Potassium chloride extended release

Product NDC
70518-2291
11-digit product format
705182291
Labeler code
70518
Product ID
70518-2291_919f8c8e-ef60-cf9d-e053-2995a90af967
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Potassium chloride
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA205993
Marketing category
ANDA
Marketing start
2019-08-30
Marketing end
0000-00-00
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
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 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct70518-2291DDiscontinued by firm2026-08-03
excluded packagepackage70518-229170518-2291-0DDiscontinued by firm2026-08-03

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 packagepackage70518-2291-0d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage70518-2291-0f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage70518-2291-02ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage70518-2291-0a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage70518-2291-0cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage70518-2291-0cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage70518-2291-0302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage70518-2291-0ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage70518-2291-00efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage70518-2291-0ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage70518-2291-0367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage70518-2291-0557ba5c1ecfa…9c80585c8c6e…

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
A205993-001POTASSIUM CHLORIDEPOTASSIUM CHLORIDE8MEQTABLET, EXTENDED RELEASE / ORALAB22015-11-05
A205993-002POTASSIUM CHLORIDEPOTASSIUM CHLORIDE10MEQTABLET, EXTENDED RELEASE / ORALAB22015-11-05

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A205993-001AB2
A205993-002AB2

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 UTC2026-02A205993-001POTASSIUM CHLORIDE8MEQTABLET, EXTENDED RELEASE / ORALAB22015-11-05011fe1cb6892…
2026-02-19 14:30 UTC2026-02A205993-002POTASSIUM CHLORIDE10MEQTABLET, EXTENDED RELEASE / ORALAB22015-11-05011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A205993-001POTASSIUM CHLORIDE8MEQTABLET, EXTENDED RELEASE / ORALAB22015-11-0531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A205993-002POTASSIUM CHLORIDE10MEQTABLET, EXTENDED RELEASE / ORALAB22015-11-0531067a03dcf5…
2025-08-23 18:47 UTC2025-08A205993-001POTASSIUM CHLORIDE8MEQTABLET, EXTENDED RELEASE / ORALAB22015-11-056a471c1ec25d…
2025-08-23 18:47 UTC2025-08A205993-002POTASSIUM CHLORIDE10MEQTABLET, EXTENDED RELEASE / ORALAB22015-11-056a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A205993-001POTASSIUM CHLORIDE8MEQTABLET, EXTENDED RELEASE / ORALAB22015-11-05fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A205993-002POTASSIUM CHLORIDE10MEQTABLET, EXTENDED RELEASE / ORALAB22015-11-05fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A205993-001POTASSIUM CHLORIDE8MEQTABLET, EXTENDED RELEASE / ORALAB22015-11-05b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A205993-002POTASSIUM CHLORIDE10MEQTABLET, EXTENDED RELEASE / ORALAB22015-11-05b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A205993-001POTASSIUM CHLORIDE8MEQTABLET, EXTENDED RELEASE / ORALAB22015-11-0503ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A205993-002POTASSIUM CHLORIDE10MEQTABLET, EXTENDED RELEASE / ORALAB22015-11-0503ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A205993-001POTASSIUM CHLORIDE8MEQTABLET, EXTENDED RELEASE / ORALAB22015-11-052680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A205993-002POTASSIUM CHLORIDE10MEQTABLET, EXTENDED RELEASE / ORALAB22015-11-052680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A205993-001POTASSIUM CHLORIDE8MEQTABLET, EXTENDED RELEASE / ORALAB22015-11-055bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A205993-002POTASSIUM CHLORIDE10MEQTABLET, EXTENDED RELEASE / ORALAB22015-11-055bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A205993-001POTASSIUM CHLORIDE8MEQTABLET, EXTENDED RELEASE / ORALAB22015-11-05d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A205993-002POTASSIUM CHLORIDE10MEQTABLET, EXTENDED RELEASE / ORALAB22015-11-05d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A205993-001POTASSIUM CHLORIDE8MEQTABLET, EXTENDED RELEASE / ORALAB22015-11-05d06236e962d9…
2024-10-29 15:01 UTC2024-10A205993-002POTASSIUM CHLORIDE10MEQTABLET, EXTENDED RELEASE / ORALAB22015-11-05d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A205993-001POTASSIUM CHLORIDE8MEQTABLET, EXTENDED RELEASE / ORALAB22015-11-0579d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A205993-002POTASSIUM CHLORIDE10MEQTABLET, EXTENDED RELEASE / ORALAB22015-11-0579d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A205993-001POTASSIUM CHLORIDE8MEQTABLET, EXTENDED RELEASE / ORALAB22015-11-05301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A205993-002POTASSIUM CHLORIDE10MEQTABLET, EXTENDED RELEASE / ORALAB22015-11-05301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A205993-001POTASSIUM CHLORIDE8MEQTABLET, EXTENDED RELEASE / ORALAB22015-11-051e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A205993-002POTASSIUM CHLORIDE10MEQTABLET, EXTENDED RELEASE / ORALAB22015-11-051e350fbaab3a…
2024-05-31 18:47 UTC2024-05A205993-001POTASSIUM CHLORIDE8MEQTABLET, EXTENDED RELEASE / ORALAB22015-11-058072bd15b7f6…
2024-05-31 18:47 UTC2024-05A205993-002POTASSIUM CHLORIDE10MEQTABLET, EXTENDED RELEASE / ORALAB22015-11-058072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A205993-001POTASSIUM CHLORIDE8MEQTABLET, EXTENDED RELEASE / ORALAB22015-11-055c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A205993-002POTASSIUM CHLORIDE10MEQTABLET, EXTENDED RELEASE / ORALAB22015-11-055c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A205993-001POTASSIUM CHLORIDE8MEQTABLET, EXTENDED RELEASE / ORALAB22015-11-055d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A205993-002POTASSIUM CHLORIDE10MEQTABLET, EXTENDED RELEASE / ORALAB22015-11-055d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A205993-001POTASSIUM CHLORIDE8MEQTABLET, EXTENDED RELEASE / ORALAB22015-11-054b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A205993-002POTASSIUM CHLORIDE10MEQTABLET, EXTENDED RELEASE / ORALAB22015-11-054b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A205993-001POTASSIUM CHLORIDE8MEQTABLET, EXTENDED RELEASE / ORALAB22015-11-0574a2ff9319b5…
2019-12-13 00:20 UTC2019-12A205993-002POTASSIUM CHLORIDE10MEQTABLET, EXTENDED RELEASE / ORALAB22015-11-0574a2ff9319b5…
2022-03-09 01:35 UTC2022-03A205993-001POTASSIUM CHLORIDE8MEQTABLET, EXTENDED RELEASE / ORALAB22015-11-05bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A205993-002POTASSIUM CHLORIDE10MEQTABLET, EXTENDED RELEASE / ORALAB22015-11-05bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A205993-001POTASSIUM CHLORIDE8MEQTABLET, EXTENDED RELEASE / ORALAB22015-11-05782e0a99824c…
2021-12-28 21:50 UTC2021-12A205993-002POTASSIUM CHLORIDE10MEQTABLET, EXTENDED RELEASE / ORALAB22015-11-05782e0a99824c…

