Potassium Chloride

Product NDC: 60687-561
11-digit product format: 606870561
Labeler code: 60687
Product ID: 60687-561_ae6bd5dc-eb3a-1d87-e053-2a95a90a97d9
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Potassium Chloride
Dosage form: TABLET, EXTENDED RELEASE
Route: ORAL
Labeler: American Health Packaging
Application: ANDA203562
Marketing category: ANDA
Marketing start: 2020-09-01
Marketing end: 0000-00-00
Substance: POTASSIUM CHLORIDE
Active strength: 750 mg/1
Pharmacologic classes: Potassium Compounds [CS],Potassium Salt [EPC],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA]
NDC exclude flag: No
Listing certified through: 2021-12-31
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 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	60687-561		D	Discontinued by firm		2026-08-03
excluded package	package	60687-561	60687-561-09	D	Discontinued by firm		2026-08-03

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 · 24 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	60687-561-09	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	60687-561-09	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	60687-561-09	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	60687-561-09	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	60687-561-09	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	60687-561-09	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	60687-561-09	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	60687-561-09	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	60687-561-09	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	60687-561-09	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	60687-561-09	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	60687-561-09	`557ba5c1ecfa…`	`9c80585c8c6e…`

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-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A203562-001	POTASSIUM CHLORIDE	POTASSIUM CHLORIDE	10MEQ	TABLET, EXTENDED RELEASE / ORAL	AB1		2016-07-26
A203562-002	POTASSIUM CHLORIDE	POTASSIUM CHLORIDE	20MEQ	TABLET, EXTENDED RELEASE / ORAL	AB1		2016-07-26

Therapeutic equivalence codes#

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

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

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
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A203562-001	POTASSIUM CHLORIDE	10MEQ	TABLET, EXTENDED RELEASE / ORAL	AB1	2016-07-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203562-002	POTASSIUM CHLORIDE	20MEQ	TABLET, EXTENDED RELEASE / ORAL	AB1	2016-07-26	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203562-001	POTASSIUM CHLORIDE	10MEQ	TABLET, EXTENDED RELEASE / ORAL	AB1	2016-07-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203562-002	POTASSIUM CHLORIDE	20MEQ	TABLET, EXTENDED RELEASE / ORAL	AB1	2016-07-26	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A203562-001	POTASSIUM CHLORIDE	10MEQ	TABLET, EXTENDED RELEASE / ORAL	AB1	2016-07-26	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203562-002	POTASSIUM CHLORIDE	20MEQ	TABLET, EXTENDED RELEASE / ORAL	AB1	2016-07-26	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203562-001	POTASSIUM CHLORIDE	10MEQ	TABLET, EXTENDED RELEASE / ORAL	AB1	2016-07-26	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203562-002	POTASSIUM CHLORIDE	20MEQ	TABLET, EXTENDED RELEASE / ORAL	AB1	2016-07-26	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203562-001	POTASSIUM CHLORIDE	10MEQ	TABLET, EXTENDED RELEASE / ORAL	AB1	2016-07-26	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203562-002	POTASSIUM CHLORIDE	20MEQ	TABLET, EXTENDED RELEASE / ORAL	AB1	2016-07-26	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203562-001	POTASSIUM CHLORIDE	10MEQ	TABLET, EXTENDED RELEASE / ORAL	AB1	2016-07-26	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203562-002	POTASSIUM CHLORIDE	20MEQ	TABLET, EXTENDED RELEASE / ORAL	AB1	2016-07-26	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203562-001	POTASSIUM CHLORIDE	10MEQ	TABLET, EXTENDED RELEASE / ORAL	AB1	2016-07-26	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203562-002	POTASSIUM CHLORIDE	20MEQ	TABLET, EXTENDED RELEASE / ORAL	AB1	2016-07-26	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203562-001	POTASSIUM CHLORIDE	10MEQ	TABLET, EXTENDED RELEASE / ORAL	AB1	2016-07-26	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203562-002	POTASSIUM CHLORIDE	20MEQ	TABLET, EXTENDED RELEASE / ORAL	AB1	2016-07-26	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203562-001	POTASSIUM CHLORIDE	10MEQ	TABLET, EXTENDED RELEASE / ORAL	AB1	2016-07-26	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203562-002	POTASSIUM CHLORIDE	20MEQ	TABLET, EXTENDED RELEASE / ORAL	AB1	2016-07-26	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A203562-001	POTASSIUM CHLORIDE	10MEQ	TABLET, EXTENDED RELEASE / ORAL	AB1	2016-07-26	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A203562-002	POTASSIUM CHLORIDE	20MEQ	TABLET, EXTENDED RELEASE / ORAL	AB1	2016-07-26	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203562-001	POTASSIUM CHLORIDE	10MEQ	TABLET, EXTENDED RELEASE / ORAL	AB1	2016-07-26	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203562-002	POTASSIUM CHLORIDE	20MEQ	TABLET, EXTENDED RELEASE / ORAL	AB1	2016-07-26	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203562-001	POTASSIUM CHLORIDE	10MEQ	TABLET, EXTENDED RELEASE / ORAL	AB1	2016-07-26	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203562-002	POTASSIUM CHLORIDE	20MEQ	TABLET, EXTENDED RELEASE / ORAL	AB1	2016-07-26	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203562-001	POTASSIUM CHLORIDE	10MEQ	TABLET, EXTENDED RELEASE / ORAL	AB1	2016-07-26	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203562-002	POTASSIUM CHLORIDE	20MEQ	TABLET, EXTENDED RELEASE / ORAL	AB1	2016-07-26	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A203562-001	POTASSIUM CHLORIDE	10MEQ	TABLET, EXTENDED RELEASE / ORAL	AB1	2016-07-26	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A203562-002	POTASSIUM CHLORIDE	20MEQ	TABLET, EXTENDED RELEASE / ORAL	AB1	2016-07-26	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A203562-001	POTASSIUM CHLORIDE	10MEQ	TABLET, EXTENDED RELEASE / ORAL	AB1	2016-07-26	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A203562-002	POTASSIUM CHLORIDE	20MEQ	TABLET, EXTENDED RELEASE / ORAL	AB1	2016-07-26	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A203562-001	POTASSIUM CHLORIDE	10MEQ	TABLET, EXTENDED RELEASE / ORAL	AB1	2016-07-26	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A203562-002	POTASSIUM CHLORIDE	20MEQ	TABLET, EXTENDED RELEASE / ORAL	AB1	2016-07-26	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A203562-001	POTASSIUM CHLORIDE	10MEQ	TABLET, EXTENDED RELEASE / ORAL	AB1	2016-07-26	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A203562-002	POTASSIUM CHLORIDE	20MEQ	TABLET, EXTENDED RELEASE / ORAL	AB1	2016-07-26	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A203562-001	POTASSIUM CHLORIDE	10MEQ	TABLET, EXTENDED RELEASE / ORAL	AB1	2016-07-26	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A203562-002	POTASSIUM CHLORIDE	20MEQ	TABLET, EXTENDED RELEASE / ORAL	AB1	2016-07-26	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A203562-001	POTASSIUM CHLORIDE	10MEQ	TABLET, EXTENDED RELEASE / ORAL	AB1	2016-07-26	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A203562-002	POTASSIUM CHLORIDE	20MEQ	TABLET, EXTENDED RELEASE / ORAL	AB1	2016-07-26	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A203562-001	POTASSIUM CHLORIDE	10MEQ	TABLET, EXTENDED RELEASE / ORAL	AB1	2016-07-26	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A203562-002	POTASSIUM CHLORIDE	20MEQ	TABLET, EXTENDED RELEASE / ORAL	AB1	2016-07-26	`782e0a99824c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 82 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A203562-001	AB1	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203562-002	AB1	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203562-001	AB1	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203562-002	AB1	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A203562-001	AB1	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203562-002	AB1	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203562-001	AB1	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203562-002	AB1	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203562-001	AB1	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203562-002	AB1	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203562-001	AB1	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203562-002	AB1	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203562-001	AB1	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203562-002	AB1	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203562-001	AB1	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203562-002	AB1	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203562-001	AB1	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203562-002	AB1	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A203562-001	AB1	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A203562-002	AB1	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203562-001	AB1	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203562-002	AB1	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203562-001	AB1	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203562-002	AB1	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203562-001	AB1	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203562-002	AB1	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A203562-001	AB1	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A203562-002	AB1	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A203562-001	AB1	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A203562-002	AB1	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A203562-001	AB1	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A203562-002	AB1	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A203562-001	AB1	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A203562-002	AB1	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A203562-001	AB1	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A203562-002	AB1	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A203562-001	AB1	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A203562-002	AB1	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A203562-001	AB1	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A203562-002	AB1	1	`782e0a99824c…`

