Potassium Chloride

Product NDC
68084-524
11-digit product format
680840524
Labeler code
68084
Product ID
68084-524_9982e1cc-ff91-3a69-e053-2995a90a370b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Potassium Chloride
Dosage form
TABLET, FILM COATED, EXTENDED RELEASE
Route
ORAL
Labeler
American Health Packaging
Application
NDA018279
Marketing category
NDA AUTHORIZED GENERIC
Marketing start
2013-02-05
Marketing end
2020-08-31
Substance
POTASSIUM CHLORIDE
Active strength
750 mg/1
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
0000-00-00
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 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct68084-524DDiscontinued by firm2026-08-17
excluded packagepackage68084-52468084-524-01DDiscontinued 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 · 24 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 packagepackage68084-524-01d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage68084-524-01f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage68084-524-012ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage68084-524-01a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage68084-524-01cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage68084-524-01cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage68084-524-01302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage68084-524-01ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage68084-524-010efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage68084-524-01ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage68084-524-01367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage68084-524-01557ba5c1ecfa…9c80585c8c6e…

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

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N018279-001K-TABPOTASSIUM CHLORIDE10MEQ **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, EXTENDED RELEASE / ORALRLD, Approved before 1982
N018279-002K-TABPOTASSIUM CHLORIDE8MEQ **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, EXTENDED RELEASE / ORALRLD1988-08-01
N018279-003K-TABPOTASSIUM CHLORIDE20MEQ **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, EXTENDED RELEASE / ORALRLD2013-11-25

