Application 018238

Type: NDA
Sponsor: NESHER PHARMS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	MICRO-K	POTASSIUM CHLORIDE	CAPSULE, EXTENDED RELEASE;ORAL	8MEQ	Yes	No
002	MICRO-K 10	POTASSIUM CHLORIDE	CAPSULE, EXTENDED RELEASE;ORAL	10MEQ	Yes	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

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
N018238-001	MICRO-K	POTASSIUM CHLORIDE	8MEQ Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE, EXTENDED RELEASE / ORAL		RLD, Approved before 1982
N018238-002	MICRO-K 10	POTASSIUM CHLORIDE	10MEQ Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE, EXTENDED RELEASE / ORAL		RLD	1984-05-14

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 2 of 3 · 88 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2019-12-13 00:20 UTC	2019-12	N018238-001	MICRO-K	8MEQ	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD, Approved before 1982		`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N018238-002	MICRO-K 10	10MEQ	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD	1984-05-14	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N018238-001	MICRO-K	8MEQ Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE, EXTENDED RELEASE / ORAL		RLD, Approved before 1982		`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N018238-002	MICRO-K 10	10MEQ Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE, EXTENDED RELEASE / ORAL		RLD	1984-05-14	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N018238-001	MICRO-K	8MEQ Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	CAPSULE, EXTENDED RELEASE / ORAL		RLD, Approved before 1982		`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N018238-002	MICRO-K 10	10MEQ Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	CAPSULE, EXTENDED RELEASE / ORAL		RLD	1984-05-14	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N018238-001	MICRO-K	8MEQ Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	CAPSULE, EXTENDED RELEASE / ORAL		RLD, Approved before 1982		`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N018238-002	MICRO-K 10	10MEQ Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	CAPSULE, EXTENDED RELEASE / ORAL		RLD	1984-05-14	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N018238-001	MICRO-K	8MEQ Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	CAPSULE, EXTENDED RELEASE / ORAL		RLD, Approved before 1982		`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N018238-002	MICRO-K 10	10MEQ Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	CAPSULE, EXTENDED RELEASE / ORAL		RLD	1984-05-14	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N018238-001	MICRO-K	8MEQ	CAPSULE, EXTENDED RELEASE / ORAL		RLD, Approved before 1982		`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N018238-002	MICRO-K 10	10MEQ	CAPSULE, EXTENDED RELEASE / ORAL		RLD	1984-05-14	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N018238-001	MICRO-K	8MEQ	CAPSULE, EXTENDED RELEASE / ORAL		RLD, Approved before 1982		`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N018238-002	MICRO-K 10	10MEQ	CAPSULE, EXTENDED RELEASE / ORAL		RLD	1984-05-14	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N018238-001	MICRO-K	8MEQ	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD, Approved before 1982		`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N018238-002	MICRO-K 10	10MEQ	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD	1984-05-14	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N018238-001	MICRO-K	8MEQ	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD, Approved before 1982		`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N018238-002	MICRO-K 10	10MEQ	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD	1984-05-14	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N018238-001	MICRO-K	8MEQ	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD, Approved before 1982		`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N018238-002	MICRO-K 10	10MEQ	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD	1984-05-14	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N018238-001	MICRO-K	8MEQ Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE, EXTENDED RELEASE / ORAL		RLD, Approved before 1982		`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N018238-002	MICRO-K 10	10MEQ Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE, EXTENDED RELEASE / ORAL		RLD	1984-05-14	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N018238-001	MICRO-K	8MEQ Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE, EXTENDED RELEASE / ORAL		RLD, Approved before 1982		`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	N018238-002	MICRO-K 10	10MEQ Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE, EXTENDED RELEASE / ORAL		RLD	1984-05-14	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N018238-001	MICRO-K	8MEQ Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE, EXTENDED RELEASE / ORAL		RLD, Approved before 1982		`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	N018238-002	MICRO-K 10	10MEQ Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE, EXTENDED RELEASE / ORAL		RLD	1984-05-14	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N018238-001	MICRO-K	8MEQ Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE, EXTENDED RELEASE / ORAL		RLD, Approved before 1982		`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N018238-002	MICRO-K 10	10MEQ Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE, EXTENDED RELEASE / ORAL		RLD	1984-05-14	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N018238-001	MICRO-K	8MEQ Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE, EXTENDED RELEASE / ORAL		RLD, Approved before 1982		`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N018238-002	MICRO-K 10	10MEQ Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE, EXTENDED RELEASE / ORAL		RLD	1984-05-14	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N018238-001	MICRO-K	8MEQ Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE, EXTENDED RELEASE / ORAL		RLD, Approved before 1982		`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N018238-002	MICRO-K 10	10MEQ Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE, EXTENDED RELEASE / ORAL		RLD	1984-05-14	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N018238-001	MICRO-K	8MEQ Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE, EXTENDED RELEASE / ORAL		RLD, Approved before 1982		`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N018238-002	MICRO-K 10	10MEQ Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE, EXTENDED RELEASE / ORAL		RLD	1984-05-14	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N018238-001	MICRO-K	8MEQ Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE, EXTENDED RELEASE / ORAL		RLD, Approved before 1982		`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	N018238-002	MICRO-K 10	10MEQ Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE, EXTENDED RELEASE / ORAL		RLD	1984-05-14	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N018238-001	MICRO-K	8MEQ Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE, EXTENDED RELEASE / ORAL		RLD, Approved before 1982		`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	N018238-002	MICRO-K 10	10MEQ Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE, EXTENDED RELEASE / ORAL		RLD	1984-05-14	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N018238-001	MICRO-K	8MEQ Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE, EXTENDED RELEASE / ORAL		RLD, Approved before 1982		`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N018238-002	MICRO-K 10	10MEQ Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE, EXTENDED RELEASE / ORAL		RLD	1984-05-14	`3a93d1ddd44b…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2019-12-13 00:20 UTC	2019-12	N018238-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N018238-002	AB	1	`74a2ff9319b5…`
2019-12-14 00:12 UTC	2019-12	N018238-001	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N018238-002	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N018238-001	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N018238-002	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N018238-001	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N018238-002	AB	1	`ea99ee380514…`

