Potassium Chloride
- Product NDC
- 0615-8570
- 11-digit product format
- 006158570
- Labeler code
- 0615
- Product ID
- 0615-8570_d87ff31d-3d0c-4f33-bdf2-7d19191078a8
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Potassium Chloride
- Dosage form
- TABLET, FILM COATED, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- NCS HealthCare of KY, LLC dba Vangard Labs
- Application
- ANDA209314
- Marketing category
- ANDA
- Marketing start
- 2023-08-07
- 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 |
|---|---|---|---|---|---|---|---|
| A209314-001 | POTASSIUM CHLORIDE | POTASSIUM CHLORIDE | 8MEQ | TABLET, EXTENDED RELEASE / ORAL | AB2 | 2018-06-22 | |
| A209314-002 | POTASSIUM CHLORIDE | POTASSIUM CHLORIDE | 10MEQ | TABLET, EXTENDED RELEASE / ORAL | AB2 | 2018-06-22 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A209314-001 | AB2 |
| A209314-002 | AB2 |
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 | A209314-001 | POTASSIUM CHLORIDE | 8MEQ | TABLET, EXTENDED RELEASE / ORAL | AB2 | 2018-06-22 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A209314-002 | POTASSIUM CHLORIDE | 10MEQ | TABLET, EXTENDED RELEASE / ORAL | AB2 | 2018-06-22 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A209314-001 | POTASSIUM CHLORIDE | 8MEQ | TABLET, EXTENDED RELEASE / ORAL | AB2 | 2018-06-22 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A209314-002 | POTASSIUM CHLORIDE | 10MEQ | TABLET, EXTENDED RELEASE / ORAL | AB2 | 2018-06-22 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A209314-001 | POTASSIUM CHLORIDE | 8MEQ | TABLET, EXTENDED RELEASE / ORAL | AB2 | 2018-06-22 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A209314-002 | POTASSIUM CHLORIDE | 10MEQ | TABLET, EXTENDED RELEASE / ORAL | AB2 | 2018-06-22 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A209314-001 | POTASSIUM CHLORIDE | 8MEQ | TABLET, EXTENDED RELEASE / ORAL | AB2 | 2018-06-22 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A209314-002 | POTASSIUM CHLORIDE | 10MEQ | TABLET, EXTENDED RELEASE / ORAL | AB2 | 2018-06-22 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A209314-001 | POTASSIUM CHLORIDE | 8MEQ | TABLET, EXTENDED RELEASE / ORAL | AB2 | 2018-06-22 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A209314-002 | POTASSIUM CHLORIDE | 10MEQ | TABLET, EXTENDED RELEASE / ORAL | AB2 | 2018-06-22 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A209314-001 | POTASSIUM CHLORIDE | 8MEQ | TABLET, EXTENDED RELEASE / ORAL | AB2 | 2018-06-22 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A209314-002 | POTASSIUM CHLORIDE | 10MEQ | TABLET, EXTENDED RELEASE / ORAL | AB2 | 2018-06-22 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A209314-001 | POTASSIUM CHLORIDE | 8MEQ | TABLET, EXTENDED RELEASE / ORAL | AB2 | 2018-06-22 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A209314-002 | POTASSIUM CHLORIDE | 10MEQ | TABLET, EXTENDED RELEASE / ORAL | AB2 | 2018-06-22 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A209314-001 | POTASSIUM CHLORIDE | 8MEQ | TABLET, EXTENDED RELEASE / ORAL | AB2 | 2018-06-22 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A209314-002 | POTASSIUM CHLORIDE | 10MEQ | TABLET, EXTENDED RELEASE / ORAL | AB2 | 2018-06-22 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A209314-001 | POTASSIUM CHLORIDE | 8MEQ | TABLET, EXTENDED RELEASE / ORAL | AB2 | 2018-06-22 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A209314-002 | POTASSIUM CHLORIDE | 10MEQ | TABLET, EXTENDED RELEASE / ORAL | AB2 | 2018-06-22 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A209314-001 | POTASSIUM CHLORIDE | 8MEQ | TABLET, EXTENDED RELEASE / ORAL | AB2 | 2018-06-22 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A209314-002 | POTASSIUM CHLORIDE | 10MEQ | TABLET, EXTENDED RELEASE / ORAL | AB2 | 2018-06-22 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A209314-001 | POTASSIUM CHLORIDE | 8MEQ | TABLET, EXTENDED RELEASE / ORAL | AB2 | 2018-06-22 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A209314-002 | POTASSIUM CHLORIDE | 10MEQ | TABLET, EXTENDED RELEASE / ORAL | AB2 | 2018-06-22 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A209314-001 | POTASSIUM CHLORIDE | 8MEQ | TABLET, EXTENDED RELEASE / ORAL | AB2 | 2018-06-22 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A209314-002 | POTASSIUM CHLORIDE | 10MEQ | TABLET, EXTENDED RELEASE / ORAL | AB2 | 2018-06-22 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A209314-001 | POTASSIUM CHLORIDE | 8MEQ | TABLET, EXTENDED RELEASE / ORAL | AB2 | 2018-06-22 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A209314-002 | POTASSIUM CHLORIDE | 10MEQ | TABLET, EXTENDED RELEASE / ORAL | AB2 | 2018-06-22 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | A209314-001 | POTASSIUM CHLORIDE | 8MEQ | TABLET, EXTENDED RELEASE / ORAL | AB2 | 2018-06-22 | 8072bd15b7f6… | |
