Potassium Chloride for Oral Solution

Product NDC
69543-379
11-digit product format
695430379
Labeler code
69543
Product ID
69543-379_fe0079fd-f9b5-4c66-89c2-f742db92ea63
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Potassium Chloride
Dosage form
POWDER, FOR SOLUTION
Route
ORAL
Labeler
Virtus Pharmaceuticals
Application
NDA208019
Marketing category
NDA
Marketing start
2017-01-09
Marketing end
0000-00-00
Substance
POTASSIUM CHLORIDE
Active strength
2 g/1.58g
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
2021-12-31
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 · 3 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct69543-379DDiscontinued by firm2026-08-17
excluded packagepackage69543-37969543-379-10DDiscontinued by firm2026-08-17
excluded packagepackage69543-37969543-379-30DDiscontinued by firm2026-08-17

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 · 36 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage69543-379-10d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage69543-379-30d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage69543-379-10f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage69543-379-30f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage69543-379-102ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage69543-379-302ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage69543-379-10a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage69543-379-30a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage69543-379-10cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage69543-379-30cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage69543-379-10cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage69543-379-30cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage69543-379-10302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage69543-379-30302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage69543-379-10ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage69543-379-30ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage69543-379-100efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage69543-379-300efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage69543-379-10ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage69543-379-30ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage69543-379-10367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage69543-379-30367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage69543-379-10557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage69543-379-30557ba5c1ecfa…9c80585c8c6e…

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

Orange Book products#

Current product rows page 1 of 1 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N208019-001POTASSIUM CHLORIDEPOTASSIUM CHLORIDE20MEQFOR SOLUTION / ORALAARLD2015-08-19
N208019-002POKONZAPOTASSIUM CHLORIDE10MEQFOR SOLUTION / ORALRLD2023-08-25
N208019-003POTASSIUM CHLORIDEPOTASSIUM CHLORIDE40MEQFOR SOLUTION / ORALRLD2023-08-25
N208019-004POKONZAPOTASSIUM CHLORIDE15MEQFOR SOLUTION / ORALRLD2025-11-12

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
N208019-001AA

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 3 · 86 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07N208019-001POTASSIUM CHLORIDE20MEQFOR SOLUTION / ORALAARLD2015-08-19caaa826d4ba7…
2026-08-18 06:07:402026-07N208019-002POKONZA10MEQFOR SOLUTION / ORALRLD2023-08-25caaa826d4ba7…
2026-08-18 06:07:402026-07N208019-003POTASSIUM CHLORIDE40MEQFOR SOLUTION / ORALRLD2023-08-25caaa826d4ba7…
2026-08-18 06:07:402026-07N208019-004POKONZA15MEQFOR SOLUTION / ORALRLD2025-11-12caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N208019-001POTASSIUM CHLORIDE20MEQFOR SOLUTION / ORALAARLD2015-08-19011fe1cb6892…
2026-02-19 14:30 UTC2026-02N208019-002POKONZA10MEQFOR SOLUTION / ORALRLD2023-08-25011fe1cb6892…
2026-02-19 14:30 UTC2026-02N208019-003POTASSIUM CHLORIDE40MEQFOR SOLUTION / ORALRLD, RS2023-08-25011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N208019-001POTASSIUM CHLORIDE20MEQFOR SOLUTION / ORALAARLD2015-08-1931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N208019-002POKONZA10MEQFOR SOLUTION / ORALRLD2023-08-2531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N208019-003POTASSIUM CHLORIDE40MEQFOR SOLUTION / ORALRLD, RS2023-08-2531067a03dcf5…
2025-08-23 18:47 UTC2025-08N208019-001POTASSIUM CHLORIDE20MEQFOR SOLUTION / ORALAARLD, RS2015-08-196a471c1ec25d…
2025-08-23 18:47 UTC2025-08N208019-002POKONZA10MEQFOR SOLUTION / ORALRLD2023-08-256a471c1ec25d…
2025-08-23 18:47 UTC2025-08N208019-003POTASSIUM CHLORIDE40MEQFOR SOLUTION / ORALRLD2023-08-256a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N208019-001POTASSIUM CHLORIDE20MEQFOR SOLUTION / ORALAARLD, RS2015-08-19fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N208019-002POKONZA10MEQFOR SOLUTION / ORALRLD2023-08-25fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N208019-003POTASSIUM CHLORIDE40MEQFOR SOLUTION / ORALRLD2023-08-25fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N208019-001POTASSIUM CHLORIDE20MEQFOR SOLUTION / ORALAARLD, RS2015-08-19b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N208019-002POKONZA10MEQFOR SOLUTION / ORALRLD2023-08-25b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N208019-003POTASSIUM CHLORIDE40MEQFOR SOLUTION / ORALRLD2023-08-25b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N208019-001POTASSIUM CHLORIDE20MEQFOR SOLUTION / ORALAARLD2015-08-1903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N208019-002POKONZA10MEQFOR SOLUTION / ORALRLD2023-08-2503ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N208019-003POTASSIUM CHLORIDE40MEQFOR SOLUTION / ORALRLD, RS2023-08-2503ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N208019-001POTASSIUM CHLORIDE20MEQFOR SOLUTION / ORALAARLD2015-08-192680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N208019-002POKONZA10MEQFOR SOLUTION / ORALRLD2023-08-252680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N208019-003POTASSIUM CHLORIDE40MEQFOR SOLUTION / ORALRLD, RS2023-08-252680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N208019-001POTASSIUM CHLORIDE20MEQFOR SOLUTION / ORALAARLD2015-08-195bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N208019-002POKONZA10MEQFOR SOLUTION / ORALRLD2023-08-255bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N208019-003POTASSIUM CHLORIDE40MEQFOR SOLUTION / ORALRLD, RS2023-08-255bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N208019-001POTASSIUM CHLORIDE20MEQFOR SOLUTION / ORALAARLD2015-08-19d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N208019-002POKONZA10MEQFOR SOLUTION / ORALRLD2023-08-25d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N208019-003POTASSIUM CHLORIDE40MEQFOR SOLUTION / ORALRLD, RS2023-08-25d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N208019-001POTASSIUM CHLORIDE20MEQFOR SOLUTION / ORALAARLD2015-08-19d06236e962d9…
2024-10-29 15:01 UTC2024-10N208019-002POKONZA10MEQFOR SOLUTION / ORALRLD2023-08-25d06236e962d9…
2024-10-29 15:01 UTC2024-10N208019-003POTASSIUM CHLORIDE40MEQFOR SOLUTION / ORALRLD, RS2023-08-25d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N208019-001POTASSIUM CHLORIDE20MEQFOR SOLUTION / ORALAARLD2015-08-1979d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N208019-002POKONZA10MEQFOR SOLUTION / ORALRLD2023-08-2579d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N208019-003POTASSIUM CHLORIDE40MEQFOR SOLUTION / ORALRLD, RS2023-08-2579d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N208019-001POTASSIUM CHLORIDE20MEQFOR SOLUTION / ORALAARLD2015-08-19301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N208019-002POKONZA10MEQFOR SOLUTION / ORALRLD2023-08-25301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N208019-003POTASSIUM CHLORIDE40MEQFOR SOLUTION / ORALRLD, RS2023-08-25301d65b070ca…

