Potassium Chloride

Product NDC: 0121-0841
11-digit product format: 001210841
Labeler code: 0121
Product ID: 0121-0841_cd3a937e-3347-6368-e053-2a95a90abe56
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: POTASSIUM CHLORIDE
Dosage form: SOLUTION
Route: ORAL
Labeler: Pharmaceutical Associates, Inc.
Application: ANDA210766
Marketing category: ANDA
Marketing start: 2019-04-02
Marketing end: 0000-00-00
Substance: POTASSIUM CHLORIDE
Active strength: 40 meq/15mL
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: 2022-12-31
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 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	0121-0841		D	Discontinued by firm		2026-08-17
excluded package	package	0121-0841	0121-0841-15	D	Discontinued by firm		2026-08-17

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 · 4 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	0121-0841-15	`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	0121-0841-15	`f5e01cc5f278…`	`a2eaf40c39c3…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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
A210766-001	POTASSIUM CHLORIDE	POTASSIUM CHLORIDE	20MEQ/15ML	SOLUTION / ORAL	AA		2019-03-29
A210766-002	POTASSIUM CHLORIDE	POTASSIUM CHLORIDE	40MEQ/15ML	SOLUTION / ORAL	AA		2019-03-29

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A210766-001	AA
A210766-002	AA

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 · 84 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
2026-08-18 06:07:40	2026-07	A210766-001	POTASSIUM CHLORIDE	20MEQ/15ML	SOLUTION / ORAL	AA	2019-03-29	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A210766-002	POTASSIUM CHLORIDE	40MEQ/15ML	SOLUTION / ORAL	AA	2019-03-29	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A210766-001	POTASSIUM CHLORIDE	20MEQ/15ML	SOLUTION / ORAL	AA	2019-03-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A210766-002	POTASSIUM CHLORIDE	40MEQ/15ML	SOLUTION / ORAL	AA	2019-03-29	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210766-001	POTASSIUM CHLORIDE	20MEQ/15ML	SOLUTION / ORAL	AA	2019-03-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210766-002	POTASSIUM CHLORIDE	40MEQ/15ML	SOLUTION / ORAL	AA	2019-03-29	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A210766-001	POTASSIUM CHLORIDE	20MEQ/15ML	SOLUTION / ORAL	AA	2019-03-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A210766-002	POTASSIUM CHLORIDE	40MEQ/15ML	SOLUTION / ORAL	AA	2019-03-29	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210766-001	POTASSIUM CHLORIDE	20MEQ/15ML	SOLUTION / ORAL	AA	2019-03-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210766-002	POTASSIUM CHLORIDE	40MEQ/15ML	SOLUTION / ORAL	AA	2019-03-29	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210766-001	POTASSIUM CHLORIDE	20MEQ/15ML	SOLUTION / ORAL	AA	2019-03-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210766-002	POTASSIUM CHLORIDE	40MEQ/15ML	SOLUTION / ORAL	AA	2019-03-29	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210766-001	POTASSIUM CHLORIDE	20MEQ/15ML	SOLUTION / ORAL	AA	2019-03-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210766-002	POTASSIUM CHLORIDE	40MEQ/15ML	SOLUTION / ORAL	AA	2019-03-29	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210766-001	POTASSIUM CHLORIDE	20MEQ/15ML	SOLUTION / ORAL	AA	2019-03-29	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210766-002	POTASSIUM CHLORIDE	40MEQ/15ML	SOLUTION / ORAL	AA	2019-03-29	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210766-001	POTASSIUM CHLORIDE	20MEQ/15ML	SOLUTION / ORAL	AA	2019-03-29	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210766-002	POTASSIUM CHLORIDE	40MEQ/15ML	SOLUTION / ORAL	AA	2019-03-29	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210766-001	POTASSIUM CHLORIDE	20MEQ/15ML	SOLUTION / ORAL	AA	2019-03-29	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210766-002	POTASSIUM CHLORIDE	40MEQ/15ML	SOLUTION / ORAL	AA	2019-03-29	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A210766-001	POTASSIUM CHLORIDE	20MEQ/15ML	SOLUTION / ORAL	AA	2019-03-29	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A210766-002	POTASSIUM CHLORIDE	40MEQ/15ML	SOLUTION / ORAL	AA	2019-03-29	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210766-001	POTASSIUM CHLORIDE	20MEQ/15ML	SOLUTION / ORAL	AA	2019-03-29	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210766-002	POTASSIUM CHLORIDE	40MEQ/15ML	SOLUTION / ORAL	AA	2019-03-29	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210766-001	POTASSIUM CHLORIDE	20MEQ/15ML	SOLUTION / ORAL	AA	2019-03-29	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210766-002	POTASSIUM CHLORIDE	40MEQ/15ML	SOLUTION / ORAL	AA	2019-03-29	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210766-001	POTASSIUM CHLORIDE	20MEQ/15ML	SOLUTION / ORAL	AA	2019-03-29	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210766-002	POTASSIUM CHLORIDE	40MEQ/15ML	SOLUTION / ORAL	AA	2019-03-29	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A210766-001	POTASSIUM