potassium chloride
- Product NDC
- 43547-553
- 11-digit product format
- 435470553
- Labeler code
- 43547
- Product ID
- 43547-553_580cdd01-0999-41cc-a4a1-6798a71ef6d5
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- potassium chloride
- Dosage form
- CAPSULE, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Solco Healthcare LLC
- Application
- ANDA209026
- Marketing category
- ANDA
- Marketing start
- 2019-04-30
- 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
- 2026-12-31
- Current FDA listing
- Yes
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A209026-001 | POTASSIUM CHLORIDE | POTASSIUM CHLORIDE | 8MEQ | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2019-06-11 | |
| A209026-002 | POTASSIUM CHLORIDE | POTASSIUM CHLORIDE | 10MEQ | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2019-06-11 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A209026-001 | AB |
| A209026-002 | 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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | A209026-001 | POTASSIUM CHLORIDE | 8MEQ | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2019-06-11 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A209026-002 | POTASSIUM CHLORIDE | 10MEQ | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2019-06-11 | 84e616aacf4f… | |
| 2026-08-18 06:07:40 | 2026-07 | A209026-001 | POTASSIUM CHLORIDE | 8MEQ | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2019-06-11 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A209026-002 | POTASSIUM CHLORIDE | 10MEQ | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2019-06-11 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | A209026-001 | POTASSIUM CHLORIDE | 8MEQ | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2019-06-11 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A209026-002 | POTASSIUM CHLORIDE | 10MEQ | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2019-06-11 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A209026-001 | POTASSIUM CHLORIDE | 8MEQ | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2019-06-11 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A209026-002 | POTASSIUM CHLORIDE | 10MEQ | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2019-06-11 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A209026-001 | POTASSIUM CHLORIDE | 8MEQ | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2019-06-11 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A209026-002 | POTASSIUM CHLORIDE | 10MEQ | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2019-06-11 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A209026-001 | POTASSIUM CHLORIDE | 8MEQ | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2019-06-11 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A209026-002 | POTASSIUM CHLORIDE | 10MEQ | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2019-06-11 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A209026-001 | POTASSIUM CHLORIDE | 8MEQ | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2019-06-11 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A209026-002 | POTASSIUM CHLORIDE | 10MEQ | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2019-06-11 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A209026-001 | POTASSIUM CHLORIDE | 8MEQ | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2019-06-11 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A209026-002 | POTASSIUM CHLORIDE | 10MEQ | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2019-06-11 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A209026-001 | POTASSIUM CHLORIDE | 8MEQ | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2019-06-11 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A209026-002 | POTASSIUM CHLORIDE | 10MEQ | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2019-06-11 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A209026-001 | POTASSIUM CHLORIDE | 8MEQ | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2019-06-11 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A209026-002 | POTASSIUM CHLORIDE | 10MEQ | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2019-06-11 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A209026-001 | POTASSIUM CHLORIDE | 8MEQ | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2019-06-11 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A209026-002 | POTASSIUM CHLORIDE | 10MEQ | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2019-06-11 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A209026-001 | POTASSIUM CHLORIDE | 8MEQ | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2019-06-11 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A209026-002 | POTASSIUM CHLORIDE | 10MEQ | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2019-06-11 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A209026-001 | POTASSIUM CHLORIDE | 8MEQ | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2019-06-11 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A209026-002 | POTASSIUM CHLORIDE | 10MEQ | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2019-06-11 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A209026-001 | POTASSIUM CHLORIDE | 8MEQ | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2019-06-11 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A209026-002 | POTASSIUM CHLORIDE | 10MEQ | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2019-06-11 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A209026-001 | POTASSIUM CHLORIDE | 8MEQ | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2019-06-11 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A209026-002 | POTASSIUM CHLORIDE | 10MEQ | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2019-06-11 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | A209026-001 | POTASSIUM CHLORIDE | 8MEQ | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2019-06-11 | 8072bd15b7f6… | |
| 2024-05-31 18:47 UTC | 2024-05 | A209026-002 | POTASSIUM CHLORIDE | 10MEQ | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2019-06-11 | 8072bd15b7f6… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A209026-001 | POTASSIUM CHLORIDE | 8MEQ | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2019-06-11 | 5c6f7cd8ea54… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A209026-002 | POTASSIUM CHLORIDE | 10MEQ | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2019-06-11 | 5c6f7cd8ea54… | |