| 2024-05-31 18:47 UTC | 2024-05 | A209314-002 | POTASSIUM CHLORIDE | 10MEQ | TABLET, EXTENDED RELEASE / ORAL | AB2 | 2018-06-22 | 8072bd15b7f6… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A209314-001 | POTASSIUM CHLORIDE | 8MEQ | TABLET, EXTENDED RELEASE / ORAL | AB2 | 2018-06-22 | 5c6f7cd8ea54… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A209314-002 | POTASSIUM CHLORIDE | 10MEQ | TABLET, EXTENDED RELEASE / ORAL | AB2 | 2018-06-22 | 5c6f7cd8ea54… | |
| 2022-04-08 23:34 UTC | 2022-04 | A209314-001 | POTASSIUM CHLORIDE | 8MEQ | TABLET, EXTENDED RELEASE / ORAL | AB2 | 2018-06-22 | 5d02ea3f76ae… | |
| 2022-04-08 23:34 UTC | 2022-04 | A209314-002 | POTASSIUM CHLORIDE | 10MEQ | TABLET, EXTENDED RELEASE / ORAL | AB2 | 2018-06-22 | 5d02ea3f76ae… | |
| 2022-04-04 05:41 UTC | 2022-04 | A209314-001 | POTASSIUM CHLORIDE | 8MEQ | TABLET, EXTENDED RELEASE / ORAL | AB2 | 2018-06-22 | 4b0b4de00fa7… | |
| 2022-04-04 05:41 UTC | 2022-04 | A209314-002 | POTASSIUM CHLORIDE | 10MEQ | TABLET, EXTENDED RELEASE / ORAL | AB2 | 2018-06-22 | 4b0b4de00fa7… | |
| 2019-12-13 00:20 UTC | 2019-12 | A209314-001 | POTASSIUM CHLORIDE | 8MEQ | TABLET, EXTENDED RELEASE / ORAL | AB2 | 2018-06-22 | 74a2ff9319b5… | |
| 2019-12-13 00:20 UTC | 2019-12 | A209314-002 | POTASSIUM CHLORIDE | 10MEQ | TABLET, EXTENDED RELEASE / ORAL | AB2 | 2018-06-22 | 74a2ff9319b5… | |
| 2022-03-09 01:35 UTC | 2022-03 | A209314-001 | POTASSIUM CHLORIDE | 8MEQ | TABLET, EXTENDED RELEASE / ORAL | AB2 | 2018-06-22 | bb7c543d1eb4… | |
| 2022-03-09 01:35 UTC | 2022-03 | A209314-002 | POTASSIUM CHLORIDE | 10MEQ | TABLET, EXTENDED RELEASE / ORAL | AB2 | 2018-06-22 | bb7c543d1eb4… | |
| 2021-12-28 21:50 UTC | 2021-12 | A209314-001 | POTASSIUM CHLORIDE | 8MEQ | TABLET, EXTENDED RELEASE / ORAL | AB2 | 2018-06-22 | 782e0a99824c… | |
| 2021-12-28 21:50 UTC | 2021-12 | A209314-002 | POTASSIUM CHLORIDE | 10MEQ | TABLET, EXTENDED RELEASE / ORAL | AB2 | 2018-06-22 | 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 | A209314-001 | AB2 | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A209314-002 | AB2 | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A209314-001 | AB2 | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A209314-002 | AB2 | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A209314-001 | AB2 | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A209314-002 | AB2 | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A209314-001 | AB2 | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A209314-002 | AB2 | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A209314-001 | AB2 | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A209314-002 | AB2 | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A209314-001 | AB2 | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A209314-002 | AB2 | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A209314-001 | AB2 | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A209314-002 | AB2 | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A209314-001 | AB2 | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A209314-002 | AB2 | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A209314-001 | AB2 | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A209314-002 | AB2 | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A209314-001 | AB2 | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A209314-002 | AB2 | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A209314-001 | AB2 | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A209314-002 | AB2 | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A209314-001 | AB2 | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A209314-002 | AB2 | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A209314-001 | AB2 | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A209314-002 | AB2 | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | A209314-001 | AB2 | 1 | 8072bd15b7f6… |
