Potassium Chloride

Product NDC
0121-2520
11-digit product format
001212520
Labeler code
0121
Product ID
0121-2520_cd3a937e-3347-6368-e053-2a95a90abe56
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
POTASSIUM CHLORIDE
Dosage form
SOLUTION
Route
ORAL
Labeler
Pharmaceutical Associates, Inc.
Application
ANDA210766
Marketing category
ANDA
Marketing start
2019-04-02
Marketing end
0000-00-00
Substance
POTASSIUM CHLORIDE
Active strength
40 meq/30mL
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
2022-12-31
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 productproduct0121-2520DDiscontinued by firm2026-08-11
excluded packagepackage0121-25200121-2520-00DDiscontinued by firm2026-08-11
excluded packagepackage0121-25200121-2520-30DDiscontinued by firm2026-08-11
excluded packagepackage0121-25200121-2520-40DDiscontinued by firm2026-08-11
excluded packagepackage0121-25200121-2520-50DDiscontinued by firm2026-08-11

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 · 37 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 packagepackage0121-2520-40d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage0121-2520-00d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage0121-2520-30d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage0121-2520-50d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage0121-2520-40f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage0121-2520-00f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage0121-2520-30f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage0121-2520-50f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage0121-2520-002ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage0121-2520-402ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage0121-2520-502ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage0121-2520-00a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage0121-2520-40a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage0121-2520-50a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage0121-2520-00cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage0121-2520-40cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage0121-2520-50cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage0121-2520-00cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage0121-2520-40cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage0121-2520-50cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage0121-2520-00302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage0121-2520-40302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage0121-2520-50302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage0121-2520-00ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage0121-2520-40ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage0121-2520-50ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage0121-2520-000efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage0121-2520-400efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage0121-2520-500efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage0121-2520-00ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage0121-2520-40ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage0121-2520-50ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage0121-2520-00367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage0121-2520-40367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage0121-2520-50367a005e9d99…383a685ebd0f…

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
A210766-001POTASSIUM CHLORIDEPOTASSIUM CHLORIDE20MEQ/15MLSOLUTION / ORALAA2019-03-29
A210766-002POTASSIUM CHLORIDEPOTASSIUM CHLORIDE40MEQ/15MLSOLUTION / ORALAA2019-03-29

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A210766-001AA
A210766-002AA

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 UTC2026-02A210766-001POTASSIUM CHLORIDE20MEQ/15MLSOLUTION / ORALAA2019-03-29011fe1cb6892…
2026-02-19 14:30 UTC2026-02A210766-002POTASSIUM CHLORIDE40MEQ/15MLSOLUTION / ORALAA2019-03-29011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A210766-001POTASSIUM CHLORIDE20MEQ/15MLSOLUTION / ORALAA2019-03-2931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A210766-002POTASSIUM CHLORIDE40MEQ/15MLSOLUTION / ORALAA2019-03-2931067a03dcf5…
2025-08-23 18:47 UTC2025-08A210766-001POTASSIUM CHLORIDE20MEQ/15MLSOLUTION / ORALAA2019-03-296a471c1ec25d…
2025-08-23 18:47 UTC2025-08A210766-002POTASSIUM CHLORIDE40MEQ/15MLSOLUTION / ORALAA2019-03-296a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A210766-001POTASSIUM CHLORIDE20MEQ/15MLSOLUTION / ORALAA2019-03-29fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A210766-002POTASSIUM CHLORIDE40MEQ/15MLSOLUTION / ORALAA2019-03-29fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A210766-001POTASSIUM CHLORIDE20MEQ/15MLSOLUTION / ORALAA2019-03-29b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A210766-002POTASSIUM CHLORIDE40MEQ/15MLSOLUTION / ORALAA2019-03-29b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A210766-001POTASSIUM CHLORIDE20MEQ/15MLSOLUTION / ORALAA2019-03-2903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A210766-002POTASSIUM CHLORIDE40MEQ/15MLSOLUTION / ORALAA2019-03-2903ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A210766-001POTASSIUM CHLORIDE20MEQ/15MLSOLUTION / ORALAA2019-03-292680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A210766-002POTASSIUM CHLORIDE40MEQ/15MLSOLUTION / ORALAA2019-03-292680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A210766-001POTASSIUM CHLORIDE20MEQ/15MLSOLUTION / ORALAA2019-03-295bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A210766-002POTASSIUM CHLORIDE40MEQ/15MLSOLUTION / ORALAA2019-03-295bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A210766-001POTASSIUM CHLORIDE20MEQ/15MLSOLUTION / ORALAA2019-03-29d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A210766-002POTASSIUM CHLORIDE40MEQ/15MLSOLUTION / ORALAA2019-03-29d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A210766-001POTASSIUM CHLORIDE20MEQ/15MLSOLUTION / ORALAA2019-03-29d06236e962d9…
2024-10-29 15:01 UTC2024-10A210766-002POTASSIUM CHLORIDE40MEQ/15MLSOLUTION / ORALAA2019-03-29d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A210766-001POTASSIUM CHLORIDE20MEQ/15MLSOLUTION / ORALAA2019-03-2979d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A210766-002POTASSIUM CHLORIDE40MEQ/15MLSOLUTION / ORALAA2019-03-2979d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A210766-001POTASSIUM CHLORIDE20MEQ/15MLSOLUTION / ORALAA2019-03-29301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A210766-002POTASSIUM CHLORIDE40MEQ/15MLSOLUTION / ORALAA2019-03-29301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A210766-001POTASSIUM CHLORIDE20MEQ/15MLSOLUTION / ORALAA2019-03-291e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A210766-002POTASSIUM CHLORIDE40MEQ/15MLSOLUTION / ORALAA2019-03-291e350fbaab3a…
2024-05-31 18:47 UTC2024-05A210766-001POTASSIUM CHLORIDE20MEQ/15MLSOLUTION / ORALAA2019-03-298072bd15b7f6…
2024-05-31 18:47 UTC2024-05A210766-002POTASSIUM CHLORIDE40MEQ/15MLSOLUTION / ORALAA2019-03-298072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A210766-001POTASSIUM CHLORIDE20MEQ/15MLSOLUTION / ORALAA2019-03-295c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A210766-002POTASSIUM CHLORIDE40MEQ/15MLSOLUTION / ORALAA2019-03-295c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A210766-001POTASSIUM CHLORIDE20MEQ/15MLSOLUTION / ORALAA2019-03-295d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A210766-002POTASSIUM CHLORIDE40MEQ/15MLSOLUTION / ORALAA2019-03-295d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A210766-001POTASSIUM CHLORIDE20MEQ/15MLSOLUTION / ORALAA2019-03-294b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A210766-002POTASSIUM CHLORIDE40MEQ/15MLSOLUTION / ORALAA2019-03-294b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A210766-001POTASSIUM CHLORIDE20MEQ/15MLSOLUTION / ORALAA2019-03-2974a2ff9319b5…
2019-12-13 00:20 UTC2019-12A210766-002POTASSIUM CHLORIDE40MEQ/15MLSOLUTION / ORALAA2019-03-2974a2ff9319b5…
2022-03-09 01:35 UTC2022-03A210766-001POTASSIUM CHLORIDE20MEQ/15MLSOLUTION / ORALAA2019-03-29bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A210766-002POTASSIUM CHLORIDE40MEQ/15MLSOLUTION / ORALAA2019-03-29bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A210766-001POTASSIUM CHLORIDE20MEQ/15MLSOLUTION / ORALAA2019-03-29782e0a99824c…
2021-12-28 21:50 UTC2021-12A210766-002POTASSIUM CHLORIDE40MEQ/15MLSOLUTION / ORALAA2019-03-29782e0a99824c…

