Potassium Chloride

Product NDC
70518-1203
11-digit product format
705181203
Labeler code
70518
Product ID
70518-1203_e327e815-df9d-63e7-e053-2a95a90ac95e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Potassium Chloride
Dosage form
CAPSULE, EXTENDED RELEASE
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA202868
Marketing category
ANDA
Marketing start
2018-05-15
Marketing end
0000-00-00
Substance
POTASSIUM CHLORIDE
Active strength
750 mg/1
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
2023-12-31
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 · 5 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct70518-1203DDiscontinued by firm2026-08-17
excluded packagepackage70518-120370518-1203-0DDiscontinued by firm2026-08-17
excluded packagepackage70518-120370518-1203-1DDiscontinued by firm2026-08-17
excluded packagepackage70518-120370518-1203-2DDiscontinued by firm2026-08-17
excluded packagepackage70518-120370518-1203-3DDiscontinued 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 · 40 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 packagepackage70518-1203-1d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage70518-1203-2d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage70518-1203-3d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage70518-1203-0d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage70518-1203-1f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage70518-1203-2f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage70518-1203-3f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage70518-1203-0f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage70518-1203-22ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage70518-1203-12ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage70518-1203-02ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage70518-1203-2a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage70518-1203-1a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage70518-1203-0a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage70518-1203-2cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage70518-1203-1cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage70518-1203-0cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage70518-1203-2cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage70518-1203-1cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage70518-1203-0cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage70518-1203-1302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage70518-1203-0302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage70518-1203-2302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage70518-1203-1ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage70518-1203-0ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage70518-1203-2ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage70518-1203-10efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage70518-1203-00efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage70518-1203-20efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage70518-1203-1ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage70518-1203-0ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage70518-1203-2ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage70518-1203-1367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage70518-1203-0367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage70518-1203-2367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage70518-1203-1557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage70518-1203-0557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage70518-1203-2557ba5c1ecfa…9c80585c8c6e…

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
A202868-001POTASSIUM CHLORIDEPOTASSIUM CHLORIDE10MEQCAPSULE, EXTENDED RELEASE / ORAL2016-01-19