| 2024-05-31 18:47 UTC | 2024-05 | A209314-002 | AB2 | 1 | 8072bd15b7f6… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A209314-001 | AB2 | 1 | 5c6f7cd8ea54… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A209314-002 | AB2 | 1 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | A209314-001 | AB2 | 1 | 5d02ea3f76ae… |
| 2022-04-08 23:34 UTC | 2022-04 | A209314-002 | AB2 | 1 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | A209314-001 | AB2 | 1 | 4b0b4de00fa7… |
| 2022-04-04 05:41 UTC | 2022-04 | A209314-002 | AB2 | 1 | 4b0b4de00fa7… |
| 2019-12-13 00:20 UTC | 2019-12 | A209314-001 | AB2 | 1 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | A209314-002 | AB2 | 1 | 74a2ff9319b5… |
| 2022-03-09 01:35 UTC | 2022-03 | A209314-001 | AB2 | 1 | bb7c543d1eb4… |
| 2022-03-09 01:35 UTC | 2022-03 | A209314-002 | AB2 | 1 | bb7c543d1eb4… |
| 2021-12-28 21:50 UTC | 2021-12 | A209314-001 | AB2 | 1 | 782e0a99824c… |
| 2021-12-28 21:50 UTC | 2021-12 | A209314-002 | AB2 | 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 |
|---|---|
| 628953 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| bf632e1d-73f3-4df1-ad12-e555fa6a56e9 | Available on FDA.report |
DailyMed Product Concepts#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 0615-8570-05 | Potassium Chloride | 15 in 1 BLISTER PACK | TABLET, FILM COATED, EXTENDED RE | 15 | 1 | |
| 0615-8570-14 | Potassium Chloride | 14 in 1 BLISTER PACK | TABLET, FILM COATED, EXTENDED RE | 14 | 1 | |
| 0615-8570-39 | Potassium Chloride | 30 in 1 BLISTER PACK | TABLET, FILM COATED, EXTENDED RE | 30 | 1 |
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 | A-S Medication Solutions | 30527e49-6648-44f3-97b2-9c51783ac003 | 2026-07-01 | Warnings, Adverse reactions | 209314 ANDA209314 |
| Potassium Chloride | POTASSIUM CHLORIDE | St. Mary's Medical Park Pharmacy | 549c9d28-bf8b-2dc2-e063-6294a90abe7b | 2026-06-19 | Warnings, Adverse reactions | 209314 ANDA209314 |
| Potassium Chloride | POTASSIUM CHLORIDE | A-S Medication Solutions | 0ac9b8dc-0c8e-4cdc-ab9d-bd8cab4f4958 | 2025-11-05 | Warnings, Adverse reactions | 209314 ANDA209314 |
| Potassium Chloride | POTASSIUM CHLORIDE | Epic Pharma, LLC | 00615fad-ad3b-46e8-a89d-48290d937ae2 | 2025-09-23 | Warnings, Adverse reactions | 209314 ANDA209314 |
| Potassium Chloride | POTASSIUM CHLORIDE | Aphena Pharma Solutions - Tennessee, LLC | 3dfac7ca-2c2e-e709-e063-6394a90adbb3 | 2025-09-04 | Warnings, Adverse reactions | 209314 ANDA209314 |
| Potassium Chloride | POTASSIUM CHLORIDE | Slate Run Pharmaceuticals, LLC | 0cc57ece-f15a-4160-a5ea-8d6fa9f9e754 | 2025-08-07 | Warnings, Adverse reactions | 209314 ANDA209314 |
| Potassium Chloride | POTASSIUM CHLORIDE | NCS HealthCare of KY, LLC dba Vangard Labs | bf632e1d-73f3-4df1-ad12-e555fa6a56e9 | 2025-02-27 | Warnings, Adverse reactions | 209314 ANDA209314 0615-8570 |
| Potassium Chloride | POTASSIUM CHLORIDE | Proficient Rx LP | 7238d1d5-23c1-44d5-98fc-20d1d4e5a8ce | 2025-01-01 | Warnings, Adverse reactions | 209314 ANDA209314 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 628953 | potassium chloride 10 MEQ (750 MG) Extended Release Oral Tablet | PSN | bf632e1d-73f3-4df1-ad12-e555fa6a56e9 | 1 |
| 628953 | potassium chloride 10 MEQ Extended Release Oral Tablet | SCD | bf632e1d-73f3-4df1-ad12-e555fa6a56e9 | 1 |
| 628953 | K+ Chloride 10 MEQ Extended Release Oral Tablet | SY | bf632e1d-73f3-4df1-ad12-e555fa6a56e9 | 1 |
| 628953 | Pot Chloride 10 MEQ Extended Release Oral Tablet | SY | bf632e1d-73f3-4df1-ad12-e555fa6a56e9 | 1 |
| 628953 | potassium chloride 750 MG (potassium 10 mEq) Extended Release Oral Tablet | SY | bf632e1d-73f3-4df1-ad12-e555fa6a56e9 | 1 |
| 628953 | potassium chloride 750 MG Extended Release Oral Tablet | SY | bf632e1d-73f3-4df1-ad12-e555fa6a56e9 | 1 |
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|
| 0615-8570-05 | 00615857005 | 15 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK (0615-8570-05) | 2025-02-24 | No | No | Current |
| 0615-8570-14 | 00615857014 | 14 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK (0615-8570-14) | 2025-02-24 | No | No | Current |
| 0615-8570-39 | 00615857039 | 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK (0615-8570-39) | 2025-02-24 | No | No | Current |