Application 018238
- Type
- NDA
- Sponsor
- NESHER PHARMS
Application Products#
| 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 |
Orange Book products#
| 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N018238-001 | MICRO-K | POTASSIUM CHLORIDE | 8MEQ **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE, EXTENDED RELEASE / ORAL | RLD, Approved before 1982 | ||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| MICRO-K 10 | POTASSIUM CHLORIDE | 10MEQ **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 1984-05-14 |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.
| Captured | Edition | Application-product | Trade name | Strength | Dosage form / route | Product TE source text | RLD / RS | Approval date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-08-18 06:07:40 | 2026-07 | N018238-001 | MICRO-K | 8MEQ **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE, EXTENDED RELEASE / ORAL | RLD, Approved before 1982 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | N018238-002 | MICRO-K 10 | 10MEQ **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 1984-05-14 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | N018238-001 | MICRO-K | 8MEQ **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE, EXTENDED RELEASE / ORAL | RLD, Approved before 1982 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | 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 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | 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 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | 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 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | 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 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | 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 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | 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 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | 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 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | 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 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | 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 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | 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 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | 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 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | 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 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | 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 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | 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 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | 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 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | 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 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | 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 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | 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 | d06236e962d9… | ||
| 2024-10-29 15:01 UTC | 2024-10 | 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 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | 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 | 79d66fd596c7… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | 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 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | 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 | 301d65b070ca… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | 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 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | 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 | 1e350fbaab3a… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | 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 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | 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 | 8072bd15b7f6… | ||
| 2024-05-31 18:47 UTC | 2024-05 | 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 | 8072bd15b7f6… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | 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 | 5c6f7cd8ea54… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | 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 | 5c6f7cd8ea54… | |
