POTASSIUM CHLORIDE

Product NDC
43602-283
11-digit product format
436020283
Labeler code
43602
Product ID
43602-283_ddde8a6a-992e-4bc4-9fc6-da9dfc08e092
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Potassium CHLORIDE
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Ascent Pharmaceuticals, Inc.
Application
ANDA214422
Marketing category
ANDA
Marketing start
2020-12-30
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
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 · 3 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct43602-283DDiscontinued by firm2026-08-17
excluded packagepackage43602-28343602-283-05DDiscontinued by firm2026-08-17
excluded packagepackage43602-28343602-283-30DDiscontinued 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 · 3 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopeProduct NDCPackage NDCCodeStatusReporting periodArchiveSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproduct43602-283DDiscontinued by firmexcluded / ndc_excluded.zipd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage43602-28343602-283-30DDiscontinued by firmexcluded / ndc_excluded.zipd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage43602-28343602-283-05DDiscontinued by firmexcluded / ndc_excluded.zipd630ba8d3edf…732f749b63fb…

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
A214422-001POTASSIUM CHLORIDEPOTASSIUM CHLORIDE10MEQTABLET, EXTENDED RELEASE / ORALAB12020-12-29
A214422-002POTASSIUM CHLORIDEPOTASSIUM CHLORIDE15MEQTABLET, EXTENDED RELEASE / ORALAB12020-12-29
A214422-003POTASSIUM CHLORIDEPOTASSIUM CHLORIDE20MEQTABLET, EXTENDED RELEASE / ORALAB12020-12-29

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-productTE code
A214422-001AB1
A214422-002AB1
A214422-003AB1

