Potassium Chloride

Product NDC: 43353-215
11-digit product format: 433530215
Labeler code: 43353
Product ID: 43353-215_781c4c71-059d-40d0-bcd3-0867dcb550f3
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: potassium chloride
Dosage form: TABLET, EXTENDED RELEASE
Route: ORAL
Labeler: Aphena Pharma Solutions - Tennessee, LLC
Application: ANDA076368
Marketing category: ANDA
Marketing start: 2004-08-18
Marketing end: 0000-00-00
Substance: POTASSIUM CHLORIDE
Active strength: 20 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: No
Listing certified through: 2019-12-31
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 · 9 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	43353-215		I	Inactivated by FDA	2026-08-10
excluded package	package	43353-215	43353-215-30	I	Inactivated by FDA	2026-08-10
excluded package	package	43353-215	43353-215-45	I	Inactivated by FDA	2026-08-10
excluded package	package	43353-215	43353-215-53	I	Inactivated by FDA	2026-08-10
excluded package	package	43353-215	43353-215-60	I	Inactivated by FDA	2026-08-10
excluded package	package	43353-215	43353-215-70	I	Inactivated by FDA	2026-08-10
excluded package	package	43353-215	43353-215-73	I	Inactivated by FDA	2026-08-10
excluded package	package	43353-215	43353-215-80	I	Inactivated by FDA	2026-08-10
excluded package	package	43353-215	43353-215-92	I	Inactivated by FDA	2026-08-10

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 4 · 189 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	43353-215-30	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	43353-215-60	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	43353-215-92	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	43353-215-80	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	43353-215-53	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	43353-215-45	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	43353-215-73	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	43353-215-70	`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	43353-215-30	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	43353-215-60	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	43353-215-92	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	43353-215-80	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	43353-215-53	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	43353-215-45	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	43353-215-73	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	43353-215-70	`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	43353-215-30	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	43353-215-60	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	43353-215-92	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	43353-215-80	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	43353-215-53	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	43353-215-45	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	43353-215-73	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	43353-215-70	`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	43353-215-30	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	43353-215-60	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	43353-215-92	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	43353-215-80	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	43353-215-53	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	43353-215-45	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	43353-215-73	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	43353-215-70	`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	43353-215-30	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	43353-215-60	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	43353-215-92	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	43353-215-80	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	43353-215-53	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	43353-215-45	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	43353-215-73	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	43353-215-70	`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	43353-215-30	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	43353-215-60	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	43353-215-92	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	43353-215-80	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	43353-215-53	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	43353-215-45	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	43353-215-73	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	43353-215-70	`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	43353-215-30	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	43353-215-60	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	43353-215-92	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	43353-215-80	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	43353-215-53	`302b2466d912…`	`e7b80fea0513…`

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
A076368-001	POTASSIUM CHLORIDE	POTASSIUM CHLORIDE	20MEQ	TABLET, EXTENDED RELEASE / ORAL	AB1		2004-08-18
A076368-002	POTASSIUM CHLORIDE	POTASSIUM CHLORIDE	10MEQ	TABLET, EXTENDED RELEASE / ORAL	AB1		2019-06-05

