potassium chloride

Product NDC
68001-367
11-digit product format
680010367
Labeler code
68001
Product ID
68001-367_83d51a49-303a-40a3-ba48-43c45dc865cb
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
potassium chloride
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
BluePoint Laboratories
Application
ANDA203562
Marketing category
ANDA
Marketing start
2018-06-30
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
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 productproduct68001-367DDiscontinued by firm2026-08-03
excluded packagepackage68001-36768001-367-00DDiscontinued by firm2026-08-03
excluded packagepackage68001-36768001-367-03DDiscontinued 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 · 30 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 packagepackage68001-367-03d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage68001-367-00d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage68001-367-03f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage68001-367-00f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage68001-367-032ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage68001-367-002ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage68001-367-03a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage68001-367-00a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage68001-367-03cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage68001-367-00cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage68001-367-03cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage68001-367-00cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage68001-367-03302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage68001-367-00302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage68001-367-03ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage68001-367-00ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage68001-367-030efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage68001-367-000efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage68001-367-03ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage68001-367-00ad56d346431e…cc804d4bbf1e…

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
A203562-001POTASSIUM CHLORIDEPOTASSIUM CHLORIDE10MEQTABLET, EXTENDED RELEASE / ORALAB12016-07-26
A203562-002POTASSIUM CHLORIDEPOTASSIUM CHLORIDE20MEQTABLET, EXTENDED RELEASE / ORALAB12016-07-26

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A203562-001AB1
A203562-002AB1

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 UTC2026-02A203562-001POTASSIUM CHLORIDE10MEQTABLET, EXTENDED RELEASE / ORALAB12016-07-26011fe1cb6892…
2026-02-19 14:30 UTC2026-02A203562-002POTASSIUM CHLORIDE20MEQTABLET, EXTENDED RELEASE / ORALAB12016-07-26011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203562-001POTASSIUM CHLORIDE10MEQTABLET, EXTENDED RELEASE / ORALAB12016-07-2631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203562-002POTASSIUM CHLORIDE20MEQTABLET, EXTENDED RELEASE / ORALAB12016-07-2631067a03dcf5…
2025-08-23 18:47 UTC2025-08A203562-001POTASSIUM CHLORIDE10MEQTABLET, EXTENDED RELEASE / ORALAB12016-07-266a471c1ec25d…
2025-08-23 18:47 UTC2025-08A203562-002POTASSIUM CHLORIDE20MEQTABLET, EXTENDED RELEASE / ORALAB12016-07-266a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203562-001POTASSIUM CHLORIDE10MEQTABLET, EXTENDED RELEASE / ORALAB12016-07-26fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203562-002POTASSIUM CHLORIDE20MEQTABLET, EXTENDED RELEASE / ORALAB12016-07-26fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203562-001POTASSIUM CHLORIDE10MEQTABLET, EXTENDED RELEASE / ORALAB12016-07-26b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203562-002POTASSIUM CHLORIDE20MEQTABLET, EXTENDED RELEASE / ORALAB12016-07-26b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203562-001POTASSIUM CHLORIDE10MEQTABLET, EXTENDED RELEASE / ORALAB12016-07-2603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203562-002POTASSIUM CHLORIDE20MEQTABLET, EXTENDED RELEASE / ORALAB12016-07-2603ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203562-001POTASSIUM CHLORIDE10MEQTABLET, EXTENDED RELEASE / ORALAB12016-07-262680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203562-002POTASSIUM CHLORIDE20MEQTABLET, EXTENDED RELEASE / ORALAB12016-07-262680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A203562-001POTASSIUM CHLORIDE10MEQTABLET, EXTENDED RELEASE / ORALAB12016-07-265bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A203562-002POTASSIUM CHLORIDE20MEQTABLET, EXTENDED RELEASE / ORALAB12016-07-265bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A203562-001POTASSIUM CHLORIDE10MEQTABLET, EXTENDED RELEASE / ORALAB12016-07-26d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A203562-002POTASSIUM CHLORIDE20MEQTABLET, EXTENDED RELEASE / ORALAB12016-07-26d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A203562-001POTASSIUM CHLORIDE10MEQTABLET, EXTENDED RELEASE / ORALAB12016-07-26d06236e962d9…
2024-10-29 15:01 UTC2024-10A203562-002POTASSIUM CHLORIDE20MEQTABLET, EXTENDED RELEASE / ORALAB12016-07-26d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A203562-001POTASSIUM CHLORIDE10MEQTABLET, EXTENDED RELEASE / ORALAB12016-07-2679d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A203562-002POTASSIUM CHLORIDE20MEQTABLET, EXTENDED RELEASE / ORALAB12016-07-2679d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A203562-001POTASSIUM CHLORIDE10MEQTABLET, EXTENDED RELEASE / ORALAB12016-07-26301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A203562-002POTASSIUM CHLORIDE20MEQTABLET, EXTENDED RELEASE / ORALAB12016-07-26301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A203562-001POTASSIUM CHLORIDE10MEQTABLET, EXTENDED RELEASE / ORALAB12016-07-261e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A203562-002POTASSIUM CHLORIDE20MEQTABLET, EXTENDED RELEASE / ORALAB12016-07-261e350fbaab3a…
2024-05-31 18:47 UTC2024-05A203562-001POTASSIUM CHLORIDE10MEQTABLET, EXTENDED RELEASE / ORALAB12016-07-268072bd15b7f6…
2024-05-31 18:47 UTC2024-05A203562-002POTASSIUM CHLORIDE20MEQTABLET, EXTENDED RELEASE / ORALAB12016-07-268072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A203562-001POTASSIUM CHLORIDE10MEQTABLET, EXTENDED RELEASE / ORALAB12016-07-265c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A203562-002POTASSIUM CHLORIDE20MEQTABLET, EXTENDED RELEASE / ORALAB12016-07-265c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A203562-001POTASSIUM CHLORIDE10MEQTABLET, EXTENDED RELEASE / ORALAB12016-07-265d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A203562-002POTASSIUM CHLORIDE20MEQTABLET, EXTENDED RELEASE / ORALAB12016-07-265d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A203562-001POTASSIUM CHLORIDE10MEQTABLET, EXTENDED RELEASE / ORALAB12016-07-264b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A203562-002POTASSIUM CHLORIDE20MEQTABLET, EXTENDED RELEASE / ORALAB12016-07-264b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A203562-001POTASSIUM CHLORIDE10MEQTABLET, EXTENDED RELEASE / ORALAB12016-07-2674a2ff9319b5…
2019-12-13 00:20 UTC2019-12A203562-002POTASSIUM CHLORIDE20MEQTABLET, EXTENDED RELEASE / ORALAB12016-07-2674a2ff9319b5…
2022-03-09 01:35 UTC2022-03A203562-001POTASSIUM CHLORIDE10MEQTABLET, EXTENDED RELEASE / ORALAB12016-07-26bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A203562-002POTASSIUM CHLORIDE20MEQTABLET, EXTENDED RELEASE / ORALAB12016-07-26bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A203562-001POTASSIUM CHLORIDE10MEQTABLET, EXTENDED RELEASE / ORALAB12016-07-26782e0a99824c…
2021-12-28 21:50 UTC2021-12A203562-002POTASSIUM CHLORIDE20MEQTABLET, EXTENDED RELEASE / ORALAB12016-07-26782e0a99824c…

