Potassium Chloride
- Product NDC
- 50268-674
- Requested package NDC
- 50268-674-15
- 11-digit product format
- 502680674
- Labeler code
- 50268
- Product ID
- 50268-674_47fb4ce6-78ac-6467-e063-6294a90ace55
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Potassium Chloride
- Dosage form
- SOLUTION
- Route
- ORAL
- Labeler
- AvPAK
- Application
- ANDA210041
- Marketing category
- ANDA
- Marketing start
- 2023-01-26
- Substance
- POTASSIUM CHLORIDE
- Active strength
- 1.5 g/15mL
- 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 |
|---|---|---|---|---|---|---|---|
| A210041-001 | POTASSIUM CHLORIDE | POTASSIUM CHLORIDE | 20MEQ/15ML | SOLUTION / ORAL | AA | 2018-07-19 | |
| A210041-002 | POTASSIUM CHLORIDE | POTASSIUM CHLORIDE | 40MEQ/15ML | SOLUTION / ORAL | AA | 2018-07-19 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A210041-001 | AA |
| A210041-002 | AA |
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 | A210041-001 | POTASSIUM CHLORIDE | 20MEQ/15ML | SOLUTION / ORAL | AA | 2018-07-19 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A210041-002 | POTASSIUM CHLORIDE | 40MEQ/15ML | SOLUTION / ORAL | AA | 2018-07-19 | 84e616aacf4f… | |
| 2026-08-18 06:07:40 | 2026-07 | A210041-001 | POTASSIUM CHLORIDE | 20MEQ/15ML | SOLUTION / ORAL | AA | 2018-07-19 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A210041-002 | POTASSIUM CHLORIDE | 40MEQ/15ML | SOLUTION / ORAL | AA | 2018-07-19 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | A210041-001 | POTASSIUM CHLORIDE | 20MEQ/15ML | SOLUTION / ORAL | AA | 2018-07-19 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A210041-002 | POTASSIUM CHLORIDE | 40MEQ/15ML | SOLUTION / ORAL | AA | 2018-07-19 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A210041-001 | POTASSIUM CHLORIDE | 20MEQ/15ML | SOLUTION / ORAL | AA | 2018-07-19 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A210041-002 | POTASSIUM CHLORIDE | 40MEQ/15ML | SOLUTION / ORAL | AA | 2018-07-19 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A210041-001 | POTASSIUM CHLORIDE | 20MEQ/15ML | SOLUTION / ORAL | AA | 2018-07-19 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A210041-002 | POTASSIUM CHLORIDE | 40MEQ/15ML | SOLUTION / ORAL | AA | 2018-07-19 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A210041-001 | POTASSIUM CHLORIDE | 20MEQ/15ML | SOLUTION / ORAL | AA | 2018-07-19 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A210041-002 | POTASSIUM CHLORIDE | 40MEQ/15ML | SOLUTION / ORAL | AA | 2018-07-19 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A210041-001 | POTASSIUM CHLORIDE | 20MEQ/15ML | SOLUTION / ORAL | AA | 2018-07-19 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A210041-002 | POTASSIUM CHLORIDE | 40MEQ/15ML | SOLUTION / ORAL | AA | 2018-07-19 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A210041-001 | POTASSIUM CHLORIDE | 20MEQ/15ML | SOLUTION / ORAL | AA | 2018-07-19 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A210041-002 | POTASSIUM CHLORIDE | 40MEQ/15ML | SOLUTION / ORAL | AA | 2018-07-19 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A210041-001 | POTASSIUM CHLORIDE | 20MEQ/15ML | SOLUTION / ORAL | AA | 2018-07-19 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A210041-002 | POTASSIUM CHLORIDE | 40MEQ/15ML | SOLUTION / ORAL | AA | 2018-07-19 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A210041-001 | POTASSIUM CHLORIDE | 20MEQ/15ML | SOLUTION / ORAL | AA | 2018-07-19 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A210041-002 | POTASSIUM CHLORIDE | 40MEQ/15ML | SOLUTION / ORAL | AA | 2018-07-19 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A210041-001 | POTASSIUM CHLORIDE | 20MEQ/15ML | SOLUTION / ORAL | AA | 2018-07-19 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A210041-002 | POTASSIUM CHLORIDE | 40MEQ/15ML | SOLUTION / ORAL | AA | 2018-07-19 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A210041-001 | POTASSIUM CHLORIDE | 20MEQ/15ML | SOLUTION / ORAL | AA | 2018-07-19 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A210041-002 | POTASSIUM CHLORIDE | 40MEQ/15ML | SOLUTION / ORAL | AA | 2018-07-19 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A210041-001 | POTASSIUM CHLORIDE | 20MEQ/15ML | SOLUTION / ORAL | AA | 2018-07-19 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A210041-002 | POTASSIUM CHLORIDE | 40MEQ/15ML | SOLUTION / ORAL | AA | 2018-07-19 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A210041-001 | POTASSIUM CHLORIDE | 20MEQ/15ML | SOLUTION / ORAL | AA | 2018-07-19 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A210041-002 | POTASSIUM CHLORIDE | 40MEQ/15ML | SOLUTION / ORAL | AA | 2018-07-19 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A210041-001 | POTASSIUM CHLORIDE | 20MEQ/15ML | SOLUTION / ORAL | AA | 2018-07-19 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A210041-002 | POTASSIUM CHLORIDE | 40MEQ/15ML | SOLUTION / ORAL | AA | 2018-07-19 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | A210041-001 | POTASSIUM CHLORIDE | 20MEQ/15ML | SOLUTION / ORAL | AA | 2018-07-19 | 8072bd15b7f6… | |
| 2024-05-31 18:47 UTC | 2024-05 | A210041-002 | POTASSIUM CHLORIDE | 40MEQ/15ML | SOLUTION / ORAL | AA | 2018-07-19 | 8072bd15b7f6… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A210041-001 | POTASSIUM CHLORIDE | 20MEQ/15ML | SOLUTION / ORAL | AA | 2018-07-19 | 5c6f7cd8ea54… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A210041-002 | POTASSIUM CHLORIDE | 40MEQ/15ML | SOLUTION / ORAL | AA | 2018-07-19 | 5c6f7cd8ea54… | |
| 2022-04-08 23:34 UTC | 2022-04 | A210041-001 | POTASSIUM CHLORIDE | 20MEQ/15ML | SOLUTION / ORAL | AA | 2018-07-19 | 5d02ea3f76ae… | |
| 2022-04-08 23:34 UTC | 2022-04 | A210041-002 | POTASSIUM CHLORIDE | 40MEQ/15ML | SOLUTION / ORAL | AA | 2018-07-19 | 5d02ea3f76ae… | |
| 2022-04-04 05:41 UTC | 2022-04 | A210041-001 | POTASSIUM CHLORIDE | 20MEQ/15ML | SOLUTION / ORAL | AA | 2018-07-19 | 4b0b4de00fa7… | |
| 2022-04-04 05:41 UTC | 2022-04 | A210041-002 | POTASSIUM CHLORIDE | 40MEQ/15ML | SOLUTION / ORAL | AA | 2018-07-19 | 4b0b4de00fa7… | |
| 2019-12-13 00:20 UTC | 2019-12 | A210041-001 | POTASSIUM CHLORIDE | 20MEQ/15ML | SOLUTION / ORAL | AA | 2018-07-19 | 74a2ff9319b5… | |
| 2019-12-13 00:20 UTC | 2019-12 | A210041-002 | POTASSIUM CHLORIDE | 40MEQ/15ML | SOLUTION / ORAL | AA | 2018-07-19 | 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 | A210041-001 | AA | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A210041-002 | AA | 1 | 84e616aacf4f… |
| 2026-08-18 06:07:40 | 2026-07 | A210041-001 | AA | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A210041-002 | AA | 1 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | A210041-001 | AA | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A210041-002 | AA | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A210041-001 | AA | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A210041-002 | AA | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A210041-001 | AA | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A210041-002 | AA | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A210041-001 | AA | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A210041-002 | AA | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A210041-001 | AA | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A210041-002 | AA | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A210041-001 | AA | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A210041-002 | AA | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A210041-001 | AA | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A210041-002 | AA | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A210041-001 | AA | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A210041-002 | AA | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A210041-001 | AA | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A210041-002 | AA | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A210041-001 | AA | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A210041-002 | AA | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A210041-001 | AA | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A210041-002 | AA | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A210041-001 | AA | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A210041-002 | AA | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A210041-001 | AA | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A210041-002 | AA | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | A210041-001 | AA | 1 | 8072bd15b7f6… |