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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
potassium chloride	POTASSIUM CHLORIDE	Glenmark Pharmaceuticals Inc., USA	63bedd99-0596-49d2-ad04-d1d8ac15cc42	2026-07-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203562 application number: ANDA203562
potassium chloride	POTASSIUM CHLORIDE	Redpharm Drug	3735d41a-7787-6b92-e063-6294a90add45	2025-12-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203562 application number: ANDA203562
Potassium Chloride ER	POTASSIUM CHLORIDE ER	Direct_Rx	f988aa11-60ef-411e-e053-6294a90a522a	2025-01-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203562 application number: ANDA203562
potassium chloride	POTASSIUM CHLORIDE	A-S Medication Solutions	3a720078-f455-44ab-a883-e3c13d83a74c	2024-11-18	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203562 application number: ANDA203562
potassium chloride	POTASSIUM CHLORIDE	A-S Medication Solutions	cf014023-5300-455f-9f7f-fefb2e363986	2024-11-18	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203562 application number: ANDA203562
potassium chloride	POTASSIUM CHLORIDE	Bryant Ranch Prepack	f22606a5-ac9f-44fc-bb7b-08f3cf56c999	2024-11-12	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203562 application number: ANDA203562
potassium chloride	POTASSIUM CHLORIDE	Bryant Ranch Prepack	bc42a691-a486-4ece-b9f7-faf6cc5df6b5	2024-08-29	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203562 application number: ANDA203562

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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
60687-561-09	60687056109	80 BLISTER PACK in 1 BOX, UNIT-DOSE (60687-561-09) > 1 TABLET, EXTENDED RELEASE in 1 BLISTER PACK (60687-561-11)	80 blister pack	2020-09-01	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Potassium Chloride Extended-release Tablets, USP 8456109/0420 Rx Only	American Health Packaging	2020-09-03	HUMAN PRESCRIPTION DRUG LABEL	1