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 UTC2026-02A203562-001AB11011fe1cb6892…
2026-02-19 14:30 UTC2026-02A203562-002AB11011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203562-001AB1131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203562-002AB1131067a03dcf5…
2025-08-23 18:47 UTC2025-08A203562-001AB116a471c1ec25d…
2025-08-23 18:47 UTC2025-08A203562-002AB116a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203562-001AB11fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203562-002AB11fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203562-001AB11b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203562-002AB11b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203562-001AB1103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203562-002AB1103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203562-001AB112680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203562-002AB112680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A203562-001AB115bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A203562-002AB115bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A203562-001AB11d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A203562-002AB11d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A203562-001AB11d06236e962d9…
2024-10-29 15:01 UTC2024-10A203562-002AB11d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A203562-001AB1179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A203562-002AB1179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A203562-001AB11301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A203562-002AB11301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A203562-001AB111e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A203562-002AB111e350fbaab3a…
2024-05-31 18:47 UTC2024-05A203562-001AB118072bd15b7f6…
2024-05-31 18:47 UTC2024-05A203562-002AB118072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A203562-001AB115c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A203562-002AB115c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A203562-001AB115d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A203562-002AB115d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A203562-001AB114b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A203562-002AB114b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A203562-001AB1174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A203562-002AB1174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A203562-001AB11bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A203562-002AB11bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A203562-001AB11782e0a99824c…
2021-12-28 21:50 UTC2021-12A203562-002AB11782e0a99824c…

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68001-367-00EA - Each68001-3673f20e019-8d44-4c03-80ee-c6d64802a08112019-02-13
68001-367-03EA - Each68001-367ac921f56-844b-448d-9f83-a3bdf3d7770a12019-02-13

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 · 7 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
potassium chloridePOTASSIUM CHLORIDEGlenmark Pharmaceuticals Inc., USA63bedd99-0596-49d2-ad04-d1d8ac15cc422026-07-08Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203562
application number: ANDA203562
potassium chloridePOTASSIUM CHLORIDERedpharm Drug3735d41a-7787-6b92-e063-6294a90add452025-12-24Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203562
application number: ANDA203562
Potassium Chloride ERPOTASSIUM CHLORIDE ERDirect_Rxf988aa11-60ef-411e-e053-6294a90a522a2025-01-22Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203562
application number: ANDA203562
potassium chloridePOTASSIUM CHLORIDEA-S Medication Solutions3a720078-f455-44ab-a883-e3c13d83a74c2024-11-18Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203562
application number: ANDA203562
potassium chloridePOTASSIUM CHLORIDEA-S Medication Solutionscf014023-5300-455f-9f7f-fefb2e3639862024-11-18Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203562
application number: ANDA203562
potassium chloridePOTASSIUM CHLORIDEBryant Ranch Prepackf22606a5-ac9f-44fc-bb7b-08f3cf56c9992024-11-12Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203562
application number: ANDA203562
potassium chloridePOTASSIUM CHLORIDEBryant Ranch Prepackbc42a691-a486-4ece-b9f7-faf6cc5df6b52024-08-29Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203562
application number: ANDA203562

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
68001-367-0068001036700100 TABLET, EXTENDED RELEASE in 1 BOTTLE (68001-367-00) 2018-06-300000-00-00NoNoCurrent
68001-367-0368001036703500 TABLET, EXTENDED RELEASE in 1 BOTTLE (68001-367-03) 2018-06-300000-00-00NoNoCurrent