FDA.reportPublic FDA data

Potassium Chloride

Product NDC
0904-7293
11-digit product format
009047293
Labeler code
0904
Product ID
0904-7293_7e4c4d5e-c399-4985-af8f-0be1177fa380
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Potassium Chloride
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Major Pharmaceuticals
Application
ANDA212861
Marketing category
ANDA
Marketing start
2023-05-01
Marketing end
2026-11-30
Substance
POTASSIUM CHLORIDE
Active strength
1500 mg/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
Current FDA listing
Yes

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
A212861-001POTASSIUM CHLORIDEPOTASSIUM CHLORIDE10MEQTABLET, EXTENDED RELEASE / ORAL2020-05-08
A212861-002POTASSIUM CHLORIDEPOTASSIUM CHLORIDE15MEQTABLET, EXTENDED RELEASE / ORAL2020-05-08
A212861-003POTASSIUM CHLORIDEPOTASSIUM CHLORIDE20MEQTABLET, EXTENDED RELEASE / ORAL2020-05-08

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 · 114 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A212861-001POTASSIUM CHLORIDE10MEQTABLET, EXTENDED RELEASE / ORAL2020-05-08caaa826d4ba7…
2026-08-18 06:07:402026-07A212861-002POTASSIUM CHLORIDE15MEQTABLET, EXTENDED RELEASE / ORAL2020-05-08caaa826d4ba7…
2026-08-18 06:07:402026-07A212861-003POTASSIUM CHLORIDE20MEQTABLET, EXTENDED RELEASE / ORAL2020-05-08caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A212861-001POTASSIUM CHLORIDE10MEQTABLET, EXTENDED RELEASE / ORAL2020-05-08011fe1cb6892…
2026-02-19 14:30 UTC2026-02A212861-002POTASSIUM CHLORIDE15MEQTABLET, EXTENDED RELEASE / ORAL2020-05-08011fe1cb6892…
2026-02-19 14:30 UTC2026-02A212861-003POTASSIUM CHLORIDE20MEQTABLET, EXTENDED RELEASE / ORAL2020-05-08011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A212861-001POTASSIUM CHLORIDE10MEQTABLET, EXTENDED RELEASE / ORAL2020-05-0831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A212861-002POTASSIUM CHLORIDE15MEQTABLET, EXTENDED RELEASE / ORAL2020-05-0831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A212861-003POTASSIUM CHLORIDE20MEQTABLET, EXTENDED RELEASE / ORAL2020-05-0831067a03dcf5…
2025-08-23 18:47 UTC2025-08A212861-001POTASSIUM CHLORIDE10MEQTABLET, EXTENDED RELEASE / ORALAB12020-05-086a471c1ec25d…
2025-08-23 18:47 UTC2025-08A212861-002POTASSIUM CHLORIDE15MEQTABLET, EXTENDED RELEASE / ORAL2020-05-086a471c1ec25d…
2025-08-23 18:47 UTC2025-08A212861-003POTASSIUM CHLORIDE20MEQTABLET, EXTENDED RELEASE / ORALAB12020-05-086a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A212861-001POTASSIUM CHLORIDE10MEQTABLET, EXTENDED RELEASE / ORALAB12020-05-08fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A212861-002POTASSIUM CHLORIDE15MEQTABLET, EXTENDED RELEASE / ORAL2020-05-08fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A212861-003POTASSIUM CHLORIDE20MEQTABLET, EXTENDED RELEASE / ORALAB12020-05-08fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A212861-001POTASSIUM CHLORIDE10MEQTABLET, EXTENDED RELEASE / ORALAB12020-05-08b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A212861-002POTASSIUM CHLORIDE15MEQTABLET, EXTENDED RELEASE / ORAL2020-05-08b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A212861-003POTASSIUM CHLORIDE20MEQTABLET, EXTENDED RELEASE / ORALAB12020-05-08b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A212861-001POTASSIUM CHLORIDE10MEQTABLET, EXTENDED RELEASE / ORALAB12020-05-0803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A212861-002POTASSIUM CHLORIDE15MEQTABLET, EXTENDED RELEASE / ORAL2020-05-0803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A212861-003POTASSIUM CHLORIDE20MEQTABLET, EXTENDED RELEASE / ORALAB12020-05-0803ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A212861-001POTASSIUM CHLORIDE10MEQTABLET, EXTENDED RELEASE / ORALAB12020-05-082680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A212861-002POTASSIUM CHLORIDE15MEQTABLET, EXTENDED RELEASE / ORAL2020-05-082680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A212861-003POTASSIUM CHLORIDE20MEQTABLET, EXTENDED RELEASE / ORALAB12020-05-082680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A212861-001POTASSIUM CHLORIDE10MEQTABLET, EXTENDED RELEASE / ORALAB12020-05-085bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A212861-002POTASSIUM CHLORIDE15MEQTABLET, EXTENDED RELEASE / ORAL2020-05-085bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A212861-003POTASSIUM CHLORIDE20MEQTABLET, EXTENDED RELEASE / ORALAB12020-05-085bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A212861-001POTASSIUM CHLORIDE10MEQTABLET, EXTENDED RELEASE / ORALAB12020-05-08d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A212861-002POTASSIUM CHLORIDE15MEQTABLET, EXTENDED RELEASE / ORAL2020-05-08d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A212861-003POTASSIUM CHLORIDE20MEQTABLET, EXTENDED RELEASE / ORALAB12020-05-08d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A212861-001POTASSIUM CHLORIDE10MEQTABLET, EXTENDED RELEASE / ORALAB12020-05-08d06236e962d9…