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 · 108 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A214422-001POTASSIUM CHLORIDE10MEQTABLET, EXTENDED RELEASE / ORALAB12020-12-29caaa826d4ba7…
2026-08-18 06:07:402026-07A214422-002POTASSIUM CHLORIDE15MEQTABLET, EXTENDED RELEASE / ORALAB12020-12-29caaa826d4ba7…
2026-08-18 06:07:402026-07A214422-003POTASSIUM CHLORIDE20MEQTABLET, EXTENDED RELEASE / ORALAB12020-12-29caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A214422-001POTASSIUM CHLORIDE10MEQTABLET, EXTENDED RELEASE / ORALAB12020-12-29011fe1cb6892…
2026-02-19 14:30 UTC2026-02A214422-002POTASSIUM CHLORIDE15MEQTABLET, EXTENDED RELEASE / ORALAB12020-12-29011fe1cb6892…
2026-02-19 14:30 UTC2026-02A214422-003POTASSIUM CHLORIDE20MEQTABLET, EXTENDED RELEASE / ORALAB12020-12-29011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A214422-001POTASSIUM CHLORIDE10MEQTABLET, EXTENDED RELEASE / ORALAB12020-12-2931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A214422-002POTASSIUM CHLORIDE15MEQTABLET, EXTENDED RELEASE / ORALAB12020-12-2931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A214422-003POTASSIUM CHLORIDE20MEQTABLET, EXTENDED RELEASE / ORALAB12020-12-2931067a03dcf5…
2025-08-23 18:47 UTC2025-08A214422-001POTASSIUM CHLORIDE10MEQTABLET, EXTENDED RELEASE / ORALAB12020-12-296a471c1ec25d…
2025-08-23 18:47 UTC2025-08A214422-002POTASSIUM CHLORIDE15MEQTABLET, EXTENDED RELEASE / ORALAB12020-12-296a471c1ec25d…
2025-08-23 18:47 UTC2025-08A214422-003POTASSIUM CHLORIDE20MEQTABLET, EXTENDED RELEASE / ORALAB12020-12-296a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A214422-001POTASSIUM CHLORIDE10MEQTABLET, EXTENDED RELEASE / ORALAB12020-12-29fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A214422-002POTASSIUM CHLORIDE15MEQTABLET, EXTENDED RELEASE / ORALAB12020-12-29fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A214422-003POTASSIUM CHLORIDE20MEQTABLET, EXTENDED RELEASE / ORALAB12020-12-29fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A214422-001POTASSIUM CHLORIDE10MEQTABLET, EXTENDED RELEASE / ORALAB12020-12-29b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A214422-002POTASSIUM CHLORIDE15MEQTABLET, EXTENDED RELEASE / ORALAB12020-12-29b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A214422-003POTASSIUM CHLORIDE20MEQTABLET, EXTENDED RELEASE / ORALAB12020-12-29b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A214422-001POTASSIUM CHLORIDE10MEQTABLET, EXTENDED RELEASE / ORALAB12020-12-2903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A214422-002POTASSIUM CHLORIDE15MEQTABLET, EXTENDED RELEASE / ORALAB12020-12-2903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A214422-003POTASSIUM CHLORIDE20MEQTABLET, EXTENDED RELEASE / ORALAB12020-12-2903ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A214422-001POTASSIUM CHLORIDE10MEQTABLET, EXTENDED RELEASE / ORALAB12020-12-292680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A214422-002POTASSIUM CHLORIDE15MEQTABLET, EXTENDED RELEASE / ORALAB12020-12-292680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A214422-003POTASSIUM CHLORIDE20MEQTABLET, EXTENDED RELEASE / ORALAB12020-12-292680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A214422-001POTASSIUM CHLORIDE10MEQTABLET, EXTENDED RELEASE / ORALAB12020-12-295bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A214422-002POTASSIUM CHLORIDE15MEQTABLET, EXTENDED RELEASE / ORALAB12020-12-295bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A214422-003POTASSIUM CHLORIDE20MEQTABLET, EXTENDED RELEASE / ORALAB12020-12-295bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A214422-001POTASSIUM CHLORIDE10MEQTABLET, EXTENDED RELEASE / ORALAB12020-12-29d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A214422-002POTASSIUM CHLORIDE15MEQTABLET, EXTENDED RELEASE / ORALAB12020-12-29d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A214422-003POTASSIUM CHLORIDE20MEQTABLET, EXTENDED RELEASE / ORALAB12020-12-29d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A214422-001POTASSIUM CHLORIDE10MEQTABLET, EXTENDED RELEASE / ORALAB12020-12-29d06236e962d9…
2024-10-29 15:01 UTC2024-10A214422-002POTASSIUM CHLORIDE15MEQTABLET, EXTENDED RELEASE / ORALAB12020-12-29d06236e962d9…
2024-10-29 15:01 UTC2024-10A214422-003POTASSIUM CHLORIDE20MEQTABLET, EXTENDED RELEASE / ORALAB12020-12-29d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A214422-001POTASSIUM CHLORIDE10MEQTABLET, EXTENDED RELEASE / ORALAB12020-12-2979d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A214422-002POTASSIUM CHLORIDE15MEQTABLET, EXTENDED RELEASE / ORALAB12020-12-2979d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A214422-003POTASSIUM CHLORIDE20MEQTABLET, EXTENDED RELEASE / ORALAB12020-12-2979d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A214422-001POTASSIUM CHLORIDE10MEQTABLET, EXTENDED RELEASE / ORALAB12020-12-29301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A214422-002POTASSIUM CHLORIDE15MEQTABLET, EXTENDED RELEASE / ORALAB12020-12-29301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A214422-003POTASSIUM CHLORIDE20MEQTABLET, EXTENDED RELEASE / ORALAB12020-12-29301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A214422-001POTASSIUM CHLORIDE10MEQTABLET, EXTENDED RELEASE / ORALAB12020-12-291e350fbaab3a…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 108 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A214422-001AB11caaa826d4ba7…
2026-08-18 06:07:402026-07A214422-002AB11caaa826d4ba7…
2026-08-18 06:07:402026-07A214422-003AB11caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A214422-001AB11011fe1cb6892…
2026-02-19 14:30 UTC2026-02A214422-002AB11011fe1cb6892…
2026-02-19 14:30 UTC2026-02A214422-003AB11011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A214422-001AB1131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A214422-002AB1131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A214422-003AB1131067a03dcf5…
2025-08-23 18:47 UTC2025-08A214422-001AB116a471c1ec25d…
2025-08-23 18:47 UTC2025-08A214422-002AB116a471c1ec25d…
2025-08-23 18:47 UTC2025-08A214422-003AB116a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A214422-001AB11fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A214422-002AB11fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A214422-003AB11fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A214422-001AB11b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A214422-002AB11b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A214422-003AB11b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A214422-001AB1103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A214422-002AB1103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A214422-003AB1103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A214422-001AB112680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A214422-002AB112680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A214422-003AB112680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A214422-001AB115bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A214422-002AB115bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A214422-003AB115bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A214422-001AB11d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A214422-002AB11d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A214422-003AB11d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A214422-001AB11d06236e962d9…
2024-10-29 15:01 UTC2024-10A214422-002AB11d06236e962d9…
2024-10-29 15:01 UTC2024-10A214422-003AB11d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A214422-001AB1179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A214422-002AB1179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A214422-003AB1179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A214422-001AB11301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A214422-002AB11301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A214422-003AB11301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A214422-001AB111e350fbaab3a…

