Application 019439

Type: NDA
Sponsor: SCHERING

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	POTASSIUM CHLORIDE	POTASSIUM CHLORIDE	TABLET, EXTENDED RELEASE;ORAL	20MEQ Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	Yes	No
002	POTASSIUM CHLORIDE	POTASSIUM CHLORIDE	TABLET, EXTENDED RELEASE;ORAL	10MEQ Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	Yes	No

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
N019439-001	POTASSIUM CHLORIDE	POTASSIUM CHLORIDE	20MEQ Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL		RLD	1986-06-13
N019439-002	POTASSIUM CHLORIDE	POTASSIUM CHLORIDE	10MEQ Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL		RLD	1986-06-13

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	RLD / RS	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	N019439-001	POTASSIUM CHLORIDE	20MEQ Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	1986-06-13	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N019439-002	POTASSIUM CHLORIDE	10MEQ Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	1986-06-13	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N019439-001	POTASSIUM CHLORIDE	20MEQ Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	1986-06-13	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N019439-002	POTASSIUM CHLORIDE	10MEQ Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	1986-06-13	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N019439-001	POTASSIUM CHLORIDE	20MEQ Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	1986-06-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N019439-002	POTASSIUM CHLORIDE	10MEQ Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	1986-06-13	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019439-001	POTASSIUM CHLORIDE	20MEQ Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	1986-06-13	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019439-002	POTASSIUM CHLORIDE	10MEQ Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	1986-06-13	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N019439-001	POTASSIUM CHLORIDE	20MEQ Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	1986-06-13	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N019439-002	POTASSIUM CHLORIDE	10MEQ Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	1986-06-13	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019439-001	POTASSIUM CHLORIDE	20MEQ Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	1986-06-13	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019439-002	POTASSIUM CHLORIDE	10MEQ Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	1986-06-13	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N019439-001	POTASSIUM CHLORIDE	20MEQ Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	1986-06-13	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N019439-002	POTASSIUM CHLORIDE	10MEQ Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	1986-06-13	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N019439-001	POTASSIUM CHLORIDE	20MEQ Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	1986-06-13	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N019439-002	POTASSIUM CHLORIDE	10MEQ Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	1986-06-13	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N019439-001	POTASSIUM CHLORIDE	20MEQ Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	1986-06-13	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N019439-002	POTASSIUM CHLORIDE	10MEQ Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	1986-06-13	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N019439-001	POTASSIUM CHLORIDE	20MEQ Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	1986-06-13	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N019439-002	POTASSIUM CHLORIDE	10MEQ Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	1986-06-13	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N019439-001	POTASSIUM CHLORIDE	20MEQ Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	1986-06-13	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N019439-002	POTASSIUM CHLORIDE	10MEQ Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	1986-06-13	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N019439-001	POTASSIUM CHLORIDE	20MEQ Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	1986-06-13	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N019439-002	POTASSIUM CHLORIDE	10MEQ Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	1986-06-13	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N019439-001	POTASSIUM CHLORIDE	20MEQ Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	1986-06-13	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N019439-002	POTASSIUM CHLORIDE	10MEQ Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	1986-06-13	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N019439-001	POTASSIUM CHLORIDE	20MEQ Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	1986-06-13	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N019439-002	POTASSIUM CHLORIDE	10MEQ Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	1986-06-13	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N019439-001	POTASSIUM CHLORIDE	20MEQ Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	1986-06-13	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N019439-002	POTASSIUM CHLORIDE	10MEQ Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	1986-06-13	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N019439-001	POTASSIUM CHLORIDE	20MEQ Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	1986-06-13	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N019439-002	POTASSIUM CHLORIDE	10MEQ Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	1986-06-13	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N019439-001	POTASSIUM CHLORIDE	20MEQ Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	1986-06-13	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N019439-002	POTASSIUM CHLORIDE	10MEQ Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	1986-06-13	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N019439-001	POTASSIUM CHLORIDE	20MEQ	TABLET, EXTENDED RELEASE / ORAL	RLD	1986-06-13	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N019439-002	POTASSIUM CHLORIDE	10MEQ	TABLET, EXTENDED RELEASE / ORAL	RLD	1986-06-13	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N019439-001	POTASSIUM CHLORIDE	20MEQ	TABLET, EXTENDED RELEASE / ORAL	RLD	1986-06-13	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N019439-002	POTASSIUM CHLORIDE	10MEQ	TABLET, EXTENDED RELEASE / ORAL	RLD	1986-06-13	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N019439-001	POTASSIUM CHLORIDE	20MEQ Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	1986-06-13	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N019439-002	POTASSIUM CHLORIDE	10MEQ Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	1986-06-13	`74a2ff9319b5…`

