Potassium chloride extended release

Product NDC: 63629-8443
Requested package NDC: 63629-8443-1
11-digit product format: 636298443
Labeler code: 63629
Product ID: 63629-8443_071c380b-54db-46ac-bb8b-4df038198e0a
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Potassium chloride
Dosage form: TABLET, EXTENDED RELEASE
Route: ORAL
Labeler: Bryant Ranch Prepack
Application: ANDA205993
Marketing category: ANDA
Marketing start: 2015-12-11
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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	63629-8443	63629-8443-1	D	Discontinued by firm		2026-08-03

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 11 matching rows.

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

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

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
A205993-001	POTASSIUM CHLORIDE	POTASSIUM CHLORIDE	8MEQ	TABLET, EXTENDED RELEASE / ORAL	AB2		2015-11-05
A205993-002	POTASSIUM CHLORIDE	POTASSIUM CHLORIDE	10MEQ	TABLET, EXTENDED RELEASE / ORAL	AB2		2015-11-05

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A205993-001	AB2
A205993-002	AB2

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	A205993-001	POTASSIUM CHLORIDE	8MEQ	TABLET, EXTENDED RELEASE / ORAL	AB2	2015-11-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A205993-002	POTASSIUM CHLORIDE	10MEQ	TABLET, EXTENDED RELEASE / ORAL	AB2	2015-11-05	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205993-001	POTASSIUM CHLORIDE	8MEQ	TABLET, EXTENDED RELEASE / ORAL	AB2	2015-11-05	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205993-002	POTASSIUM CHLORIDE	10MEQ	TABLET, EXTENDED RELEASE / ORAL	AB2	2015-11-05	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A205993-001	POTASSIUM CHLORIDE	8MEQ	TABLET, EXTENDED RELEASE / ORAL	AB2	2015-11-05	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A205993-002	POTASSIUM CHLORIDE	10MEQ	TABLET, EXTENDED RELEASE / ORAL	AB2	2015-11-05	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205993-001	POTASSIUM CHLORIDE	8MEQ	TABLET, EXTENDED RELEASE / ORAL	AB2	2015-11-05	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205993-002	POTASSIUM CHLORIDE	10MEQ	TABLET, EXTENDED RELEASE / ORAL	AB2	2015-11-05	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205993-001	POTASSIUM CHLORIDE	8MEQ	TABLET, EXTENDED RELEASE / ORAL	AB2	2015-11-05	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205993-002	POTASSIUM CHLORIDE	10MEQ	TABLET, EXTENDED RELEASE / ORAL	AB2	2015-11-05	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205993-001	POTASSIUM CHLORIDE	8MEQ	TABLET, EXTENDED RELEASE / ORAL	AB2	2015-11-05	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205993-002	POTASSIUM CHLORIDE	10MEQ	TABLET, EXTENDED RELEASE / ORAL	AB2	2015-11-05	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205993-001	POTASSIUM CHLORIDE	8MEQ	TABLET, EXTENDED RELEASE / ORAL	AB2	2015-11-05	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205993-002	POTASSIUM CHLORIDE	10MEQ	TABLET, EXTENDED RELEASE / ORAL	AB2	2015-11-05	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205993-001	POTASSIUM CHLORIDE	8MEQ	TABLET, EXTENDED RELEASE / ORAL	AB2	2015-11-05	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205993-002	POTASSIUM CHLORIDE	10MEQ	TABLET, EXTENDED RELEASE / ORAL	AB2	2015-11-05	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205993-001	POTASSIUM CHLORIDE	8MEQ	TABLET, EXTENDED RELEASE / ORAL	AB2	2015-11-05	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205993-002	POTASSIUM CHLORIDE	10MEQ	TABLET, EXTENDED RELEASE / ORAL	AB2	2015-11-05	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A205993-001	POTASSIUM CHLORIDE	8MEQ	TABLET, EXTENDED RELEASE / ORAL	AB2	2015-11-05	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A205993-002	POTASSIUM CHLORIDE	10MEQ	TABLET, EXTENDED RELEASE / ORAL	AB2	2015-11-05	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A205993-001	POTASSIUM CHLORIDE	8MEQ	TABLET, EXTENDED RELEASE / ORAL	AB2	2015-11-05	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A205993-002	POTASSIUM CHLORIDE	10MEQ	TABLET, EXTENDED RELEASE / ORAL	AB2	2015-11-05	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A205993-001	POTASSIUM CHLORIDE	8MEQ	TABLET, EXTENDED RELEASE / ORAL	AB2	2015-11-05	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A205993-002	POTASSIUM CHLORIDE	10MEQ	TABLET, EXTENDED RELEASE / ORAL	AB2	2015-11-05	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A205993-001	POTASSIUM CHLORIDE	8MEQ	TABLET, EXTENDED RELEASE / ORAL	AB2	2015-11-05	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A205993-002	POTASSIUM CHLORIDE	10MEQ	TABLET, EXTENDED RELEASE / ORAL	AB2	2015-11-05	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A205993-001	POTASSIUM CHLORIDE	8MEQ	TABLET, EXTENDED RELEASE / ORAL	AB2	2015-11-05	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A205993-002	POTASSIUM CHLORIDE	