| 2022-04-08 23:34 UTC | 2022-04 | N018238-001 | MICRO-K | 8MEQ | CAPSULE, EXTENDED RELEASE / ORAL | RLD, Approved before 1982 | 5d02ea3f76ae… | ||
| 2022-04-08 23:34 UTC | 2022-04 | N018238-002 | MICRO-K 10 | 10MEQ | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 1984-05-14 | 5d02ea3f76ae… | |
| 2022-04-04 05:41 UTC | 2022-04 | N018238-001 | MICRO-K | 8MEQ | CAPSULE, EXTENDED RELEASE / ORAL | RLD, Approved before 1982 | 4b0b4de00fa7… | ||
| 2022-04-04 05:41 UTC | 2022-04 | N018238-002 | MICRO-K 10 | 10MEQ | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 1984-05-14 | 4b0b4de00fa7… | |
| 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… |
Observed Orange Book normalized TE history#
| 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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Potassium Chloride | POTASSIUM CHLORIDE | Amneal Pharmaceuticals LLC | f9965f73-e189-423f-bd10-c4a0ed12b485 | 2026-08-01 | Warnings, Adverse reactions | POTASSIUM CHLORIDE |
| Potassium Chloride | POTASSIUM CHLORIDE | REMEDYREPACK INC. | 16c775e4-0dd8-4e9f-b2bf-dd2b639374cf | 2026-07-31 | Warnings, Adverse reactions | POTASSIUM CHLORIDE |
| Potassium Chloride Extended-Release | POTASSIUM CHLORIDE | REMEDYREPACK INC. | 7ec22e8e-6643-44fe-804d-ca0b0b266663 | 2026-07-31 | Warnings, Adverse reactions | POTASSIUM CHLORIDE |
| Potassium Chloride Extended-Release | POTASSIUM CHLORIDE | Upsher-Smith Laboratories, LLC | 02707146-331f-4511-a187-0152fc8bca85 | 2026-07-24 | Warnings, Adverse reactions | POTASSIUM CHLORIDE |
| Potassium Chloride | POTASSIUM CHLORIDE | Major Pharmaceuticals | 6c080e51-4eb7-4e96-b29f-eb1cce381304 | 2026-07-14 | Warnings, Adverse reactions | POTASSIUM CHLORIDE |
| Potassium Chloride | POTASSIUM CHLORIDE | ATLANTIC BIOLOGICALS CORP. | 104ccc91-2aaf-4bb7-bb64-77c29413f60e | 2026-07-10 | Warnings, Adverse reactions | POTASSIUM CHLORIDE |
| potassium chloride | POTASSIUM CHLORIDE | Glenmark Pharmaceuticals Inc., USA | 63bedd99-0596-49d2-ad04-d1d8ac15cc42 | 2026-07-08 | Warnings, Adverse reactions | POTASSIUM CHLORIDE |
| POTASSIUM CHLORIDE | POTASSIUM CHLORIDE | Hospira, Inc. | 559a0a8c-a8fe-40a5-b196-21f9308780ab | 2026-07-01 | Warnings, Adverse reactions | POTASSIUM CHLORIDE |
| Potassium Chloride | POTASSIUM CHLORIDE | A-S Medication Solutions | 30527e49-6648-44f3-97b2-9c51783ac003 | 2026-07-01 | Warnings, Adverse reactions | POTASSIUM CHLORIDE |
| Potassium Chloride | POTASSIUM CHLORIDE | Amneal Pharmaceuticals NY LLC | 590dd25c-c4cb-489a-a09b-eccbf1d37c1f | 2026-07-01 | Warnings, Adverse reactions | POTASSIUM CHLORIDE |
| Potassium Chloride | POTASSIUM CHLORIDE | St. Mary's Medical Park Pharmacy | 549c9d28-bf8b-2dc2-e063-6294a90abe7b | 2026-06-19 | Warnings, Adverse reactions | POTASSIUM CHLORIDE |
| Potassium Chloride | POTASSIUM CHLORIDE | REMEDYREPACK INC. | f75713cf-6902-4160-94cb-335a1ecdbbbe | 2026-06-12 | Warnings, Adverse reactions | POTASSIUM CHLORIDE |
| Potassium Chloride | POTASSIUM CHLORIDE | Northwind Health Company, LLC | 548953ac-31c5-a181-e063-6294a90a3b77 | 2026-06-12 | Warnings, Adverse reactions | POTASSIUM CHLORIDE |
| Potassium Chloride | POTASSIUM CHLORIDE | Redpharm Drug | 5261dfe5-d62b-d618-e063-6294a90a96e7 | 2026-05-22 | Warnings, Adverse reactions | POTASSIUM CHLORIDE |
| Potassium Chloride | POTASSIUM CHLORIDE | Aphena Pharma Solutions - Tennessee, LLC | d2e84d34-e042-477f-9944-3fcb95301217 | 2026-05-20 | Warnings, Adverse reactions | POTASSIUM CHLORIDE |
| potassium chloride | POTASSIUM CHLORIDE | Northstar Rx LLC | b19a3fbf-cdbb-4f86-ac61-5dfb07e0a51a | 2026-05-18 | Warnings, Adverse reactions | POTASSIUM CHLORIDE |
| Potassium Chloride | POTASSIUM CHLORIDE | Bryant Ranch Prepack | 9088ca44-5585-4551-8e2c-168f306520d4 | 2026-03-30 | Warnings, Adverse reactions | POTASSIUM CHLORIDE |
| Potassium Chloride | POTASSIUM CHLORIDE | Ajenat Pharmaceuticals LLC | ab066a84-5455-419e-a1da-354a3f15a73d | 2026-03-23 | Warnings, Adverse reactions | POTASSIUM CHLORIDE |
| Potassium Chloride Extended-Release | POTASSIUM CHLORIDE | Bryant Ranch Prepack | ff44dcd5-b255-4d80-83ee-3c8f922c99eb | 2026-03-11 | Warnings, Adverse reactions | POTASSIUM CHLORIDE |
| Potassium Chloride | POTASSIUM CHLORIDE | Amneal Pharmaceuticals of New York LLC | cd56e147-92d6-46ce-ae00-63fac08d49b5 | 2026-03-03 | Warnings, Adverse reactions | POTASSIUM CHLORIDE |
NDC Listings For This Application#
| 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 |