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
9e37788c-b1bf-42ae-aac9-b60601606144Product name820260122
95250459-30e4-45c1-b08a-993044f49109Product name220250805
d9771140-739b-484b-ae64-b79528ff1211Product name320250801
efd58dcf-540a-4531-8766-e713129ca6f2Product name120250307
1527ac37-808d-43be-a63e-74e1258dbe46Product name920250219
bed0530e-f939-4541-956b-6928a2f6404fProduct name120241008
cefa60e2-a5b5-493e-9c54-24735b7dc509Product name620240814
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
9fcb7a91-de07-4f00-aabf-e4d6fda403d5Product name820230322
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
9badc7be-250a-44ab-aa36-926af3f02679Product name120210527
0ec3537a-6c9b-432a-896c-b9ea8723049aProduct name920200701
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
7916de40-e296-41f0-b811-6d0df1a33e2cProduct name920180627
cefa60e2-a5b5-493e-9c54-24735b7dc509Product name220171212
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
26acd337-b838-40ac-bcbc-05c3b81c8712Product name120170323
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
5668b646-cd56-c3c7-bdea-3f6b1a8840dbProduct name120140508
810ab97e-f109-f41c-7c83-6a652a9cbf43Product name120140508
87711080-88eb-65c5-b2dd-bf99e700a372Product name120140508
8dbefedf-0a0d-a224-5a3c-66dc9e11c2ddProduct name120140508
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43602-283POTASSIUM CHLORIDE TABLET, EXTENDED RELEASE POTASSIUM CHLORIDE TABLET, EXTENDED RELEASE [ASCENT PHARMACEUTICALS, INC.]3Legacy NDC20210108_c47c0704-26f1-41ba-8af6-50250686d612.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 · 7 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
potassium chloridePOTASSIUM CHLORIDENorthstar Rx LLCb19a3fbf-cdbb-4f86-ac61-5dfb07e0a51a2026-05-18Warnings, Adverse reactionsExact identifier
application applno (ANDA): 214422
application number: ANDA214422
POTASSIUM CHLORIDEPOTASSIUM CHLORIDEAphena Pharma Solutions - Tennessee, LLC61fe55c2-fc9a-4fae-899a-06601baa78e12025-11-19Warnings, Adverse reactionsExact identifier
application applno (ANDA): 214422
application number: ANDA214422
POTASSIUM CHLORIDEPOTASSIUM CHLORIDEA-S Medication Solutions162a8ab5-76cf-48fa-8487-7780ed65647e2025-07-31Warnings, Adverse reactionsExact identifier
application applno (ANDA): 214422
application number: ANDA214422
POTASSIUM CHLORIDEPOTASSIUM CHLORIDEA-S Medication Solutions14db14ba-fd0d-4b2a-9f1c-a62b3b82306f2025-07-31Warnings, Adverse reactionsExact identifier
application applno (ANDA): 214422
application number: ANDA214422
POTASSIUM CHLORIDEPOTASSIUM CHLORIDEBryant Ranch Prepackd396477a-6b15-4782-9c85-b9663b83c4842024-05-23Warnings, Adverse reactionsExact identifier
application applno (ANDA): 214422
application number: ANDA214422
POTASSIUM CHLORIDEPOTASSIUM CHLORIDEXLCare Pharmaceuticals, Inc.7fd82f08-8ad0-4ee2-8eb6-5c973f98baee2024-05-21Warnings, Adverse reactionsExact identifier
application applno (ANDA): 214422
application number: ANDA214422
POTASSIUM CHLORIDEPOTASSIUM CHLORIDECamber Pharmaceuticals, Inc.b1e827aa-b2fb-4fa5-984d-ddd94338ff532024-05-14Warnings, Adverse reactionsExact identifier
application applno (ANDA): 214422
application number: ANDA214422

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
43602-283-0543602028305500 TABLET, EXTENDED RELEASE in 1 BOTTLE (43602-283-05) 2020-12-300000-00-00NoNoCurrent
43602-283-304360202833030 TABLET, EXTENDED RELEASE in 1 BOTTLE (43602-283-30) 2020-12-300000-00-00NoNoCurrent