FDA.reportPublic FDA data

potassium chloride

Product NDC
71335-1781
11-digit product format
713351781
Labeler code
71335
Product ID
71335-1781_9ab3989d-07c9-44d3-b84b-a7b1405d17db
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
potassium chloride
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA203562
Marketing category
ANDA
Marketing start
2016-07-26
Substance
POTASSIUM CHLORIDE
Active strength
750 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
Listing certified through
2026-12-31
Current FDA listing
Yes

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
A203562-001POTASSIUM CHLORIDEPOTASSIUM CHLORIDE10MEQTABLET, EXTENDED RELEASE / ORALAB12016-07-26
A203562-002POTASSIUM CHLORIDEPOTASSIUM CHLORIDE20MEQTABLET, EXTENDED RELEASE / ORALAB12016-07-26

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A203562-001AB1
A203562-002AB1

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 · 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 UTC2026-02A203562-001POTASSIUM CHLORIDE10MEQTABLET, EXTENDED RELEASE / ORALAB12016-07-26011fe1cb6892…
2026-02-19 14:30 UTC2026-02A203562-002POTASSIUM CHLORIDE20MEQTABLET, EXTENDED RELEASE / ORALAB12016-07-26011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203562-001POTASSIUM CHLORIDE10MEQTABLET, EXTENDED RELEASE / ORALAB12016-07-2631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203562-002POTASSIUM CHLORIDE20MEQTABLET, EXTENDED RELEASE / ORALAB12016-07-2631067a03dcf5…
2025-08-23 18:47 UTC2025-08A203562-001POTASSIUM CHLORIDE10MEQTABLET, EXTENDED RELEASE / ORALAB12016-07-266a471c1ec25d…
2025-08-23 18:47 UTC2025-08A203562-002POTASSIUM CHLORIDE20MEQTABLET, EXTENDED RELEASE / ORALAB12016-07-266a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203562-001POTASSIUM CHLORIDE10MEQTABLET, EXTENDED RELEASE / ORALAB12016-07-26fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203562-002POTASSIUM CHLORIDE20MEQTABLET, EXTENDED RELEASE / ORALAB12016-07-26fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203562-001POTASSIUM CHLORIDE10MEQTABLET, EXTENDED RELEASE / ORALAB12016-07-26b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203562-002POTASSIUM CHLORIDE20MEQTABLET, EXTENDED RELEASE / ORALAB12016-07-26b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203562-001POTASSIUM CHLORIDE10MEQTABLET, EXTENDED RELEASE / ORALAB12016-07-2603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203562-002POTASSIUM CHLORIDE20MEQTABLET, EXTENDED RELEASE / ORALAB12016-07-2603ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203562-001POTASSIUM CHLORIDE10MEQTABLET, EXTENDED RELEASE / ORALAB12016-07-262680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203562-002POTASSIUM CHLORIDE20MEQTABLET, EXTENDED RELEASE / ORALAB12016-07-262680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A203562-001POTASSIUM CHLORIDE10MEQTABLET, EXTENDED RELEASE / ORALAB12016-07-265bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A203562-002POTASSIUM CHLORIDE20MEQTABLET, EXTENDED RELEASE / ORALAB12016-07-265bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A203562-001POTASSIUM CHLORIDE10MEQTABLET, EXTENDED RELEASE / ORALAB12016-07-26d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A203562-002POTASSIUM CHLORIDE20MEQTABLET, EXTENDED RELEASE / ORALAB12016-07-26d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A203562-001POTASSIUM CHLORIDE10MEQTABLET, EXTENDED RELEASE / ORALAB12016-07-26d06236e962d9…
2024-10-29 15:01 UTC2024-10A203562-002POTASSIUM CHLORIDE20MEQTABLET, EXTENDED RELEASE / ORALAB12016-07-26d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A203562-001POTASSIUM CHLORIDE10MEQTABLET, EXTENDED RELEASE / ORALAB12016-07-2679d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A203562-002POTASSIUM CHLORIDE20MEQTABLET, EXTENDED RELEASE / ORALAB12016-07-2679d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A203562-001POTASSIUM CHLORIDE10MEQTABLET, EXTENDED RELEASE / ORALAB12016-07-26301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A203562-002POTASSIUM CHLORIDE20MEQTABLET, EXTENDED RELEASE / ORALAB12016-07-26301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A203562-001POTASSIUM CHLORIDE10MEQTABLET, EXTENDED RELEASE / ORALAB12016-07-261e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A203562-002POTASSIUM CHLORIDE20MEQTABLET, EXTENDED RELEASE / ORALAB12016-07-261e350fbaab3a…
2024-05-31 18:47 UTC2024-05A203562-001POTASSIUM CHLORIDE10MEQTABLET, EXTENDED RELEASE / ORALAB12016-07-268072bd15b7f6…
2024-05-31 18:47 UTC2024-05A203562-002POTASSIUM CHLORIDE20MEQTABLET, EXTENDED RELEASE / ORALAB12016-07-268072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A203562-001POTASSIUM CHLORIDE10MEQTABLET, EXTENDED RELEASE / ORALAB12016-07-265c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A203562-002POTASSIUM CHLORIDE20MEQTABLET, EXTENDED RELEASE / ORALAB12016-07-265c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A203562-001POTASSIUM CHLORIDE10MEQTABLET, EXTENDED RELEASE / ORALAB12016-07-265d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A203562-002POTASSIUM CHLORIDE20MEQTABLET, EXTENDED RELEASE / ORALAB12016-07-265d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A203562-001POTASSIUM CHLORIDE10MEQTABLET, EXTENDED RELEASE / ORALAB12016-07-264b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A203562-002POTASSIUM CHLORIDE20MEQTABLET, EXTENDED RELEASE / ORALAB12016-07-264b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A203562-001POTASSIUM CHLORIDE10MEQTABLET, EXTENDED RELEASE / ORALAB12016-07-2674a2ff9319b5…
2019-12-13 00:20 UTC2019-12A203562-002POTASSIUM CHLORIDE20MEQTABLET, EXTENDED RELEASE / ORALAB12016-07-2674a2ff9319b5…
2022-03-09 01:35 UTC2022-03A203562-001POTASSIUM CHLORIDE10MEQTABLET, EXTENDED RELEASE / ORALAB12016-07-26bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A203562-002POTASSIUM CHLORIDE20MEQTABLET, EXTENDED RELEASE / ORALAB12016-07-26bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A203562-001POTASSIUM CHLORIDE10MEQTABLET, EXTENDED RELEASE / ORALAB12016-07-26782e0a99824c…
2021-12-28 21:50 UTC2021-12A203562-002POTASSIUM CHLORIDE20MEQTABLET, EXTENDED RELEASE / ORALAB12016-07-26782e0a99824c…

