Potassium Chloride

Product NDC
66689-048
Requested package NDC
66689-048-99
11-digit product format
666890048
Labeler code
66689
Product ID
66689-048_2d1d7b4e-5ac0-46a0-ba85-0470b0935693
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Potassium Chloride
Dosage form
SOLUTION
Route
ORAL
Labeler
VistaPharm, Inc.
Application
NDA206814
Marketing category
NDA
Marketing start
2015-02-15
Marketing end
0000-00-00
Substance
POTASSIUM CHLORIDE
Active strength
40 meq/30mL
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 packagepackage66689-04866689-048-99DDiscontinued 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 · 12 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…
2024-07-10 04:00 UTC · source 2024-07-09557ba5c1ecfa…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
N206814-001POTASSIUM CHLORIDEPOTASSIUM CHLORIDE20MEQ/15MLSOLUTION / ORALAARLD2014-12-22
N206814-002POTASSIUM CHLORIDEPOTASSIUM CHLORIDE40MEQ/15MLSOLUTION / ORALAARLD, RS2014-12-22
N206814-003POKONZAPOTASSIUM CHLORIDE10MEQ/15MLSOLUTION / ORALRLD2025-11-25

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
N206814-001AA
N206814-002AA

Orange Book patents#

Current patent rows page 1 of 1 · 2 matching rows.

Application-product, Patent, Expiration table
Application-productPatentExpirationUse codeCoverage / statusSubmission date
N206814-001125393142039-03-07Drug product2026-02-04
N206814-002125393142039-03-07Drug product2026-02-04

