Potassium Chloride

Product NDC: 68382-776
11-digit product format: 683820776
Labeler code: 68382
Product ID: 68382-776_c3887ec5-c66d-4d1b-bab1-07bf0e8b3d47
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Potassium Chloride
Dosage form: TABLET, FILM COATED, EXTENDED RELEASE
Route: ORAL
Labeler: Zydus Pharmaceuticals USA Inc
Application: NDA018279
Marketing category: NDA AUTHORIZED GENERIC
Marketing start: 2014-01-16
Marketing end: 0000-00-00
Substance: POTASSIUM CHLORIDE
Active strength: 600 mg/1
Pharmacologic classes: Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Osmotic Activity [MoA], Osmotic Laxative [EPC], Potassium Compounds [CS], Potassium Salt [EPC]
NDC exclude flag: No
Listing certified through: 2023-12-31
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	68382-776		D	Discontinued by firm	2026-08-11
excluded package	package	68382-776	68382-776-01	D	Discontinued by firm	2026-08-11
excluded package	package	68382-776	68382-776-10	D	Discontinued by firm	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 1 · 33 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	68382-776-01	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	68382-776-10	`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	68382-776-01	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	68382-776-10	`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	68382-776-01	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	68382-776-10	`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	68382-776-01	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	68382-776-10	`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	68382-776-01	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	68382-776-10	`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	68382-776-01	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	68382-776-10	`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	68382-776-01	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	68382-776-10	`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	68382-776-01	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	68382-776-10	`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	68382-776-01	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	68382-776-10	`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	68382-776-01	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	68382-776-10	`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	68382-776-01	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	68382-776-10	`367a005e9d99…`	`383a685ebd0f…`

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…`

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDC	Effective	Related label
68382-776-01	2020-02-25	These highlights do not include all the information needed to use potassium chloride extended-release tablets safely and effectively. See full prescribing information for potassium chloride extended-release tablets. Potassium chloride extended-release tablets, for oral use Initial U.S. Approval: 1948
68382-776-10	2020-02-25	These highlights do not include all the information needed to use potassium chloride extended-release tablets safely and effectively. See full prescribing information for potassium chloride extended-release tablets. Potassium chloride extended-release tablets, for oral use Initial U.S. Approval: 1948
68382-776-01	2020-01-31	These highlights do not include all the information needed to use potassium chloride extended-release tablets safely and effectively. See full prescribing information for potassium chloride extended-release tablets. Potassium chloride extended-release tablets, for oral use Initial U.S. Approval: 1948
68382-776-10	2020-01-31	These highlights do not include all the information needed to use potassium chloride extended-release tablets safely and effectively. See full prescribing information for potassium chloride extended-release tablets. Potassium chloride extended-release tablets, for oral use Initial U.S. Approval: 1948

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
68382-776-01	EA - Each	68382-776	088b3e45-fe39-4a7d-875b-75baf4092a6e	1	2015-01-05
68382-776-10	EA - Each	68382-776	f6ac7b71-e4a8-47a4-8c21-5e19a80ab8c8	1	2015-01-05

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
POTASSIUM CHLORIDE	ACTIVE INGREDIENT	660YQ98I10	POTASSIUM CHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [ZYDUS PHARMACEUTICALS USA INC]	1448
POTASSIUM CATION	ACTIVE MOIETY	295O53K152	POTASSIUM CHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [ZYDUS PHARMACEUTICALS USA INC]	1448
.ALPHA.-TOCOPHEROL	INACTIVE INGREDIENT	H4N855PNZ1	POTASSIUM CHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [ZYDUS PHARMACEUTICALS USA INC]	1448
CASTOR OIL	INACTIVE INGREDIENT	D5340Y2I9G	POTASSIUM CHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [ZYDUS PHARMACEUTICALS USA INC]	1448
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	POTASSIUM CHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [ZYDUS PHARMACEUTICALS USA INC]	1448
ETHYLCELLULOSES	INACTIVE INGREDIENT	7Z8S9VYZ4B	POTASSIUM CHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [ZYDUS PHARMACEUTICALS USA INC]	1448
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	POTASSIUM CHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [ZYDUS PHARMACEUTICALS USA INC]	1448
PARAFFIN	INACTIVE INGREDIENT	I9O0E3H2ZE	POTASSIUM CHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [ZYDUS PHARMACEUTICALS USA INC]	1448
POLYVINYL ACETATE	INACTIVE INGREDIENT	32K497ZK2U	POTASSIUM CHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [ZYDUS PHARMACEUTICALS USA INC]	1448
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	POTASSIUM CHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [ZYDUS PHARMACEUTICALS USA INC]	1448
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	POTASSIUM CHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [ZYDUS PHARMACEUTICALS USA INC]	1448
VANILLIN	INACTIVE INGREDIENT	CHI530446X	POTASSIUM CHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [ZYDUS PHARMACEUTICALS USA INC]	1448

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	Marketing start	Marketing end	Sample	Exclude flag	Status
68382-776-01	68382077601	100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (68382-776-01)	2014-01-16	0000-00-00	No	No	Current
68382-776-10	68382077610	1000 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (68382-776-10)	2014-01-16	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Potassium Chloride	A-S Medication Solutions	2020-01-18	HUMAN PRESCRIPTION DRUG LABEL	13
Potassium Chloride	Zydus Pharmaceuticals USA Inc	2018-05-01	HUMAN PRESCRIPTION DRUG LABEL	1476