Potassium Chloride
- Product NDC
- 69238-1067
- 11-digit product format
- 692381067
- Labeler code
- 69238
- Product ID
- 69238-1067_62f268dd-e0e5-4e01-a109-e807a6c9d1b5
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Potassium Chloride
- Dosage form
- TABLET, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Amneal Pharmaceuticals NY LLC
- Application
- ANDA212861
- Marketing category
- ANDA
- Marketing start
- 2020-05-11
- Marketing end
- 0000-00-00
- Substance
- POTASSIUM CHLORIDE
- Active strength
- 1125 mg/1
- Pharmacologic classes
- Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Osmotic Activity [MoA], Osmotic Laxative [EPC], Potassium Compounds [CS], Potassium Salt [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2023-12-31
- 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 | 69238-1067 | D | Discontinued by firm | 2026-08-17 | ||
| excluded package | package | 69238-1067 | 69238-1067-1 | D | Discontinued by firm | 2026-08-17 |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A212861-001 | POTASSIUM CHLORIDE | POTASSIUM CHLORIDE | 10MEQ | TABLET, EXTENDED RELEASE / ORAL | 2020-05-08 | ||
| A212861-002 | POTASSIUM CHLORIDE | POTASSIUM CHLORIDE | 15MEQ | TABLET, EXTENDED RELEASE / ORAL | 2020-05-08 | ||
| A212861-003 | POTASSIUM CHLORIDE | POTASSIUM CHLORIDE | 20MEQ | TABLET, EXTENDED RELEASE / ORAL | 2020-05-08 |
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 | A212861-001 | POTASSIUM CHLORIDE | 10MEQ | TABLET, EXTENDED RELEASE / ORAL | 2020-05-08 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A212861-002 | POTASSIUM CHLORIDE | 15MEQ | TABLET, EXTENDED RELEASE / ORAL | 2020-05-08 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A212861-003 | POTASSIUM CHLORIDE | 20MEQ | TABLET, EXTENDED RELEASE / ORAL | 2020-05-08 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A212861-001 | POTASSIUM CHLORIDE | 10MEQ | TABLET, EXTENDED RELEASE / ORAL | 2020-05-08 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A212861-002 | POTASSIUM CHLORIDE | 15MEQ | TABLET, EXTENDED RELEASE / ORAL | 2020-05-08 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A212861-003 | POTASSIUM CHLORIDE | 20MEQ | TABLET, EXTENDED RELEASE / ORAL | 2020-05-08 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A212861-001 | POTASSIUM CHLORIDE | 10MEQ | TABLET, EXTENDED RELEASE / ORAL | 2020-05-08 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A212861-002 | POTASSIUM CHLORIDE | 15MEQ | TABLET, EXTENDED RELEASE / ORAL | 2020-05-08 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A212861-003 | POTASSIUM CHLORIDE | 20MEQ | TABLET, EXTENDED RELEASE / ORAL | 2020-05-08 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A212861-001 | POTASSIUM CHLORIDE | 10MEQ | TABLET, EXTENDED RELEASE / ORAL | AB1 | 2020-05-08 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A212861-002 | POTASSIUM CHLORIDE | 15MEQ | TABLET, EXTENDED RELEASE / ORAL | 2020-05-08 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A212861-003 | POTASSIUM CHLORIDE | 20MEQ | TABLET, EXTENDED RELEASE / ORAL | AB1 | 2020-05-08 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A212861-001 | POTASSIUM CHLORIDE | 10MEQ | TABLET, EXTENDED RELEASE / ORAL | AB1 | 2020-05-08 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A212861-002 | POTASSIUM CHLORIDE | 15MEQ | TABLET, EXTENDED RELEASE / ORAL | 2020-05-08 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A212861-003 | POTASSIUM CHLORIDE | 20MEQ | TABLET, EXTENDED RELEASE / ORAL | AB1 | 2020-05-08 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A212861-001 | POTASSIUM CHLORIDE | 10MEQ | TABLET, EXTENDED RELEASE / ORAL | AB1 | 2020-05-08 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A212861-002 | POTASSIUM CHLORIDE | 15MEQ | TABLET, EXTENDED RELEASE / ORAL | 2020-05-08 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A212861-003 | POTASSIUM CHLORIDE | 20MEQ | TABLET, EXTENDED RELEASE / ORAL | AB1 | 2020-05-08 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A212861-001 | POTASSIUM CHLORIDE | 10MEQ | TABLET, EXTENDED RELEASE / ORAL | AB1 | 2020-05-08 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A212861-002 | POTASSIUM CHLORIDE | 15MEQ | TABLET, EXTENDED RELEASE / ORAL | 2020-05-08 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A212861-003 | POTASSIUM CHLORIDE | 20MEQ | TABLET, EXTENDED RELEASE / ORAL | AB1 | 2020-05-08 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A212861-001 | POTASSIUM CHLORIDE | 10MEQ | TABLET, EXTENDED RELEASE / ORAL | AB1 | 2020-05-08 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A212861-002 | POTASSIUM CHLORIDE | 15MEQ | TABLET, EXTENDED RELEASE / ORAL | 2020-05-08 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A212861-003 | POTASSIUM CHLORIDE | 20MEQ | TABLET, EXTENDED RELEASE / ORAL | AB1 | 2020-05-08 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A212861-001 | POTASSIUM CHLORIDE | 10MEQ | TABLET, EXTENDED RELEASE / ORAL | AB1 | 2020-05-08 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A212861-002 | POTASSIUM CHLORIDE | 15MEQ | TABLET, EXTENDED RELEASE / ORAL | 2020-05-08 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A212861-003 | POTASSIUM CHLORIDE | 20MEQ | TABLET, EXTENDED RELEASE / ORAL | AB1 | 2020-05-08 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A212861-001 | POTASSIUM CHLORIDE | 10MEQ | TABLET, EXTENDED RELEASE / ORAL | AB1 | 2020-05-08 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A212861-002 | POTASSIUM CHLORIDE | 15MEQ | TABLET, EXTENDED