K-Tab

Product NDC: 43353-790
11-digit product format: 433530790
Labeler code: 43353
Product ID: 43353-790_7c37fbd5-1883-41e4-ac9b-cc4b5ca3efd0
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Potassium Chloride
Dosage form: TABLET, FILM COATED, EXTENDED RELEASE
Route: ORAL
Labeler: Aphena Pharma Solutions - Tennessee, LLC
Application: NDA018279
Marketing category: NDA
Marketing start: 1980-06-09
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: 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	43353-790		I	Inactivated by FDA	2026-08-11
excluded package	package	43353-790	43353-790-30	I	Inactivated by FDA	2026-08-11
excluded package	package	43353-790	43353-790-53	I	Inactivated by FDA	2026-08-11
excluded package	package	43353-790	43353-790-60	I	Inactivated by FDA	2026-08-11
excluded package	package	43353-790	43353-790-70	I	Inactivated by FDA	2026-08-11
excluded package	package	43353-790	43353-790-80	I	Inactivated by FDA	2026-08-11
excluded package	package	43353-790	43353-790-85	I	Inactivated by FDA	2026-08-11
excluded package	package	43353-790	43353-790-92	I	Inactivated by FDA	2026-08-11
excluded package	package	43353-790	43353-790-94	I	Inactivated by FDA	2026-08-11

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	43353-790-92	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	43353-790-85	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	43353-790-80	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	43353-790-60	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	43353-790-30	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	43353-790-70	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	43353-790-53	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	43353-790-94	`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	43353-790-92	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	43353-790-85	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	43353-790-80	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	43353-790-60	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	43353-790-30	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	43353-790-70	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	43353-790-53	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	43353-790-94	`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	43353-790-92	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	43353-790-85	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	43353-790-80	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	43353-790-60	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	43353-790-30	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	43353-790-70	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	43353-790-53	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	43353-790-94	`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	43353-790-92	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	43353-790-85	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	43353-790-80	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	43353-790-60	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	43353-790-30	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	43353-790-70	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	43353-790-53	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	43353-790-94	`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	43353-790-92	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	43353-790-85	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	43353-790-80	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	43353-790-60	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	43353-790-30	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	43353-790-70	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	43353-790-53	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	43353-790-94	`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	43353-790-92	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	43353-790-85	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	43353-790-80	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	43353-790-60	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	43353-790-30	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	43353-790-70	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	43353-790-53	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	43353-790-94	`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	43353-790-92	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	43353-790-85	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	43353-790-80	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	43353-790-60	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	43353-790-30	`302b2466d912…`	`e7b80fea0513…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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	RLD / RS	Approval date
N018279-001	K-TAB	POTASSIUM CHLORIDE	10MEQ Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD, Approved before 1982
N018279-002	K-TAB	POTASSIUM CHLORIDE	8MEQ Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	1988-08-01
N018279-003	K-TAB	POTASSIUM CHLORIDE	20MEQ Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	2013-11-25

