Potassium Chloride

Product NDC
67296-1006
Requested package NDC
67296-1006-1
11-digit product format
672961006
Labeler code
67296
Product ID
67296-1006_d60f9a37-90bf-7879-e053-2995a90a4d55
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Potassium Chloride
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
RedPharm Drug, Inc.
Application
ANDA075604
Marketing category
ANDA
Marketing start
2002-04-10
Marketing end
0000-00-00
Substance
POTASSIUM CHLORIDE
Active strength
10 meq/1
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 packagepackage67296-100667296-1006-1IInactivated by FDA2026-10-05

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 · 16 matching rows.

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

Captured / source date, Code, Status table
Captured / source dateCodeStatusSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05IInactivated by FDAd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26IInactivated by FDAf5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31IInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28IInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21IInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10IInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31IInactivated by FDA302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20IInactivated by FDAed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10IInactivated by FDA0efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08IInactivated by FDAad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03IInactivated by FDA367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09IInactivated by FDA557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28IInactivated by FDA8af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14IInactivated by FDA834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08IInactivated by FDA1332a3947898…d4bfe170f9cd…
2019-12-08 06:16 UTC · source 2019-12-05EExcluded after deficient or non-compliant submission was not corrected110d247fa046…a55b01930146…

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
A075604-001POTASSIUM CHLORIDEPOTASSIUM CHLORIDE10MEQTABLET, EXTENDED RELEASE / ORALAB12002-04-10
A075604-002POTASSIUM CHLORIDEPOTASSIUM CHLORIDE20MEQTABLET, EXTENDED RELEASE / ORALAB12002-04-10

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A075604-001AB1
A075604-002AB1

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 · 86 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A075604-001POTASSIUM CHLORIDE10MEQTABLET, EXTENDED RELEASE / ORALAB12002-04-1084e616aacf4f…
2026-09-14 22:38:342026-08A075604-002POTASSIUM CHLORIDE20MEQTABLET, EXTENDED RELEASE / ORALAB12002-04-1084e616aacf4f…
2026-08-18 06:07:402026-07A075604-001POTASSIUM CHLORIDE10MEQTABLET, EXTENDED RELEASE / ORALAB12002-04-10caaa826d4ba7…
2026-08-18 06:07:402026-07A075604-002POTASSIUM CHLORIDE20MEQTABLET, EXTENDED RELEASE / ORALAB12002-04-10caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A075604-001POTASSIUM CHLORIDE10MEQTABLET, EXTENDED RELEASE / ORALAB12002-04-10011fe1cb6892…
2026-02-19 14:30 UTC2026-02A075604-002POTASSIUM CHLORIDE20MEQTABLET, EXTENDED RELEASE / ORALAB12002-04-10011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075604-001POTASSIUM CHLORIDE10MEQTABLET, EXTENDED RELEASE / ORALAB12002-04-1031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075604-002POTASSIUM CHLORIDE20MEQTABLET, EXTENDED RELEASE / ORALAB12002-04-1031067a03dcf5…
2025-08-23 18:47 UTC2025-08A075604-001POTASSIUM CHLORIDE10MEQTABLET, EXTENDED RELEASE / ORALAB12002-04-106a471c1ec25d…
2025-08-23 18:47 UTC2025-08A075604-002POTASSIUM CHLORIDE20MEQTABLET, EXTENDED RELEASE / ORALAB12002-04-106a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075604-001POTASSIUM CHLORIDE10MEQTABLET, EXTENDED RELEASE / ORALAB12002-04-10fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075604-002POTASSIUM CHLORIDE20MEQTABLET, EXTENDED RELEASE / ORALAB12002-04-10fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075604-001POTASSIUM CHLORIDE10MEQTABLET, EXTENDED RELEASE / ORALAB12002-04-10b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075604-002POTASSIUM CHLORIDE20MEQTABLET, EXTENDED RELEASE / ORALAB12002-04-10b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075604-001POTASSIUM CHLORIDE10MEQTABLET, EXTENDED RELEASE / ORALAB12002-04-1003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075604-002POTASSIUM CHLORIDE20MEQTABLET, EXTENDED RELEASE / ORALAB12002-04-1003ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075604-001POTASSIUM CHLORIDE10MEQTABLET, EXTENDED RELEASE / ORALAB12002-04-102680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075604-002POTASSIUM CHLORIDE20MEQTABLET, EXTENDED RELEASE / ORALAB12002-04-102680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075604-001POTASSIUM CHLORIDE10MEQTABLET, EXTENDED RELEASE / ORALAB12002-04-105bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075604-002POTASSIUM CHLORIDE20MEQTABLET, EXTENDED RELEASE / ORALAB12002-04-105bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075604-001POTASSIUM CHLORIDE10MEQTABLET, EXTENDED RELEASE / ORALAB12002-04-10d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075604-002POTASSIUM CHLORIDE20MEQTABLET, EXTENDED RELEASE / ORALAB12002-04-10d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A075604-001POTASSIUM CHLORIDE10MEQTABLET, EXTENDED RELEASE / ORALAB12002-04-10d06236e962d9…
2024-10-29 15:01 UTC2024-10A075604-002POTASSIUM CHLORIDE20MEQTABLET, EXTENDED RELEASE / ORALAB12002-04-10d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A075604-001POTASSIUM CHLORIDE10MEQTABLET, EXTENDED RELEASE / ORALAB12002-04-1079d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A075604-002POTASSIUM CHLORIDE20MEQTABLET, EXTENDED RELEASE / ORALAB12002-04-1079d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A075604-001POTASSIUM CHLORIDE10MEQTABLET, EXTENDED RELEASE / ORALAB12002-04-10301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A075604-002POTASSIUM CHLORIDE20MEQTABLET, EXTENDED RELEASE / ORALAB12002-04-10301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A075604-001POTASSIUM CHLORIDE10MEQTABLET, EXTENDED RELEASE / ORALAB12002-04-101e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A075604-002POTASSIUM CHLORIDE20MEQTABLET, EXTENDED RELEASE / ORALAB12002-04-101e350fbaab3a…
2024-05-31 18:47 UTC2024-05A075604-001POTASSIUM CHLORIDE10MEQTABLET, EXTENDED RELEASE / ORALAB12002-04-108072bd15b7f6…
2024-05-31 18:47 UTC2024-05A075604-002POTASSIUM CHLORIDE20MEQTABLET, EXTENDED RELEASE / ORALAB12002-04-108072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A075604-001POTASSIUM CHLORIDE10MEQTABLET, EXTENDED RELEASE / ORALAB12002-04-105c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A075604-002POTASSIUM CHLORIDE20MEQTABLET, EXTENDED RELEASE / ORALAB12002-04-105c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A075604-001POTASSIUM CHLORIDE10MEQTABLET, EXTENDED RELEASE / ORALAB12002-04-105d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A075604-002POTASSIUM CHLORIDE20MEQTABLET, EXTENDED RELEASE / ORALAB12002-04-105d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A075604-001POTASSIUM CHLORIDE10MEQTABLET, EXTENDED RELEASE / ORALAB12002-04-104b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A075604-002POTASSIUM CHLORIDE20MEQTABLET, EXTENDED RELEASE / ORALAB12002-04-104b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A075604-001POTASSIUM CHLORIDE10MEQTABLET, EXTENDED RELEASE / ORALAB12002-04-1074a2ff9319b5…
2019-12-13 00:20 UTC2019-12A075604-002POTASSIUM CHLORIDE20MEQTABLET, EXTENDED RELEASE / ORALAB12002-04-1074a2ff9319b5…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 86 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-09-14 22:38:342026-08A075604-001AB1184e616aacf4f…
2026-09-14 22:38:342026-08A075604-002AB1184e616aacf4f…
2026-08-18 06:07:402026-07A075604-001AB11caaa826d4ba7…
2026-08-18 06:07:402026-07A075604-002AB11caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A075604-001AB11011fe1cb6892…
2026-02-19 14:30 UTC2026-02A075604-002AB11011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075604-001AB1131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075604-002AB1131067a03dcf5…
2025-08-23 18:47 UTC2025-08A075604-001AB116a471c1ec25d…
2025-08-23 18:47 UTC2025-08A075604-002AB116a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075604-001AB11fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075604-002AB11fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075604-001AB11b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075604-002AB11b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075604-001AB1103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075604-002AB1103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075604-001AB112680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075604-002AB112680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075604-001AB115bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075604-002AB115bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075604-001AB11d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075604-002AB11d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A075604-001AB11d06236e962d9…
2024-10-29 15:01 UTC2024-10A075604-002AB11d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A075604-001AB1179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A075604-002AB1179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A075604-001AB11301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A075604-002AB11301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A075604-001AB111e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A075604-002AB111e350fbaab3a…
2024-05-31 18:47 UTC2024-05A075604-001AB118072bd15b7f6…
2024-05-31 18:47 UTC2024-05A075604-002AB118072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A075604-001AB115c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A075604-002AB115c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A075604-001AB115d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A075604-002AB115d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A075604-001AB114b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A075604-002AB114b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A075604-001AB1174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A075604-002AB1174a2ff9319b5…

