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N018238-001 | MICRO-K | POTASSIUM CHLORIDE | 8MEQ **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE, EXTENDED RELEASE / ORAL | RLD, Approved before 1982 | ||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| MICRO-K 10 | POTASSIUM CHLORIDE | 10MEQ **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 1984-05-14 |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| 2026-08 | N018238-001 | MICRO-K | 8MEQ **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE, EXTENDED RELEASE / ORAL | RLD, Approved before 1982 | 84e616aacf4f… | ||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| 2026-08 | N018238-002 | MICRO-K 10 | 10MEQ **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 1984-05-14 | 84e616aacf4f… | |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| 2026-07 | N018238-001 | MICRO-K | 8MEQ **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE, EXTENDED RELEASE / ORAL | RLD, Approved before 1982 | caaa826d4ba7… | ||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 | POTASSIUM CHLORIDE | Kesin Pharma Corporation | 440dcbbb-bb31-d3fd-e063-6294a90ab2f7 | 2025-09-01 | Warnings, Adverse reactions | POTASSIUM CHLORIDE |
| Potassium Chloride | POTASSIUM CHLORIDE | A-S Medication Solutions | 8f6ea056-5e10-4de1-97f0-55f0655a6f78 | 2025-08-27 | Warnings, Adverse reactions | POTASSIUM CHLORIDE |
| Potassium Chloride | POTASSIUM CHLORIDE | A-S Medication Solutions | 8757d093-747b-4e97-af6d-4064b16178b2 | 2025-08-27 | Warnings, Adverse reactions | POTASSIUM CHLORIDE |
| Potassium Chloride | POTASSIUM CHLORIDE | American Health Packaging | 149770d0-3a2c-4e75-80a3-ec842907920d | 2025-08-25 | Warnings, Adverse reactions | POTASSIUM CHLORIDE |
| Potassium Chloride | POTASSIUM CHLORIDE | Henry Schein, Inc. | bf8e8ac7-e6a8-4571-a0ea-7bcab89290f6 | 2025-08-12 | Warnings, Adverse reactions | POTASSIUM CHLORIDE |
| Potassium Chloride | POTASSIUM CHLORIDE | AvKARE | 3bdfced1-6e62-9e92-e063-6294a90a28aa | 2025-08-08 | Warnings, Adverse reactions | POTASSIUM CHLORIDE |
| Potassium Chloride Extended-Release | POTASSIUM CHLORIDE | Aphena Pharma Solutions - Tennessee, LLC | 3be29fcc-765e-8653-e063-6394a90a59d5 | 2025-08-08 | Warnings, Adverse reactions | POTASSIUM CHLORIDE |
| KLOR-CON | POTASSIUM CHLORIDE | Upsher-Smith Laboratories, LLC | 4340c3f2-ecf8-44cd-9b69-217f543e24e2 | 2025-08-08 | Warnings, Adverse reactions | POTASSIUM CHLORIDE |
| Potassium Chloride | POTASSIUM CHLORIDE | Slate Run Pharmaceuticals, LLC | 94ae03cc-b620-0dbb-e053-2a95a90a922c | 2025-08-07 | Warnings, Adverse reactions | POTASSIUM CHLORIDE |
| Potassium Chloride | POTASSIUM CHLORIDE | Slate Run Pharmaceuticals, LLC | 0cc57ece-f15a-4160-a5ea-8d6fa9f9e754 | 2025-08-07 | Warnings, Adverse reactions | POTASSIUM CHLORIDE |
| Potassium Chloride | POTASSIUM CHLORIDE | PD-Rx Pharmaceuticals, Inc. | 47a87fb6-5e61-41c9-b759-10f7c74a67ce | 2025-08-05 | Warnings, Adverse reactions | POTASSIUM CHLORIDE |
| POTASSIUM CHLORIDE | POTASSIUM CHLORIDE | American Health Packaging | 7956883f-0d31-4081-bbea-d9ea320a193b | 2025-08-04 | Warnings, Adverse reactions | POTASSIUM CHLORIDE |
| POTASSIUM CHLORIDE EXTENDED RELEASE | POTASSIUM CHLORIDE | Aphena Pharma Solutions - Tennessee, LLC | 3b403d60-4246-d765-e063-6394a90a12e8 | 2025-07-31 | Warnings, Adverse reactions | POTASSIUM CHLORIDE |
| POTASSIUM CHLORIDE | POTASSIUM CHLORIDE | A-S Medication Solutions | 162a8ab5-76cf-48fa-8487-7780ed65647e | 2025-07-31 | Warnings, Adverse reactions | POTASSIUM CHLORIDE |
| POTASSIUM CHLORIDE | POTASSIUM CHLORIDE | A-S Medication Solutions | 14db14ba-fd0d-4b2a-9f1c-a62b3b82306f | 2025-07-31 | Warnings, Adverse reactions | POTASSIUM CHLORIDE |
| Potassium Chloride | POTASSIUM CHLORIDE | AvKARE | 8baf3f25-c78b-6c08-e053-2995a90a667e | 2025-07-23 | Warnings, Adverse reactions | POTASSIUM CHLORIDE |
| Potassium Chloride | POTASSIUM CHLORIDE | AvKARE | 8bb030b7-104a-373b-e053-2995a90ab580 | 2025-07-23 | Warnings, Adverse reactions | POTASSIUM CHLORIDE |
| Potassium Chloride | POTASSIUM CHLORIDE | Guardian Drug Company | 296eda62-ea8e-7a0c-e063-6294a90a9274 | 2025-07-22 | Warnings, Adverse reactions | POTASSIUM CHLORIDE |
| Potassium Chloride | POTASSIUM CHLORIDE | Genus Lifesciences | 14cd12ee-a4a3-465a-9550-58c9ef0e4f21 | 2025-07-21 | Warnings, Adverse reactions | POTASSIUM CHLORIDE |
| Potassium chloride | POTASSIUM CHLORIDE | Camber Pharmaceuticals, Inc. | fb2f6e74-4c1f-40c5-88a1-b88c069d4c75 | 2025-07-17 | 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 |