Potassium Chloride
- Product NDC
- 42291-679
- 11-digit product format
- 422910679
- Labeler code
- 42291
- Product ID
- 42291-679_4871a1e2-6b72-31fb-e063-6394a90a7297
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Potassium Chloride
- Dosage form
- CAPSULE, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- AvKARE
- Application
- ANDA077419
- Marketing category
- ANDA
- Marketing start
- 2013-03-05
- 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
- 2027-12-31
- Current FDA listing
- Yes
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | A077419-001 | POTASSIUM CHLORIDE | 8MEQ | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2008-06-02 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A077419-002 | POTASSIUM CHLORIDE | 10MEQ | CAPSULE, EXTENDED RELEASE / ORAL | AB | RS | 2008-06-02 | 84e616aacf4f… |
| 2026-08-18 06:07:40 | 2026-07 | A077419-001 | POTASSIUM CHLORIDE | 8MEQ | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2008-06-02 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A077419-002 | POTASSIUM CHLORIDE | 10MEQ | CAPSULE, EXTENDED RELEASE / ORAL | AB | RS | 2008-06-02 | caaa826d4ba7… |
| 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… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 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… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A077419-001 | AB | 1 | 87673890dc5c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A077419-002 | AB | 1 | 87673890dc5c… |
| 2021-03-12 10:30 UTC | 2021-03 | A077419-001 | AB | 1 | 5aa47cf7b7d7… |
| 2021-03-12 10:30 UTC | 2021-03 | A077419-002 | AB | 1 | 5aa47cf7b7d7… |
| 2020-12-22 03:56 UTC | 2020-12 | A077419-001 | AB | 1 | 8869cabd3fbd… |
| 2020-12-22 03:56 UTC | 2020-12 | A077419-002 | AB | 1 | 8869cabd3fbd… |
| 2020-11-12 02:37 UTC | 2020-11 | A077419-001 | AB | 1 | c0c555d07b60… |
| 2020-11-12 02:37 UTC | 2020-11 | A077419-002 | AB | 1 | c0c555d07b60… |
| 2019-12-14 00:12 UTC | 2019-12 | A077419-001 | AB | 1 | 3f01610625f2… |
| 2019-12-14 00:12 UTC | 2019-12 | A077419-002 | AB | 1 | 3f01610625f2… |
| 2019-09-15 20:21 UTC | 2019-09 | A077419-001 | AB | 1 | b00525d2431f… |
| 2019-09-15 20:21 UTC | 2019-09 | A077419-002 | AB | 1 | b00525d2431f… |
| 2019-07-19 19:46 UTC | 2019-07 | A077419-001 | AB | 1 | ea99ee380514… |
| 2019-07-19 19:46 UTC | 2019-07 | A077419-002 | AB | 1 | ea99ee380514… |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A077419-001 | AB | 1 | 6a51e52b5d6a… |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A077419-002 | AB | 1 | 6a51e52b5d6a… |
| 2024-02-18 07:12 UTC | 2024-02 | A077419-001 | AB | 1 | 1c564ffb4f44… |
| 2024-02-18 07:12 UTC | 2024-02 | A077419-002 | AB | 1 | 1c564ffb4f44… |
| 2023-12-20 04:57 UTC | 2023-12 | A077419-001 | AB | 1 | ea1830bbd6c7… |
| 2023-12-20 04:57 UTC | 2023-12 | A077419-002 | AB | 1 | ea1830bbd6c7… |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A077419-001 | AB | 1 | a72a2bbeb626… |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A077419-002 | AB | 1 | a72a2bbeb626… |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A077419-001 | AB | 1 | 9b2671bbb829… |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A077419-002 | AB | 1 | 9b2671bbb829… |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A077419-001 | AB | 1 | a67488948f0b… |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A077419-002 | AB | 1 | a67488948f0b… |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A077419-001 | AB | 1 | 3f0d92c62455… |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A077419-002 | AB | 1 | 3f0d92c62455… |