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 UTC2026-02A210766-001AA1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A210766-002AA1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A210766-001AA131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A210766-002AA131067a03dcf5…
2025-08-23 18:47 UTC2025-08A210766-001AA16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A210766-002AA16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A210766-001AA1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A210766-002AA1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A210766-001AA1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A210766-002AA1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A210766-001AA103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A210766-002AA103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A210766-001AA12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A210766-002AA12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A210766-001AA15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A210766-002AA15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A210766-001AA1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A210766-002AA1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A210766-001AA1d06236e962d9…
2024-10-29 15:01 UTC2024-10A210766-002AA1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A210766-001AA179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A210766-002AA179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A210766-001AA1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A210766-002AA1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A210766-001AA11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A210766-002AA11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A210766-001AA18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A210766-002AA18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A210766-001AA15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A210766-002AA15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A210766-001AA15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A210766-002AA15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A210766-001AA14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A210766-002AA14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A210766-001AA174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A210766-002AA174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A210766-001AA1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A210766-002AA1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A210766-001AA1782e0a99824c…
2021-12-28 21:50 UTC2021-12A210766-002AA1782e0a99824c…

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0121-2520-00ML - Milliliter0121-252065bebcae-30f4-47c2-9e80-f45636d6da4a12020-02-13
0121-2520-30ML - Milliliter0121-25202f3bbe61-049a-4619-b67d-10d76c185d6112019-05-02
0121-2520-40ML - Milliliter0121-25208aeca543-bb13-4873-bba0-c2dce6bf457912020-02-13
0121-2520-50ML - Milliliter0121-2520cd1bd8ca-c3e3-4267-859a-e902df6d43da12021-10-08

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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
POTASSIUM CHLORIDEPOTASSIUM CHLORIDEMajor Pharmaceuticals33ad1eb2-1f05-461c-b01d-82dee42315562026-02-11Warnings, Adverse reactionsExact identifier
application applno (ANDA): 210766
application number: ANDA210766
Potassium ChloridePOTASSIUM CHLORIDEPAI Holdings, LLC dba PAI Pharmae848477f-b10d-4249-b322-b70cd6a062de2024-11-19Warnings, Adverse reactionsExact identifier
application applno (ANDA): 210766
application number: ANDA210766

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0121-2520-000012125200010 TRAY in 1 CASE (0121-2520-00) > 10 CUP, UNIT-DOSE in 1 TRAY > 30 mL in 1 CUP, UNIT-DOSE10 tray2019-04-020000-00-00NoNoCurrent
0121-2520-300012125203010 TRAY in 1 CASE (0121-2520-30) > 10 CUP, UNIT-DOSE in 1 TRAY > 30 mL in 1 CUP, UNIT-DOSE10 tray2019-04-020000-00-00NoNoCurrent
0121-2520-40001212520404 TRAY in 1 CASE (0121-2520-40) > 10 CUP, UNIT-DOSE in 1 TRAY > 30 mL in 1 CUP, UNIT-DOSE4 tray2019-04-020000-00-00NoNoCurrent
0121-2520-50001212520505 TRAY in 1 CASE (0121-2520-50) > 10 CUP, UNIT-DOSE in 1 TRAY > 30 mL in 1 CUP, UNIT-DOSE5 tray2019-04-020000-00-00NoNoCurrent