10MEQ	TABLET, EXTENDED RELEASE / ORAL	AB2	2015-11-05	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A205993-001	POTASSIUM CHLORIDE	8MEQ	TABLET, EXTENDED RELEASE / ORAL	AB2	2015-11-05	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A205993-002	POTASSIUM CHLORIDE	10MEQ	TABLET, EXTENDED RELEASE / ORAL	AB2	2015-11-05	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A205993-001	POTASSIUM CHLORIDE	8MEQ	TABLET, EXTENDED RELEASE / ORAL	AB2	2015-11-05	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A205993-002	POTASSIUM CHLORIDE	10MEQ	TABLET, EXTENDED RELEASE / ORAL	AB2	2015-11-05	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A205993-001	POTASSIUM CHLORIDE	8MEQ	TABLET, EXTENDED RELEASE / ORAL	AB2	2015-11-05	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A205993-002	POTASSIUM CHLORIDE	10MEQ	TABLET, EXTENDED RELEASE / ORAL	AB2	2015-11-05	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A205993-001	POTASSIUM CHLORIDE	8MEQ	TABLET, EXTENDED RELEASE / ORAL	AB2	2015-11-05	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A205993-002	POTASSIUM CHLORIDE	10MEQ	TABLET, EXTENDED RELEASE / ORAL	AB2	2015-11-05	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A205993-001	POTASSIUM CHLORIDE	8MEQ	TABLET, EXTENDED RELEASE / ORAL	AB2	2015-11-05	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A205993-002	POTASSIUM CHLORIDE	10MEQ	TABLET, EXTENDED RELEASE / ORAL	AB2	2015-11-05	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A205993-001	POTASSIUM CHLORIDE	8MEQ	TABLET, EXTENDED RELEASE / ORAL	AB2	2015-11-05	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A205993-002	POTASSIUM CHLORIDE	10MEQ	TABLET, EXTENDED RELEASE / ORAL	AB2	2015-11-05	`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	A205993-001	AB2	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A205993-002	AB2	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205993-001	AB2	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205993-002	AB2	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A205993-001	AB2	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A205993-002	AB2	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205993-001	AB2	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205993-002	AB2	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205993-001	AB2	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205993-002	AB2	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205993-001	AB2	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205993-002	AB2	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205993-001	AB2	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205993-002	AB2	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205993-001	AB2	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205993-002	AB2	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205993-001	AB2	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205993-002	AB2	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A205993-001	AB2	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A205993-002	AB2	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A205993-001	AB2	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A205993-002	AB2	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A205993-001	AB2	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A205993-002	AB2	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A205993-001	AB2	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A205993-002	AB2	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A205993-001	AB2	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A205993-002	AB2	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A205993-001	AB2	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A205993-002	AB2	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A205993-001	AB2	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A205993-002	AB2	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A205993-001	AB2	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A205993-002	AB2	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A205993-001	AB2	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A205993-002	AB2	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A205993-001	AB2	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A205993-002	AB2	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A205993-001	AB2	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A205993-002	AB2	1	`782e0a99824c…`

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
63629-8443-1	EA - Each	63629-8443	01c901ee-7c90-47f3-8c91-a552b667885b	1	2021-06-02

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
63629-8443-1	63629844301	100 TABLET, EXTENDED RELEASE in 1 BOTTLE (63629-8443-1)	2016-01-06	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Potassium chloride extended release	Bryant Ranch Prepack	2024-01-11	HUMAN PRESCRIPTION DRUG LABEL	103