Potassium Chloride

Product NDC: 59651-430
11-digit product format: 596510430
Labeler code: 59651
Product ID: 59651-430_d1038d80-ef7d-456a-9f47-0c5df1ca8811
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Potassium Chloride
Dosage form: TABLET, EXTENDED RELEASE
Route: ORAL
Labeler: Aurobindo Pharma Limited
Application: ANDA214728
Marketing category: ANDA
Marketing start: 2021-03-31
Substance: POTASSIUM CHLORIDE
Active strength: 1125 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 43.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	Approval date
A214728-001	POTASSIUM CHLORIDE	POTASSIUM CHLORIDE	10MEQ	TABLET, EXTENDED RELEASE / ORAL	2021-03-31
A214728-002	POTASSIUM CHLORIDE	POTASSIUM CHLORIDE	15MEQ	TABLET, EXTENDED RELEASE / ORAL	2021-03-31
A214728-003	POTASSIUM CHLORIDE	POTASSIUM CHLORIDE	20MEQ	TABLET, EXTENDED RELEASE / ORAL	2021-03-31

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
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A214728-001	POTASSIUM CHLORIDE	10MEQ	TABLET, EXTENDED RELEASE / ORAL	2021-03-31	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A214728-002	POTASSIUM CHLORIDE	15MEQ	TABLET, EXTENDED RELEASE / ORAL	2021-03-31	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A214728-003	POTASSIUM CHLORIDE	20MEQ	TABLET, EXTENDED RELEASE / ORAL	2021-03-31	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A214728-001	POTASSIUM CHLORIDE	10MEQ	TABLET, EXTENDED RELEASE / ORAL	2021-03-31	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A214728-002	POTASSIUM CHLORIDE	15MEQ	TABLET, EXTENDED RELEASE / ORAL	2021-03-31	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A214728-003	POTASSIUM CHLORIDE	20MEQ	TABLET, EXTENDED RELEASE / ORAL	2021-03-31	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A214728-001	POTASSIUM CHLORIDE	10MEQ	TABLET, EXTENDED RELEASE / ORAL	2021-03-31	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A214728-002	POTASSIUM CHLORIDE	15MEQ	TABLET, EXTENDED RELEASE / ORAL	2021-03-31	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A214728-003	POTASSIUM CHLORIDE	20MEQ	TABLET, EXTENDED RELEASE / ORAL	2021-03-31	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214728-001	POTASSIUM CHLORIDE	10MEQ	TABLET, EXTENDED RELEASE / ORAL	2021-03-31	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214728-002	POTASSIUM CHLORIDE	15MEQ	TABLET, EXTENDED RELEASE / ORAL	2021-03-31	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214728-003	POTASSIUM CHLORIDE	20MEQ	TABLET, EXTENDED RELEASE / ORAL	2021-03-31	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A214728-001	POTASSIUM CHLORIDE	10MEQ	TABLET, EXTENDED RELEASE / ORAL	2021-03-31	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A214728-002	POTASSIUM CHLORIDE	15MEQ	TABLET, EXTENDED RELEASE / ORAL	2021-03-31	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A214728-003	POTASSIUM CHLORIDE	20MEQ	TABLET, EXTENDED RELEASE / ORAL	2021-03-31	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214728-001	POTASSIUM CHLORIDE	10MEQ	TABLET, EXTENDED RELEASE / ORAL	2021-03-31	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214728-002	POTASSIUM CHLORIDE	15MEQ	TABLET, EXTENDED RELEASE / ORAL	2021-03-31	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214728-003	POTASSIUM CHLORIDE	20MEQ	TABLET, EXTENDED RELEASE / ORAL	2021-03-31	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214728-001	POTASSIUM CHLORIDE	10MEQ	TABLET, EXTENDED RELEASE / ORAL	2021-03-31	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214728-002	POTASSIUM CHLORIDE	15MEQ	TABLET, EXTENDED RELEASE / ORAL	2021-03-31	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214728-003	POTASSIUM CHLORIDE	20MEQ	TABLET, EXTENDED RELEASE / ORAL	2021-03-31	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214728-001	POTASSIUM CHLORIDE	10MEQ	TABLET, EXTENDED RELEASE / ORAL	2021-03-31	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214728-002	POTASSIUM CHLORIDE	15MEQ	TABLET, EXTENDED RELEASE / ORAL	2021-03-31	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214728-003	POTASSIUM CHLORIDE	20MEQ	TABLET, EXTENDED