Potassium Chloride

Product NDC
60505-6185
Requested package NDC
60505-6185-6
11-digit product format
605056185
Labeler code
60505
Product ID
60505-6185_e8d857f5-2895-b451-3566-14ba9b508460
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Potassium Chloride
Dosage form
SOLUTION
Route
ORAL
Labeler
Apotex Corp
Application
ANDA211067
Marketing category
ANDA
Marketing start
2021-10-07
Marketing end
0000-00-00
Substance
POTASSIUM CHLORIDE
Active strength
40 meq/15mL
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 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage60505-618560505-6185-6DDiscontinued by firm2026-10-05

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 · 11 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…383a685ebd0f…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
A211067-001POTASSIUM CHLORIDEPOTASSIUM CHLORIDE20MEQ/15MLSOLUTION / ORAL2018-08-08
A211067-002POTASSIUM CHLORIDEPOTASSIUM CHLORIDE40MEQ/15MLSOLUTION / ORAL2018-08-08

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
2026-09-14 22:38:342026-08A211067-001POTASSIUM CHLORIDE20MEQ/15MLSOLUTION / ORAL2018-08-0884e616aacf4f…
2026-09-14 22:38:342026-08A211067-002POTASSIUM CHLORIDE40MEQ/15MLSOLUTION / ORAL2018-08-0884e616aacf4f…
2026-08-18 06:07:402026-07A211067-001POTASSIUM CHLORIDE20MEQ/15MLSOLUTION / ORAL2018-08-08caaa826d4ba7…
2026-08-18 06:07:402026-07A211067-002POTASSIUM CHLORIDE40MEQ/15MLSOLUTION / ORAL2018-08-08caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A211067-001POTASSIUM CHLORIDE20MEQ/15MLSOLUTION / ORALAA2018-08-08011fe1cb6892…
2026-02-19 14:30 UTC2026-02A211067-002POTASSIUM CHLORIDE40MEQ/15MLSOLUTION / ORALAA2018-08-08011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A211067-001POTASSIUM CHLORIDE20MEQ/15MLSOLUTION / ORALAA2018-08-0831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A211067-002POTASSIUM CHLORIDE40MEQ/15MLSOLUTION / ORALAA2018-08-0831067a03dcf5…
2025-08-23 18:47 UTC2025-08A211067-001POTASSIUM CHLORIDE20MEQ/15MLSOLUTION / ORALAA2018-08-086a471c1ec25d…
2025-08-23 18:47 UTC2025-08A211067-002POTASSIUM CHLORIDE40MEQ/15MLSOLUTION / ORALAA2018-08-086a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A211067-001POTASSIUM CHLORIDE20MEQ/15MLSOLUTION / ORALAA2018-08-08fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A211067-002POTASSIUM CHLORIDE40MEQ/15MLSOLUTION / ORALAA2018-08-08fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A211067-001POTASSIUM CHLORIDE20MEQ/15MLSOLUTION / ORALAA2018-08-08b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A211067-002POTASSIUM CHLORIDE40MEQ/15MLSOLUTION / ORALAA2018-08-08b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A211067-001POTASSIUM CHLORIDE20MEQ/15MLSOLUTION / ORALAA2018-08-0803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A211067-002POTASSIUM CHLORIDE40MEQ/15MLSOLUTION / ORALAA2018-08-0803ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A211067-001POTASSIUM CHLORIDE20MEQ/15MLSOLUTION / ORALAA2018-08-082680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A211067-002POTASSIUM CHLORIDE40MEQ/15MLSOLUTION / ORALAA2018-08-082680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A211067-001POTASSIUM CHLORIDE20MEQ/15MLSOLUTION / ORALAA2018-08-085bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A211067-002POTASSIUM CHLORIDE40MEQ/15MLSOLUTION / ORALAA2018-08-085bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A211067-001POTASSIUM CHLORIDE20MEQ/15MLSOLUTION / ORALAA2018-08-08d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A211067-002POTASSIUM CHLORIDE40MEQ/15MLSOLUTION / ORALAA2018-08-08d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A211067-001POTASSIUM CHLORIDE20MEQ/15MLSOLUTION / ORALAA2018-08-08d06236e962d9…
2024-10-29 15:01 UTC2024-10A211067-002POTASSIUM CHLORIDE40MEQ/15MLSOLUTION / ORALAA2018-08-08d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A211067-001POTASSIUM CHLORIDE20MEQ/15MLSOLUTION / ORALAA2018-08-0879d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A211067-002POTASSIUM CHLORIDE40MEQ/15MLSOLUTION / ORALAA2018-08-0879d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A211067-001POTASSIUM CHLORIDE20MEQ/15MLSOLUTION / ORALAA2018-08-08301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A211067-002POTASSIUM CHLORIDE40MEQ/15MLSOLUTION / ORALAA2018-08-08301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A211067-001POTASSIUM CHLORIDE20MEQ/15MLSOLUTION / ORALAA2018-08-081e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A211067-002POTASSIUM CHLORIDE40MEQ/15MLSOLUTION / ORALAA2018-08-081e350fbaab3a…
2024-05-31 18:47 UTC2024-05A211067-001POTASSIUM CHLORIDE20MEQ/15MLSOLUTION / ORALAA2018-08-088072bd15b7f6…
2024-05-31 18:47 UTC2024-05A211067-002POTASSIUM CHLORIDE40MEQ/15MLSOLUTION / ORALAA2018-08-088072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A211067-001POTASSIUM CHLORIDE20MEQ/15MLSOLUTION / ORALAA2018-08-085c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A211067-002POTASSIUM CHLORIDE40MEQ/15MLSOLUTION / ORALAA2018-08-085c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A211067-001POTASSIUM CHLORIDE20MEQ/15MLSOLUTION / ORALAA2018-08-085d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A211067-002POTASSIUM CHLORIDE40MEQ/15MLSOLUTION / ORALAA2018-08-085d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A211067-001POTASSIUM CHLORIDE20MEQ/15MLSOLUTION / ORALAA2018-08-084b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A211067-002POTASSIUM CHLORIDE40MEQ/15MLSOLUTION / ORALAA2018-08-084b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A211067-001POTASSIUM CHLORIDE20MEQ/15MLSOLUTION / ORALAA2018-08-0874a2ff9319b5…
2019-12-13 00:20 UTC2019-12A211067-002POTASSIUM CHLORIDE40MEQ/15MLSOLUTION / ORALAA2018-08-0874a2ff9319b5…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 80 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A211067-001AA1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A211067-002AA1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A211067-001AA131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A211067-002AA131067a03dcf5…
2025-08-23 18:47 UTC2025-08A211067-001AA16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A211067-002AA16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A211067-001AA1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A211067-002AA1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A211067-001AA1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A211067-002AA1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A211067-001AA103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A211067-002AA103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A211067-001AA12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A211067-002AA12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A211067-001AA15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A211067-002AA15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A211067-001AA1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A211067-002AA1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A211067-001AA1d06236e962d9…
2024-10-29 15:01 UTC2024-10A211067-002AA1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A211067-001AA179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A211067-002AA179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A211067-001AA1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A211067-002AA1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A211067-001AA11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A211067-002AA11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A211067-001AA18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A211067-002AA18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A211067-001AA15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A211067-002AA15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A211067-001AA15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A211067-002AA15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A211067-001AA14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A211067-002AA14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A211067-001AA174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A211067-002AA174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A211067-001AA1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A211067-002AA1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A211067-001AA1782e0a99824c…
2021-12-28 21:50 UTC2021-12A211067-002AA1782e0a99824c…

