Potassium Chloride

Product NDC: 57297-798
11-digit product format: 572970798
Labeler code: 57297
Product ID: 57297-798_7a1a98c3-91ae-4852-be41-c119160231c3
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Potassium Chloride
Dosage form: CAPSULE, COATED, EXTENDED RELEASE
Route: ORAL
Labeler: LUPIN LIMITED
Application: ANDA203002
Marketing category: ANDA
Marketing start: 2016-01-18
Marketing end: 0000-00-00
Substance: POTASSIUM CHLORIDE
Active strength: 8 meq/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: E
Listing certified through: 2017-12-31
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 · 3 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	57297-798		D	Discontinued by firm	2026-10-05
excluded package	package	57297-798	57297-798-01	D	Discontinued by firm	2026-10-05
excluded package	package	57297-798	57297-798-02	D	Discontinued by firm	2026-10-05

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 · 41 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Code	Status	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	57297-798-02	D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	57297-798-02	D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		I	Inactivated by FDA	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	57297-798-02	I	Inactivated by FDA	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	57297-798-01	I	Inactivated by FDA	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		I	Inactivated by FDA	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	57297-798-02	I	Inactivated by FDA	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	57297-798-01	I	Inactivated by FDA	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		I	Inactivated by FDA	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	57297-798-02	I	Inactivated by FDA	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	57297-798-01	I	Inactivated by FDA	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		I	Inactivated by FDA	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	57297-798-02	I	Inactivated by FDA	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	57297-798-01	I	Inactivated by FDA	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		I	Inactivated by FDA	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	57297-798-02	I	Inactivated by FDA	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	57297-798-01	I	Inactivated by FDA	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		I	Inactivated by FDA	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	57297-798-02	I	Inactivated by FDA	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	57297-798-01	I	Inactivated by FDA	`1332a3947898…`	`d4bfe170f9cd…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded product	product		I	Inactivated by FDA	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	57297-798-02	I	Inactivated by FDA	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	57297-798-01	I	Inactivated by FDA	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded product	product		I	Inactivated by FDA	`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	57297-798-02	I	Inactivated by FDA	`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	57297-798-01	I	Inactivated by FDA	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded product	product		I	Inactivated by FDA	`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	57297-798-02	I	Inactivated by FDA	`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	57297-798-01	I	Inactivated by FDA	`bd6a592717d7…`	`303034d00443…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded product	product		I	Inactivated by FDA	`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	57297-798-02	I	Inactivated by FDA	`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	57297-798-01	I	Inactivated by FDA	`8dfbde2a14a4…`	`c9ff85d89658…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded product	product		I	Inactivated by FDA	`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	57297-798-02	I	Inactivated by FDA	`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	57297-798-01	I	Inactivated by FDA	`e2bbac7714bc…`	`27bdfed8d636…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded product	product		I	Inactivated by FDA	`9bebd1f3094a…`	`5416666fcb17…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded package	package	57297-798-02	I	Inactivated by FDA	`9bebd1f3094a…`	`5416666fcb17…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded package	package	57297-798-01	I	Inactivated by FDA	`9bebd1f3094a…`	`5416666fcb17…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded product	product		E	Excluded after deficient or non-compliant submission was not corrected	`110d247fa046…`	`a55b01930146…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded package	package	57297-798-01	E	Excluded after deficient or non-compliant submission was not corrected	`110d247fa046…`	`a55b01930146…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded package	package	57297-798-02	E	Excluded after deficient or non-compliant submission was not corrected	`110d247fa046…`	`a55b01930146…`

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

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
A203002-001	POTASSIUM CHLORIDE	POTASSIUM CHLORIDE	8MEQ	CAPSULE, EXTENDED RELEASE / ORAL			2015-12-18
A203002-002	POTASSIUM CHLORIDE	POTASSIUM CHLORIDE	10MEQ	CAPSULE, EXTENDED RELEASE / ORAL			2015-12-18