RELEASE / ORAL	2021-03-31	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214728-001	POTASSIUM CHLORIDE	10MEQ	TABLET, EXTENDED RELEASE / ORAL	2021-03-31	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214728-002	POTASSIUM CHLORIDE	15MEQ	TABLET, EXTENDED RELEASE / ORAL	2021-03-31	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214728-003	POTASSIUM CHLORIDE	20MEQ	TABLET, EXTENDED RELEASE / ORAL	2021-03-31	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214728-001	POTASSIUM CHLORIDE	10MEQ	TABLET, EXTENDED RELEASE / ORAL	2021-03-31	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214728-002	POTASSIUM CHLORIDE	15MEQ	TABLET, EXTENDED RELEASE / ORAL	2021-03-31	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214728-003	POTASSIUM CHLORIDE	20MEQ	TABLET, EXTENDED RELEASE / ORAL	2021-03-31	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214728-001	POTASSIUM CHLORIDE	10MEQ	TABLET, EXTENDED RELEASE / ORAL	2021-03-31	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214728-002	POTASSIUM CHLORIDE	15MEQ	TABLET, EXTENDED RELEASE / ORAL	2021-03-31	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214728-003	POTASSIUM CHLORIDE	20MEQ	TABLET, EXTENDED RELEASE / ORAL	2021-03-31	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A214728-001	POTASSIUM CHLORIDE	10MEQ	TABLET, EXTENDED RELEASE / ORAL	2021-03-31	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A214728-002	POTASSIUM CHLORIDE	15MEQ	TABLET, EXTENDED RELEASE / ORAL	2021-03-31	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A214728-003	POTASSIUM CHLORIDE	20MEQ	TABLET, EXTENDED RELEASE / ORAL	2021-03-31	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A214728-001	POTASSIUM CHLORIDE	10MEQ	TABLET, EXTENDED RELEASE / ORAL	2021-03-31	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A214728-002	POTASSIUM CHLORIDE	15MEQ	TABLET, EXTENDED RELEASE / ORAL	2021-03-31	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A214728-003	POTASSIUM CHLORIDE	20MEQ	TABLET, EXTENDED RELEASE / ORAL	2021-03-31	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A214728-001	POTASSIUM CHLORIDE	10MEQ	TABLET, EXTENDED RELEASE / ORAL	2021-03-31	`301d65b070ca…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A214728-001	AB1	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A214728-002	AB1	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A214728-003	AB1	1	`87673890dc5c…`

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: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
POTASSIUM CHLORIDE	1125 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
660YQ98I10	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
403888	Internal RxNorm lookup
1801294	Internal RxNorm lookup
1801298	Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
Identifier	FDA.report destination
deb6b462-397f-4527-ae26-40dc5d5857bc	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
9e37788c-b1bf-42ae-aac9-b60601606144	Product name	8	20260122
95250459-30e4-45c1-b08a-993044f49109	Product name	2	20250805
d9771140-739b-484b-ae64-b79528ff1211	Product name	3	20250801
efd58dcf-540a-4531-8766-e713129ca6f2	Product name	1	20250307
1527ac37-808d-43be-a63e-74e1258dbe46	Product name	9	20250219
bed0530e-f939-4541-956b-6928a2f6404f	Product name	1	20241008
cefa60e2-a5b5-493e-9c54-24735b7dc509	Product name	6	20240814
362d7abb-94e6-4c60-9a58-266894157713	Product name	1	20231023
9fcb7a91-de07-4f00-aabf-e4d6fda403d5	Product name	8	20230322
6bd95106-a412-1dad-b9cc-4cb74bfb27ce	Product name	2	20230315
9badc7be-250a-44ab-aa36-926af3f02679	Product name	1	20210527
0ec3537a-6c9b-432a-896c-b9ea8723049a	Product name	9	20200701
444b3e50-f226-46ef-bfca-2e7035d140cd	Product name	1	20190611
816b97af-edc5-4060-aff1-b814bdbcad50	Product name	1	20190415
7cda52fc-125f-421c-8fea-bc1974370c49	Product name	2	20180703
7916de40-e296-41f0-b811-6d0df1a33e2c	Product name	9	20180627
cefa60e2-a5b5-493e-9c54-24735b7dc509	Product name	2	20171212
419aab54-5d5a-4146-9453-026d4a9991be	Product name	2	20170525
26acd337-b838-40ac-bcbc-05c3b81c8712	Product name	1	20170323
d5e51f11-ad28-caa4-4b49-4143974782ad	Product name	1	20150831
