FDA.reportPublic FDA data

potassium chloride

Product NDC
40032-168
Requested package NDC
40032-168-01
11-digit product format
400320168
Labeler code
40032
Product ID
40032-168_69533b48-eb7a-4cca-b672-95b570bfd950
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
potassium chloride
Dosage form
SOLUTION
Route
ORAL
Labeler
Novel Laboratories, Inc.
Application
ANDA209786
Marketing category
ANDA
Marketing start
2018-09-24
Marketing end
0000-00-00
Substance
POTASSIUM CHLORIDE
Active strength
1 meq/mL
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
2020-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage40032-16840032-168-01IInactivated by FDA2026-08-11

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 9 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Code, Status table
Captured / source dateCodeStatusSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05IInactivated by FDAd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26IInactivated by FDAf5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31IInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28IInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21IInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10IInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31UExcluded because listing certification expired302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20UExcluded because listing certification expireded331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10UExcluded because listing certification expired0efc9e666f02…f202fb6c5f17…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A209786-001POTASSIUM CHLORIDEPOTASSIUM CHLORIDE20MEQ/15MLSOLUTION / ORALAA2018-08-29
A209786-002POTASSIUM CHLORIDEPOTASSIUM CHLORIDE40MEQ/15MLSOLUTION / ORALAA2018-08-29

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-productTE code
A209786-001AA
A209786-002AA

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 3 · 82 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A209786-001POTASSIUM CHLORIDE20MEQ/15MLSOLUTION / ORALAA2018-08-29011fe1cb6892…
2026-02-19 14:30 UTC2026-02A209786-002POTASSIUM CHLORIDE40MEQ/15MLSOLUTION / ORALAA2018-08-29011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A209786-001POTASSIUM CHLORIDE20MEQ/15MLSOLUTION / ORALAA2018-08-2931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A209786-002POTASSIUM CHLORIDE40MEQ/15MLSOLUTION / ORALAA2018-08-2931067a03dcf5…
2025-08-23 18:47 UTC2025-08A209786-001POTASSIUM CHLORIDE20MEQ/15MLSOLUTION / ORALAA2018-08-296a471c1ec25d…
2025-08-23 18:47 UTC2025-08A209786-002POTASSIUM CHLORIDE40MEQ/15MLSOLUTION / ORALAA2018-08-296a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A209786-001POTASSIUM CHLORIDE20MEQ/15MLSOLUTION / ORALAA2018-08-29fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A209786-002POTASSIUM CHLORIDE40MEQ/15MLSOLUTION / ORALAA2018-08-29fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A209786-001POTASSIUM CHLORIDE20MEQ/15MLSOLUTION / ORALAA2018-08-29b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A209786-002POTASSIUM CHLORIDE40MEQ/15MLSOLUTION / ORALAA2018-08-29b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A209786-001POTASSIUM CHLORIDE20MEQ/15MLSOLUTION / ORALAA2018-08-2903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A209786-002POTASSIUM CHLORIDE40MEQ/15MLSOLUTION / ORALAA2018-08-2903ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A209786-001POTASSIUM CHLORIDE20MEQ/15MLSOLUTION / ORALAA2018-08-292680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A209786-002POTASSIUM CHLORIDE40MEQ/15MLSOLUTION / ORALAA2018-08-292680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A209786-001POTASSIUM CHLORIDE20MEQ/15MLSOLUTION / ORALAA2018-08-295bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A209786-002POTASSIUM CHLORIDE40MEQ/15MLSOLUTION / ORALAA2018-08-295bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A209786-001POTASSIUM CHLORIDE20MEQ/15MLSOLUTION / ORALAA2018-08-29d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A209786-002POTASSIUM CHLORIDE40MEQ/15MLSOLUTION / ORALAA2018-08-29d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A209786-001POTASSIUM CHLORIDE20MEQ/15MLSOLUTION / ORALAA2018-08-29d06236e962d9…
2024-10-29 15:01 UTC2024-10A209786-002POTASSIUM CHLORIDE40MEQ/15MLSOLUTION / ORALAA2018-08-29d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A209786-001POTASSIUM CHLORIDE20MEQ/15MLSOLUTION / ORALAA2018-08-2979d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A209786-002POTASSIUM CHLORIDE40MEQ/15MLSOLUTION / ORALAA2018-08-2979d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A209786-001POTASSIUM CHLORIDE20MEQ/15MLSOLUTION / ORALAA2018-08-29301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A209786-002POTASSIUM CHLORIDE40MEQ/15MLSOLUTION / ORALAA2018-08-29301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A209786-001POTASSIUM CHLORIDE20MEQ/15MLSOLUTION / ORALAA2018-08-291e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A209786-002POTASSIUM CHLORIDE40MEQ/15MLSOLUTION / ORALAA2018-08-291e350fbaab3a…
2024-05-31 18:47 UTC2024-05A209786-001POTASSIUM CHLORIDE20MEQ/15MLSOLUTION / ORALAA2018-08-298072bd15b7f6…
2024-05-31 18:47 UTC2024-05A209786-002POTASSIUM CHLORIDE40MEQ/15MLSOLUTION / ORALAA2018-08-298072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A209786-001POTASSIUM CHLORIDE20MEQ/15MLSOLUTION / ORALAA2018-08-295c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A209786-002POTASSIUM CHLORIDE40MEQ/15MLSOLUTION / ORALAA2018-08-295c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A209786-001POTASSIUM CHLORIDE20MEQ/15MLSOLUTION / ORALAA2018-08-295d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A209786-002POTASSIUM CHLORIDE40MEQ/15MLSOLUTION / ORALAA2018-08-295d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A209786-001POTASSIUM CHLORIDE20MEQ/15MLSOLUTION / ORALAA2018-08-294b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A209786-002POTASSIUM CHLORIDE40MEQ/15MLSOLUTION / ORALAA2018-08-294b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A209786-001POTASSIUM CHLORIDE20MEQ/15MLSOLUTION / ORALAA2018-08-2974a2ff9319b5…
2019-12-13 00:20 UTC2019-12A209786-002POTASSIUM CHLORIDE40MEQ/15MLSOLUTION / ORALAA2018-08-2974a2ff9319b5…
2022-03-09 01:35 UTC2022-03A209786-001POTASSIUM CHLORIDE20MEQ/15MLSOLUTION / ORALAA2018-08-29bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A209786-002POTASSIUM CHLORIDE40MEQ/15MLSOLUTION / ORALAA2018-08-29bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A209786-001POTASSIUM CHLORIDE20MEQ/15MLSOLUTION / ORALAA2018-08-29782e0a99824c…
2021-12-28 21:50 UTC2021-12A209786-002POTASSIUM CHLORIDE40MEQ/15MLSOLUTION / ORALAA2018-08-29782e0a99824c…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 82 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A209786-001AA1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A209786-002AA1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A209786-001AA131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A209786-002AA131067a03dcf5…
2025-08-23 18:47 UTC2025-08A209786-001AA16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A209786-002AA16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A209786-001AA1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A209786-002AA1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A209786-001AA1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A209786-002AA1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A209786-001AA103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A209786-002AA103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A209786-001AA12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A209786-002AA12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A209786-001AA15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A209786-002AA15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A209786-001AA1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A209786-002AA1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A209786-001AA1d06236e962d9…
2024-10-29 15:01 UTC2024-10A209786-002AA1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A209786-001AA179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A209786-002AA179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A209786-001AA1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A209786-002AA1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A209786-001AA11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A209786-002AA11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A209786-001AA18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A209786-002AA18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A209786-001AA15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A209786-002AA15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A209786-001AA15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A209786-002AA15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A209786-001AA14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A209786-002AA14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A209786-001AA174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A209786-002AA174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A209786-001AA1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A209786-002AA1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A209786-001AA1782e0a99824c…
2021-12-28 21:50 UTC2021-12A209786-002AA1782e0a99824c…

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
40032-168-012025-01-30C16284748780-12cef2736-a76b-d83d-e063-dadaa90ab31fThese highlights do not include all the information needed to use POTASSIUM CHLORIDE safely and effectively. See full prescribing information for POTASSIUM CHLORIDE. POTASSIUM CHLORIDE oral solution Initial U.S. Approval:1948

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
40032-168-01potassium chloride473 mL in 1 BOTTLESOLUTION4734

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
40032-168POTASSIUM CHLORIDE SOLUTION [NOVEL LABORATORIES, INC.]4Legacy NDC, 1 package rows20191221_d0f24788-3a28-470c-acf4-2bc5397ae3be.zip

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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
POTASSIUM CHLORIDEPOTASSIUM CHLORIDELupin Pharmaceuticals,Inc.28c49165-d8c9-443a-b000-953b8e1ec55c2020-11-20Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209786
application number: ANDA209786

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312515potassium chloride 20 MEQ in 15 mL Oral SolutionPSNd0f24788-3a28-470c-acf4-2bc5397ae3be4
314182potassium chloride 40 MEQ in 15 mL Oral SolutionPSNd0f24788-3a28-470c-acf4-2bc5397ae3be4
312515potassium chloride 1.33 MEQ/ML Oral SolutionSCDd0f24788-3a28-470c-acf4-2bc5397ae3be4
314182potassium chloride 2.67 MEQ/ML Oral SolutionSCDd0f24788-3a28-470c-acf4-2bc5397ae3be4
312515K+ Chloride 1.33 MEQ/ML Oral SolutionSYd0f24788-3a28-470c-acf4-2bc5397ae3be4
314182K+ Chloride 2.67 MEQ/ML Oral SolutionSYd0f24788-3a28-470c-acf4-2bc5397ae3be4
312515Pot Chloride 1.33 MEQ/ML Oral SolutionSYd0f24788-3a28-470c-acf4-2bc5397ae3be4
314182Pot Chloride 2.67 MEQ/ML Oral SolutionSYd0f24788-3a28-470c-acf4-2bc5397ae3be4
312515potassium chloride 1.5 GM per 15 ML Oral SolutionSYd0f24788-3a28-470c-acf4-2bc5397ae3be4
312515potassium chloride 10 % Oral SolutionSYd0f24788-3a28-470c-acf4-2bc5397ae3be4
314182potassium chloride 20 % Oral SolutionSYd0f24788-3a28-470c-acf4-2bc5397ae3be4
312515potassium chloride 20 MEQ per 15 ML Oral SolutionSYd0f24788-3a28-470c-acf4-2bc5397ae3be4
314182potassium chloride 20 MEQ per 30 ML Oral SolutionSYd0f24788-3a28-470c-acf4-2bc5397ae3be4
314182potassium chloride 3 GM per 15 ML Oral SolutionSYd0f24788-3a28-470c-acf4-2bc5397ae3be4
314182potassium chloride 40 MEQ per 15 ML Oral SolutionSYd0f24788-3a28-470c-acf4-2bc5397ae3be4
312515potassium chloride 40 MEQ per 30 ML Oral SolutionSYd0f24788-3a28-470c-acf4-2bc5397ae3be4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
40032-168-0140032016801473 mL in 1 BOTTLE (40032-168-01) 473 ml2018-09-240000-00-00NoNoCurrent