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 · 88 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07N206814-001POTASSIUM CHLORIDE20MEQ/15MLSOLUTION / ORALAARLD2014-12-22caaa826d4ba7…
2026-08-18 06:07:402026-07N206814-002POTASSIUM CHLORIDE40MEQ/15MLSOLUTION / ORALAARLD, RS2014-12-22caaa826d4ba7…
2026-08-18 06:07:402026-07N206814-003POKONZA10MEQ/15MLSOLUTION / ORALRLD2025-11-25caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N206814-001POTASSIUM CHLORIDE20MEQ/15MLSOLUTION / ORALAARLD2014-12-22011fe1cb6892…
2026-02-19 14:30 UTC2026-02N206814-002POTASSIUM CHLORIDE40MEQ/15MLSOLUTION / ORALAARLD, RS2014-12-22011fe1cb6892…
2026-02-19 14:30 UTC2026-02N206814-003POKONZA10MEQ/15MLSOLUTION / ORALRLD2025-11-25011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N206814-001POTASSIUM CHLORIDE20MEQ/15MLSOLUTION / ORALAARLD2014-12-2231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N206814-002POTASSIUM CHLORIDE40MEQ/15MLSOLUTION / ORALAARLD, RS2014-12-2231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N206814-003POKONZA10MEQ/15MLSOLUTION / ORALRLD2025-11-2531067a03dcf5…
2025-08-23 18:47 UTC2025-08N206814-001POTASSIUM CHLORIDE20MEQ/15MLSOLUTION / ORALAARLD2014-12-226a471c1ec25d…
2025-08-23 18:47 UTC2025-08N206814-002POTASSIUM CHLORIDE40MEQ/15MLSOLUTION / ORALAARLD, RS2014-12-226a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N206814-001POTASSIUM CHLORIDE20MEQ/15MLSOLUTION / ORALAARLD2014-12-22fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N206814-002POTASSIUM CHLORIDE40MEQ/15MLSOLUTION / ORALAARLD, RS2014-12-22fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N206814-001POTASSIUM CHLORIDE20MEQ/15MLSOLUTION / ORALAARLD2014-12-22b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N206814-002POTASSIUM CHLORIDE40MEQ/15MLSOLUTION / ORALAARLD, RS2014-12-22b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N206814-001POTASSIUM CHLORIDE20MEQ/15MLSOLUTION / ORALAARLD2014-12-2203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N206814-002POTASSIUM CHLORIDE40MEQ/15MLSOLUTION / ORALAARLD, RS2014-12-2203ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N206814-001POTASSIUM CHLORIDE20MEQ/15MLSOLUTION / ORALAARLD2014-12-222680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N206814-002POTASSIUM CHLORIDE40MEQ/15MLSOLUTION / ORALAARLD, RS2014-12-222680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N206814-001POTASSIUM CHLORIDE20MEQ/15MLSOLUTION / ORALAARLD2014-12-225bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N206814-002POTASSIUM CHLORIDE40MEQ/15MLSOLUTION / ORALAARLD, RS2014-12-225bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N206814-001POTASSIUM CHLORIDE20MEQ/15MLSOLUTION / ORALAARLD2014-12-22d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N206814-002POTASSIUM CHLORIDE40MEQ/15MLSOLUTION / ORALAARLD, RS2014-12-22d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N206814-001POTASSIUM CHLORIDE20MEQ/15MLSOLUTION / ORALAARLD2014-12-22d06236e962d9…
2024-10-29 15:01 UTC2024-10N206814-002POTASSIUM CHLORIDE40MEQ/15MLSOLUTION / ORALAARLD, RS2014-12-22d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N206814-001POTASSIUM CHLORIDE20MEQ/15MLSOLUTION / ORALAARLD2014-12-2279d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N206814-002POTASSIUM CHLORIDE40MEQ/15MLSOLUTION / ORALAARLD, RS2014-12-2279d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N206814-001POTASSIUM CHLORIDE20MEQ/15MLSOLUTION / ORALAARLD2014-12-22301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N206814-002POTASSIUM CHLORIDE40MEQ/15MLSOLUTION / ORALAARLD, RS2014-12-22301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N206814-001POTASSIUM CHLORIDE20MEQ/15MLSOLUTION / ORALAARLD2014-12-221e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N206814-002POTASSIUM CHLORIDE40MEQ/15MLSOLUTION / ORALAARLD, RS2014-12-221e350fbaab3a…
2024-05-31 18:47 UTC2024-05N206814-001POTASSIUM CHLORIDE20MEQ/15MLSOLUTION / ORALAARLD2014-12-228072bd15b7f6…
2024-05-31 18:47 UTC2024-05N206814-002POTASSIUM CHLORIDE40MEQ/15MLSOLUTION / ORALAARLD, RS2014-12-228072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N206814-001POTASSIUM CHLORIDE20MEQ/15MLSOLUTION / ORALAARLD2014-12-225c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N206814-002POTASSIUM CHLORIDE40MEQ/15MLSOLUTION / ORALAARLD, RS2014-12-225c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N206814-001POTASSIUM CHLORIDE20MEQ/15MLSOLUTION / ORALAARLD2014-12-225d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N206814-002POTASSIUM CHLORIDE40MEQ/15MLSOLUTION / ORALAARLD, RS2014-12-225d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N206814-001POTASSIUM CHLORIDE20MEQ/15MLSOLUTION / ORALAARLD2014-12-224b0b4de00fa7…
2022-04-04 05:41 UTC2022-04N206814-002POTASSIUM CHLORIDE40MEQ/15MLSOLUTION / ORALAARLD, RS2014-12-224b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N206814-001POTASSIUM CHLORIDE20MEQ/15MLSOLUTION / ORALAARLD2014-12-2274a2ff9319b5…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 84 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07N206814-001AA1caaa826d4ba7…
2026-08-18 06:07:402026-07N206814-002AA1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N206814-001AA1011fe1cb6892…
2026-02-19 14:30 UTC2026-02N206814-002AA1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N206814-001AA131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N206814-002AA131067a03dcf5…
2025-08-23 18:47 UTC2025-08N206814-001AA16a471c1ec25d…
2025-08-23 18:47 UTC2025-08N206814-002AA16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N206814-001AA1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N206814-002AA1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N206814-001AA1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N206814-002AA1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N206814-001AA103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N206814-002AA103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N206814-001AA12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N206814-002AA12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N206814-001AA15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N206814-002AA15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N206814-001AA1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N206814-002AA1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N206814-001AA1d06236e962d9…
2024-10-29 15:01 UTC2024-10N206814-002AA1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N206814-001AA179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N206814-002AA179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N206814-001AA1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N206814-002AA1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N206814-001AA11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N206814-002AA11e350fbaab3a…
2024-05-31 18:47 UTC2024-05N206814-001AA18072bd15b7f6…
2024-05-31 18:47 UTC2024-05N206814-002AA18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N206814-001AA15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N206814-002AA15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N206814-001AA15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N206814-002AA15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N206814-001AA14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04N206814-002AA14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N206814-001AA174a2ff9319b5…
2019-12-13 00:20 UTC2019-12N206814-002AA174a2ff9319b5…
2022-03-09 01:35 UTC2022-03N206814-001AA1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03N206814-002AA1bb7c543d1eb4…