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A076368-001	AB1
A076368-002	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	A076368-001	POTASSIUM CHLORIDE	20MEQ	TABLET, EXTENDED RELEASE / ORAL	AB1	2004-08-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076368-002	POTASSIUM CHLORIDE	10MEQ	TABLET, EXTENDED RELEASE / ORAL	AB1	2019-06-05	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076368-001	POTASSIUM CHLORIDE	20MEQ	TABLET, EXTENDED RELEASE / ORAL	AB1	2004-08-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076368-002	POTASSIUM CHLORIDE	10MEQ	TABLET, EXTENDED RELEASE / ORAL	AB1	2019-06-05	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076368-001	POTASSIUM CHLORIDE	20MEQ	TABLET, EXTENDED RELEASE / ORAL	AB1	2004-08-18	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076368-002	POTASSIUM CHLORIDE	10MEQ	TABLET, EXTENDED RELEASE / ORAL	AB1	2019-06-05	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076368-001	POTASSIUM CHLORIDE	20MEQ	TABLET, EXTENDED RELEASE / ORAL	AB1	2004-08-18	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076368-002	POTASSIUM CHLORIDE	10MEQ	TABLET, EXTENDED RELEASE / ORAL	AB1	2019-06-05	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076368-001	POTASSIUM CHLORIDE	20MEQ	TABLET, EXTENDED RELEASE / ORAL	AB1	2004-08-18	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076368-002	POTASSIUM CHLORIDE	10MEQ	TABLET, EXTENDED RELEASE / ORAL	AB1	2019-06-05	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076368-001	POTASSIUM CHLORIDE	20MEQ	TABLET, EXTENDED RELEASE / ORAL	AB1	2004-08-18	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076368-002	POTASSIUM CHLORIDE	10MEQ	TABLET, EXTENDED RELEASE / ORAL	AB1	2019-06-05	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076368-001	POTASSIUM CHLORIDE	20MEQ	TABLET, EXTENDED RELEASE / ORAL	AB1	2004-08-18	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076368-002	POTASSIUM CHLORIDE	10MEQ	TABLET, EXTENDED RELEASE / ORAL	AB1	2019-06-05	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076368-001	POTASSIUM CHLORIDE	20MEQ	TABLET, EXTENDED RELEASE / ORAL	AB1	2004-08-18	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076368-002	POTASSIUM CHLORIDE	10MEQ	TABLET, EXTENDED RELEASE / ORAL	AB1	2019-06-05	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076368-001	POTASSIUM CHLORIDE	20MEQ	TABLET, EXTENDED RELEASE / ORAL	AB1	2004-08-18	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076368-002	POTASSIUM CHLORIDE	10MEQ	TABLET, EXTENDED RELEASE / ORAL	AB1	2019-06-05	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076368-001	POTASSIUM CHLORIDE	20MEQ	TABLET, EXTENDED RELEASE / ORAL	AB1	2004-08-18	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A076368-002	POTASSIUM CHLORIDE	10MEQ	TABLET, EXTENDED RELEASE / ORAL	AB1	2019-06-05	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076368-001	POTASSIUM CHLORIDE	20MEQ	TABLET, EXTENDED RELEASE / ORAL	AB1	2004-08-18	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076368-002	POTASSIUM CHLORIDE	10MEQ	TABLET, EXTENDED RELEASE / ORAL	AB1	2019-06-05	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076368-001	POTASSIUM CHLORIDE	20MEQ	TABLET, EXTENDED RELEASE / ORAL	AB1	2004-08-18	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076368-002	POTASSIUM CHLORIDE	10MEQ	TABLET, EXTENDED RELEASE / ORAL	AB1	2019-06-05	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076368-001	POTASSIUM CHLORIDE	20MEQ	TABLET, EXTENDED RELEASE / ORAL	AB1	2004-08-18	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076368-002	POTASSIUM CHLORIDE	10MEQ	TABLET, EXTENDED RELEASE / ORAL	AB1	2019-06-05	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A076368-001	POTASSIUM CHLORIDE	20MEQ	TABLET, EXTENDED RELEASE / ORAL	AB1	2004-08-18	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A076368-002	POTASSIUM CHLORIDE	10MEQ	TABLET, EXTENDED RELEASE / ORAL	AB1	2019-06-05	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076368-001	POTASSIUM CHLORIDE	20MEQ	TABLET, EXTENDED RELEASE / ORAL	AB1	2004-08-18	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076368-002	POTASSIUM CHLORIDE	10MEQ	TABLET, EXTENDED RELEASE / ORAL	AB1	2019-06-05	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A076368-001	POTASSIUM CHLORIDE	20MEQ	TABLET, EXTENDED RELEASE / ORAL	AB1	2004-08-18	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A076368-002	POTASSIUM CHLORIDE	10MEQ	TABLET, EXTENDED RELEASE / ORAL	AB1	2019-06-05	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A076368-001	POTASSIUM CHLORIDE	20MEQ	TABLET, EXTENDED RELEASE / ORAL	AB1	2004-08-18	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A076368-002	POTASSIUM CHLORIDE	10MEQ	TABLET, EXTENDED RELEASE / ORAL	AB1	2019-06-05	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A076368-001	POTASSIUM CHLORIDE	20MEQ	TABLET, EXTENDED RELEASE / ORAL	AB1	2004-08-18	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A076368-002	POTASSIUM CHLORIDE	10MEQ	TABLET, EXTENDED RELEASE / ORAL	AB1	2019-06-05	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A076368-001	POTASSIUM CHLORIDE	20MEQ	TABLET, EXTENDED RELEASE / ORAL	AB1	2004-08-18	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A076368-002	POTASSIUM CHLORIDE	10MEQ	TABLET, EXTENDED RELEASE / ORAL	AB1	2019-06-05	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A076368-001	POTASSIUM CHLORIDE	20MEQ	TABLET, EXTENDED RELEASE / ORAL	AB1	2004-08-18	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A076368-002	POTASSIUM CHLORIDE	10MEQ	TABLET, EXTENDED RELEASE / ORAL	AB1	2019-06-05	`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	A076368-001	AB1	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076368-002	AB1	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076368-001	AB1	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076368-002	AB1	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076368-001	AB1	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076368-002	AB1	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076368-001	AB1	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076368-002	AB1	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076368-001	AB1	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076368-002	AB1	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076368-001	AB1	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076368-002	AB1	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076368-001	AB1	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076368-002	AB1	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076368-001	AB1	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076368-002	AB1	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076368-001	AB1	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076368-002	AB1	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076368-001	AB1	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A076368-002	AB1	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076368-001	AB1	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076368-002	AB1	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076368-001	AB1	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076368-002	AB1	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076368-001	AB1	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076368-002	AB1	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A076368-001	AB1	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A076368-002	AB1	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076368-001	AB1	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076368-002	AB1	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A076368-001	AB1	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A076368-002	AB1	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A076368-001	AB1	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A076368-002	AB1	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A076368-001	AB1	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A076368-002	AB1	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A076368-001	AB1	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A076368-002	AB1	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A076368-001	AB1	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A076368-002	AB1	1	`782e0a99824c…`

