Potassium Chloride

Product NDC
60219-1617
Requested package NDC
60219-1617-3
11-digit product format
602191617
Labeler code
60219
Product ID
60219-1617_d8dc08f5-f4d7-4474-807a-c189b577966d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Potassium Chloride
Dosage form
FOR SOLUTION
Route
ORAL
Labeler
Amneal Pharmaceuticals LLC
Application
ANDA210902
Marketing category
ANDA
Marketing start
2023-11-25
Substance
POTASSIUM CHLORIDE
Active strength
1.5 g/1.58g
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
2027-12-31
Current FDA listing
Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A210902-001POTASSIUM CHLORIDEPOTASSIUM CHLORIDE20MEQFOR SOLUTION / ORALAA2019-05-23

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A210902-001AA

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 2 · 43 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A210902-001POTASSIUM CHLORIDE20MEQFOR SOLUTION / ORALAA2019-05-2384e616aacf4f…
2026-08-18 06:07:402026-07A210902-001POTASSIUM CHLORIDE20MEQFOR SOLUTION / ORALAA2019-05-23caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A210902-001POTASSIUM CHLORIDE20MEQFOR SOLUTION / ORALAA2019-05-23011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A210902-001POTASSIUM CHLORIDE20MEQFOR SOLUTION / ORALAA2019-05-2331067a03dcf5…
2025-08-23 18:47 UTC2025-08A210902-001POTASSIUM CHLORIDE20MEQFOR SOLUTION / ORALAA2019-05-236a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A210902-001POTASSIUM CHLORIDE20MEQFOR SOLUTION / ORALAA2019-05-23fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A210902-001POTASSIUM CHLORIDE20MEQFOR SOLUTION / ORALAA2019-05-23b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A210902-001POTASSIUM CHLORIDE20MEQFOR SOLUTION / ORALAA2019-05-2303ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A210902-001POTASSIUM CHLORIDE20MEQFOR SOLUTION / ORALAA2019-05-232680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A210902-001POTASSIUM CHLORIDE20MEQFOR SOLUTION / ORALAA2019-05-235bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A210902-001POTASSIUM CHLORIDE20MEQFOR SOLUTION / ORALAA2019-05-23d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A210902-001POTASSIUM CHLORIDE20MEQFOR SOLUTION / ORALAA2019-05-23d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A210902-001POTASSIUM CHLORIDE20MEQFOR SOLUTION / ORALAA2019-05-2379d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A210902-001POTASSIUM CHLORIDE20MEQFOR SOLUTION / ORALAA2019-05-23301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A210902-001POTASSIUM CHLORIDE20MEQFOR SOLUTION / ORALAA2019-05-231e350fbaab3a…
2024-05-31 18:47 UTC2024-05A210902-001POTASSIUM CHLORIDE20MEQFOR SOLUTION / ORALAA2019-05-238072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A210902-001POTASSIUM CHLORIDE20MEQFOR SOLUTION / ORALAA2019-05-235c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A210902-001POTASSIUM CHLORIDE20MEQFOR SOLUTION / ORALAA2019-05-235d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A210902-001POTASSIUM CHLORIDE20MEQFOR SOLUTION / ORALAA2019-05-234b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A210902-001POTASSIUM CHLORIDE20MEQFOR SOLUTION / ORALAA2019-05-2374a2ff9319b5…
2022-03-09 01:35 UTC2022-03A210902-001POTASSIUM CHLORIDE20MEQFOR SOLUTION / ORALAA2019-05-23bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A210902-001POTASSIUM CHLORIDE20MEQFOR SOLUTION / ORALAA2019-05-23782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A210902-001POTASSIUM CHLORIDE20MEQFOR SOLUTION / ORALAA2019-05-2387673890dc5c…
2021-03-12 10:30 UTC2021-03A210902-001POTASSIUM CHLORIDE20MEQFOR SOLUTION / ORALAA2019-05-235aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A210902-001POTASSIUM CHLORIDE20MEQFOR SOLUTION / ORALAA2019-05-238869cabd3fbd…
2020-11-12 02:37 UTC2020-11A210902-001POTASSIUM CHLORIDE20MEQFOR SOLUTION / ORALAA2019-05-23c0c555d07b60…
2019-12-14 00:12 UTC2019-12A210902-001POTASSIUM CHLORIDE20MEQFOR SOLUTION / ORALAA2019-05-233f01610625f2…
2019-09-15 20:21 UTC2019-09A210902-001POTASSIUM CHLORIDE20MEQFOR SOLUTION / ORALAA2019-05-23b00525d2431f…
2019-07-19 19:46 UTC2019-07A210902-001POTASSIUM CHLORIDE20MEQFOR SOLUTION / ORALAA2019-05-23ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A210902-001POTASSIUM CHLORIDE20MEQFOR SOLUTION / ORALAA2019-05-236a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A210902-001POTASSIUM CHLORIDE20MEQFOR SOLUTION / ORALAA2019-05-231c564ffb4f44…
2023-12-20 04:57 UTC2023-12A210902-001POTASSIUM CHLORIDE20MEQFOR SOLUTION / ORALAA2019-05-23ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A210902-001POTASSIUM CHLORIDE20MEQFOR SOLUTION / ORALAA2019-05-23a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A210902-001POTASSIUM CHLORIDE20MEQFOR SOLUTION / ORALAA2019-05-239b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A210902-001POTASSIUM CHLORIDE20MEQFOR SOLUTION / ORALAA2019-05-23a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A210902-001POTASSIUM CHLORIDE20MEQFOR SOLUTION / ORALAA2019-05-233f0d92c62455…
2023-05-13 08:27 UTC2023-05A210902-001POTASSIUM CHLORIDE20MEQFOR SOLUTION / ORALAA2019-05-23053a50430f4f…
2023-01-26 05:58 UTC2023-01A210902-001POTASSIUM CHLORIDE20MEQFOR SOLUTION / ORALAA2019-05-233bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A210902-001POTASSIUM CHLORIDE20MEQFOR SOLUTION / ORALAA2019-05-233a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A210902-001POTASSIUM CHLORIDE20MEQFOR SOLUTION / ORALAA2019-05-23f41ea6bd6efb…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 43 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-09-14 22:38:342026-08A210902-001AA184e616aacf4f…
2026-08-18 06:07:402026-07A210902-001AA1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A210902-001AA1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A210902-001AA131067a03dcf5…
2025-08-23 18:47 UTC2025-08A210902-001AA16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A210902-001AA1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A210902-001AA1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A210902-001AA103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A210902-001AA12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A210902-001AA15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A210902-001AA1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A210902-001AA1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A210902-001AA179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A210902-001AA1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A210902-001AA11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A210902-001AA18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A210902-001AA15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A210902-001AA15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A210902-001AA14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A210902-001AA174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A210902-001AA1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A210902-001AA1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A210902-001AA187673890dc5c…
2021-03-12 10:30 UTC2021-03A210902-001AA15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A210902-001AA18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A210902-001AA1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A210902-001AA13f01610625f2…
2019-09-15 20:21 UTC2019-09A210902-001AA1b00525d2431f…
2019-07-19 19:46 UTC2019-07A210902-001AA1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A210902-001AA16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A210902-001AA11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A210902-001AA1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A210902-001AA1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A210902-001AA19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A210902-001AA1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A210902-001AA13f0d92c62455…
2023-05-13 08:27 UTC2023-05A210902-001AA1053a50430f4f…
2023-01-26 05:58 UTC2023-01A210902-001AA13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A210902-001AA13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A210902-001AA1f41ea6bd6efb…

