POTASSIUM CHLORIDE
- Product NDC
- 60687-653
- 11-digit product format
- 606870653
- Labeler code
- 60687
- Product ID
- 60687-653_25c6ada8-4a15-0896-e063-6294a90a0fdb
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- POTASSIUM CHLORIDE
- Dosage form
- CAPSULE, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- American Health Packaging
- Application
- ANDA208864
- Marketing category
- ANDA
- Marketing start
- 2022-10-20
- 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 |
|---|---|---|---|---|---|---|---|
| A208864-001 | POTASSIUM CHLORIDE | POTASSIUM CHLORIDE | 8MEQ | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2017-03-17 | |
| A208864-002 | POTASSIUM CHLORIDE | POTASSIUM CHLORIDE | 10MEQ | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2017-03-17 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A208864-001 | AB |
| A208864-002 | 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 | A208864-001 | POTASSIUM CHLORIDE | 8MEQ | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2017-03-17 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A208864-002 | POTASSIUM CHLORIDE | 10MEQ | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2017-03-17 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A208864-001 | POTASSIUM CHLORIDE | 8MEQ | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2017-03-17 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A208864-002 | POTASSIUM CHLORIDE | 10MEQ | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2017-03-17 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A208864-001 | POTASSIUM CHLORIDE | 8MEQ | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2017-03-17 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A208864-002 | POTASSIUM CHLORIDE | 10MEQ | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2017-03-17 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A208864-001 | POTASSIUM CHLORIDE | 8MEQ | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2017-03-17 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A208864-002 | POTASSIUM CHLORIDE | 10MEQ | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2017-03-17 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A208864-001 | POTASSIUM CHLORIDE | 8MEQ | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2017-03-17 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A208864-002 | POTASSIUM CHLORIDE | 10MEQ | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2017-03-17 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A208864-001 | POTASSIUM CHLORIDE | 8MEQ | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2017-03-17 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A208864-002 | POTASSIUM CHLORIDE | 10MEQ | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2017-03-17 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A208864-001 | POTASSIUM CHLORIDE | 8MEQ | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2017-03-17 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A208864-002 | POTASSIUM CHLORIDE | 10MEQ | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2017-03-17 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A208864-001 | POTASSIUM CHLORIDE | 8MEQ | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2017-03-17 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A208864-002 | POTASSIUM CHLORIDE | 10MEQ | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2017-03-17 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A208864-001 | POTASSIUM CHLORIDE | 8MEQ | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2017-03-17 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A208864-002 | POTASSIUM CHLORIDE | 10MEQ | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2017-03-17 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A208864-001 | POTASSIUM CHLORIDE | 8MEQ | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2017-03-17 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A208864-002 | POTASSIUM CHLORIDE | 10MEQ | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2017-03-17 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A208864-001 | POTASSIUM CHLORIDE | 8MEQ | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2017-03-17 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A208864-002 | POTASSIUM CHLORIDE | 10MEQ | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2017-03-17 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A208864-001 | POTASSIUM CHLORIDE | 8MEQ | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2017-03-17 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A208864-002 | POTASSIUM CHLORIDE | 10MEQ | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2017-03-17 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A208864-001 | POTASSIUM CHLORIDE | 8MEQ | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2017-03-17 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A208864-002 | POTASSIUM CHLORIDE | 10MEQ | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2017-03-17 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | A208864-001 | POTASSIUM CHLORIDE | 8MEQ | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2017-03-17 | 8072bd15b7f6… | |
| 2024-05-31 18:47 UTC | 2024-05 | A208864-002 | POTASSIUM CHLORIDE | 10MEQ | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2017-03-17 | 8072bd15b7f6… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A208864-001 | POTASSIUM CHLORIDE | 8MEQ | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2017-03-17 | 5c6f7cd8ea54… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A208864-002 | POTASSIUM CHLORIDE | 10MEQ | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2017-03-17 | 5c6f7cd8ea54… | |
| 2022-04-08 23:34 UTC | 2022-04 | A208864-001 | POTASSIUM CHLORIDE | 8MEQ | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2017-03-17 | 5d02ea3f76ae… | |
| 2022-04-08 23:34 UTC | 2022-04 | A208864-002 | POTASSIUM CHLORIDE | 10MEQ | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2017-03-17 | 5d02ea3f76ae… | |
| 2022-04-04 05:41 UTC | 2022-04 | A208864-001 | POTASSIUM CHLORIDE | 8MEQ | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2017-03-17 | 4b0b4de00fa7… | |
| 2022-04-04 05:41 UTC | 2022-04 | A208864-002 | POTASSIUM CHLORIDE | 10MEQ | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2017-03-17 | 4b0b4de00fa7… | |
| 2019-12-13 00:20 UTC | 2019-12 | A208864-001 | POTASSIUM CHLORIDE | 8MEQ | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2017-03-17 | 74a2ff9319b5… | |
| 2019-12-13 00:20 UTC | 2019-12 | A208864-002 | POTASSIUM CHLORIDE | 10MEQ | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2017-03-17 | 74a2ff9319b5… | |
| 2022-03-09 01:35 UTC | 2022-03 | A208864-001 | POTASSIUM CHLORIDE | 8MEQ | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2017-03-17 | bb7c543d1eb4… | |
| 2022-03-09 01:35 UTC | 2022-03 | A208864-002 | POTASSIUM CHLORIDE | 10MEQ | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2017-03-17 | bb7c543d1eb4… | |
| 2021-12-28 21:50 UTC | 2021-12 | A208864-001 | POTASSIUM CHLORIDE | 8MEQ | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2017-03-17 | 782e0a99824c… | |
| 2021-12-28 21:50 UTC | 2021-12 | A208864-002 | POTASSIUM CHLORIDE | 10MEQ | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2017-03-17 | 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 | A208864-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A208864-002 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A208864-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A208864-002 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A208864-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A208864-002 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A208864-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A208864-002 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A208864-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A208864-002 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A208864-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A208864-002 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A208864-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A208864-002 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A208864-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A208864-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A208864-001 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A208864-002 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A208864-001 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A208864-002 | AB | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A208864-001 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A208864-002 | AB | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A208864-001 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A208864-002 | AB | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A208864-001 | AB | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A208864-002 | AB | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | A208864-001 | AB | 1 | 8072bd15b7f6… |