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

FDA-Initiated Inactive NDC Indexing#

NDC, Related label table
NDC	Related label
43353-215-30	POTASSIUM CHLORIDE EXTENDED RELEASE TABLETS USP 20 mEq K Rx Only 173714
43353-215-45	POTASSIUM CHLORIDE EXTENDED RELEASE TABLETS USP 20 mEq K Rx Only 173714
43353-215-53	POTASSIUM CHLORIDE EXTENDED RELEASE TABLETS USP 20 mEq K Rx Only 173714
43353-215-60	POTASSIUM CHLORIDE EXTENDED RELEASE TABLETS USP 20 mEq K Rx Only 173714
43353-215-70	POTASSIUM CHLORIDE EXTENDED RELEASE TABLETS USP 20 mEq K Rx Only 173714
43353-215-73	POTASSIUM CHLORIDE EXTENDED RELEASE TABLETS USP 20 mEq K Rx Only 173714
43353-215-80	POTASSIUM CHLORIDE EXTENDED RELEASE TABLETS USP 20 mEq K Rx Only 173714
43353-215-92	POTASSIUM CHLORIDE EXTENDED RELEASE TABLETS USP 20 mEq K Rx Only 173714

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
43353-215-30	Potassium Chloride	30 in 1 BOTTLE, PLASTIC	TABLET, EXTENDED RELEASE	30	2
43353-215-45	Potassium Chloride	45 in 1 BOTTLE, PLASTIC	TABLET, EXTENDED RELEASE	45	2
43353-215-53	Potassium Chloride	60 in 1 BOTTLE, PLASTIC	TABLET, EXTENDED RELEASE	60	2
43353-215-60	Potassium Chloride	90 in 1 BOTTLE, PLASTIC	TABLET, EXTENDED RELEASE	90	2
43353-215-70	Potassium Chloride	120 in 1 BOTTLE, PLASTIC	TABLET, EXTENDED RELEASE	120	2
43353-215-73	Potassium Chloride	135 in 1 BOTTLE, PLASTIC	TABLET, EXTENDED RELEASE	135	2
43353-215-80	Potassium Chloride	180 in 1 BOTTLE, PLASTIC	TABLET, EXTENDED RELEASE	180	2
43353-215-92	Potassium Chloride	270 in 1 BOTTLE, PLASTIC	TABLET, EXTENDED RELEASE	270	2

