Potassium Chloride

Product NDC: 67046-1032
11-digit product format: 670461032
Labeler code: 67046
Product ID: 67046-1032_598f6131-7589-5ac2-e063-6394a90a561d
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Potassium Chloride
Dosage form: TABLET, FILM COATED, EXTENDED RELEASE
Route: ORAL
Labeler: Coupler LLC
Application: ANDA210921
Marketing category: ANDA
Marketing start: 2026-08-21
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
Listing certified through: 2027-12-31
Current FDA listing: Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
A210921-001	POTASSIUM CHLORIDE	POTASSIUM CHLORIDE	8MEQ	TABLET, EXTENDED RELEASE / ORAL	AB2		2018-12-19
A210921-002	POTASSIUM CHLORIDE	POTASSIUM CHLORIDE	10MEQ	TABLET, EXTENDED RELEASE / ORAL	AB2		2018-12-19

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A210921-001	AB2
A210921-002	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 · 86 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
2026-09-14 22:38:34	2026-08	A210921-001	POTASSIUM CHLORIDE	8MEQ	TABLET, EXTENDED RELEASE / ORAL	AB2	2018-12-19	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A210921-002	POTASSIUM CHLORIDE	10MEQ	TABLET, EXTENDED RELEASE / ORAL	AB2	2018-12-19	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A210921-001	POTASSIUM CHLORIDE	8MEQ	TABLET, EXTENDED RELEASE / ORAL	AB2	2018-12-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A210921-002	POTASSIUM CHLORIDE	10MEQ	TABLET, EXTENDED RELEASE / ORAL	AB2	2018-12-19	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A210921-001	POTASSIUM CHLORIDE	8MEQ	TABLET, EXTENDED RELEASE / ORAL	AB2	2018-12-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A210921-002	POTASSIUM CHLORIDE	10MEQ	TABLET, EXTENDED RELEASE / ORAL	AB2	2018-12-19	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210921-001	POTASSIUM CHLORIDE	8MEQ	TABLET, EXTENDED RELEASE / ORAL	AB2	2018-12-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210921-002	POTASSIUM CHLORIDE	10MEQ	TABLET, EXTENDED RELEASE / ORAL	AB2	2018-12-19	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A210921-001	POTASSIUM CHLORIDE	8MEQ	TABLET, EXTENDED RELEASE / ORAL	AB2	2018-12-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A210921-002	POTASSIUM CHLORIDE	10MEQ	TABLET, EXTENDED RELEASE / ORAL	AB2	2018-12-19	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210921-001	POTASSIUM CHLORIDE	8MEQ	TABLET, EXTENDED RELEASE / ORAL	AB2	2018-12-19	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210921-002	POTASSIUM CHLORIDE	10MEQ	TABLET, EXTENDED RELEASE / ORAL	AB2	2018-12-19	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210921-001	POTASSIUM CHLORIDE	8MEQ	TABLET, EXTENDED RELEASE / ORAL	AB2	2018-12-19	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210921-002	POTASSIUM CHLORIDE	10MEQ	TABLET, EXTENDED RELEASE / ORAL	AB2	2018-12-19	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210921-001	POTASSIUM CHLORIDE	8MEQ	TABLET, EXTENDED RELEASE / ORAL	AB2	2018-12-19	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210921-002	POTASSIUM CHLORIDE	10MEQ	TABLET, EXTENDED RELEASE / ORAL	AB2	2018-12-19	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210921-001	POTASSIUM CHLORIDE	8MEQ	TABLET, EXTENDED RELEASE / ORAL	AB2	2018-12-19	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210921-002	POTASSIUM CHLORIDE	10MEQ	TABLET, EXTENDED RELEASE / ORAL	AB2	2018-12-19	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210921-001	POTASSIUM CHLORIDE	8MEQ	TABLET, EXTENDED RELEASE / ORAL	AB2	2018-12-19	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210921-002	POTASSIUM CHLORIDE	10MEQ	TABLET, EXTENDED RELEASE / ORAL	AB2	2018-12-19	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210921-001	POTASSIUM CHLORIDE	8MEQ	TABLET, EXTENDED RELEASE / ORAL	AB2	2018-12-19	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210921-002	POTASSIUM CHLORIDE	10MEQ	TABLET, EXTENDED RELEASE / ORAL	AB2	2018-12-19	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A210921-001	POTASSIUM CHLORIDE	8MEQ	TABLET, EXTENDED RELEASE / ORAL	AB2	2018-12-19	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A210921-002	POTASSIUM CHLORIDE	10MEQ	TABLET, EXTENDED RELEASE / ORAL	AB2	2018-12-19	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210921-001	POTASSIUM CHLORIDE	8MEQ	TABLET, EXTENDED RELEASE / ORAL	AB2	2018-12-19	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210921-002	POTASSIUM CHLORIDE	10MEQ	TABLET, EXTENDED RELEASE / ORAL	AB2	2018-12-19	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210921-001	POTASSIUM CHLORIDE	8MEQ	TABLET, EXTENDED RELEASE / ORAL	AB2	2018-12-19	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210921-002	POTASSIUM CHLORIDE	10MEQ	TABLET, EXTENDED RELEASE / ORAL	AB2	2018-12-19	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210921-001	POTASSIUM CHLORIDE	8MEQ	TABLET, EXTENDED RELEASE / ORAL	AB2	2018-12-19	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210921-002	POTASSIUM CHLORIDE	10MEQ	TABLET, EXTENDED RELEASE / ORAL	AB2	2018-12-19	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A210921-001	POTASSIUM CHLORIDE	8MEQ	TABLET, EXTENDED RELEASE / ORAL	AB2	2018-12-19	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A210921-002	POTASSIUM CHLORIDE	10MEQ	TABLET, EXTENDED RELEASE / ORAL	AB2	2018-12-19	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A210921-001	POTASSIUM CHLORIDE	8MEQ	TABLET, EXTENDED RELEASE / ORAL	AB2	2018-12-19	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A210921-002	POTASSIUM CHLORIDE	10MEQ	TABLET, EXTENDED RELEASE / ORAL	AB2	2018-12-19	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A210921-001	POTASSIUM CHLORIDE	8MEQ	TABLET, EXTENDED RELEASE / ORAL	AB2	2018-12-19	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A210921-002	POTASSIUM CHLORIDE	10MEQ	TABLET, EXTENDED RELEASE / ORAL	AB2	2018-12-19	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A210921-001	POTASSIUM CHLORIDE	8MEQ	TABLET, EXTENDED RELEASE / ORAL	AB2	2018-12-19	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A210921-002	POTASSIUM CHLORIDE	10MEQ	TABLET, EXTENDED RELEASE / ORAL	AB2	2018-12-19	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A210921-001	POTASSIUM CHLORIDE	8MEQ	TABLET, EXTENDED RELEASE / ORAL	AB2	2018-12-19	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A210921-002	POTASSIUM CHLORIDE	10MEQ	TABLET, EXTENDED RELEASE / ORAL	AB2	2018-12-19	`74a2ff9319b5…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 86 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A210921-001	AB2	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A210921-002	AB2	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A210921-001	AB2	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A210921-002	AB2	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A210921-001	AB2	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A210921-002	AB2	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210921-001	AB2	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210921-002	AB2	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A210921-001	AB2	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A210921-002	AB2	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210921-001	AB2	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210921-002	AB2	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210921-001	AB2	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210921-002	AB2	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210921-001	AB2	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210921-002	AB2	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210921-001	AB2	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210921-002	AB2	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210921-001	AB2	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210921-002	AB2	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210921-001	AB2	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210921-002	AB2	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A210921-001	AB2	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A210921-002	AB2	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210921-001	AB2	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210921-002	AB2	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210921-001	AB2	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210921-002	AB2	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210921-001	AB2	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210921-002	AB2	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A210921-001	AB2	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A210921-002	AB2	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A210921-001	AB2	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A210921-002	AB2	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A210921-001	AB2	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A210921-002	AB2	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A210921-001	AB2	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A210921-002	AB2	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A210921-001	AB2	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A210921-002	AB2	1	`74a2ff9319b5…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product: Yes
Brand name base: Potassium Chloride
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
POTASSIUM CHLORIDE	750 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
660YQ98I10	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
628953	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
598f61d7-a665-5d02-e063-6394a90a8905	Available on FDA.report