Reported adverse events (FAERS/openFDA)#

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

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
67296-1006-12024-01-30C16284748780-11030e365-2629-111a-e063-dadaa90a10e24e180cd5-2fd2-5047-e054-00144ff88e88

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67296-1006-1Potassium Chloride10 in 1 BOTTLETABLET, EXTENDED RELEASE103

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67296-1006POTASSIUM CHLORIDE TABLET, EXTENDED RELEASE [REDPHARM DRUG, INC.]3Legacy NDC, 1 package rows20220121_4e180cd5-2fd2-5047-e054-00144ff88e88.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
Potassium ChloridePOTASSIUM CHLORIDEAmerican Health Packagingb165ad93-1dc1-4863-9f0b-d7b97c42c94c2025-06-23Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075604
application number: ANDA075604
Potassium ChloridePOTASSIUM CHLORIDEProficient Rx LP61daa681-05a0-4b2f-a6d0-c6fc1044f5212024-02-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075604
application number: ANDA075604
Potassium ChloridePOTASSIUM CHLORIDEActavis Pharma, Inc.db002ae3-f54c-40a4-9cb4-e5681bf426e32022-08-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075604
application number: ANDA075604

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1801298potassium chloride 10 MEQ Microencapsulated Extended Release Oral TabletPSN4e180cd5-2fd2-5047-e054-00144ff88e883
1801298Microencapsulated potassium chloride 10 MEQ Extended Release Oral TabletSCD4e180cd5-2fd2-5047-e054-00144ff88e883
1801298Microencapsulated K+ Chloride 10 MEQ Extended Release Oral TabletSY4e180cd5-2fd2-5047-e054-00144ff88e883
1801298Microencapsulated Pot Chloride 10 MEQ Extended Release Oral TabletSY4e180cd5-2fd2-5047-e054-00144ff88e883
1801298potassium chloride 10 MEQ Microencapsulated Extended Release Oral TabletSY4e180cd5-2fd2-5047-e054-00144ff88e883
1801298potassium chloride 750 MG Microencapsulated Extended Release OralSY4e180cd5-2fd2-5047-e054-00144ff88e883

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
67296-1006-16729610060110 TABLET, EXTENDED RELEASE in 1 BOTTLE (67296-1006-1) 2002-04-100000-00-00NoNoCurrent