RELEASE / ORAL | 2020-05-08 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A212861-003 | POTASSIUM CHLORIDE | 20MEQ | TABLET, EXTENDED RELEASE / ORAL | AB1 | 2020-05-08 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A212861-001 | POTASSIUM CHLORIDE | 10MEQ | TABLET, EXTENDED RELEASE / ORAL | AB1 | 2020-05-08 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A212861-002 | POTASSIUM CHLORIDE | 15MEQ | TABLET, EXTENDED RELEASE / ORAL | 2020-05-08 | d06236e962d9… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A212861-003 | POTASSIUM CHLORIDE | 20MEQ | TABLET, EXTENDED RELEASE / ORAL | AB1 | 2020-05-08 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A212861-001 | POTASSIUM CHLORIDE | 10MEQ | TABLET, EXTENDED RELEASE / ORAL | AB1 | 2020-05-08 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A212861-002 | POTASSIUM CHLORIDE | 15MEQ | TABLET, EXTENDED RELEASE / ORAL | 2020-05-08 | 79d66fd596c7… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A212861-003 | POTASSIUM CHLORIDE | 20MEQ | TABLET, EXTENDED RELEASE / ORAL | AB1 | 2020-05-08 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A212861-001 | POTASSIUM CHLORIDE | 10MEQ | TABLET, EXTENDED RELEASE / ORAL | AB1 | 2020-05-08 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A212861-002 | POTASSIUM CHLORIDE | 15MEQ | TABLET, EXTENDED RELEASE / ORAL | 2020-05-08 | 301d65b070ca… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A212861-003 | POTASSIUM CHLORIDE | 20MEQ | TABLET, EXTENDED RELEASE / ORAL | AB1 | 2020-05-08 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A212861-001 | POTASSIUM CHLORIDE | 10MEQ | TABLET, EXTENDED RELEASE / ORAL | AB1 | 2020-05-08 | 1e350fbaab3a… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2025-08-23 18:47 UTC | 2025-08 | A212861-001 | AB1 | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A212861-003 | AB1 | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A212861-001 | AB1 | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A212861-003 | AB1 | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A212861-001 | AB1 | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A212861-003 | AB1 | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A212861-001 | AB1 | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A212861-003 | AB1 | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A212861-001 | AB1 | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A212861-003 | AB1 | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A212861-001 | AB1 | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A212861-003 | AB1 | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A212861-001 | AB1 | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A212861-003 | AB1 | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A212861-001 | AB1 | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A212861-003 | AB1 | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A212861-001 | AB1 | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A212861-003 | AB1 | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A212861-001 | AB1 | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A212861-003 | AB1 | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A212861-001 | AB1 | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A212861-003 | AB1 | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | A212861-001 | AB1 | 1 | 8072bd15b7f6… |
| 2024-05-31 18:47 UTC | 2024-05 | A212861-003 | AB1 | 1 | 8072bd15b7f6… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A212861-001 | AB1 | 1 | 5c6f7cd8ea54… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A212861-003 | AB1 | 1 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | A212861-001 | AB1 | 1 | 5d02ea3f76ae… |
| 2022-04-08 23:34 UTC | 2022-04 | A212861-003 | AB1 | 1 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | A212861-001 | AB1 | 1 | 4b0b4de00fa7… |
| 2022-04-04 05:41 UTC | 2022-04 | A212861-003 | AB1 | 1 | 4b0b4de00fa7… |
| 2022-03-09 01:35 UTC | 2022-03 | A212861-001 | AB1 | 1 | bb7c543d1eb4… |
| 2022-03-09 01:35 UTC | 2022-03 | A212861-003 | AB1 | 1 | bb7c543d1eb4… |
| 2021-12-28 21:50 UTC | 2021-12 | A212861-001 | AB1 | 1 | 782e0a99824c… |
| 2021-12-28 21:50 UTC | 2021-12 | A212861-003 | AB1 | 1 | 782e0a99824c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A212861-001 | AB1 | 1 | 87673890dc5c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A212861-003 | AB1 | 1 | 87673890dc5c… |
| 2021-03-12 10:30 UTC | 2021-03 | A212861-001 | AB1 | 1 | 5aa47cf7b7d7… |
| 2021-03-12 10:30 UTC | 2021-03 | A212861-003 | AB1 | 1 | 5aa47cf7b7d7… |
| 2020-12-22 03:56 UTC | 2020-12 | A212861-001 | AB1 | 1 | 8869cabd3fbd… |
| 2020-12-22 03:56 UTC | 2020-12 | A212861-003 | AB1 | 1 | 8869cabd3fbd… |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 69238-1067 | POTASSIUM CHLORIDE TABLET, EXTENDED RELEASE [AMNEAL PHARMACEUTICALS NY LLC] | 12 | Legacy NDC | 20231231_a0bed01f-cf33-4a2f-b9ae-1cbb2f85665f.zip |
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 | Major Pharmaceuticals | 7c2274f2-5a7f-4a4a-8b7b-44f6ef9a84a4 | 2025-09-05 | Warnings, Adverse reactions | 212861 ANDA212861 |
| Potassium Chloride | POTASSIUM CHLORIDE | A-S Medication Solutions | 5aa0adf8-7b84-4cb0-be31-5c3333a6cc44 | 2023-12-11 | Warnings, Adverse reactions | 212861 ANDA212861 |
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 69238-1067-1 | 69238106701 | 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (69238-1067-1) | 2020-05-11 | 0000-00-00 | No | No | Current |