Potassium Chloride
- Product NDC
- 55289-218
- 11-digit product format
- 552890218
- Labeler code
- 55289
- Product ID
- 55289-218_e9adecd3-6dba-d489-e053-2a95a90a27c0
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Potassium Chloride
- Dosage form
- CAPSULE, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- PD-Rx Pharmaceuticals, Inc.
- Application
- ANDA077419
- Marketing category
- ANDA
- Marketing start
- 2008-08-25
- Marketing end
- 0000-00-00
- Substance
- POTASSIUM CHLORIDE
- Active strength
- 750 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 | 55289-218 | D | Discontinued by firm | 2026-08-03 | ||
| excluded package | package | 55289-218 | 55289-218-30 | D | Discontinued by firm | 2026-08-03 |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A077419-001 | POTASSIUM CHLORIDE | POTASSIUM CHLORIDE | 8MEQ | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2008-06-02 | |
| A077419-002 | POTASSIUM CHLORIDE | POTASSIUM CHLORIDE | 10MEQ | CAPSULE, EXTENDED RELEASE / ORAL | AB | RS | 2008-06-02 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A077419-001 | AB |
| A077419-002 | AB |
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | A077419-001 | POTASSIUM CHLORIDE | 8MEQ | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2008-06-02 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A077419-002 | POTASSIUM CHLORIDE | 10MEQ | CAPSULE, EXTENDED RELEASE / ORAL | AB | RS | 2008-06-02 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A077419-001 | POTASSIUM CHLORIDE | 8MEQ | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2008-06-02 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A077419-002 | POTASSIUM CHLORIDE | 10MEQ | CAPSULE, EXTENDED RELEASE / ORAL | AB | RS | 2008-06-02 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A077419-001 | POTASSIUM CHLORIDE | 8MEQ | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2008-06-02 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A077419-002 | POTASSIUM CHLORIDE | 10MEQ | CAPSULE, EXTENDED RELEASE / ORAL | AB | RS | 2008-06-02 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A077419-001 | POTASSIUM CHLORIDE | 8MEQ | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2008-06-02 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A077419-002 | POTASSIUM CHLORIDE | 10MEQ | CAPSULE, EXTENDED RELEASE / ORAL | AB | RS | 2008-06-02 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A077419-001 | POTASSIUM CHLORIDE | 8MEQ | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2008-06-02 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A077419-002 | POTASSIUM CHLORIDE | 10MEQ | CAPSULE, EXTENDED RELEASE / ORAL | AB | RS | 2008-06-02 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A077419-001 | POTASSIUM CHLORIDE | 8MEQ | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2008-06-02 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A077419-002 | POTASSIUM CHLORIDE | 10MEQ | CAPSULE, EXTENDED RELEASE / ORAL | AB | RS | 2008-06-02 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A077419-001 | POTASSIUM CHLORIDE | 8MEQ | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2008-06-02 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A077419-002 | POTASSIUM CHLORIDE | 10MEQ | CAPSULE, EXTENDED RELEASE / ORAL | AB | RS | 2008-06-02 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A077419-001 | POTASSIUM CHLORIDE | 8MEQ | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2008-06-02 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A077419-002 | POTASSIUM CHLORIDE | 10MEQ | CAPSULE, EXTENDED RELEASE / ORAL | AB | RS | 2008-06-02 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A077419-001 | POTASSIUM CHLORIDE | 8MEQ | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2008-06-02 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A077419-002 | POTASSIUM CHLORIDE | 10MEQ | CAPSULE, EXTENDED RELEASE / ORAL | AB | RS | 2008-06-02 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A077419-001 | POTASSIUM CHLORIDE | 8MEQ | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2008-06-02 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A077419-002 | POTASSIUM CHLORIDE | 10MEQ | CAPSULE, EXTENDED RELEASE / ORAL | AB | RS | 2008-06-02 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A077419-001 | POTASSIUM CHLORIDE | 8MEQ | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2008-06-02 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A077419-002 | POTASSIUM CHLORIDE | 10MEQ | CAPSULE, EXTENDED RELEASE / ORAL | AB | RS | 2008-06-02 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A077419-001 | POTASSIUM CHLORIDE | 8MEQ | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2008-06-02 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A077419-002 | POTASSIUM CHLORIDE | 10MEQ | CAPSULE, EXTENDED RELEASE / ORAL | AB | RS | 2008-06-02 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A077419-001 | POTASSIUM CHLORIDE | 8MEQ | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2008-06-02 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A077419-002 | POTASSIUM CHLORIDE | 10MEQ | CAPSULE, EXTENDED RELEASE / ORAL | AB | RS | 2008-06-02 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | A077419-001 | POTASSIUM CHLORIDE | 8MEQ | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2008-06-02 | 8072bd15b7f6… | |