Observed Orange Book patent history#

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2026-08-18 06:07:402026-07N206814-001125393142039-03-07Drug product2026-02-04caaa826d4ba7…
2026-08-18 06:07:402026-07N206814-002125393142039-03-07Drug product2026-02-04caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N206814-001125393142039-03-07Drug product2026-02-04011fe1cb6892…
2026-02-19 14:30 UTC2026-02N206814-002125393142039-03-07Drug product2026-02-04011fe1cb6892…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N206814-001125393142039-03-07Drug product2026-02-04a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N206814-002125393142039-03-07Drug product2026-02-04a50c72e98297…

FDA-Initiated Inactive NDC Indexing#

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
66689-048-01ML - Milliliter66689-04804048e35-54ff-49f7-a269-a76a390a11d912016-01-13
66689-048-30ML - Milliliter66689-048bf6d3390-6215-4f17-a64c-b1d095d5acf912017-07-07
66689-048-50ML - Milliliter66689-048601a4244-7b9f-44d2-b84d-dd5cf4948c8012016-01-13
66689-048-80ML - Milliliter66689-048170da888-dd49-4bf4-b773-89dd87c17eb612017-07-07

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Potassium ChlorideACTIVE INGREDIENT660YQ98I10POTASSIUM CHLORIDE SOLUTION [VISTAPHARM INC.]1
Chloride IonACTIVE MOIETYQ32ZN48698POTASSIUM CHLORIDE SOLUTION [VISTAPHARM INC.]1
Anhydrous Citric AcidINACTIVE INGREDIENTXF417D3PSLPOTASSIUM CHLORIDE SOLUTION [VISTAPHARM INC.]1
FD&C Yellow NO. 6INACTIVE INGREDIENTH77VEI93A8POTASSIUM CHLORIDE SOLUTION [VISTAPHARM INC.]1
GlycerinINACTIVE INGREDIENTPDC6A3C0OXPOTASSIUM CHLORIDE SOLUTION [VISTAPHARM INC.]1
MethylparabenINACTIVE INGREDIENTA2I8C7HI9TPOTASSIUM CHLORIDE SOLUTION [VISTAPHARM INC.]1
Propylene GlycolINACTIVE INGREDIENT6DC9Q167V3POTASSIUM CHLORIDE SOLUTION [VISTAPHARM INC.]1
PropylparabenINACTIVE INGREDIENTZ8IX2SC1OHPOTASSIUM CHLORIDE SOLUTION [VISTAPHARM INC.]1
SucraloseINACTIVE INGREDIENT96K6UQ3ZD4POTASSIUM CHLORIDE SOLUTION [VISTAPHARM INC.]1
Trisodium Citrate DihydrateINACTIVE INGREDIENTB22547B95KPOTASSIUM CHLORIDE SOLUTION [VISTAPHARM INC.]1
WaterINACTIVE INGREDIENT059QF0KO0RPOTASSIUM CHLORIDE SOLUTION [VISTAPHARM INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
66689-048POTASSIUM CHLORIDE SOLUTION [VISTAPHARM, LLC]15Legacy NDC20240511_142c30ff-a839-4616-8167-ad4b07d8456f.zip

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
POKONZA potassium chloridePOTASSIUM CHLORIDECarwin Pharmaceutical Associates, LLC2d938cbf-27aa-4f9c-a582-5564d3b724652026-01-22Warnings, Adverse reactionsExact identifier
application applno (NDA): 206814
application number: NDA206814
Potassium ChloridePOTASSIUM CHLORIDEGenus Lifesciences14cd12ee-a4a3-465a-9550-58c9ef0e4f212025-07-21Warnings, Adverse reactionsExact identifier
application applno (NDA): 206814
application number: NDA206814
Potassium ChloridePOTASSIUM CHLORIDEEndo USA, Inc.e5214432-3517-4a90-9412-036752bd11392025-02-10Warnings, Adverse reactionsExact identifier
application applno (NDA): 206814
application number: NDA206814

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
66689-048-996668900489910 TRAY in 1 CASE (66689-048-99) > 10 CUP in 1 TRAY > 30 mL in 1 CUP (66689-048-01) 10 tray2020-06-250000-00-00NoNoCurrent