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 4 · 123 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N018279-001	K-TAB	10MEQ Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD, Approved before 1982		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N018279-002	K-TAB	8MEQ Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	1988-08-01	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N018279-003	K-TAB	20MEQ Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	2013-11-25	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N018279-001	K-TAB	10MEQ Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD, Approved before 1982		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N018279-002	K-TAB	8MEQ Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	1988-08-01	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N018279-003	K-TAB	20MEQ Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	2013-11-25	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N018279-001	K-TAB	10MEQ Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD, Approved before 1982		`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N018279-002	K-TAB	8MEQ Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	1988-08-01	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N018279-003	K-TAB	20MEQ Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	2013-11-25	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N018279-001	K-TAB	10MEQ Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD, Approved before 1982		`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N018279-002	K-TAB	8MEQ Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	1988-08-01	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N018279-003	K-TAB	20MEQ Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	2013-11-25	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N018279-001	K-TAB	10MEQ Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD, Approved before 1982		`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N018279-002	K-TAB	8MEQ Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	1988-08-01	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N018279-003	K-TAB	20MEQ Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	2013-11-25	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N018279-001	K-TAB	10MEQ Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD, Approved before 1982		`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N018279-002	K-TAB	8MEQ Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	1988-08-01	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N018279-003	K-TAB	20MEQ Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	2013-11-25	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N018279-001	K-TAB	10MEQ Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD, Approved before 1982		`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N018279-002	K-TAB	8MEQ Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	1988-08-01	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N018279-003	K-TAB	20MEQ Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	2013-11-25	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N018279-001	K-TAB	10MEQ Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD, Approved before 1982		`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N018279-002	K-TAB	8MEQ Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	1988-08-01	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N018279-003	K-TAB	20MEQ Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	2013-11-25	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N018279-001	K-TAB	10MEQ Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD, Approved before 1982		`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N018279-002	K-TAB	8MEQ Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	1988-08-01	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N018279-003	K-TAB	20MEQ Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	2013-11-25	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N018279-001	K-TAB	10MEQ Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD, Approved before 1982		`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N018279-002	K-TAB	8MEQ Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	1988-08-01	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N018279-003	K-TAB	20MEQ Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	2013-11-25	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N018279-001	K-TAB	10MEQ Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD, Approved before 1982		`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N018279-002	K-TAB	8MEQ Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	1988-08-01	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N018279-003	K-TAB	20MEQ Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	2013-11-25	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N018279-001	K-TAB	10MEQ Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD, Approved before 1982		`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N018279-002	K-TAB	8MEQ Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	1988-08-01	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N018279-003	K-TAB	20MEQ Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	2013-11-25	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N018279-001	K-TAB	10MEQ Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD, Approved before 1982		`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N018279-002	K-TAB	8MEQ Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	1988-08-01	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N018279-003	K-TAB	20MEQ Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	2013-11-25	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N018279-001	K-TAB	10MEQ Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD, Approved before 1982		`8072bd15b7f6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 47 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N018279-001	AB3	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N018279-003	AB3	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N018279-001	AB3	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N018279-003	AB3	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N018279-001	AB3	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N018279-002	BC	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N018279-003	AB3	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N018279-001	AB3	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N018279-002	BC	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N018279-003	AB3	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N018279-001	AB3	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N018279-002	BC	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N018279-003	AB3	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N018279-001	AB3	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N018279-002	BC	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N018279-003	AB3	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N018279-001	AB3	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N018279-002	BC	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N018279-003	AB3	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N018279-001	AB3	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N018279-002	BC	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N018279-003	AB3	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N018279-001	AB3	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N018279-002	BC	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N018279-003	AB3	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N018279-001	AB3	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N018279-002	BC	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N018279-003	AB3	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N018279-001	AB3	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N018279-002	BC	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N018279-003	AB3	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N018279-001	AB3	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N018279-002	BC	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N018279-003	AB2	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N018279-001	AB3	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N018279-002	BC	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N018279-003	AB2	1	`ea99ee380514…`
2023-01-26 05:58 UTC	2023-01	N018279-001	AB3	1	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	N018279-003	AB3	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N018279-001	AB3	1	`3a93d1ddd44b…`

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
43353-790-30	K-TAB® (potassium chloride extended-release tablets, USP)
43353-790-53	K-TAB® (potassium chloride extended-release tablets, USP)
43353-790-60	K-TAB® (potassium chloride extended-release tablets, USP)
43353-790-70	K-TAB® (potassium chloride extended-release tablets, USP)
43353-790-80	K-TAB® (potassium chloride extended-release tablets, USP)
43353-790-85	K-TAB® (potassium chloride extended-release tablets, USP)
43353-790-92	K-TAB® (potassium chloride extended-release tablets, USP)
43353-790-94	K-TAB® (potassium chloride extended-release tablets, USP)

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
43353-790-30	K-Tab	30 in 1 BOTTLE, PLASTIC	TABLET, FILM COATED, EXTENDED RE	30	2
43353-790-53	K-Tab	60 in 1 BOTTLE, PLASTIC	TABLET, FILM COATED, EXTENDED RE	60	2
43353-790-60	K-Tab	90 in 1 BOTTLE, PLASTIC	TABLET, FILM COATED, EXTENDED RE	90	2
43353-790-70	K-Tab	120 in 1 BOTTLE, PLASTIC	TABLET, FILM COATED, EXTENDED RE	120	2
43353-790-80	K-Tab	180 in 1 BOTTLE, PLASTIC	TABLET, FILM COATED, EXTENDED RE	180	2
43353-790-85	K-Tab	200 in 1 BOTTLE, PLASTIC	TABLET, FILM COATED, EXTENDED RE	200	2
43353-790-92	K-Tab	270 in 1 BOTTLE, PLASTIC	TABLET, FILM COATED, EXTENDED RE	270	2
43353-790-94	K-Tab	360 in 1 BOTTLE, PLASTIC	TABLET, FILM COATED, EXTENDED RE	360	2