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
CapturedEditionApplication-productExclusivity codeExpirationSource SHA-256
2019-12-13 00:20 UTC2019-12A211067-001CGT2019-02-2574a2ff9319b5…
2019-12-13 00:20 UTC2019-12A211067-002CGT2019-03-0674a2ff9319b5…
2019-12-14 00:12 UTC2019-12A211067-001CGT2019-02-253f01610625f2…
2019-12-14 00:12 UTC2019-12A211067-002CGT2019-03-063f01610625f2…
2019-09-15 20:21 UTC2019-09A211067-001CGT2019-02-25b00525d2431f…
2019-09-15 20:21 UTC2019-09A211067-002CGT2019-03-06b00525d2431f…
2019-07-19 19:46 UTC2019-07A211067-001CGT2019-02-25ea99ee380514…
2019-07-19 19:46 UTC2019-07A211067-002CGT2019-03-06ea99ee380514…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
60505-6185-6ML - Milliliter60505-618548ee61f1-fde2-4c02-9c77-fa1f3b46b68e12018-09-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60505-6185POTASSIUM CHLORIDE SOLUTION [APOTEX CORP]12Legacy NDC20250523_18ab4157-e99a-bff3-9ef8-9bb5c32ca36b.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
60505-6185-6605056185061 BOTTLE, PLASTIC in 1 CARTON (60505-6185-6) > 473 mL in 1 BOTTLE, PLASTIC2021-10-070000-00-00NoNoCurrent