| 2022-04-08 23:34 UTC | 2022-04 | A209026-001 | POTASSIUM CHLORIDE | 8MEQ | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2019-06-11 | 5d02ea3f76ae… | |
| 2022-04-08 23:34 UTC | 2022-04 | A209026-002 | POTASSIUM CHLORIDE | 10MEQ | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2019-06-11 | 5d02ea3f76ae… | |
| 2022-04-04 05:41 UTC | 2022-04 | A209026-001 | POTASSIUM CHLORIDE | 8MEQ | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2019-06-11 | 4b0b4de00fa7… | |
| 2022-04-04 05:41 UTC | 2022-04 | A209026-002 | POTASSIUM CHLORIDE | 10MEQ | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2019-06-11 | 4b0b4de00fa7… | |
| 2019-12-13 00:20 UTC | 2019-12 | A209026-001 | POTASSIUM CHLORIDE | 8MEQ | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2019-06-11 | 74a2ff9319b5… | |
| 2019-12-13 00:20 UTC | 2019-12 | A209026-002 | POTASSIUM CHLORIDE | 10MEQ | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2019-06-11 | 74a2ff9319b5… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | A209026-001 | AB | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A209026-002 | AB | 1 | 84e616aacf4f… |
| 2026-08-18 06:07:40 | 2026-07 | A209026-001 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A209026-002 | AB | 1 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | A209026-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A209026-002 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A209026-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A209026-002 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A209026-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A209026-002 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A209026-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A209026-002 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A209026-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A209026-002 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A209026-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A209026-002 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A209026-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A209026-002 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A209026-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A209026-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A209026-001 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A209026-002 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A209026-001 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A209026-002 | AB | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A209026-001 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A209026-002 | AB | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A209026-001 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A209026-002 | AB | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A209026-001 | AB | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A209026-002 | AB | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | A209026-001 | AB | 1 | 8072bd15b7f6… |
| 2024-05-31 18:47 UTC | 2024-05 | A209026-002 | AB | 1 | 8072bd15b7f6… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A209026-001 | AB | 1 | 5c6f7cd8ea54… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A209026-002 | AB | 1 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | A209026-001 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-08 23:34 UTC | 2022-04 | A209026-002 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | A209026-001 | AB | 1 | 4b0b4de00fa7… |
| 2022-04-04 05:41 UTC | 2022-04 | A209026-002 | AB | 1 | 4b0b4de00fa7… |
| 2019-12-13 00:20 UTC | 2019-12 | A209026-001 | AB | 1 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | A209026-002 | AB | 1 | 74a2ff9319b5… |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- potassium chloride
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| POTASSIUM CHLORIDE | 750 mg/1 |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| 660YQ98I10 | Internal UNII lookup |
Harmonized RxCUI identifiers#
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 52d91d76-8c7f-40f1-9f5c-e05962cabedd | Available on FDA.report |
DailyMed Product Concepts#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 43547-553-10 | potassium chloride | 100 in 1 BOTTLE | CAPSULE, EXTENDED RELEASE | 100 | 3 | |
| 43547-553-50 | potassium chloride | 500 in 1 BOTTLE | CAPSULE, EXTENDED RELEASE | 500 | 3 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 43547-553-10 | EA - Each | 43547-553 | f0953f86-50f9-4710-a610-0750904c467b | 1 | 2021-02-05 |
| 43547-553-50 | EA - Each | 43547-553 | 76c770aa-42ea-4066-a987-40c18009768c | 1 | 2021-02-05 |
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 | Solco Healthcare LLC | 52d91d76-8c7f-40f1-9f5c-e05962cabedd | 2025-07-15 | Warnings, Adverse reactions | 209026 ANDA209026 43547-553 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 312504 | potassium chloride 10 MEQ Extended Release Oral Capsule | PSN | 52d91d76-8c7f-40f1-9f5c-e05962cabedd | 3 |
| 315183 | potassium chloride 8 MEQ (600 MG) Extended Release Oral Capsule | PSN | 52d91d76-8c7f-40f1-9f5c-e05962cabedd | 3 |
| 312504 | potassium chloride 10 MEQ Extended Release Oral Capsule | SCD | 52d91d76-8c7f-40f1-9f5c-e05962cabedd | 3 |
| 315183 | potassium chloride 8 MEQ Extended Release Oral Capsule | SCD | 52d91d76-8c7f-40f1-9f5c-e05962cabedd | 3 |
| 312504 | K+ Chloride 10 MEQ Extended Release Oral Capsule | SY | 52d91d76-8c7f-40f1-9f5c-e05962cabedd | 3 |
| 315183 | K+ Chloride 8 MEQ Extended Release Oral Capsule | SY | 52d91d76-8c7f-40f1-9f5c-e05962cabedd | 3 |
| 312504 | Pot Chloride 10 MEQ Extended Release Oral Capsule | SY | 52d91d76-8c7f-40f1-9f5c-e05962cabedd | 3 |
| 315183 | Pot Chloride 8 MEQ Extended Release Oral Capsule | SY | 52d91d76-8c7f-40f1-9f5c-e05962cabedd | 3 |
| 315183 | potassium chloride 600 MG Extended Release Oral Capsule | SY | 52d91d76-8c7f-40f1-9f5c-e05962cabedd | 3 |
| 312504 | potassium chloride 750 MG Extended Release Oral Capsule | SY | 52d91d76-8c7f-40f1-9f5c-e05962cabedd | 3 |
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 43547-553-10 | 43547055310 | 100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (43547-553-10) | 2019-04-30 | 0000-00-00 | No | No | Current |
| 43547-553-50 | 43547055350 | 500 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (43547-553-50) | 2019-04-30 | 0000-00-00 | No | No | Current |