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 · 189 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 generic name: POTASSIUM CHLORIDE
Potassium Chloride	POTASSIUM CHLORIDE	Coupler LLC	598f61d7-a665-5d02-e063-6394a90a8905	2026-08-21	Warnings, Adverse reactions	Name fallback generic name: POTASSIUM CHLORIDE
Potassium Chloride	POTASSIUM CHLORIDE	Preferred Pharmaceuticals Inc.	3f19ed0e-6c73-482c-94d6-d3205318fd6f	2026-08-17	Warnings, Adverse reactions	Name fallback generic name: POTASSIUM CHLORIDE
Potassium Chloride	POTASSIUM CHLORIDE	Amneal Pharmaceuticals LLC	f9965f73-e189-423f-bd10-c4a0ed12b485	2026-08-01	Warnings, Adverse reactions	Name fallback generic name: POTASSIUM CHLORIDE
Potassium Chloride	POTASSIUM CHLORIDE	REMEDYREPACK INC.	16c775e4-0dd8-4e9f-b2bf-dd2b639374cf	2026-07-31	Warnings, Adverse reactions	Name fallback 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 generic name: POTASSIUM CHLORIDE
Potassium Chloride	POTASSIUM CHLORIDE	ATLANTIC BIOLOGICALS CORP.	104ccc91-2aaf-4bb7-bb64-77c29413f60e	2026-07-10	Warnings, Adverse reactions	Name fallback generic name: POTASSIUM CHLORIDE
POTASSIUM CHLORIDE	POTASSIUM CHLORIDE	Hospira, Inc.	559a0a8c-a8fe-40a5-b196-21f9308780ab	2026-07-01	Warnings, Adverse reactions	Name fallback 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 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 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 generic name: POTASSIUM CHLORIDE
Potassium Chloride	POTASSIUM CHLORIDE	REMEDYREPACK INC.	f75713cf-6902-4160-94cb-335a1ecdbbbe	2026-06-12	Warnings, Adverse reactions	Name fallback 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 generic name: POTASSIUM CHLORIDE
Potassium Chloride	POTASSIUM CHLORIDE	Redpharm Drug	5261dfe5-d62b-d618-e063-6294a90a96e7	2026-05-22	Warnings, Adverse reactions	Name fallback 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 generic name: POTASSIUM CHLORIDE
potassium chloride	POTASSIUM CHLORIDE	Northstar Rx LLC	b19a3fbf-cdbb-4f86-ac61-5dfb07e0a51a	2026-05-18	Warnings, Adverse reactions	Name fallback generic name: POTASSIUM CHLORIDE
Potassium Chloride	POTASSIUM CHLORIDE	Bryant Ranch Prepack	9088ca44-5585-4551-8e2c-168f306520d4	2026-03-30	Warnings, Adverse reactions	Name fallback generic name: POTASSIUM CHLORIDE
Potassium Chloride	POTASSIUM CHLORIDE	Ajenat Pharmaceuticals LLC	ab066a84-5455-419e-a1da-354a3f15a73d	2026-03-23	Warnings, Adverse reactions	Name fallback generic name: POTASSIUM CHLORIDE

Reported adverse events (FAERS/openFDA)#

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

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 11 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0615-7646	potassium chloride	potassium chloride	NCS HealthCare of KY, Inc dba Vangard Labs	NDA AUTHORIZED GENERIC	Current
0615-7694	potassium chloride	potassium chloride	NCS HealthCare of KY, Inc dba Vangard Labs	NDA AUTHORIZED GENERIC	Current
51477-001	potassium chloride	potassium chloride	Nesher Pharmaceuticals (USA) LLC	NDA AUTHORIZED GENERIC	Current
51477-002	potassium chloride	potassium chloride	Nesher Pharmaceuticals (USA) LLC	NDA AUTHORIZED GENERIC	Current
68084-419	potassium chloride	potassium chloride	American Health Packaging	NDA AUTHORIZED GENERIC	Current
68382-701	POTASSIUM CHLORIDE	potassium chloride	Zydus Pharmaceuticals (USA) Inc.	NDA AUTHORIZED GENERIC	Current
68382-701	POTASSIUM CHLORIDE	potassium chloride	Zydus Pharmaceuticals (USA) Inc.	NDA AUTHORIZED GENERIC	Current
68382-701	POTASSIUM CHLORIDE	potassium chloride	Zydus Pharmaceuticals (USA) Inc.	NDA AUTHORIZED GENERIC	Current
68382-702	POTASSIUM CHLORIDE	potassium chloride	Zydus Pharmaceuticals (USA) Inc.	NDA AUTHORIZED GENERIC	Current
68382-702	POTASSIUM CHLORIDE	potassium chloride	Zydus Pharmaceuticals (USA) Inc.	NDA AUTHORIZED GENERIC	Current
68382-702	POTASSIUM CHLORIDE	potassium chloride	Zydus Pharmaceuticals (USA) Inc.	NDA AUTHORIZED GENERIC	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
53987	SUPPL	2018-05-03
53979	SUPPL	2018-05-02
40787	SUPPL	2009-01-12
40786	SUPPL	2009-01-12
14953	SUPPL	2003-08-25