POTASSIUM CHLORIDE
- Product NDC
- 43602-283
- 11-digit product format
- 436020283
- Labeler code
- 43602
- Product ID
- 43602-283_ddde8a6a-992e-4bc4-9fc6-da9dfc08e092
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Potassium CHLORIDE
- Dosage form
- TABLET, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Ascent Pharmaceuticals, Inc.
- Application
- ANDA214422
- Marketing category
- ANDA
- Marketing start
- 2020-12-30
- Marketing end
- 0000-00-00
- Substance
- POTASSIUM CHLORIDE
- Active strength
- 750 mg/1
- Pharmacologic classes
- Potassium Compounds [CS],Potassium Salt [EPC],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2022-12-31
- Current FDA listing
- Historical FDA.report record
NDC auxiliary status#
These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.
| Dataset | Scope | Product NDC | Package NDC | Code | Status | Reporting period | Source date |
|---|---|---|---|---|---|---|---|
| excluded product | product | 43602-283 | D | Discontinued by firm | 2026-08-17 | ||
| excluded package | package | 43602-283 | 43602-283-05 | D | Discontinued by firm | 2026-08-17 | |
| excluded package | package | 43602-283 | 43602-283-30 | D | Discontinued by firm | 2026-08-17 |
Observed NDC auxiliary status history#
This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
| Captured / source date | Dataset | Scope | Product NDC | Package NDC | Code | Status | Reporting period | Archive | Snapshot | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|---|---|
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded product | product | 43602-283 | D | Discontinued by firm | excluded / ndc_excluded.zip | d630ba8d3edf… | 732f749b63fb… | ||
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 43602-283 | 43602-283-30 | D | Discontinued by firm | excluded / ndc_excluded.zip | d630ba8d3edf… | 732f749b63fb… | |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 43602-283 | 43602-283-05 | D | Discontinued by firm | excluded / ndc_excluded.zip | d630ba8d3edf… | 732f749b63fb… |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A214422-001 | POTASSIUM CHLORIDE | POTASSIUM CHLORIDE | 10MEQ | TABLET, EXTENDED RELEASE / ORAL | AB1 | 2020-12-29 | |
| A214422-002 | POTASSIUM CHLORIDE | POTASSIUM CHLORIDE | 15MEQ | TABLET, EXTENDED RELEASE / ORAL | AB1 | 2020-12-29 | |
| A214422-003 | POTASSIUM CHLORIDE | POTASSIUM CHLORIDE | 20MEQ | TABLET, EXTENDED RELEASE / ORAL | AB1 | 2020-12-29 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A214422-001 | AB1 |
| A214422-002 | AB1 |
| A214422-003 | AB1 |
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 | A214422-001 | POTASSIUM CHLORIDE | 10MEQ | TABLET, EXTENDED RELEASE / ORAL | AB1 | 2020-12-29 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A214422-002 | POTASSIUM CHLORIDE | 15MEQ | TABLET, EXTENDED RELEASE / ORAL | AB1 | 2020-12-29 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A214422-003 | POTASSIUM CHLORIDE | 20MEQ | TABLET, EXTENDED RELEASE / ORAL | AB1 | 2020-12-29 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | A214422-001 | POTASSIUM CHLORIDE | 10MEQ | TABLET, EXTENDED RELEASE / ORAL | AB1 | 2020-12-29 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A214422-002 | POTASSIUM CHLORIDE | 15MEQ | TABLET, EXTENDED RELEASE / ORAL | AB1 | 2020-12-29 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A214422-003 | POTASSIUM CHLORIDE | 20MEQ | TABLET, EXTENDED RELEASE / ORAL | AB1 | 2020-12-29 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A214422-001 | POTASSIUM CHLORIDE | 10MEQ | TABLET, EXTENDED RELEASE / ORAL | AB1 | 2020-12-29 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A214422-002 | POTASSIUM CHLORIDE | 15MEQ | TABLET, EXTENDED RELEASE / ORAL | AB1 | 2020-12-29 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A214422-003 | POTASSIUM CHLORIDE | 20MEQ | TABLET, EXTENDED RELEASE / ORAL | AB1 | 2020-12-29 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A214422-001 | POTASSIUM CHLORIDE | 10MEQ | TABLET, EXTENDED RELEASE / ORAL | AB1 | 2020-12-29 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A214422-002 | POTASSIUM CHLORIDE | 15MEQ | TABLET, EXTENDED RELEASE / ORAL | AB1 | 2020-12-29 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A214422-003 | POTASSIUM CHLORIDE | 20MEQ | TABLET, EXTENDED RELEASE / ORAL | AB1 | 2020-12-29 