| 2024-05-31 18:47 UTC | 2024-05 | A210041-002 | AA | 1 | 8072bd15b7f6… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A210041-001 | AA | 1 | 5c6f7cd8ea54… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A210041-002 | AA | 1 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | A210041-001 | AA | 1 | 5d02ea3f76ae… |
| 2022-04-08 23:34 UTC | 2022-04 | A210041-002 | AA | 1 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | A210041-001 | AA | 1 | 4b0b4de00fa7… |
| 2022-04-04 05:41 UTC | 2022-04 | A210041-002 | AA | 1 | 4b0b4de00fa7… |
| 2019-12-13 00:20 UTC | 2019-12 | A210041-001 | AA | 1 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | A210041-002 | AA | 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
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| POTASSIUM CHLORIDE | 1.5 g/15mL |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| 660YQ98I10 | Internal UNII lookup |
Harmonized RxCUI identifiers#
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| f32df7c0-33eb-e6d6-e053-2a95a90a2e8d | Available on FDA.report |
DailyMed Product Concepts#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 50268-674-11 | Potassium Chloride | 15 mL in 1 CUP | SOLUTION | 15 | 2 | |
| 50268-674-15 | Potassium Chloride | 50 in 1 BOX | SOLUTION | 50 | 2 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 50268-674-11 | ML - Milliliter | 50268-674 | de5df4ca-9098-466e-b7ce-406be48c0801 | 1 | 2023-02-06 |
| 50268-674-15 | ML - Milliliter | 50268-674 | 76e9a9f0-d5f9-40da-a973-7e94b964d6f8 | 1 | 2023-02-06 |
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 | ATLANTIC BIOLOGICALS CORP. | 104ccc91-2aaf-4bb7-bb64-77c29413f60e | 2026-07-10 | Warnings, Adverse reactions | 210041 ANDA210041 |
| Potassium Chloride | POTASSIUM CHLORIDE | Amneal Pharmaceuticals NY LLC | 590dd25c-c4cb-489a-a09b-eccbf1d37c1f | 2026-07-01 | Warnings, Adverse reactions | 210041 ANDA210041 |
| Potassium Chloride | POTASSIUM CHLORIDE | AvPAK | f32df7c0-33eb-e6d6-e053-2a95a90a2e8d | 2026-01-09 | Warnings, Adverse reactions | 210041 ANDA210041 50268-674-15 50268-674 50268067415 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 312515 | potassium chloride 20 MEQ in 15 mL Oral Solution | PSN | f32df7c0-33eb-e6d6-e053-2a95a90a2e8d | 2 |
| 314182 | potassium chloride 40 MEQ in 15 mL Oral Solution | PSN | f32df7c0-33eb-e6d6-e053-2a95a90a2e8d | 2 |
| 312515 | potassium chloride 1.33 MEQ/ML Oral Solution | SCD | f32df7c0-33eb-e6d6-e053-2a95a90a2e8d | 2 |
| 314182 | potassium chloride 2.67 MEQ/ML Oral Solution | SCD | f32df7c0-33eb-e6d6-e053-2a95a90a2e8d | 2 |
| 312515 | K+ Chloride 1.33 MEQ/ML Oral Solution | SY | f32df7c0-33eb-e6d6-e053-2a95a90a2e8d | 2 |
| 314182 | K+ Chloride 2.67 MEQ/ML Oral Solution | SY | f32df7c0-33eb-e6d6-e053-2a95a90a2e8d | 2 |
| 312515 | Pot Chloride 1.33 MEQ/ML Oral Solution | SY | f32df7c0-33eb-e6d6-e053-2a95a90a2e8d | 2 |
| 314182 | Pot Chloride 2.67 MEQ/ML Oral Solution | SY | f32df7c0-33eb-e6d6-e053-2a95a90a2e8d | 2 |
| 312515 | potassium chloride 1.5 GM per 15 ML Oral Solution | SY | f32df7c0-33eb-e6d6-e053-2a95a90a2e8d | 2 |
| 312515 | potassium chloride 10 % Oral Solution | SY | f32df7c0-33eb-e6d6-e053-2a95a90a2e8d | 2 |
| 314182 | potassium chloride 20 % Oral Solution | SY | f32df7c0-33eb-e6d6-e053-2a95a90a2e8d | 2 |
| 312515 | potassium chloride 20 MEQ per 15 ML Oral Solution | SY | f32df7c0-33eb-e6d6-e053-2a95a90a2e8d | 2 |
| 314182 | potassium chloride 20 MEQ per 30 ML Oral Solution | SY | f32df7c0-33eb-e6d6-e053-2a95a90a2e8d | 2 |
| 314182 | potassium chloride 3 GM per 15 ML Oral Solution | SY | f32df7c0-33eb-e6d6-e053-2a95a90a2e8d | 2 |
| 314182 | potassium chloride 40 MEQ per 15 ML Oral Solution | SY | f32df7c0-33eb-e6d6-e053-2a95a90a2e8d | 2 |
| 312515 | potassium chloride 40 MEQ per 30 ML Oral Solution | SY | f32df7c0-33eb-e6d6-e053-2a95a90a2e8d | 2 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 50268-674-15 | 50268067415 | 50 CUP in 1 BOX (50268-674-15) / 15 mL in 1 CUP (50268-674-11) | 50 cup | 2023-01-26 | No | No | Current |