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 06:07:402026-07A202868-001POTASSIUM CHLORIDE10MEQCAPSULE, EXTENDED RELEASE / ORAL2016-01-19caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A202868-001POTASSIUM CHLORIDE10MEQCAPSULE, EXTENDED RELEASE / ORAL2016-01-19011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202868-001POTASSIUM CHLORIDE10MEQCAPSULE, EXTENDED RELEASE / ORAL2016-01-1931067a03dcf5…
2025-08-23 18:47 UTC2025-08A202868-001POTASSIUM CHLORIDE10MEQCAPSULE, EXTENDED RELEASE / ORAL2016-01-196a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202868-001POTASSIUM CHLORIDE10MEQCAPSULE, EXTENDED RELEASE / ORAL2016-01-19fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202868-001POTASSIUM CHLORIDE10MEQCAPSULE, EXTENDED RELEASE / ORAL2016-01-19b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202868-001POTASSIUM CHLORIDE10MEQCAPSULE, EXTENDED RELEASE / ORAL2016-01-1903ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202868-001POTASSIUM CHLORIDE10MEQCAPSULE, EXTENDED RELEASE / ORAL2016-01-192680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A202868-001POTASSIUM CHLORIDE10MEQCAPSULE, EXTENDED RELEASE / ORALAB2016-01-195bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A202868-001POTASSIUM CHLORIDE10MEQCAPSULE, EXTENDED RELEASE / ORAL2016-01-19d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A202868-001POTASSIUM CHLORIDE10MEQCAPSULE, EXTENDED RELEASE / ORAL2016-01-19d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A202868-001POTASSIUM CHLORIDE10MEQCAPSULE, EXTENDED RELEASE / ORALAB2016-01-1979d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A202868-001POTASSIUM CHLORIDE10MEQCAPSULE, EXTENDED RELEASE / ORALAB2016-01-19301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A202868-001POTASSIUM CHLORIDE10MEQCAPSULE, EXTENDED RELEASE / ORALAB2016-01-191e350fbaab3a…
2024-05-31 18:47 UTC2024-05A202868-001POTASSIUM CHLORIDE10MEQCAPSULE, EXTENDED RELEASE / ORALAB2016-01-198072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A202868-001POTASSIUM CHLORIDE10MEQCAPSULE, EXTENDED RELEASE / ORALAB2016-01-195c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A202868-001POTASSIUM CHLORIDE10MEQCAPSULE, EXTENDED RELEASE / ORALAB2016-01-195d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A202868-001POTASSIUM CHLORIDE10MEQCAPSULE, EXTENDED RELEASE / ORALAB2016-01-194b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A202868-001POTASSIUM CHLORIDE10MEQCAPSULE, EXTENDED RELEASE / ORALAB2016-01-1974a2ff9319b5…
2022-03-09 01:35 UTC2022-03A202868-001POTASSIUM CHLORIDE10MEQCAPSULE, EXTENDED RELEASE / ORALAB2016-01-19bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A202868-001POTASSIUM CHLORIDE10MEQCAPSULE, EXTENDED RELEASE / ORALAB2016-01-19782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A202868-001POTASSIUM CHLORIDE10MEQCAPSULE, EXTENDED RELEASE / ORALAB2016-01-1987673890dc5c…
2021-03-12 10:30 UTC2021-03A202868-001POTASSIUM CHLORIDE10MEQCAPSULE, EXTENDED RELEASE / ORALAB2016-01-195aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A202868-001POTASSIUM CHLORIDE10MEQCAPSULE, EXTENDED RELEASE / ORALAB2016-01-198869cabd3fbd…
2020-11-12 02:37 UTC2020-11A202868-001POTASSIUM CHLORIDE10MEQCAPSULE, EXTENDED RELEASE / ORALAB2016-01-19c0c555d07b60…
2019-12-14 00:12 UTC2019-12A202868-001POTASSIUM CHLORIDE10MEQCAPSULE, EXTENDED RELEASE / ORALAB2016-01-193f01610625f2…
2019-09-15 20:21 UTC2019-09A202868-001POTASSIUM CHLORIDE10MEQCAPSULE, EXTENDED RELEASE / ORALAB2016-01-19b00525d2431f…
2019-07-19 19:46 UTC2019-07A202868-001POTASSIUM CHLORIDE10MEQCAPSULE, EXTENDED RELEASE / ORALAB2016-01-19ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A202868-001POTASSIUM CHLORIDE10MEQCAPSULE, EXTENDED RELEASE / ORALAB2016-01-196a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A202868-001POTASSIUM CHLORIDE10MEQCAPSULE, EXTENDED RELEASE / ORALAB2016-01-191c564ffb4f44…
2023-12-20 04:57 UTC2023-12A202868-001POTASSIUM CHLORIDE10MEQCAPSULE, EXTENDED RELEASE / ORALAB2016-01-19ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A202868-001POTASSIUM CHLORIDE10MEQCAPSULE, EXTENDED RELEASE / ORALAB2016-01-19a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A202868-001POTASSIUM CHLORIDE10MEQCAPSULE, EXTENDED RELEASE / ORALAB2016-01-199b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A202868-001POTASSIUM CHLORIDE10MEQCAPSULE, EXTENDED RELEASE / ORALAB2016-01-19a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A202868-001POTASSIUM CHLORIDE10MEQCAPSULE, EXTENDED RELEASE / ORALAB2016-01-193f0d92c62455…
2023-05-13 08:27 UTC2023-05A202868-001POTASSIUM CHLORIDE10MEQCAPSULE, EXTENDED RELEASE / ORALAB2016-01-19053a50430f4f…
2023-01-26 05:58 UTC2023-01A202868-001POTASSIUM CHLORIDE10MEQCAPSULE, EXTENDED RELEASE / ORALAB2016-01-193bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A202868-001POTASSIUM CHLORIDE10MEQCAPSULE, EXTENDED RELEASE / ORALAB2016-01-193a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A202868-001POTASSIUM CHLORIDE10MEQCAPSULE, EXTENDED RELEASE / ORALAB2016-01-19f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A202868-001POTASSIUM CHLORIDE10MEQCAPSULE, EXTENDED RELEASE / ORALAB2016-01-19e64feba35796…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A202868-001AB15bbf6a4d5a75…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A202868-001AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A202868-001AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A202868-001AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A202868-001AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A202868-001AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A202868-001AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A202868-001AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A202868-001AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A202868-001AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A202868-001AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A202868-001AB187673890dc5c…
2021-03-12 10:30 UTC2021-03A202868-001AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A202868-001AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A202868-001AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A202868-001AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A202868-001AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A202868-001AB1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A202868-001AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A202868-001AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A202868-001AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A202868-001AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A202868-001AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A202868-001AB1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A202868-001AB13f0d92c62455…
2023-05-13 08:27 UTC2023-05A202868-001AB1053a50430f4f…
2023-01-26 05:58 UTC2023-01A202868-001AB13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A202868-001AB13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A202868-001AB1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A202868-001AB1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A202868-001AB1cb3db0bc1861…

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 · 3 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Potassium ChloridePOTASSIUM CHLORIDEBluePoint Laboratories431ff2ef-567c-4b60-af43-f4da61febaad2019-07-03Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202868
application number: ANDA202868
Potassium ChloridePOTASSIUM CHLORIDENorthstar Rx LLCdded25a9-3df4-463a-8685-d2bc03ea4edb2018-07-16Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202868
application number: ANDA202868
Potassium ChloridePOTASSIUM CHLORIDEGlenmark Pharmaceuticals Inc., USA5b054142-7372-4641-be27-dca630a97ad92016-04-29Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202868
application number: ANDA202868

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
70518-1203-17051812030190 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (70518-1203-1) 2018-09-070000-00-00NoNoCurrent
70518-1203-27051812030230 CAPSULE, EXTENDED RELEASE in 1 BLISTER PACK (70518-1203-2) 2021-12-300000-00-00NoNoCurrent