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 UTC2026-02A205993-001AB21011fe1cb6892…
2026-02-19 14:30 UTC2026-02A205993-002AB21011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A205993-001AB2131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A205993-002AB2131067a03dcf5…
2025-08-23 18:47 UTC2025-08A205993-001AB216a471c1ec25d…
2025-08-23 18:47 UTC2025-08A205993-002AB216a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A205993-001AB21fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A205993-002AB21fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A205993-001AB21b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A205993-002AB21b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A205993-001AB2103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A205993-002AB2103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A205993-001AB212680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A205993-002AB212680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A205993-001AB215bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A205993-002AB215bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A205993-001AB21d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A205993-002AB21d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A205993-001AB21d06236e962d9…
2024-10-29 15:01 UTC2024-10A205993-002AB21d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A205993-001AB2179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A205993-002AB2179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A205993-001AB21301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A205993-002AB21301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A205993-001AB211e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A205993-002AB211e350fbaab3a…
2024-05-31 18:47 UTC2024-05A205993-001AB218072bd15b7f6…
2024-05-31 18:47 UTC2024-05A205993-002AB218072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A205993-001AB215c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A205993-002AB215c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A205993-001AB215d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A205993-002AB215d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A205993-001AB214b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A205993-002AB214b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A205993-001AB2174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A205993-002AB2174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A205993-001AB21bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A205993-002AB21bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A205993-001AB21782e0a99824c…
2021-12-28 21:50 UTC2021-12A205993-002AB21782e0a99824c…