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 · 11 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Potassium Chloride	POTASSIUM CHLORIDE	Coupler LLC	598f61d7-a665-5d02-e063-6394a90a8905	2026-08-21	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210921 application number: ANDA210921 ndc (product): 67046-1032
Potassium Chloride	POTASSIUM CHLORIDE	Preferred Pharmaceuticals Inc.	3f19ed0e-6c73-482c-94d6-d3205318fd6f	2026-08-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210921 application number: ANDA210921
Potassium Chloride	POTASSIUM CHLORIDE	REMEDYREPACK INC.	16c775e4-0dd8-4e9f-b2bf-dd2b639374cf	2026-07-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210921 application number: ANDA210921
Potassium Chloride	POTASSIUM CHLORIDE	Bryant Ranch Prepack	9088ca44-5585-4551-8e2c-168f306520d4	2026-03-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210921 application number: ANDA210921
Potassium Chloride	POTASSIUM CHLORIDE	Northwind Health Company, LLC	f3081031-8234-5732-e053-2995a90aebeb	2026-01-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210921 application number: ANDA210921
Potassium Chloride	POTASSIUM CHLORIDE	Major Pharmaceuticals	a9d68a40-75e3-4c5c-b5d7-1d6160527fa7	2025-09-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210921 application number: ANDA210921
Potassium Chloride	POTASSIUM CHLORIDE	Aphena Pharma Solutions - Tennessee, LLC	3dfa63fc-f8de-f1e0-e063-6294a90a8d47	2025-09-04	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210921 application number: ANDA210921
Potassium Chloride	POTASSIUM CHLORIDE	American Health Packaging	a67f5ba7-ac23-4bdc-9563-cb7fd049a951	2024-01-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210921 application number: ANDA210921
Potassium Chloride	POTASSIUM CHLORIDE	A-S Medication Solutions	e1670127-c551-441b-bac4-39f10a6d156f	2023-09-18	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210921 application number: ANDA210921
Potassium Chloride	POTASSIUM CHLORIDE	BluePoint Laboratories	73c911bb-4d39-4793-acba-90ed4b0eff46	2022-10-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210921 application number: ANDA210921
Potassium Chloride	POTASSIUM CHLORIDE	Aurobindo Pharma Limited	d43beabe-b801-4319-ad36-9a80856b94bd	2021-04-29	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210921 application number: ANDA210921

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	Sample	Exclude flag	Status
67046-1032-3	67046103203	30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK (67046-1032-3)	2026-08-21	No	No	Current