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A214422-001 | POTASSIUM CHLORIDE | 10MEQ | TABLET, EXTENDED RELEASE / ORAL | AB1 | 2020-12-29 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A214422-002 | POTASSIUM CHLORIDE | 15MEQ | TABLET, EXTENDED RELEASE / ORAL | AB1 | 2020-12-29 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A214422-003 | POTASSIUM CHLORIDE | 20MEQ | TABLET, EXTENDED RELEASE / ORAL | AB1 | 2020-12-29 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A214422-001 | POTASSIUM CHLORIDE | 10MEQ | TABLET, EXTENDED RELEASE / ORAL | AB1 | 2020-12-29 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A214422-002 | POTASSIUM CHLORIDE | 15MEQ | TABLET, EXTENDED RELEASE / ORAL | AB1 | 2020-12-29 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A214422-003 | POTASSIUM CHLORIDE | 20MEQ | TABLET, EXTENDED RELEASE / ORAL | AB1 | 2020-12-29 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A214422-001 | POTASSIUM CHLORIDE | 10MEQ | TABLET, EXTENDED RELEASE / ORAL | AB1 | 2020-12-29 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A214422-002 | POTASSIUM CHLORIDE | 15MEQ | TABLET, EXTENDED RELEASE / ORAL | AB1 | 2020-12-29 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A214422-003 | POTASSIUM CHLORIDE | 20MEQ | TABLET, EXTENDED RELEASE / ORAL | AB1 | 2020-12-29 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A214422-001 | POTASSIUM CHLORIDE | 10MEQ | TABLET, EXTENDED RELEASE / ORAL | AB1 | 2020-12-29 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A214422-002 | POTASSIUM CHLORIDE | 15MEQ | TABLET, EXTENDED RELEASE / ORAL | AB1 | 2020-12-29 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A214422-003 | POTASSIUM CHLORIDE | 20MEQ | TABLET, EXTENDED RELEASE / ORAL | AB1 | 2020-12-29 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A214422-001 | POTASSIUM CHLORIDE | 10MEQ | TABLET, EXTENDED RELEASE / ORAL | AB1 | 2020-12-29 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A214422-002 | POTASSIUM CHLORIDE | 15MEQ | TABLET, EXTENDED RELEASE / ORAL | AB1 | 2020-12-29 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A214422-003 | POTASSIUM CHLORIDE | 20MEQ | TABLET, EXTENDED RELEASE / ORAL | AB1 | 2020-12-29 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A214422-001 | POTASSIUM CHLORIDE | 10MEQ | TABLET, EXTENDED RELEASE / ORAL | AB1 | 2020-12-29 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A214422-002 | POTASSIUM CHLORIDE | 15MEQ | TABLET, EXTENDED RELEASE / ORAL | AB1 | 2020-12-29 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A214422-003 | POTASSIUM CHLORIDE | 20MEQ | TABLET, EXTENDED RELEASE / ORAL | AB1 | 2020-12-29 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A214422-001 | POTASSIUM CHLORIDE | 10MEQ | TABLET, EXTENDED RELEASE / ORAL | AB1 | 2020-12-29 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A214422-002 | POTASSIUM CHLORIDE | 15MEQ | TABLET, EXTENDED RELEASE / ORAL | AB1 | 2020-12-29 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A214422-003 | POTASSIUM CHLORIDE | 20MEQ | TABLET, EXTENDED RELEASE / ORAL | AB1 | 2020-12-29 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A214422-001 | POTASSIUM CHLORIDE | 10MEQ | TABLET, EXTENDED RELEASE / ORAL | AB1 | 2020-12-29 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A214422-002 | POTASSIUM CHLORIDE | 15MEQ | TABLET, EXTENDED RELEASE / ORAL | AB1 | 2020-12-29 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A214422-003 | POTASSIUM CHLORIDE | 20MEQ | TABLET, EXTENDED RELEASE / ORAL | AB1 | 2020-12-29 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A214422-001 | POTASSIUM CHLORIDE | 10MEQ | TABLET, EXTENDED RELEASE / ORAL | AB1 | 2020-12-29 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A214422-002 | POTASSIUM CHLORIDE | 15MEQ | TABLET, EXTENDED RELEASE / ORAL | AB1 | 2020-12-29 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A214422-003 | POTASSIUM CHLORIDE | 20MEQ | TABLET, EXTENDED RELEASE / ORAL | AB1 | 2020-12-29 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A214422-001 | POTASSIUM CHLORIDE | 10MEQ | TABLET, EXTENDED RELEASE / ORAL | AB1 | 2020-12-29 | 1e350fbaab3a… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-08-18 06:07:40 | 2026-07 | A214422-001 | AB1 | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A214422-002 | AB1 | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A214422-003 | AB1 | 1 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | A214422-001 | AB1 | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A214422-002 | AB1 | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A214422-003 | AB1 | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A214422-001 | AB1 | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A214422-002 | AB1 | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A214422-003 | AB1 | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A214422-001 | AB1 | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A214422-002 | AB1 | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A214422-003 | AB1 | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A214422-001 | AB1 | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A214422-002 | AB1 | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A214422-003 | AB1 | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A214422-001 | AB1 | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A214422-002 | AB1 | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A214422-003 | AB1 | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A214422-001 | AB1 | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A214422-002 | AB1 | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A214422-003 | AB1 | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A214422-001 | AB1 | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A214422-002 | AB1 | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A214422-003 | AB1 | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A214422-001 | AB1 | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A214422-002 | AB1 | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A214422-003 | AB1 | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A214422-001 | AB1 | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A214422-002 | AB1 | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A214422-003 | AB1 | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A214422-001 | AB1 | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A214422-002 | AB1 | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A214422-003 | AB1 | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A214422-001 | AB1 | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A214422-002 | AB1 | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A214422-003 | AB1 | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A214422-001 | AB1 | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A214422-002 | AB1 | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A214422-003 | AB1 | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A214422-001 | AB1 | 1 | 1e350fbaab3a… |
DailyMed Product Concepts#
DailyMed Dashboard NDC Coverage#
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 | Northstar Rx LLC | b19a3fbf-cdbb-4f86-ac61-5dfb07e0a51a | 2026-05-18 | Warnings, Adverse reactions | 214422 ANDA214422 |
| POTASSIUM CHLORIDE | POTASSIUM CHLORIDE | Aphena Pharma Solutions - Tennessee, LLC | 61fe55c2-fc9a-4fae-899a-06601baa78e1 | 2025-11-19 | Warnings, Adverse reactions | 214422 ANDA214422 |
| POTASSIUM CHLORIDE | POTASSIUM CHLORIDE | A-S Medication Solutions | 162a8ab5-76cf-48fa-8487-7780ed65647e | 2025-07-31 | Warnings, Adverse reactions | 214422 ANDA214422 |
| POTASSIUM CHLORIDE | POTASSIUM CHLORIDE | A-S Medication Solutions | 14db14ba-fd0d-4b2a-9f1c-a62b3b82306f | 2025-07-31 | Warnings, Adverse reactions | 214422 ANDA214422 |
| POTASSIUM CHLORIDE | POTASSIUM CHLORIDE | Bryant Ranch Prepack | d396477a-6b15-4782-9c85-b9663b83c484 | 2024-05-23 | Warnings, Adverse reactions | 214422 ANDA214422 |
| POTASSIUM CHLORIDE | POTASSIUM CHLORIDE | XLCare Pharmaceuticals, Inc. | 7fd82f08-8ad0-4ee2-8eb6-5c973f98baee | 2024-05-21 | Warnings, Adverse reactions | 214422 ANDA214422 |
| POTASSIUM CHLORIDE | POTASSIUM CHLORIDE | Camber Pharmaceuticals, Inc. | b1e827aa-b2fb-4fa5-984d-ddd94338ff53 | 2024-05-14 | Warnings, Adverse reactions | 214422 ANDA214422 |
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 43602-283-05 | 43602028305 | 500 TABLET, EXTENDED RELEASE in 1 BOTTLE (43602-283-05) | 2020-12-30 | 0000-00-00 | No | No | Current |
| 43602-283-30 | 43602028330 | 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (43602-283-30) | 2020-12-30 | 0000-00-00 | No | No | Current |