2024-10-29 15:01 UTC2024-10A212861-002POTASSIUM CHLORIDE15MEQTABLET, EXTENDED RELEASE / ORAL2020-05-08d06236e962d9…
2024-10-29 15:01 UTC2024-10A212861-003POTASSIUM CHLORIDE20MEQTABLET, EXTENDED RELEASE / ORALAB12020-05-08d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A212861-001POTASSIUM CHLORIDE10MEQTABLET, EXTENDED RELEASE / ORALAB12020-05-0879d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A212861-002POTASSIUM CHLORIDE15MEQTABLET, EXTENDED RELEASE / ORAL2020-05-0879d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A212861-003POTASSIUM CHLORIDE20MEQTABLET, EXTENDED RELEASE / ORALAB12020-05-0879d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A212861-001POTASSIUM CHLORIDE10MEQTABLET, EXTENDED RELEASE / ORALAB12020-05-08301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A212861-002POTASSIUM CHLORIDE15MEQTABLET, EXTENDED RELEASE / ORAL2020-05-08301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A212861-003POTASSIUM CHLORIDE20MEQTABLET, EXTENDED RELEASE / ORALAB12020-05-08301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A212861-001POTASSIUM CHLORIDE10MEQTABLET, EXTENDED RELEASE / ORALAB12020-05-081e350fbaab3a…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 68 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2025-08-23 18:47 UTC2025-08A212861-001AB116a471c1ec25d…
2025-08-23 18:47 UTC2025-08A212861-003AB116a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A212861-001AB11fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A212861-003AB11fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A212861-001AB11b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A212861-003AB11b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A212861-001AB1103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A212861-003AB1103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A212861-001AB112680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A212861-003AB112680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A212861-001AB115bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A212861-003AB115bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A212861-001AB11d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A212861-003AB11d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A212861-001AB11d06236e962d9…
2024-10-29 15:01 UTC2024-10A212861-003AB11d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A212861-001AB1179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A212861-003AB1179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A212861-001AB11301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A212861-003AB11301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A212861-001AB111e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A212861-003AB111e350fbaab3a…
2024-05-31 18:47 UTC2024-05A212861-001AB118072bd15b7f6…
2024-05-31 18:47 UTC2024-05A212861-003AB118072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A212861-001AB115c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A212861-003AB115c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A212861-001AB115d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A212861-003AB115d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A212861-001AB114b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A212861-003AB114b0b4de00fa7…
2022-03-09 01:35 UTC2022-03A212861-001AB11bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A212861-003AB11bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A212861-001AB11782e0a99824c…
2021-12-28 21:50 UTC2021-12A212861-003AB11782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A212861-001AB1187673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A212861-003AB1187673890dc5c…
2021-03-12 10:30 UTC2021-03A212861-001AB115aa47cf7b7d7…
2021-03-12 10:30 UTC2021-03A212861-003AB115aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A212861-001AB118869cabd3fbd…
2020-12-22 03:56 UTC2020-12A212861-003AB118869cabd3fbd…