CHLORIDE	20MEQ/15ML	SOLUTION / ORAL	AA	2019-03-29	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A210766-002	POTASSIUM CHLORIDE	40MEQ/15ML	SOLUTION / ORAL	AA	2019-03-29	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A210766-001	POTASSIUM CHLORIDE	20MEQ/15ML	SOLUTION / ORAL	AA	2019-03-29	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A210766-002	POTASSIUM CHLORIDE	40MEQ/15ML	SOLUTION / ORAL	AA	2019-03-29	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A210766-001	POTASSIUM CHLORIDE	20MEQ/15ML	SOLUTION / ORAL	AA	2019-03-29	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A210766-002	POTASSIUM CHLORIDE	40MEQ/15ML	SOLUTION / ORAL	AA	2019-03-29	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A210766-001	POTASSIUM CHLORIDE	20MEQ/15ML	SOLUTION / ORAL	AA	2019-03-29	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A210766-002	POTASSIUM CHLORIDE	40MEQ/15ML	SOLUTION / ORAL	AA	2019-03-29	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A210766-001	POTASSIUM CHLORIDE	20MEQ/15ML	SOLUTION / ORAL	AA	2019-03-29	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A210766-002	POTASSIUM CHLORIDE	40MEQ/15ML	SOLUTION / ORAL	AA	2019-03-29	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A210766-001	POTASSIUM CHLORIDE	20MEQ/15ML	SOLUTION / ORAL	AA	2019-03-29	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A210766-002	POTASSIUM CHLORIDE	40MEQ/15ML	SOLUTION / ORAL	AA	2019-03-29	`bb7c543d1eb4…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 84 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A210766-001	AA	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A210766-002	AA	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A210766-001	AA	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A210766-002	AA	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210766-001	AA	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210766-002	AA	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A210766-001	AA	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A210766-002	AA	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210766-001	AA	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210766-002	AA	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210766-001	AA	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210766-002	AA	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210766-001	AA	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210766-002	AA	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210766-001	AA	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210766-002	AA	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210766-001	AA	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210766-002	AA	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210766-001	AA	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210766-002	AA	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A210766-001	AA	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A210766-002	AA	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210766-001	AA	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210766-002	AA	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210766-001	AA	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210766-002	AA	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210766-001	AA	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210766-002	AA	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A210766-001	AA	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A210766-002	AA	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A210766-001	AA	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A210766-002	AA	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A210766-001	AA	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A210766-002	AA	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A210766-001	AA	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A210766-002	AA	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A210766-001	AA	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A210766-002	AA	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A210766-001	AA	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A210766-002	AA	1	`bb7c543d1eb4…`

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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
POTASSIUM CHLORIDE	POTASSIUM CHLORIDE	Major Pharmaceuticals	33ad1eb2-1f05-461c-b01d-82dee4231556	2026-02-11	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210766 application number: ANDA210766
Potassium Chloride	POTASSIUM CHLORIDE	PAI Holdings, LLC dba PAI Pharma	e848477f-b10d-4249-b322-b70cd6a062de	2024-11-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210766 application number: ANDA210766

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	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0121-0841-15	00121084115	10 TRAY in 1 CASE (0121-0841-15) > 10 CUP, UNIT-DOSE in 1 TRAY > 15 mL in 1 CUP, UNIT-DOSE	10 tray	2019-04-02	0000-00-00	No	No	Current