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N018238-001 | MICRO-K | POTASSIUM CHLORIDE | 8MEQ **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE, EXTENDED RELEASE / ORAL | RLD, Approved before 1982 | ||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| MICRO-K 10 | POTASSIUM CHLORIDE | 10MEQ **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 1984-05-14 |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| 2026-08 | N018238-001 | MICRO-K | 8MEQ **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE, EXTENDED RELEASE / ORAL | RLD, Approved before 1982 | 84e616aacf4f… | ||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| 2026-08 | N018238-002 | MICRO-K 10 | 10MEQ **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 1984-05-14 | 84e616aacf4f… | |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| 2026-07 | N018238-001 | MICRO-K | 8MEQ **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE, EXTENDED RELEASE / ORAL | RLD, Approved before 1982 | caaa826d4ba7… | ||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 | Camber Pharmaceuticals, Inc. | b1e827aa-b2fb-4fa5-984d-ddd94338ff53 | 2024-05-14 | Warnings, Adverse reactions | POTASSIUM CHLORIDE |
| POTASSIUM CHLORIDE | POTASSIUM CHLORIDE | Bryant Ranch Prepack | 65e30d1a-50e9-4b84-ad4d-daaea91eab4b | 2024-04-09 | Warnings, Adverse reactions | POTASSIUM CHLORIDE |
| POKONZA | POTASSIUM CHLORIDE | Carwin Pharmaceutical Associates, LLC | 7c5cc705-e5da-4487-86c9-9d545a95afb4 | 2024-03-22 | Warnings, Adverse reactions | POTASSIUM CHLORIDE |
| POTASSIUM CHLORIDE | POTASSIUM CHLORIDE | Kesin Pharma Corporation | 25c2b417-eeea-4ba6-8eb9-a7d8a08c6093 | 2024-03-12 | Warnings, Adverse reactions | POTASSIUM CHLORIDE |
| Potassium Chloride | POTASSIUM CHLORIDE | Proficient Rx LP | 61daa681-05a0-4b2f-a6d0-c6fc1044f521 | 2024-02-01 | Warnings, Adverse reactions | POTASSIUM CHLORIDE |
| Potassium Chloride | POTASSIUM CHLORIDE | Lupin Pharmaceuticals,Inc. | fe08221d-74d5-490a-8db4-eaf3ed20b289 | 2024-01-30 | Warnings, Adverse reactions | POTASSIUM CHLORIDE |
| Potassium Chloride | POTASSIUM CHLORIDE | American Health Packaging | a67f5ba7-ac23-4bdc-9563-cb7fd049a951 | 2024-01-22 | Warnings, Adverse reactions | POTASSIUM CHLORIDE |
| POTASSIUM CHLORIDE | POTASSIUM CHLORIDE | Sun Pharmaceutical Industries, Inc. | 4d90d03d-7f0e-4d49-9e80-628dbc7165c0 | 2024-01-10 | Warnings, Adverse reactions | POTASSIUM CHLORIDE |
| Potassium Chloride Extended-Release | POTASSIUM CHLORIDE | Sun Pharmaceutical Industries, Inc. | 8ed8ea55-8b15-f718-e053-2a95a90a587a | 2024-01-10 | Warnings, Adverse reactions | POTASSIUM CHLORIDE |
| Potassium Chloride Extended-Release | POTASSIUM CHLORIDE | Proficient Rx LP | d0ce0bdf-5f24-4093-813f-881c61d7fcc7 | 2024-01-01 | Warnings, Adverse reactions | POTASSIUM CHLORIDE |
| POTASSIUM CHLORIDE EXTENDED RELEASE | POTASSIUM CHLORIDE | Adare Pharmaceuticals Inc | 22edb0e6-4e45-4e91-aead-3581cca293a0 | 2023-12-20 | Warnings, Adverse reactions | POTASSIUM CHLORIDE |
| Potassium Chloride | POTASSIUM CHLORIDE | A-S Medication Solutions | 5aa0adf8-7b84-4cb0-be31-5c3333a6cc44 | 2023-12-11 | Warnings, Adverse reactions | POTASSIUM CHLORIDE |
| Potassium Chloride | POTASSIUM CHLORIDE | A-S Medication Solutions | 5c4b0be5-625e-435f-9d2c-9d8fb407a8ea | 2023-12-05 | Warnings, Adverse reactions | POTASSIUM CHLORIDE |
| Potassium Chloride | POTASSIUM CHLORIDE | A-S Medication Solutions | d033c3b3-3ed6-4f23-a555-bae40cf0c48f | 2023-12-05 | Warnings, Adverse reactions | POTASSIUM CHLORIDE |
| Potassium Chloride | POTASSIUM CHLORIDE | Sun Pharmaceutical Industries, Inc. | 0a1f2f64-3b0b-5e5c-e063-6294a90a7185 | 2023-11-14 | Warnings, Adverse reactions | POTASSIUM CHLORIDE |
| Kali muriaticum | POTASSIUM CHLORIDE | Boiron | 86093c75-6de0-bb16-e053-2991aa0ab6ef | 2023-11-13 | POTASSIUM CHLORIDE | |
| Kali muriaticum | POTASSIUM CHLORIDE | Boiron | 86090ebb-0fb2-2c9c-e053-2a91aa0a0561 | 2023-11-13 | POTASSIUM CHLORIDE | |
| Kali muriaticum | POTASSIUM CHLORIDE | Boiron | 8608a8de-8133-1d4b-e053-2991aa0a907a | 2023-11-13 | POTASSIUM CHLORIDE | |
| Kali muriaticum | POTASSIUM CHLORIDE | Boiron | 860887e7-7eaf-78c2-e053-2991aa0a9a75 | 2023-11-13 | POTASSIUM CHLORIDE | |
| Kali muriaticum | POTASSIUM CHLORIDE | Boiron | 86086aab-c411-7cf2-e053-2991aa0a81bd | 2023-11-13 | 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 |