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 · 86 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
2026-09-14 22:38:34	2026-08	A203002-001	POTASSIUM CHLORIDE	8MEQ	CAPSULE, EXTENDED RELEASE / ORAL		2015-12-18	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A203002-002	POTASSIUM CHLORIDE	10MEQ	CAPSULE, EXTENDED RELEASE / ORAL		2015-12-18	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A203002-001	POTASSIUM CHLORIDE	8MEQ	CAPSULE, EXTENDED RELEASE / ORAL		2015-12-18	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A203002-002	POTASSIUM CHLORIDE	10MEQ	CAPSULE, EXTENDED RELEASE / ORAL		2015-12-18	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A203002-001	POTASSIUM CHLORIDE	8MEQ	CAPSULE, EXTENDED RELEASE / ORAL		2015-12-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203002-002	POTASSIUM CHLORIDE	10MEQ	CAPSULE, EXTENDED RELEASE / ORAL		2015-12-18	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203002-001	POTASSIUM CHLORIDE	8MEQ	CAPSULE, EXTENDED RELEASE / ORAL	AB	2015-12-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203002-002	POTASSIUM CHLORIDE	10MEQ	CAPSULE, EXTENDED RELEASE / ORAL	AB	2015-12-18	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A203002-001	POTASSIUM CHLORIDE	8MEQ	CAPSULE, EXTENDED RELEASE / ORAL	AB	2015-12-18	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203002-002	POTASSIUM CHLORIDE	10MEQ	CAPSULE, EXTENDED RELEASE / ORAL	AB	2015-12-18	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203002-001	POTASSIUM CHLORIDE	8MEQ	CAPSULE, EXTENDED RELEASE / ORAL	AB	2015-12-18	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203002-002	POTASSIUM CHLORIDE	10MEQ	CAPSULE, EXTENDED RELEASE / ORAL	AB	2015-12-18	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203002-001	POTASSIUM CHLORIDE	8MEQ	CAPSULE, EXTENDED RELEASE / ORAL	AB	2015-12-18	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203002-002	POTASSIUM CHLORIDE	10MEQ	CAPSULE, EXTENDED RELEASE / ORAL	AB	2015-12-18	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203002-001	POTASSIUM CHLORIDE	8MEQ	CAPSULE, EXTENDED RELEASE / ORAL	AB	2015-12-18	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203002-002	POTASSIUM CHLORIDE	10MEQ	CAPSULE, EXTENDED RELEASE / ORAL	AB	2015-12-18	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203002-001	POTASSIUM CHLORIDE	8MEQ	CAPSULE, EXTENDED RELEASE / ORAL	AB	2015-12-18	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203002-002	POTASSIUM CHLORIDE	10MEQ	CAPSULE, EXTENDED RELEASE / ORAL	AB	2015-12-18	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203002-001	POTASSIUM CHLORIDE	8MEQ	CAPSULE, EXTENDED RELEASE / ORAL	AB	2015-12-18	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203002-002	POTASSIUM CHLORIDE	10MEQ	CAPSULE, EXTENDED RELEASE / ORAL	AB	2015-12-18	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203002-001	POTASSIUM CHLORIDE	8MEQ	CAPSULE, EXTENDED RELEASE / ORAL	AB	2015-12-18	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203002-002	POTASSIUM CHLORIDE	10MEQ	CAPSULE, EXTENDED RELEASE / ORAL	AB	2015-12-18	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A203002-001	POTASSIUM CHLORIDE	8MEQ	CAPSULE, EXTENDED RELEASE / ORAL	AB	2015-12-18	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A203002-002	POTASSIUM CHLORIDE	10MEQ	CAPSULE, EXTENDED RELEASE / ORAL	AB	2015-12-18	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203002-001	POTASSIUM CHLORIDE	8MEQ	CAPSULE, EXTENDED RELEASE / ORAL	AB	2015-12-18	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203002-002	POTASSIUM CHLORIDE	10MEQ	CAPSULE, EXTENDED RELEASE / ORAL	AB	2015-12-18	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203002-001	POTASSIUM CHLORIDE	8MEQ	CAPSULE, EXTENDED RELEASE / ORAL	AB	2015-12-18	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203002-002	POTASSIUM CHLORIDE	10MEQ	CAPSULE, EXTENDED RELEASE / ORAL	AB	2015-12-18	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203002-001	POTASSIUM CHLORIDE	8MEQ	CAPSULE, EXTENDED RELEASE / ORAL	AB	2015-12-18	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203002-002	POTASSIUM CHLORIDE	10MEQ	CAPSULE, EXTENDED RELEASE / ORAL	AB	2015-12-18	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A203002-001	POTASSIUM CHLORIDE	8MEQ	CAPSULE, EXTENDED RELEASE / ORAL	AB	2015-12-18	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A203002-002	POTASSIUM CHLORIDE	10MEQ	CAPSULE, EXTENDED RELEASE / ORAL	AB	2015-12-18	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A203002-001	POTASSIUM CHLORIDE	8MEQ	CAPSULE, EXTENDED RELEASE / ORAL	AB	2015-12-18	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A203002-002	POTASSIUM CHLORIDE	10MEQ	CAPSULE, EXTENDED RELEASE / ORAL	AB	2015-12-18	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A203002-001	POTASSIUM CHLORIDE	8MEQ	CAPSULE, EXTENDED RELEASE / ORAL	AB	2015-12-18	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A203002-002	POTASSIUM CHLORIDE	10MEQ	CAPSULE, EXTENDED RELEASE / ORAL	AB	2015-12-18	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A203002-001	POTASSIUM CHLORIDE	8MEQ	CAPSULE, EXTENDED RELEASE / ORAL	AB	2015-12-18	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A203002-002	POTASSIUM CHLORIDE	10MEQ	CAPSULE, EXTENDED RELEASE / ORAL	AB	2015-12-18	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A203002-001	POTASSIUM CHLORIDE	8MEQ	CAPSULE, EXTENDED RELEASE / ORAL	AB	2015-12-18	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A203002-002	POTASSIUM CHLORIDE	10MEQ	CAPSULE, EXTENDED RELEASE / ORAL	AB	2015-12-18	`74a2ff9319b5…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 78 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203002-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203002-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A203002-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203002-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203002-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203002-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203002-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203002-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203002-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203002-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203002-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203002-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203002-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203002-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203002-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203002-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A203002-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A203002-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203002-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203002-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203002-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203002-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203002-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203002-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A203002-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A203002-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A203002-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A203002-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A203002-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A203002-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A203002-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A203002-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A203002-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A203002-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A203002-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A203002-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A203002-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A203002-002	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A203002-001	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A203002-002	AB	1	`87673890dc5c…`