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 10 · 200 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Potassium Chloride	POTASSIUM CHLORIDE	Cardinal Health 107, LLC	ea55ded1-e076-43de-ad3c-c75e7d0a4ebc	2026-08-24	Warnings, Adverse reactions	Name fallback brand name: Potassium Chloride generic name: POTASSIUM CHLORIDE
POTASSIUM CHLORIDE	POTASSIUM CHLORIDE ORAL	Cardinal Health 107, LLC	fea3ae21-3395-437e-b773-b180e1c98801	2026-08-24	Warnings, Adverse reactions	Name fallback brand name: POTASSIUM CHLORIDE
Potassium Chloride	POTASSIUM CHLORIDE	Coupler LLC	598f61d7-a665-5d02-e063-6394a90a8905	2026-08-21	Warnings, Adverse reactions	Name fallback brand name: Potassium Chloride generic name: POTASSIUM CHLORIDE
Potassium Chloride	POTASSIUM CHLORIDE	Preferred Pharmaceuticals Inc.	3f19ed0e-6c73-482c-94d6-d3205318fd6f	2026-08-17	Warnings, Adverse reactions	Name fallback brand name: Potassium Chloride generic name: POTASSIUM CHLORIDE
Potassium Chloride	POTASSIUM CHLORIDE	Amneal Pharmaceuticals LLC	f9965f73-e189-423f-bd10-c4a0ed12b485	2026-08-01	Warnings, Adverse reactions	Name fallback brand name: Potassium Chloride generic name: POTASSIUM CHLORIDE
Potassium Chloride	POTASSIUM CHLORIDE	REMEDYREPACK INC.	16c775e4-0dd8-4e9f-b2bf-dd2b639374cf	2026-07-31	Warnings, Adverse reactions	Name fallback brand name: Potassium Chloride generic name: POTASSIUM CHLORIDE
Potassium Chloride Extended-Release	POTASSIUM CHLORIDE	REMEDYREPACK INC.	7ec22e8e-6643-44fe-804d-ca0b0b266663	2026-07-31	Warnings, Adverse reactions	Name fallback generic name: POTASSIUM CHLORIDE
Potassium Chloride Extended-Release	POTASSIUM CHLORIDE	Upsher-Smith Laboratories, LLC	02707146-331f-4511-a187-0152fc8bca85	2026-07-24	Warnings, Adverse reactions	Name fallback generic name: POTASSIUM CHLORIDE
Potassium Chloride	POTASSIUM CHLORIDE	Major Pharmaceuticals	6c080e51-4eb7-4e96-b29f-eb1cce381304	2026-07-14	Warnings, Adverse reactions	Name fallback brand name: Potassium Chloride generic name: POTASSIUM CHLORIDE
Potassium Chloride	POTASSIUM CHLORIDE	ATLANTIC BIOLOGICALS CORP.	104ccc91-2aaf-4bb7-bb64-77c29413f60e	2026-07-10	Warnings, Adverse reactions	Name fallback brand name: Potassium Chloride generic name: POTASSIUM CHLORIDE
POTASSIUM CHLORIDE	POTASSIUM CHLORIDE	Hospira, Inc.	559a0a8c-a8fe-40a5-b196-21f9308780ab	2026-07-01	Warnings, Adverse reactions	Name fallback brand name: POTASSIUM CHLORIDE generic name: POTASSIUM CHLORIDE
Potassium Chloride	POTASSIUM CHLORIDE	A-S Medication Solutions	30527e49-6648-44f3-97b2-9c51783ac003	2026-07-01	Warnings, Adverse reactions	Name fallback brand name: Potassium Chloride generic name: POTASSIUM CHLORIDE
Potassium Chloride	POTASSIUM CHLORIDE	Amneal Pharmaceuticals NY LLC	590dd25c-c4cb-489a-a09b-eccbf1d37c1f	2026-07-01	Warnings, Adverse reactions	Name fallback brand name: Potassium Chloride generic name: POTASSIUM CHLORIDE
Potassium Chloride	POTASSIUM CHLORIDE	St. Mary's Medical Park Pharmacy	549c9d28-bf8b-2dc2-e063-6294a90abe7b	2026-06-19	Warnings, Adverse reactions	Name fallback brand name: Potassium Chloride generic name: POTASSIUM CHLORIDE
Potassium Chloride	POTASSIUM CHLORIDE	REMEDYREPACK INC.	f75713cf-6902-4160-94cb-335a1ecdbbbe	2026-06-12	Warnings, Adverse reactions	Name fallback brand name: Potassium Chloride generic name: POTASSIUM CHLORIDE
Potassium Chloride	POTASSIUM CHLORIDE	Northwind Health Company, LLC	548953ac-31c5-a181-e063-6294a90a3b77	2026-06-12	Warnings, Adverse reactions	Name fallback brand name: Potassium Chloride generic name: POTASSIUM CHLORIDE
Potassium Chloride	POTASSIUM CHLORIDE	Redpharm Drug	5261dfe5-d62b-d618-e063-6294a90a96e7	2026-05-22	Warnings, Adverse reactions	Name fallback brand name: Potassium Chloride generic name: POTASSIUM CHLORIDE
Potassium Chloride	POTASSIUM CHLORIDE	Aphena Pharma Solutions - Tennessee, LLC	d2e84d34-e042-477f-9944-3fcb95301217	2026-05-20	Warnings, Adverse reactions	Name fallback brand name: Potassium Chloride generic name: POTASSIUM CHLORIDE
potassium chloride	POTASSIUM CHLORIDE	Northstar Rx LLC	b19a3fbf-cdbb-4f86-ac61-5dfb07e0a51a	2026-05-18	Warnings, Adverse reactions	Name fallback brand name: potassium chloride generic name: POTASSIUM CHLORIDE
Potassium Chloride	POTASSIUM CHLORIDE	Bryant Ranch Prepack	9088ca44-5585-4551-8e2c-168f306520d4	2026-03-30	Warnings, Adverse reactions	Name fallback brand name: Potassium Chloride generic name: POTASSIUM CHLORIDE

Reported adverse events (FAERS/openFDA)#

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

Documents#

Document, Submission type, Date table
Document	Submission type	Date
50949	SUPPL	2018-01-02
1324	SUPPL	2008-06-16