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 UTC2026-02A203562-001AB11011fe1cb6892…
2026-02-19 14:30 UTC2026-02A203562-002AB11011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203562-001AB1131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203562-002AB1131067a03dcf5…
2025-08-23 18:47 UTC2025-08A203562-001AB116a471c1ec25d…
2025-08-23 18:47 UTC2025-08A203562-002AB116a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203562-001AB11fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203562-002AB11fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203562-001AB11b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203562-002AB11b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203562-001AB1103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203562-002AB1103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203562-001AB112680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203562-002AB112680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A203562-001AB115bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A203562-002AB115bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A203562-001AB11d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A203562-002AB11d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A203562-001AB11d06236e962d9…
2024-10-29 15:01 UTC2024-10A203562-002AB11d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A203562-001AB1179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A203562-002AB1179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A203562-001AB11301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A203562-002AB11301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A203562-001AB111e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A203562-002AB111e350fbaab3a…
2024-05-31 18:47 UTC2024-05A203562-001AB118072bd15b7f6…
2024-05-31 18:47 UTC2024-05A203562-002AB118072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A203562-001AB115c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A203562-002AB115c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A203562-001AB115d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A203562-002AB115d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A203562-001AB114b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A203562-002AB114b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A203562-001AB1174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A203562-002AB1174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A203562-001AB11bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A203562-002AB11bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A203562-001AB11782e0a99824c…
2021-12-28 21:50 UTC2021-12A203562-002AB11782e0a99824c…