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
43353-215-30	EA - Each	43353-215	d9de474f-5797-4978-8ba0-65e1f3252b94	1	2014-06-03
43353-215-45	EA - Each	43353-215	f41633c5-657b-46b0-abe8-4f5d76ed6317	1	2014-06-03
43353-215-53	EA - Each	43353-215	d3cd7c7a-b4ac-4a5a-b21a-77d71ea2e23a	1	2014-06-03
43353-215-60	EA - Each	43353-215	aa0e4af9-3869-4501-91c4-7458c89b34d1	1	2014-06-03
43353-215-70	EA - Each	43353-215	1342a341-d54c-4be1-9314-ad47f950cbc7	1	2014-07-02
43353-215-73	EA - Each	43353-215	e1d4b5a4-1bcf-4661-86e4-b4d65fa05835	1	2014-08-01
43353-215-80	EA - Each	43353-215	161d1307-8aa1-4fc0-bad3-73046e2ccf23	1	2014-06-03
43353-215-92	EA - Each	43353-215	6bacdce2-7467-4d36-ad00-838fcc7627c2	1	2014-06-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
POTASSIUM CHLORIDE	ACTIVE INGREDIENT	660YQ98I10	POTASSIUM CHLORIDE TABLET, EXTENDED RELEASE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	2
POTASSIUM CATION	ACTIVE MOIETY	295O53K152	POTASSIUM CHLORIDE TABLET, EXTENDED RELEASE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	2
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	POTASSIUM CHLORIDE TABLET, EXTENDED RELEASE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	2
CROSPOVIDONE	INACTIVE INGREDIENT	68401960MK	POTASSIUM CHLORIDE TABLET, EXTENDED RELEASE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	2
DIETHYL PHTHALATE	INACTIVE INGREDIENT	UF064M00AF	POTASSIUM CHLORIDE TABLET, EXTENDED RELEASE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	2
ETHYLCELLULOSE (100 MPA.S)	INACTIVE INGREDIENT	47MLB0F1MV	POTASSIUM CHLORIDE TABLET, EXTENDED RELEASE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	2
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	POTASSIUM CHLORIDE TABLET, EXTENDED RELEASE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
43353-215	POTASSIUM CHLORIDE TABLET, EXTENDED RELEASE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	2	Legacy NDC, 8 package rows	20140507_f11e34a4-3206-4b2b-ba87-0312785d829b.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 · 17 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Potassium Chloride Extended-Release	POTASSIUM CHLORIDE	REMEDYREPACK INC.	7ec22e8e-6643-44fe-804d-ca0b0b266663	2026-07-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076368 application number: ANDA076368
Potassium Chloride Extended-Release	POTASSIUM CHLORIDE	Bryant Ranch Prepack	ff44dcd5-b255-4d80-83ee-3c8f922c99eb	2026-03-11	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076368 application number: ANDA076368
Potassium Chloride	POTASSIUM CHLORIDE	Major Pharmaceuticals	5c2e888c-2f1e-4d5a-a456-20774ca83302	2026-02-04	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076368 application number: ANDA076368
Potassium Chloride Extended-Release	POTASSIUM CHLORIDE	Major Pharmaceuticals	7d74652b-3513-4ebb-8b47-10b3603d04a7	2026-02-04	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076368 application number: ANDA076368
Potassium Chloride Extended-Release	POTASSIUM CHLORIDE	Bryant Ranch Prepack	2feda15e-f325-41fe-a442-41a8cc62b855	2025-11-06	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076368 application number: ANDA076368
Potassium Chloride Extended-Release	POTASSIUM CHLORIDE	Bryant Ranch Prepack	6fc9eef0-3dfc-4344-85c7-9f11d9b99b65	2025-11-06	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076368 application number: ANDA076368
Potassium Chloride Extended-Release	POTASSIUM CHLORIDE	Bryant Ranch Prepack	1b64b0c9-31a2-4ee7-8818-66de906ebeda	2025-11-06	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076368 application number: ANDA076368
Potassium Chloride	POTASSIUM CHLORIDE	PD-Rx Pharmaceuticals, Inc.	47a87fb6-5e61-41c9-b759-10f7c74a67ce	2025-08-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076368 application number: ANDA076368
Potassium Chloride Extended-Release	POTASSIUM CHLORIDE	Bryant Ranch Prepack	55747ef3-9437-4bdc-9ebd-a74d8e2de1cf	2024-10-29	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076368 application number: ANDA076368
Potassium Chloride Extended-Release	POTASSIUM CHLORIDE	Bryant Ranch Prepack	473369cb-3a9b-437c-b08e-8fb38034c507	2024-10-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076368 application number: ANDA076368
Potassium Chloride Extended-Release	POTASSIUM CHLORIDE	Bryant Ranch Prepack	863e6980-4a66-48a5-a14f-828a00480c93	2024-08-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076368 application number: ANDA076368
Potassium Chloride Extended-Release	POTASSIUM CHLORIDE	American Health Packaging	8c12c5f8-5950-44e3-9473-a0b95187b43c	2024-08-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076368 application number: ANDA076368
Potassium Chloride Extended-Release	POTASSIUM CHLORIDE	Bryant Ranch Prepack	7427c29e-55c1-4c30-b091-058c8bec592f	2024-08-12	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076368 application number: ANDA076368
Potassium Chloride Extended-Release	POTASSIUM CHLORIDE	Bryant Ranch Prepack	80dd5de2-5066-472b-b1f8-88070a5c7388	2024-08-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076368 application number: ANDA076368
Potassium Chloride Extended-Release	POTASSIUM CHLORIDE	Bryant Ranch Prepack	b5a6b6f2-d073-4bd3-a66c-bf34ccabfe51	2024-07-18	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076368 application number: ANDA076368
Potassium Chloride Extended-Release	POTASSIUM CHLORIDE	Sun Pharmaceutical Industries, Inc.	8ed8ea55-8b15-f718-e053-2a95a90a587a	2024-01-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076368 application number: ANDA076368
Potassium Chloride	POTASSIUM CHLORIDE	Sun Pharmaceutical Industries, Inc.	0a1f2f64-3b0b-5e5c-e063-6294a90a7185	2023-11-14	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076368 application number: ANDA076368