290f523a-f9db-9774-b5a9-e1f908ac1782	Product name	1	20150828
0ca1d589-929b-4b33-bc5b-1d84abdafa6a	Product name	1	20150324
fc363c46-397b-4476-ac0f-70e43e8e4592	Product name	1	20150324
89dac932-b90a-4410-9ab1-84c53e57de25	Product name	1	20150316
5668b646-cd56-c3c7-bdea-3f6b1a8840db	Product name	1	20140508
810ab97e-f109-f41c-7c83-6a652a9cbf43	Product name	1	20140508
87711080-88eb-65c5-b2dd-bf99e700a372	Product name	1	20140508
8dbefedf-0a0d-a224-5a3c-66dc9e11c2dd	Product name	1	20140508
c6b65c52-69c7-df49-550a-a50c137f6218	Product name	1	20140508
ec2149b3-5c6d-5344-f757-c86411073075	Product name	1	20140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
59651-430-01	Potassium Chloride	100 in 1 BOTTLE	TABLET, EXTENDED RELEASE	100		2
59651-430-99	Potassium Chloride	1000 in 1 BOTTLE	TABLET, EXTENDED RELEASE	1000		2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
59651-430	POTASSIUM CHLORIDE TABLET, EXTENDED RELEASE [AUROBINDO PHARMA LIMITED]	2	Current NDC, Legacy NDC, 2 package rows	20210504_deb6b462-397f-4527-ae26-40dc5d5857bc.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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Potassium Chloride	POTASSIUM CHLORIDE	Aurobindo Pharma Limited	deb6b462-397f-4527-ae26-40dc5d5857bc	2021-04-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214728 application number: ANDA214728 ndc (product): 59651-430

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
660YQ98I10	POTASSIUM CHLORIDE	7447-40-7	POTASSIUM CHLORIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1801298	potassium chloride 10 MEQ Microencapsulated Extended Release Oral Tablet	PSN	deb6b462-397f-4527-ae26-40dc5d5857bc	2
403888	potassium chloride 15 MEQ Microencapsulated Extended Release Oral Tablet	PSN	deb6b462-397f-4527-ae26-40dc5d5857bc	2
1801294	potassium chloride 20 MEQ Microencapsulated Extended Release Oral Tablet	PSN	deb6b462-397f-4527-ae26-40dc5d5857bc	2
1801298	Microencapsulated potassium chloride 10 MEQ Extended Release Oral Tablet	SCD	deb6b462-397f-4527-ae26-40dc5d5857bc	2
403888	Microencapsulated potassium chloride 15 MEQ Extended Release Oral Tablet	SCD	deb6b462-397f-4527-ae26-40dc5d5857bc	2
1801294	Microencapsulated potassium chloride 20 MEQ Extended Release Oral Tablet	SCD	deb6b462-397f-4527-ae26-40dc5d5857bc	2
1801298	Microencapsulated K+ Chloride 10 MEQ Extended Release Oral Tablet	SY	deb6b462-397f-4527-ae26-40dc5d5857bc	2
403888	Microencapsulated K+ Chloride 15 MEQ Extended Release Oral Tablet	SY	deb6b462-397f-4527-ae26-40dc5d5857bc	2
1801294	Microencapsulated K+ Chloride 20 MEQ Extended Release Oral Tablet	SY	deb6b462-397f-4527-ae26-40dc5d5857bc	2
1801298	Microencapsulated Pot Chloride 10 MEQ Extended Release Oral Tablet	SY	deb6b462-397f-4527-ae26-40dc5d5857bc	2
403888	Microencapsulated Pot Chloride 15 MEQ Extended Release Oral Tablet	SY	deb6b462-397f-4527-ae26-40dc5d5857bc	2
1801294	Microencapsulated Pot Chloride 20 MEQ Extended Release Oral Tablet	SY	deb6b462-397f-4527-ae26-40dc5d5857bc	2
1801298	potassium chloride 10 MEQ Microencapsulated Extended Release Oral Tablet	SY	deb6b462-397f-4527-ae26-40dc5d5857bc	2
403888	potassium chloride 1125 MG Microencapsulated Extended Release Oral Tablet	SY	deb6b462-397f-4527-ae26-40dc5d5857bc	2
1801294	potassium chloride 1500 MG Microencapsulated Extended Release Oral Tablet	SY	deb6b462-397f-4527-ae26-40dc5d5857bc	2
1801294	potassium chloride 20 MEQ Microencapsulated Extended Release Oral Tablet	SY	deb6b462-397f-4527-ae26-40dc5d5857bc	2
1801298	potassium chloride 750 MG Microencapsulated Extended Release Oral	SY	deb6b462-397f-4527-ae26-40dc5d5857bc	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
59651-430-01	59651043001	100 TABLET, EXTENDED RELEASE in 1 BOTTLE (59651-430-01)	2021-03-31	0000-00-00	No	No	Current
59651-430-99	59651043099	1000 TABLET, EXTENDED RELEASE in 1 BOTTLE (59651-430-99)	2021-03-31	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Potassium Chloride Extended-Release Tablets, USP Rx only	Aurobindo Pharma Limited \| APL HEALTHCARE LIMITED	2021-04-30	Human Prescription Drug Label	2