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

Finished product
Yes
Brand name base
Potassium Chloride
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
POTASSIUM CHLORIDE1.5 g/1.58g

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
1867544Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
f9965f73-e189-423f-bd10-c4a0ed12b485Available 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
60219-1617-1Potassium Chloride1.58 g in 1 POUCHFOR SOLUTION1.582
60219-1617-3Potassium Chloride30 in 1 CARTONFOR SOLUTION302
60219-1617-8Potassium Chloride100 in 1 CARTONFOR SOLUTION1002

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
60219-1617-1EA - Each60219-1617f4437e92-4ac2-4862-a72f-7006d1c99c1812024-02-14
60219-1617-3EA - Each60219-161730fc9000-f058-409e-ba4d-a7b21d85277412024-02-14
60219-1617-8EA - Each60219-1617a76ac133-9b4a-4488-9fe8-eceddc57471412024-02-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60219-1617POTASSIUM CHLORIDE FOR SOLUTION [AMNEAL PHARMACEUTICALS NY LLC]2Current NDC, 3 package rows20250315_f9965f73-e189-423f-bd10-c4a0ed12b485.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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Potassium ChloridePOTASSIUM CHLORIDEAmneal Pharmaceuticals LLCf9965f73-e189-423f-bd10-c4a0ed12b4852026-08-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 210902
application number: ANDA210902
ndc (package): 60219-1617-3
ndc (product): 60219-1617
ndc11 (package): 60219161703

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1867544potassium chloride 20 MEQ (1.5 GM) Powder for Oral SolutionPSNf9965f73-e189-423f-bd10-c4a0ed12b4852
1867544potassium chloride 20 MEQ Powder for Oral SolutionSCDf9965f73-e189-423f-bd10-c4a0ed12b4852
1867544K+ Chloride 20 MEQ Powder for Oral SolutionSYf9965f73-e189-423f-bd10-c4a0ed12b4852
1867544Pot Chloride 20 MEQ Powder for Oral SolutionSYf9965f73-e189-423f-bd10-c4a0ed12b4852
1867544potassium chloride 1.5 GM Powder for Oral SolutionSYf9965f73-e189-423f-bd10-c4a0ed12b4852

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
60219-1617-36021916170330 POUCH in 1 CARTON (60219-1617-3) / 1.58 g in 1 POUCH (60219-1617-1) 30 pouch2023-11-25NoNoCurrent