Potassium chloride extended release

Product NDC: 0574-0275
11-digit product format: 005740275
Labeler code: 0574
Product ID: 0574-0275_f93209a4-1f6f-4b14-b707-dde758dbed2b
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Potassium chloride
Dosage form: TABLET, EXTENDED RELEASE
Route: ORAL
Labeler: Padagis US LLC
Application: ANDA205993
Marketing category: ANDA
Marketing start: 2015-12-11
Marketing end: 2026-05-31
Substance: POTASSIUM CHLORIDE
Active strength: 750 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
Current FDA listing: Yes

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 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	0574-0275		D	Discontinued by firm		2026-08-03
excluded package	package	0574-0275	0574-0275-11	D	Discontinued by firm		2026-08-03

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 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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
0574-0275-11	Potassium chloride extended release	10 in 1 BOX, UNIT-DOSE	TABLET, EXTENDED RELEASE	10		10
0574-0275-11	Potassium chloride extended release	10 in 1 BLISTER PACK	TABLET, EXTENDED RELEASE	10		10

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0574-0275-01	EA - Each	0574-0275	7dcbff68-0bd4-443e-a43f-5cac994b602d	1	2016-01-13
0574-0275-05	EA - Each	0574-0275	405e15bd-cfcf-4fda-b9a6-ed57fd49c725	1	2016-01-13
0574-0275-11	EA - Each	0574-0275	0c070410-da02-4bec-bd65-6a801469f6a4	1	2016-05-16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0574-0275	POTASSIUM CHLORIDE EXTENDED RELEASE (POTASSIUM CHLORIDE) TABLET, EXTENDED RELEASE [PADAGIS US LLC]	9	Current NDC, Legacy NDC, 2 package rows	20240104_ef2f9647-00b5-439c-9ec6-2cbfe6bf3f3d.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
628953	potassium chloride 10 MEQ (750 MG) Extended Release Oral Tablet	PSN	41ff55cf-4af3-487e-bd78-09703d310780	103
628953	potassium chloride 10 MEQ Extended Release Oral Tablet	SCD	41ff55cf-4af3-487e-bd78-09703d310780	103
628953	K+ Chloride 10 MEQ Extended Release Oral Tablet	SY	41ff55cf-4af3-487e-bd78-09703d310780	103
628953	Pot Chloride 10 MEQ Extended Release Oral Tablet	SY	41ff55cf-4af3-487e-bd78-09703d310780	103
628953	potassium chloride 750 MG (potassium 10 mEq) Extended Release Oral Tablet	SY	41ff55cf-4af3-487e-bd78-09703d310780	103
628953	potassium chloride 750 MG Extended Release Oral Tablet	SY	41ff55cf-4af3-487e-bd78-09703d310780	103

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0574-0275-01	00574027501	100 TABLET, EXTENDED RELEASE in 1 BOTTLE (0574-0275-01)		2015-12-18	0000-00-00	No	No	Current
0574-0275-05	00574027505	500 TABLET, EXTENDED RELEASE in 1 BOTTLE (0574-0275-05)		2015-12-18	0000-00-00	No	No	Current
0574-0275-11	00574027511	10 BLISTER PACK in 1 BOX, UNIT-DOSE (0574-0275-11) / 10 TABLET, EXTENDED RELEASE in 1 BLISTER PACK	10 blister pack	2016-05-05	2026-05-31	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Potassium chloride extended release	Cardinal Health 107, LLC	2025-10-24	HUMAN PRESCRIPTION DRUG LABEL	6
Potassium chloride extended release	Bryant Ranch Prepack	2024-01-11	HUMAN PRESCRIPTION DRUG LABEL	103
Potassium chloride extended release	Proficient Rx LP	2022-07-01	HUMAN PRESCRIPTION DRUG LABEL	2
Potassium chloride extended release	Padagis US LLC	2022-05-31	HUMAN PRESCRIPTION DRUG LABEL	10
Potassium chloride extended release	REMEDYREPACK INC.	2019-09-03	HUMAN PRESCRIPTION DRUG LABEL	1