Reported adverse events (FAERS/openFDA)#

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDC	Effective	Related label
57297-798-01	2024-12-27	POTASSIUM CHLORIDE EXTENDED-RELEASE CAPSULES USP, 600 mg (8mEq K) and 750 mg (10 mEq K) Rx only
57297-798-02	2024-12-27	POTASSIUM CHLORIDE EXTENDED-RELEASE CAPSULES USP, 600 mg (8mEq K) and 750 mg (10 mEq K) Rx only
57297-798-01	2020-01-31	POTASSIUM CHLORIDE EXTENDED-RELEASE CAPSULES USP, 600 mg (8mEq K) and 750 mg (10 mEq K) Rx only
57297-798-02	2020-01-31	POTASSIUM CHLORIDE EXTENDED-RELEASE CAPSULES USP, 600 mg (8mEq K) and 750 mg (10 mEq K) Rx only

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
57297-798	POTASSIUM CHLORIDE CAPSULE, COATED, EXTENDED RELEASE [LUPIN LIMITED]	2	Legacy NDC	20241228_56bb2200-da53-4f91-bdca-d76cc1ad6f8d.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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Potassium Chloride	POTASSIUM CHLORIDE	Lupin Pharmaceuticals, Inc.	1f33bcfe-c28a-4800-9241-685d974a5d91	2023-11-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203002 application number: ANDA203002
Potassium Chloride	POTASSIUM CHLORIDE	A-S Medication Solutions	87cc7349-5a07-4a39-be97-4e1013814f30	2023-02-06	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203002 application number: ANDA203002

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

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
POTASSIUM CHLORIDE EXTENDED-RELEASE CAPSULES USP, 600 mg (8mEq K) and 750 mg (10 mEq K) Rx only	LUPIN LIMITED	2024-12-27	HUMAN PRESCRIPTION DRUG LABEL	2