61-44eb-4b5a-e063-6294a90a4b1b1
1867544Pot Chloride 20 MEQ Powder for Oral SolutionSY3e8a6f61-44eb-4b5a-e063-6294a90a4b1b1
1867544potassium chloride 1.5 GM Powder for Oral SolutionSY3e8a6f61-44eb-4b5a-e063-6294a90a4b1b1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
10135-807-11101350807111.58 g in 1 POUCH1.58 gHistorical
10135-807-1310135080713100 POUCH in 1 CARTON (10135-807-13) / 1.58 g in 1 POUCH (10135-807-11) 100 pouch2025-08-01NoNoCurrent
10135-807-151013508071530 POUCH in 1 CARTON (10135-807-15) / 1.58 g in 1 POUCH (10135-807-11) 30 pouch2025-08-01NoNoCurrent