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
43353-790-30	EA - Each	43353-790	701b79e2-bc27-438a-9a7d-24a22d79f239	1	2014-06-03
43353-790-53	EA - Each	43353-790	fe474b8d-cbe8-40b6-a11b-baa406fa2b72	1	2013-04-01
43353-790-60	EA - Each	43353-790	3f61f346-3b13-4d39-bc36-34cc31e9c6f8	1	2013-04-01
43353-790-70	EA - Each	43353-790	56e19e03-98dc-4092-b0cc-12ba559cc9ef	1	2014-06-03
43353-790-80	EA - Each	43353-790	6141dba5-beb2-41ee-bb18-dbf6baff2fd0	1	2013-04-01
43353-790-92	EA - Each	43353-790	bb868a0d-3a12-42e9-85cc-12807870a38d	1	2013-04-01
43353-790-94	EA - Each	43353-790	f2463cac-72cc-445c-ba5f-d69b84440e7d	1	2013-04-01

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
POTASSIUM CHLORIDE	ACTIVE INGREDIENT	660YQ98I10	K-TAB (POTASSIUM CHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	2
POTASSIUM CATION	ACTIVE MOIETY	295O53K152	K-TAB (POTASSIUM CHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	2
ALPHA-TOCOPHEROL	INACTIVE INGREDIENT	H4N855PNZ1	K-TAB (POTASSIUM CHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	2
CASTOR OIL	INACTIVE INGREDIENT	D5340Y2I9G	K-TAB (POTASSIUM CHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	2
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	K-TAB (POTASSIUM CHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	2
ETHYLCELLULOSES	INACTIVE INGREDIENT	7Z8S9VYZ4B	K-TAB (POTASSIUM CHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	2
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	K-TAB (POTASSIUM CHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	2
PARAFFIN	INACTIVE INGREDIENT	I9O0E3H2ZE	K-TAB (POTASSIUM CHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	2
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	K-TAB (POTASSIUM CHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	2
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	K-TAB (POTASSIUM CHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	2
VANILLIN	INACTIVE INGREDIENT	CHI530446X	K-TAB (POTASSIUM CHLORIDE) TABLET, FILM COATED, 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
43353-790	K-TAB (POTASSIUM CHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	2	Legacy NDC, 8 package rows	20140416_d87dff5c-4e55-480d-b8ee-ab19d2280f92.zip

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
670031	K-Tab 10 MEQ (750 MG) Extended Release Oral Tablet	PSN	d87dff5c-4e55-480d-b8ee-ab19d2280f92	2
628953	potassium chloride 10 MEQ (750 MG) Extended Release Oral Tablet	PSN	d87dff5c-4e55-480d-b8ee-ab19d2280f92	2
670031	potassium chloride 10 MEQ Extended Release Oral Tablet [K-Tab]	SBD	d87dff5c-4e55-480d-b8ee-ab19d2280f92	2
628953	potassium chloride 10 MEQ Extended Release Oral Tablet	SCD	d87dff5c-4e55-480d-b8ee-ab19d2280f92	2
670031	K-Tab 10 MEQ Extended Release Oral Tablet	SY	d87dff5c-4e55-480d-b8ee-ab19d2280f92	2
628953	K+ Chloride 10 MEQ Extended Release Oral Tablet	SY	d87dff5c-4e55-480d-b8ee-ab19d2280f92	2
670031	K+ Chloride 10 MEQ Extended Release Oral Tablet [K-Tab]	SY	d87dff5c-4e55-480d-b8ee-ab19d2280f92	2
628953	Pot Chloride 10 MEQ Extended Release Oral Tablet	SY	d87dff5c-4e55-480d-b8ee-ab19d2280f92	2
670031	Pot Chloride 10 MEQ Extended Release Oral Tablet [K-Tab]	SY	d87dff5c-4e55-480d-b8ee-ab19d2280f92	2
628953	potassium chloride 750 MG (potassium 10 mEq) Extended Release Oral Tablet	SY	d87dff5c-4e55-480d-b8ee-ab19d2280f92	2
628953	potassium chloride 750 MG Extended Release Oral Tablet	SY	d87dff5c-4e55-480d-b8ee-ab19d2280f92	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
43353-790-30	43353079030	30 in 1 BOTTLE, PLASTIC	Historical
43353-790-53	43353079053	60 in 1 BOTTLE, PLASTIC	Historical
43353-790-60	43353079060	90 in 1 BOTTLE, PLASTIC	Historical
43353-790-70	43353079070	120 in 1 BOTTLE, PLASTIC	Historical
43353-790-80	43353079080	180 in 1 BOTTLE, PLASTIC	Historical
43353-790-85	43353079085	200 in 1 BOTTLE, PLASTIC	Historical
43353-790-92	43353079092	270 in 1 BOTTLE, PLASTIC	Historical
43353-790-94	43353079094	360 in 1 BOTTLE, PLASTIC	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
K-TAB® (potassium chloride extended-release tablets, USP)	Aphena Pharma Solutions - Tennessee, LLC	2014-04-11	HUMAN PRESCRIPTION DRUG LABEL	2