Additional Listing Data#

Finished product
Yes
Brand name base
potassium chloride
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
POTASSIUM CHLORIDE750 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 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
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
bc42a691-a486-4ece-b9f7-faf6cc5df6b5Available 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
71335-1781-1potassium chloride30 in 1 BOTTLETABLET, EXTENDED RELEASE30103
71335-1781-2potassium chloride60 in 1 BOTTLETABLET, EXTENDED RELEASE60103
71335-1781-3potassium chloride90 in 1 BOTTLETABLET, EXTENDED RELEASE90103
71335-1781-4potassium chloride15 in 1 BOTTLETABLET, EXTENDED RELEASE15103
71335-1781-5potassium chloride180 in 1 BOTTLETABLET, EXTENDED RELEASE180103
71335-1781-6potassium chloride28 in 1 BOTTLETABLET, EXTENDED RELEASE28103
71335-1781-7potassium chloride10 in 1 BOTTLETABLET, EXTENDED RELEASE10103

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-1781POTASSIUM CHLORIDE TABLET, EXTENDED RELEASE [BRYANT RANCH PREPACK]103Current NDC, Legacy NDC, 7 package rows20240830_bc42a691-a486-4ece-b9f7-faf6cc5df6b5.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 CHLORIDEGlenmark Pharmaceuticals Inc., USA63bedd99-0596-49d2-ad04-d1d8ac15cc422026-07-08Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203562
application number: ANDA203562
potassium chloridePOTASSIUM CHLORIDERedpharm Drug3735d41a-7787-6b92-e063-6294a90add452025-12-24Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203562
application number: ANDA203562
Potassium Chloride ERPOTASSIUM CHLORIDE ERDirect_Rxf988aa11-60ef-411e-e053-6294a90a522a2025-01-22Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203562
application number: ANDA203562
potassium chloridePOTASSIUM CHLORIDEA-S Medication Solutions3a720078-f455-44ab-a883-e3c13d83a74c2024-11-18Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203562
application number: ANDA203562
potassium chloridePOTASSIUM CHLORIDEA-S Medication Solutionscf014023-5300-455f-9f7f-fefb2e3639862024-11-18Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203562
application number: ANDA203562
potassium chloridePOTASSIUM CHLORIDEBryant Ranch Prepackf22606a5-ac9f-44fc-bb7b-08f3cf56c9992024-11-12Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203562
application number: ANDA203562
potassium chloridePOTASSIUM CHLORIDEBryant Ranch Prepackbc42a691-a486-4ece-b9f7-faf6cc5df6b52024-08-29Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203562
application number: ANDA203562
ndc (product): 71335-1781

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1801298potassium chloride 10 MEQ Microencapsulated Extended Release Oral TabletPSNbc42a691-a486-4ece-b9f7-faf6cc5df6b5103
1801298Microencapsulated potassium chloride 10 MEQ Extended Release Oral TabletSCDbc42a691-a486-4ece-b9f7-faf6cc5df6b5103
1801298Microencapsulated K+ Chloride 10 MEQ Extended Release Oral TabletSYbc42a691-a486-4ece-b9f7-faf6cc5df6b5103
1801298Microencapsulated Pot Chloride 10 MEQ Extended Release Oral TabletSYbc42a691-a486-4ece-b9f7-faf6cc5df6b5103
1801298potassium chloride 10 MEQ Microencapsulated Extended Release Oral TabletSYbc42a691-a486-4ece-b9f7-faf6cc5df6b5103
1801298potassium chloride 750 MG Microencapsulated Extended Release OralSYbc42a691-a486-4ece-b9f7-faf6cc5df6b5103

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71335-1781-17133517810130 TABLET, EXTENDED RELEASE in 1 BOTTLE (71335-1781-1) 2021-05-260000-00-00NoNoCurrent
71335-1781-27133517810260 TABLET, EXTENDED RELEASE in 1 BOTTLE (71335-1781-2) 2021-06-250000-00-00NoNoCurrent
71335-1781-37133517810390 TABLET, EXTENDED RELEASE in 1 BOTTLE (71335-1781-3) 2021-03-090000-00-00NoNoCurrent
71335-1781-47133517810415 TABLET, EXTENDED RELEASE in 1 BOTTLE (71335-1781-4) 2021-12-200000-00-00NoNoCurrent
71335-1781-571335178105180 TABLET, EXTENDED RELEASE in 1 BOTTLE (71335-1781-5) 2021-12-200000-00-00NoNoCurrent
71335-1781-67133517810628 TABLET, EXTENDED RELEASE in 1 BOTTLE (71335-1781-6) 2021-12-200000-00-00NoNoCurrent
71335-1781-77133517810710 TABLET, EXTENDED RELEASE in 1 BOTTLE (71335-1781-7) 2021-03-080000-00-00NoNoCurrent