| 2024-05-31 18:47 UTC | 2024-05 | A077419-002 | POTASSIUM CHLORIDE | 10MEQ | CAPSULE, EXTENDED RELEASE / ORAL | AB | RS | 2008-06-02 | 8072bd15b7f6… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A077419-001 | POTASSIUM CHLORIDE | 8MEQ | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2008-06-02 | 5c6f7cd8ea54… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A077419-002 | POTASSIUM CHLORIDE | 10MEQ | CAPSULE, EXTENDED RELEASE / ORAL | AB | RS | 2008-06-02 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | A077419-001 | POTASSIUM CHLORIDE | 8MEQ | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2008-06-02 | 5d02ea3f76ae… | |
| 2022-04-08 23:34 UTC | 2022-04 | A077419-002 | POTASSIUM CHLORIDE | 10MEQ | CAPSULE, EXTENDED RELEASE / ORAL | AB | RS | 2008-06-02 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | A077419-001 | POTASSIUM CHLORIDE | 8MEQ | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2008-06-02 | 4b0b4de00fa7… | |
| 2022-04-04 05:41 UTC | 2022-04 | A077419-002 | POTASSIUM CHLORIDE | 10MEQ | CAPSULE, EXTENDED RELEASE / ORAL | AB | RS | 2008-06-02 | 4b0b4de00fa7… |
| 2019-12-13 00:20 UTC | 2019-12 | A077419-001 | POTASSIUM CHLORIDE | 8MEQ | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2008-06-02 | 74a2ff9319b5… | |
| 2019-12-13 00:20 UTC | 2019-12 | A077419-002 | POTASSIUM CHLORIDE | 10MEQ | CAPSULE, EXTENDED RELEASE / ORAL | AB | RS | 2008-06-02 | 74a2ff9319b5… |
| 2022-03-09 01:35 UTC | 2022-03 | A077419-001 | POTASSIUM CHLORIDE | 8MEQ | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2008-06-02 | bb7c543d1eb4… | |
| 2022-03-09 01:35 UTC | 2022-03 | A077419-002 | POTASSIUM CHLORIDE | 10MEQ | CAPSULE, EXTENDED RELEASE / ORAL | AB | RS | 2008-06-02 | bb7c543d1eb4… |
| 2021-12-28 21:50 UTC | 2021-12 | A077419-001 | POTASSIUM CHLORIDE | 8MEQ | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2008-06-02 | 782e0a99824c… | |
| 2021-12-28 21:50 UTC | 2021-12 | A077419-002 | POTASSIUM CHLORIDE | 10MEQ | CAPSULE, EXTENDED RELEASE / ORAL | AB | RS | 2008-06-02 | 782e0a99824c… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | A077419-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A077419-002 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A077419-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A077419-002 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A077419-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A077419-002 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A077419-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A077419-002 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A077419-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A077419-002 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A077419-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A077419-002 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A077419-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A077419-002 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A077419-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A077419-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A077419-001 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A077419-002 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A077419-001 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A077419-002 | AB | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A077419-001 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A077419-002 | AB | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A077419-001 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A077419-002 | AB | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A077419-001 | AB | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A077419-002 | AB | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | A077419-001 | AB | 1 | 8072bd15b7f6… |
| 2024-05-31 18:47 UTC | 2024-05 | A077419-002 | AB | 1 | 8072bd15b7f6… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A077419-001 | AB | 1 | 5c6f7cd8ea54… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A077419-002 | AB | 1 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | A077419-001 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-08 23:34 UTC | 2022-04 | A077419-002 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | A077419-001 | AB | 1 | 4b0b4de00fa7… |
| 2022-04-04 05:41 UTC | 2022-04 | A077419-002 | AB | 1 | 4b0b4de00fa7… |
| 2019-12-13 00:20 UTC | 2019-12 | A077419-001 | AB | 1 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | A077419-002 | AB | 1 | 74a2ff9319b5… |
| 2022-03-09 01:35 UTC | 2022-03 | A077419-001 | AB | 1 | bb7c543d1eb4… |
| 2022-03-09 01:35 UTC | 2022-03 | A077419-002 | AB | 1 | bb7c543d1eb4… |
| 2021-12-28 21:50 UTC | 2021-12 | A077419-001 | AB | 1 | 782e0a99824c… |
| 2021-12-28 21:50 UTC | 2021-12 | A077419-002 | AB | 1 | 782e0a99824c… |
DailyMed Product Concepts#
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 55289-218-30 | EA - Each | 55289-218 | d67159bc-4cee-404e-9a73-c561f7c1edab | 1 | 2013-02-13 |
| 55289-218-94 | EA - Each | 55289-218 | 37238435-068b-4098-a5b0-66a558540f58 | 1 | 2013-09-04 |
DailyMed Socrata Ingredients#
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 | AvKARE | 755a4a08-04ff-d7d1-a6fc-b8aeff3ae2c6 | 2026-01-15 | Warnings, Adverse reactions | 077419 ANDA077419 |
| Potassium Chloride | POTASSIUM CHLORIDE | Actavis Pharma, Inc. | ed5baaf6-270b-4dd3-b100-36030c0098fc | 2022-08-01 | Warnings, Adverse reactions | 077419 ANDA077419 |
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 55289-218-30 | 55289021830 | 30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (55289-218-30) | 2011-02-10 | 0000-00-00 | No | No | Current |
| 55289-218-94 | 55289021894 | 270 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (55289-218-94) | 2011-02-10 | 0000-00-00 | No | No | Current |