| 2023-05-13 08:27 UTC | 2023-05 | A077419-001 | AB | 1 | 053a50430f4f… |
| 2023-05-13 08:27 UTC | 2023-05 | A077419-002 | AB | 1 | 053a50430f4f… |
| 2023-01-26 05:58 UTC | 2023-01 | A077419-001 | AB | 1 | 3bdfa0b2c4d7… |
| 2023-01-26 05:58 UTC | 2023-01 | A077419-002 | AB | 1 | 3bdfa0b2c4d7… |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A077419-001 | AB | 1 | 3a93d1ddd44b… |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A077419-002 | AB | 1 | 3a93d1ddd44b… |
| 2022-10-28 04:53 UTC | 2022-10 | A077419-001 | AB | 1 | f41ea6bd6efb… |
| 2022-10-28 04:53 UTC | 2022-10 | A077419-002 | AB | 1 | f41ea6bd6efb… |
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
- 2027-12-31
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 |
|---|---|
| 755a4a08-04ff-d7d1-a6fc-b8aeff3ae2c6 | Available on FDA.report |
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 42291-679-50 | 2022-02-03 | C162847 | 48780-1 | d6a99b39-ed6f-a426-e053-dadaa90af4c2 | Potassium Chloride Extended-release Capsules, USP |
| 42291-679-50 | 2022-01-28 | C162847 | 48780-1 | d6a99b39-ed6f-a426-e053-dadaa90af4c2 | Potassium Chloride Extended-release Capsules, USP |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 42291-679-50 | Potassium Chloride | 500 in 1 BOTTLE | CAPSULE, EXTENDED RELEASE | 500 | 9 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 42291-679-50 | EA - Each | 42291-679 | 47bcd741-4fe9-4ac9-b3af-4265e52ffcd5 | 1 | 2013-05-02 |
| 42291-679-90 | EA - Each | 42291-679 | 0136bd68-ef28-482d-8fc5-ab329acdafa2 | 1 | 2013-05-02 |
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 42291-679 |
| Potassium Chloride | POTASSIUM CHLORIDE | Actavis Pharma, Inc. | ed5baaf6-270b-4dd3-b100-36030c0098fc | 2022-08-01 | Warnings, Adverse reactions | 077419 ANDA077419 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 312504 | potassium chloride 10 MEQ Extended Release Oral Capsule | PSN | 755a4a08-04ff-d7d1-a6fc-b8aeff3ae2c6 | 9 |
| 315183 | potassium chloride 8 MEQ (600 MG) Extended Release Oral Capsule | PSN | 755a4a08-04ff-d7d1-a6fc-b8aeff3ae2c6 | 9 |
| 312504 | potassium chloride 10 MEQ Extended Release Oral Capsule | SCD | 755a4a08-04ff-d7d1-a6fc-b8aeff3ae2c6 | 9 |
| 315183 | potassium chloride 8 MEQ Extended Release Oral Capsule | SCD | 755a4a08-04ff-d7d1-a6fc-b8aeff3ae2c6 | 9 |
| 312504 | K+ Chloride 10 MEQ Extended Release Oral Capsule | SY | 755a4a08-04ff-d7d1-a6fc-b8aeff3ae2c6 | 9 |
| 315183 | K+ Chloride 8 MEQ Extended Release Oral Capsule | SY | 755a4a08-04ff-d7d1-a6fc-b8aeff3ae2c6 | 9 |
| 312504 | Pot Chloride 10 MEQ Extended Release Oral Capsule | SY | 755a4a08-04ff-d7d1-a6fc-b8aeff3ae2c6 | 9 |
| 315183 | Pot Chloride 8 MEQ Extended Release Oral Capsule | SY | 755a4a08-04ff-d7d1-a6fc-b8aeff3ae2c6 | 9 |
| 315183 | potassium chloride 600 MG Extended Release Oral Capsule | SY | 755a4a08-04ff-d7d1-a6fc-b8aeff3ae2c6 | 9 |
| 312504 | potassium chloride 750 MG Extended Release Oral Capsule | SY | 755a4a08-04ff-d7d1-a6fc-b8aeff3ae2c6 | 9 |
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 42291-679-50 | 42291067950 | 500 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (42291-679-50) | 2013-03-05 | 0000-00-00 | No | No | Current |