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 4 · 126 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07N018279-001K-TAB10MEQ **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, EXTENDED RELEASE / ORALRLD, Approved before 1982caaa826d4ba7…
2026-08-18 06:07:402026-07N018279-002K-TAB8MEQ **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, EXTENDED RELEASE / ORALRLD1988-08-01caaa826d4ba7…
2026-08-18 06:07:402026-07N018279-003K-TAB20MEQ **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, EXTENDED RELEASE / ORALRLD2013-11-25caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N018279-001K-TAB10MEQ **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, EXTENDED RELEASE / ORALRLD, Approved before 1982011fe1cb6892…
2026-02-19 14:30 UTC2026-02N018279-002K-TAB8MEQ **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, EXTENDED RELEASE / ORALRLD1988-08-01011fe1cb6892…
2026-02-19 14:30 UTC2026-02N018279-003K-TAB20MEQ **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, EXTENDED RELEASE / ORALRLD2013-11-25011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N018279-001K-TAB10MEQ **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, EXTENDED RELEASE / ORALRLD, Approved before 198231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N018279-002K-TAB8MEQ **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, EXTENDED RELEASE / ORALRLD1988-08-0131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N018279-003K-TAB20MEQ **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, EXTENDED RELEASE / ORALRLD2013-11-2531067a03dcf5…
2025-08-23 18:47 UTC2025-08N018279-001K-TAB10MEQ **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, EXTENDED RELEASE / ORALRLD, Approved before 19826a471c1ec25d…
2025-08-23 18:47 UTC2025-08N018279-002K-TAB8MEQ **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, EXTENDED RELEASE / ORALRLD1988-08-016a471c1ec25d…
2025-08-23 18:47 UTC2025-08N018279-003K-TAB20MEQ **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, EXTENDED RELEASE / ORALRLD2013-11-256a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N018279-001K-TAB10MEQ **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, EXTENDED RELEASE / ORALRLD, Approved before 1982fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N018279-002K-TAB8MEQ **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, EXTENDED RELEASE / ORALRLD1988-08-01fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N018279-003K-TAB20MEQ **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, EXTENDED RELEASE / ORALRLD2013-11-25fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N018279-001K-TAB10MEQ **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, EXTENDED RELEASE / ORALRLD, Approved before 1982b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N018279-002K-TAB8MEQ **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, EXTENDED RELEASE / ORALRLD1988-08-01b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N018279-003K-TAB20MEQ **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, EXTENDED RELEASE / ORALRLD2013-11-25b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N018279-001K-TAB10MEQ **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, EXTENDED RELEASE / ORALRLD, Approved before 198203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N018279-002K-TAB8MEQ **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, EXTENDED RELEASE / ORALRLD1988-08-0103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N018279-003K-TAB20MEQ **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, EXTENDED RELEASE / ORALRLD2013-11-2503ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N018279-001K-TAB10MEQ **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, EXTENDED RELEASE / ORALRLD, Approved before 19822680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N018279-002K-TAB8MEQ **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, EXTENDED RELEASE / ORALRLD1988-08-012680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N018279-003K-TAB20MEQ **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, EXTENDED RELEASE / ORALRLD2013-11-252680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N018279-001K-TAB10MEQ **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, EXTENDED RELEASE / ORALRLD, Approved before 19825bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N018279-002K-TAB8MEQ **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, EXTENDED RELEASE / ORALRLD1988-08-015bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N018279-003K-TAB20MEQ **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, EXTENDED RELEASE / ORALRLD2013-11-255bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N018279-001K-TAB10MEQ **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, EXTENDED RELEASE / ORALRLD, Approved before 1982d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N018279-002K-TAB8MEQ **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, EXTENDED RELEASE / ORALRLD1988-08-01d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N018279-003K-TAB20MEQ **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, EXTENDED RELEASE / ORALRLD2013-11-25d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N018279-001K-TAB10MEQ **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, EXTENDED RELEASE / ORALRLD, Approved before 1982d06236e962d9…
2024-10-29 15:01 UTC2024-10N018279-002K-TAB8MEQ **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, EXTENDED RELEASE / ORALRLD1988-08-01d06236e962d9…
2024-10-29 15:01 UTC2024-10N018279-003K-TAB20MEQ **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, EXTENDED RELEASE / ORALRLD2013-11-25d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N018279-001K-TAB10MEQ **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, EXTENDED RELEASE / ORALRLD, Approved before 198279d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N018279-002K-TAB8MEQ **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, EXTENDED RELEASE / ORALRLD1988-08-0179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N018279-003K-TAB20MEQ **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, EXTENDED RELEASE / ORALRLD2013-11-2579d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N018279-001K-TAB10MEQ **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, EXTENDED RELEASE / ORALRLD, Approved before 1982301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N018279-002K-TAB8MEQ **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, EXTENDED RELEASE / ORALRLD1988-08-01301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N018279-003K-TAB20MEQ **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, EXTENDED RELEASE / ORALRLD2013-11-25301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N018279-001K-TAB10MEQ **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, EXTENDED RELEASE / ORALRLD, Approved before 19821e350fbaab3a…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 47 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N018279-001AB315c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N018279-003AB315c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N018279-001AB315d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N018279-003AB315d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N018279-001AB314b0b4de00fa7…
2022-04-04 05:41 UTC2022-04N018279-002BC14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04N018279-003AB314b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N018279-001AB3174a2ff9319b5…
2019-12-13 00:20 UTC2019-12N018279-002BC174a2ff9319b5…
2019-12-13 00:20 UTC2019-12N018279-003AB3174a2ff9319b5…
2022-03-09 01:35 UTC2022-03N018279-001AB31bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03N018279-002BC1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03N018279-003AB31bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N018279-001AB31782e0a99824c…
2021-12-28 21:50 UTC2021-12N018279-002BC1782e0a99824c…
2021-12-28 21:50 UTC2021-12N018279-003AB31782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N018279-001AB3187673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N018279-002BC187673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N018279-003AB3187673890dc5c…
2021-03-12 10:30 UTC2021-03N018279-001AB315aa47cf7b7d7…
2021-03-12 10:30 UTC2021-03N018279-002BC15aa47cf7b7d7…
2021-03-12 10:30 UTC2021-03N018279-003AB315aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N018279-001AB318869cabd3fbd…
2020-12-22 03:56 UTC2020-12N018279-002BC18869cabd3fbd…
2020-12-22 03:56 UTC2020-12N018279-003AB318869cabd3fbd…
2020-11-12 02:37 UTC2020-11N018279-001AB31c0c555d07b60…
2020-11-12 02:37 UTC2020-11N018279-002BC1c0c555d07b60…
2020-11-12 02:37 UTC2020-11N018279-003AB31c0c555d07b60…
2019-12-14 00:12 UTC2019-12N018279-001AB313f01610625f2…
2019-12-14 00:12 UTC2019-12N018279-002BC13f01610625f2…
2019-12-14 00:12 UTC2019-12N018279-003AB313f01610625f2…
2019-09-15 20:21 UTC2019-09N018279-001AB31b00525d2431f…
2019-09-15 20:21 UTC2019-09N018279-002BC1b00525d2431f…
2019-09-15 20:21 UTC2019-09N018279-003AB21b00525d2431f…
2019-07-19 19:46 UTC2019-07N018279-001AB31ea99ee380514…
2019-07-19 19:46 UTC2019-07N018279-002BC1ea99ee380514…
2019-07-19 19:46 UTC2019-07N018279-003AB21ea99ee380514…
2023-01-26 05:58 UTC2023-01N018279-001AB313bdfa0b2c4d7…
2023-01-26 05:58 UTC2023-01N018279-003AB313bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N018279-001AB313a93d1ddd44b…

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68084-524-01EA - Each68084-5242c021e30-3ea0-4f13-b588-95d252c288e112013-03-03
68084-524-11EA - Each68084-524f519a5be-3bf2-4b79-b9c0-16b44973a66f12013-03-03

DailyMed Socrata Ingredients#