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N018238-001 | MICRO-K | POTASSIUM CHLORIDE | 8MEQ **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE, EXTENDED RELEASE / ORAL | RLD, Approved before 1982 | ||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| MICRO-K 10 | POTASSIUM CHLORIDE | 10MEQ **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 1984-05-14 |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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | N018238-001 | MICRO-K | 8MEQ **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE, EXTENDED RELEASE / ORAL | RLD, Approved before 1982 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | N018238-002 | MICRO-K 10 | 10MEQ **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 1984-05-14 | 84e616aacf4f… | |
| 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| 2026-07 | N018238-001 | MICRO-K | 8MEQ **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE, EXTENDED RELEASE / ORAL | RLD, Approved before 1982 | caaa826d4ba7… | ||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… |
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 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 |
| Potassium Chloride | POTASSIUM CHLORIDE | A-S Medication Solutions | 2d67fc67-c99f-4df2-a1e7-4d369cce12c2 | 2026-02-23 | Warnings, Adverse reactions | POTASSIUM CHLORIDE |
| POTASSIUM CHLORIDE | POTASSIUM CHLORIDE | Major Pharmaceuticals | 33ad1eb2-1f05-461c-b01d-82dee4231556 | 2026-02-11 | Warnings, Adverse reactions | POTASSIUM CHLORIDE |
| Potassium Chloride | POTASSIUM CHLORIDE | Major Pharmaceuticals | 5c2e888c-2f1e-4d5a-a456-20774ca83302 | 2026-02-04 | Warnings, Adverse reactions | POTASSIUM CHLORIDE |
| Potassium Chloride Extended-Release | POTASSIUM CHLORIDE | Major Pharmaceuticals | 7d74652b-3513-4ebb-8b47-10b3603d04a7 | 2026-02-04 | Warnings, Adverse reactions | POTASSIUM CHLORIDE |
| POTASSIUM CHLORIDE EXTENDED RELEASE | POTASSIUM CHLORIDE | Rising Pharma Holdings, Inc. | 947c11ca-ca0c-42df-8cc5-3db06458ca5b | 2026-02-01 | Warnings, Adverse reactions | POTASSIUM CHLORIDE |
| POKONZA potassium chloride | POTASSIUM CHLORIDE | Carwin Pharmaceutical Associates, LLC | 2d938cbf-27aa-4f9c-a582-5564d3b72465 | 2026-01-22 | Warnings, Adverse reactions | POTASSIUM CHLORIDE |
| Potassium Chloride | POTASSIUM CHLORIDE | AvKARE | 755a4a08-04ff-d7d1-a6fc-b8aeff3ae2c6 | 2026-01-15 | Warnings, Adverse reactions | POTASSIUM CHLORIDE |
| Potassium Chloride | POTASSIUM CHLORIDE | Advagen Pharma Limited | d528c0c1-b81f-4f7a-8518-e6911b23c3eb | 2026-01-13 | Warnings, Adverse reactions | POTASSIUM CHLORIDE |
| Sore Throat 911 | POTASSIUM CHLORIDE | DelCorean, LLC | 9ff8ff03-5921-cb3c-e053-2a95a90a094b | 2026-01-13 | Warnings | POTASSIUM CHLORIDE |
| Potassium Chloride | POTASSIUM CHLORIDE | AvPAK | f32df7c0-33eb-e6d6-e053-2a95a90a2e8d | 2026-01-09 | Warnings, Adverse reactions | POTASSIUM CHLORIDE |
| Potassium Chloride | POTASSIUM CHLORIDE | Baxter Healthcare Corporation | 092ddee4-572d-4771-8d95-880cea01097e | 2026-01-09 | Warnings, Adverse reactions | POTASSIUM CHLORIDE |
| POTASSIUM CHLORIDE | POTASSIUM CHLORIDE | Advagen Pharma Limited | a9e9d134-55d0-47ae-925f-de07e7ffa4b8 | 2026-01-07 | Warnings, Adverse reactions | POTASSIUM CHLORIDE |
| POTASSIUM CHLORIDE | POTASSIUM CHLORIDE | Advagen Pharma Ltd. | f4497c26-da16-45b0-975d-81f2c2132704 | 2026-01-07 | Warnings, Adverse reactions | POTASSIUM CHLORIDE |
| Potassium Chloride | POTASSIUM CHLORIDE | Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. | 23b10bd6-11bc-495e-bb05-ec332a9b3f21 | 2026-01-06 | Warnings, Adverse reactions | POTASSIUM CHLORIDE |
| Potassium Chloride | POTASSIUM CHLORIDE | Northwind Health Company, LLC | f2b671c9-9874-2668-e053-2a95a90a1b46 | 2026-01-01 | Warnings, Adverse reactions | POTASSIUM CHLORIDE |
| Potassium Chloride | POTASSIUM CHLORIDE | Northwind Health Company, LLC | f3081031-8234-5732-e053-2995a90aebeb | 2026-01-01 | Warnings, Adverse reactions | POTASSIUM CHLORIDE |
| Potassium Chloride | POTASSIUM CHLORIDE | Northwind Health Company, LLC | dae7c63d-eef0-58d0-e053-2a95a90a667e | 2026-01-01 | Warnings, Adverse reactions | POTASSIUM CHLORIDE |
| Potassium Chloride | POTASSIUM CHLORIDE | Northwind Health Company, LLC | db4dc4ab-e0d4-7dc7-e053-2995a90ac46e | 2026-01-01 | Warnings, Adverse reactions | POTASSIUM CHLORIDE |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
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 |