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
1801294	potassium chloride 20 MEQ Microencapsulated Extended Release Oral Tablet	PSN	f11e34a4-3206-4b2b-ba87-0312785d829b	2
1801294	Microencapsulated potassium chloride 20 MEQ Extended Release Oral Tablet	SCD	f11e34a4-3206-4b2b-ba87-0312785d829b	2
1801294	Microencapsulated K+ Chloride 20 MEQ Extended Release Oral Tablet	SY	f11e34a4-3206-4b2b-ba87-0312785d829b	2
1801294	Microencapsulated Pot Chloride 20 MEQ Extended Release Oral Tablet	SY	f11e34a4-3206-4b2b-ba87-0312785d829b	2
1801294	potassium chloride 1500 MG Microencapsulated Extended Release Oral Tablet	SY	f11e34a4-3206-4b2b-ba87-0312785d829b	2
1801294	potassium chloride 20 MEQ Microencapsulated Extended Release Oral Tablet	SY	f11e34a4-3206-4b2b-ba87-0312785d829b	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
43353-215-30	43353021530	30 in 1 BOTTLE, PLASTIC	Historical
43353-215-45	43353021545	45 in 1 BOTTLE, PLASTIC	Historical
43353-215-53	43353021553	60 in 1 BOTTLE, PLASTIC	Historical
43353-215-60	43353021560	90 in 1 BOTTLE, PLASTIC	Historical
43353-215-70	43353021570	120 in 1 BOTTLE, PLASTIC	Historical
43353-215-73	43353021573	135 in 1 BOTTLE, PLASTIC	Historical
43353-215-80	43353021580	180 in 1 BOTTLE, PLASTIC	Historical
43353-215-92	43353021592	270 in 1 BOTTLE, PLASTIC	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
POTASSIUM CHLORIDE EXTENDED RELEASE TABLETS USP 20 mEq K Rx Only 173714	Aphena Pharma Solutions - Tennessee, LLC	2014-05-06	HUMAN PRESCRIPTION DRUG LABEL	2