Additional Listing Data#

Finished product
Yes
Brand name base
Potassium Chloride

Active Ingredients#

Ingredient, Strength table
IngredientStrength
POTASSIUM CHLORIDE1500 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
660YQ98I10Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1801294Internal RxNorm lookup
1801298Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
7c2274f2-5a7f-4a4a-8b7b-44f6ef9a84a4Available on FDA.report

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 Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0904-7293-61Potassium Chloride100 in 1 CARTONTABLET, EXTENDED RELEASE1003
0904-7293-61Potassium Chloride1 in 1 BLISTER PACKTABLET, EXTENDED RELEASE13

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0904-7293-61EA - Each0904-72935195b3c6-79c7-42fb-809f-18272cdd0a3512023-09-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0904-7293POTASSIUM CHLORIDE TABLET, EXTENDED RELEASE [MAJOR PHARMACEUTICALS]2Current NDC, 2 package rows20241102_7c2274f2-5a7f-4a4a-8b7b-44f6ef9a84a4.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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Potassium ChloridePOTASSIUM CHLORIDEMajor Pharmaceuticals7c2274f2-5a7f-4a4a-8b7b-44f6ef9a84a42025-09-05Warnings, Adverse reactionsExact identifier
application applno (ANDA): 212861
application number: ANDA212861
ndc (product): 0904-7293
Potassium ChloridePOTASSIUM CHLORIDEA-S Medication Solutions5aa0adf8-7b84-4cb0-be31-5c3333a6cc442023-12-11Warnings, Adverse reactionsExact identifier
application applno (ANDA): 212861
application number: ANDA212861

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1801298potassium chloride 10 MEQ Microencapsulated Extended Release Oral TabletPSN7c2274f2-5a7f-4a4a-8b7b-44f6ef9a84a43
1801294potassium chloride 20 MEQ Microencapsulated Extended Release Oral TabletPSN7c2274f2-5a7f-4a4a-8b7b-44f6ef9a84a43
1801298Microencapsulated potassium chloride 10 MEQ Extended Release Oral TabletSCD7c2274f2-5a7f-4a4a-8b7b-44f6ef9a84a43
1801294Microencapsulated potassium chloride 20 MEQ Extended Release Oral TabletSCD7c2274f2-5a7f-4a4a-8b7b-44f6ef9a84a43
1801298Microencapsulated K+ Chloride 10 MEQ Extended Release Oral TabletSY7c2274f2-5a7f-4a4a-8b7b-44f6ef9a84a43
1801294Microencapsulated K+ Chloride 20 MEQ Extended Release Oral TabletSY7c2274f2-5a7f-4a4a-8b7b-44f6ef9a84a43
1801298Microencapsulated Pot Chloride 10 MEQ Extended Release Oral TabletSY7c2274f2-5a7f-4a4a-8b7b-44f6ef9a84a43
1801294Microencapsulated Pot Chloride 20 MEQ Extended Release Oral TabletSY7c2274f2-5a7f-4a4a-8b7b-44f6ef9a84a43
1801298potassium chloride 10 MEQ Microencapsulated Extended Release Oral TabletSY7c2274f2-5a7f-4a4a-8b7b-44f6ef9a84a43
1801294potassium chloride 1500 MG Microencapsulated Extended Release Oral TabletSY7c2274f2-5a7f-4a4a-8b7b-44f6ef9a84a43
1801294potassium chloride 20 MEQ Microencapsulated Extended Release Oral TabletSY7c2274f2-5a7f-4a4a-8b7b-44f6ef9a84a43
1801298potassium chloride 750 MG Microencapsulated Extended Release OralSY7c2274f2-5a7f-4a4a-8b7b-44f6ef9a84a43

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0904-7293-6100904729361100 BLISTER PACK in 1 CARTON (0904-7293-61) / 1 TABLET, EXTENDED RELEASE in 1 BLISTER PACK100 blister pack2023-05-012026-11-30NoNoHistorical