| 2024-05-31 18:47 UTC | 2024-05 | A208864-002 | AB | 1 | 8072bd15b7f6… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A208864-001 | AB | 1 | 5c6f7cd8ea54… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A208864-002 | AB | 1 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | A208864-001 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-08 23:34 UTC | 2022-04 | A208864-002 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | A208864-001 | AB | 1 | 4b0b4de00fa7… |
| 2022-04-04 05:41 UTC | 2022-04 | A208864-002 | AB | 1 | 4b0b4de00fa7… |
| 2019-12-13 00:20 UTC | 2019-12 | A208864-001 | AB | 1 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | A208864-002 | AB | 1 | 74a2ff9319b5… |
| 2022-03-09 01:35 UTC | 2022-03 | A208864-001 | AB | 1 | bb7c543d1eb4… |
| 2022-03-09 01:35 UTC | 2022-03 | A208864-002 | AB | 1 | bb7c543d1eb4… |
| 2021-12-28 21:50 UTC | 2021-12 | A208864-001 | AB | 1 | 782e0a99824c… |
| 2021-12-28 21:50 UTC | 2021-12 | A208864-002 | AB | 1 | 782e0a99824c… |
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#
| Identifier | FDA.report destination |
|---|---|
| 312504 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 96ea00f5-b922-4d57-b2ac-34523ea56d5f | Available on FDA.report |
DailyMed Product Concepts#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 60687-653-01 | POTASSIUM CHLORIDE | 100 in 1 CARTON | CAPSULE, EXTENDED RELEASE | 100 | 4 | |
| 60687-653-11 | POTASSIUM CHLORIDE | 1 in 1 BLISTER PACK | CAPSULE, EXTENDED RELEASE | 1 | 4 | |
| 60687-653-21 | POTASSIUM CHLORIDE | 30 in 1 CARTON | CAPSULE, EXTENDED RELEASE | 30 | 4 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 60687-653-01 | EA - Each | 60687-653 | ccb0f040-2d68-4699-a611-2525c502a84a | 1 | 2022-09-12 |
| 60687-653-11 | EA - Each | 60687-653 | 0fec01c0-9f2c-4e3d-a807-320e1cefcc87 | 1 | 2022-09-12 |
| 60687-653-21 | EA - Each | 60687-653 | 8c3021b5-d800-495b-8788-28b3a081109e | 1 | 2024-01-04 |
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 | PD-Rx Pharmaceuticals, Inc. | 018fc687-1fba-202e-e063-6294a90a5c9a | 2025-11-17 | Warnings, Adverse reactions | 208864 ANDA208864 |
| POTASSIUM CHLORIDE | POTASSIUM CHLORIDE | PD-Rx Pharmaceuticals, Inc. | cc15ef60-6956-4d34-b86d-72cdd0c0c0bb | 2025-10-02 | Warnings, Adverse reactions | 208864 ANDA208864 |
| POTASSIUM CHLORIDE | POTASSIUM CHLORIDE | PD-Rx Pharmaceuticals, Inc. | ccaaa3a2-a273-41c7-9e54-429539ea0140 | 2024-11-19 | Warnings, Adverse reactions | 208864 ANDA208864 |
| POTASSIUM CHLORIDE | POTASSIUM CHLORIDE | American Health Packaging | 96ea00f5-b922-4d57-b2ac-34523ea56d5f | 2024-10-31 | Warnings, Adverse reactions | 208864 ANDA208864 60687-653 |
| POTASSIUM CHLORIDE | POTASSIUM CHLORIDE | Bryant Ranch Prepack | 65e30d1a-50e9-4b84-ad4d-daaea91eab4b | 2024-04-09 | Warnings, Adverse reactions | 208864 ANDA208864 |
| POTASSIUM CHLORIDE | POTASSIUM CHLORIDE | Sun Pharmaceutical Industries, Inc. | 4d90d03d-7f0e-4d49-9e80-628dbc7165c0 | 2024-01-10 | Warnings, Adverse reactions | 208864 ANDA208864 |
| POTASSIUM CHLORIDE EXTENDED RELEASE | POTASSIUM CHLORIDE | Adare Pharmaceuticals Inc | 22edb0e6-4e45-4e91-aead-3581cca293a0 | 2023-12-20 | Warnings, Adverse reactions | 208864 ANDA208864 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 312504 | potassium chloride 10 MEQ Extended Release Oral Capsule | PSN | 96ea00f5-b922-4d57-b2ac-34523ea56d5f | 4 |
| 312504 | potassium chloride 10 MEQ Extended Release Oral Capsule | SCD | 96ea00f5-b922-4d57-b2ac-34523ea56d5f | 4 |
| 312504 | K+ Chloride 10 MEQ Extended Release Oral Capsule | SY | 96ea00f5-b922-4d57-b2ac-34523ea56d5f | 4 |
| 312504 | Pot Chloride 10 MEQ Extended Release Oral Capsule | SY | 96ea00f5-b922-4d57-b2ac-34523ea56d5f | 4 |
| 312504 | potassium chloride 750 MG Extended Release Oral Capsule | SY | 96ea00f5-b922-4d57-b2ac-34523ea56d5f | 4 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 60687-653-01 | 60687065301 | 100 BLISTER PACK in 1 CARTON (60687-653-01) / 1 CAPSULE, EXTENDED RELEASE in 1 BLISTER PACK (60687-653-11) | 100 blister pack | 2022-10-20 | 0000-00-00 | No | No | Current |
| 60687-653-11 | 60687065311 | 1 in 1 BLISTER PACK | Historical | |||||
| 60687-653-21 | 60687065321 | 30 BLISTER PACK in 1 CARTON (60687-653-21) / 1 CAPSULE, EXTENDED RELEASE in 1 BLISTER PACK (60687-653-11) | 30 blister pack | 2023-12-14 | No | No | Current |