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 06:07:402026-07N208019-001AA1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N208019-001AA1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N208019-001AA131067a03dcf5…
2025-08-23 18:47 UTC2025-08N208019-001AA16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N208019-001AA1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N208019-001AA1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N208019-001AA103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N208019-001AA12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N208019-001AA15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N208019-001AA1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N208019-001AA1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N208019-001AA179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N208019-001AA1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N208019-001AA11e350fbaab3a…
2024-05-31 18:47 UTC2024-05N208019-001AA18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N208019-001AA15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N208019-001AA15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N208019-001AA14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N208019-001AA174a2ff9319b5…
2022-03-09 01:35 UTC2022-03N208019-001AA1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N208019-001AA1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N208019-001AA187673890dc5c…
2021-03-12 10:30 UTC2021-03N208019-001AA15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N208019-001AA18869cabd3fbd…
2020-11-12 02:37 UTC2020-11N208019-001AA1c0c555d07b60…
2019-12-14 00:12 UTC2019-12N208019-001AA13f01610625f2…
2019-09-15 20:21 UTC2019-09N208019-001AA1b00525d2431f…
2019-07-19 19:46 UTC2019-07N208019-001AA1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N208019-001AA16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N208019-001AA11c564ffb4f44…
2023-12-20 04:57 UTC2023-12N208019-001AA1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N208019-001AA1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N208019-001AA19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N208019-001AA1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N208019-001AA13f0d92c62455…
2023-05-13 08:27 UTC2023-05N208019-001AA1053a50430f4f…
2023-01-26 05:58 UTC2023-01N208019-001AA13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N208019-001AA13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N208019-001AA1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N208019-001AA1e64feba35796…

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69543-379-01EA - Each69543-379c48b217e-2391-4455-a2d6-46d69d443e3612017-03-06
69543-379-10EA - Each69543-37903b25fdd-36fe-4f75-96e4-9aa24fe5599112017-03-06
69543-379-30EA - Each69543-3798f551ced-65fe-49e4-a1a1-11f0876cbba612017-03-06

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 · 5 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
POKONZAPOTASSIUM CHLORIDECarwin Pharmaceutical Associates, LLC0700c19e-abca-4527-8944-e4440a32e3af2025-12-18Warnings, Adverse reactionsExact identifier
application applno (NDA): 208019
application number: NDA208019
Potassium ChloridePOTASSIUM CHLORIDEIPG Pharmaceuticals, Inc.5dad0879-0f97-4c7d-98fa-baaed51cd2d82025-12-09Warnings, Adverse reactionsExact identifier
application applno (NDA): 208019
application number: NDA208019
Potassium ChloridePOTASSIUM CHLORIDEEndo USA, Inc.a64d7151-09a6-474c-83fc-36c7cf582d322025-03-26Warnings, Adverse reactionsExact identifier
application applno (NDA): 208019
application number: NDA208019
POKONZAPOTASSIUM CHLORIDECarwin Pharmaceutical Associates, LLC7c5cc705-e5da-4487-86c9-9d545a95afb42024-03-22Warnings, Adverse reactionsExact identifier
application applno (NDA): 208019
application number: NDA208019
Potassium ChloridePOTASSIUM CHLORIDEGenus Lifesciences Inc.23d818e7-c076-40de-8dc1-0b51ba4be96a2020-04-28Warnings, Adverse reactionsExact identifier
application applno (NDA): 208019
application number: NDA208019

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69543-379-1069543037910100 POUCH in 1 CARTON (69543-379-10) > 1.58 g in 1 POUCH (69543-379-01) 100 pouch2017-01-090000-00-00NoNoCurrent
69543-379-306954303793030 POUCH in 1 CARTON (69543-379-30) > 1.58 g in 1 POUCH (69543-379-01) 30 pouch2017-01-090000-00-00NoNoCurrent