Potassium chloride
- Product NDC
- 50090-7748
- Requested package NDC
- 50090-7748-0
- 11-digit product format
- 500907748
- Labeler code
- 50090
- Product ID
- 50090-7748_e2d280f2-513a-41a9-ac7e-756f30cdfb7b
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Potassium Chloride
- Dosage form
- TABLET, FILM COATED, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- A-S Medication Solutions
- Application
- ANDA215725
- Marketing category
- ANDA
- Marketing start
- 2022-07-25
- 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 |
|---|---|---|---|---|---|---|---|
| A215725-001 | POTASSIUM CHLORIDE | POTASSIUM CHLORIDE | 10MEQ | TABLET, EXTENDED RELEASE / ORAL | AB3 | 2022-07-25 | |
| A215725-002 | POTASSIUM CHLORIDE | POTASSIUM CHLORIDE | 20MEQ | TABLET, EXTENDED RELEASE / ORAL | AB3 | 2022-07-25 | |
| A215725-003 | POTASSIUM CHLORIDE | POTASSIUM CHLORIDE | 15MEQ | TABLET, EXTENDED RELEASE / ORAL | RS | 2024-08-22 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A215725-001 | AB3 |
| A215725-002 | AB3 |
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 | A215725-001 | POTASSIUM CHLORIDE | 10MEQ | TABLET, EXTENDED RELEASE / ORAL | AB3 | 2022-07-25 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A215725-002 | POTASSIUM CHLORIDE | 20MEQ | TABLET, EXTENDED RELEASE / ORAL | AB3 | 2022-07-25 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A215725-003 | POTASSIUM CHLORIDE | 15MEQ | TABLET, EXTENDED RELEASE / ORAL | RS | 2024-08-22 | 84e616aacf4f… | |
| 2026-08-18 06:07:40 | 2026-07 | A215725-001 | POTASSIUM CHLORIDE | 10MEQ | TABLET, EXTENDED RELEASE / ORAL | AB3 | 2022-07-25 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A215725-002 | POTASSIUM CHLORIDE | 20MEQ | TABLET, EXTENDED RELEASE / ORAL | AB3 | 2022-07-25 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A215725-003 | POTASSIUM CHLORIDE | 15MEQ | TABLET, EXTENDED RELEASE / ORAL | RS | 2024-08-22 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | A215725-001 | POTASSIUM CHLORIDE | 10MEQ | TABLET, EXTENDED RELEASE / ORAL | AB3 | 2022-07-25 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A215725-002 | POTASSIUM CHLORIDE | 20MEQ | TABLET, EXTENDED RELEASE / ORAL | AB3 | 2022-07-25 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A215725-003 | POTASSIUM CHLORIDE | 15MEQ | TABLET, EXTENDED RELEASE / ORAL | RS | 2024-08-22 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A215725-001 | POTASSIUM CHLORIDE | 10MEQ | TABLET, EXTENDED RELEASE / ORAL | AB3 | 2022-07-25 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A215725-002 | POTASSIUM CHLORIDE | 20MEQ | TABLET, EXTENDED RELEASE / ORAL | AB3 | 2022-07-25 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A215725-003 | POTASSIUM CHLORIDE | 15MEQ | TABLET, EXTENDED RELEASE / ORAL | RS | 2024-08-22 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A215725-001 | POTASSIUM CHLORIDE | 10MEQ | TABLET, EXTENDED RELEASE / ORAL | AB3 | 2022-07-25 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A215725-002 | POTASSIUM CHLORIDE | 20MEQ | TABLET, EXTENDED RELEASE / ORAL | AB3 | 2022-07-25 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A215725-003 | POTASSIUM CHLORIDE | 15MEQ | TABLET, EXTENDED RELEASE / ORAL | RS | 2024-08-22 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A215725-001 | POTASSIUM CHLORIDE | 10MEQ | TABLET, EXTENDED RELEASE / ORAL | AB3 | 2022-07-25 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A215725-002 | POTASSIUM CHLORIDE | 20MEQ | TABLET, EXTENDED RELEASE / ORAL | AB3 | 2022-07-25 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A215725-003 | POTASSIUM CHLORIDE | 15MEQ | TABLET, EXTENDED RELEASE / ORAL | RS | 2024-08-22 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A215725-001 | POTASSIUM CHLORIDE | 10MEQ | TABLET, EXTENDED RELEASE / ORAL | AB3 | 2022-07-25 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A215725-002 | POTASSIUM CHLORIDE | 20MEQ | TABLET, EXTENDED RELEASE / ORAL | AB3 | 2022-07-25 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A215725-003 | POTASSIUM CHLORIDE | 15MEQ | TABLET, EXTENDED RELEASE / ORAL | RS | 2024-08-22 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A215725-001 | POTASSIUM CHLORIDE | 10MEQ | TABLET, EXTENDED RELEASE / ORAL | AB3 | 2022-07-25 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A215725-002 | POTASSIUM CHLORIDE | 20MEQ | TABLET, EXTENDED RELEASE / ORAL | AB3 | 2022-07-25 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A215725-003 | POTASSIUM CHLORIDE | 15MEQ | TABLET, EXTENDED RELEASE / ORAL | RS | 2024-08-22 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A215725-001 | POTASSIUM CHLORIDE | 10MEQ | TABLET, EXTENDED RELEASE / ORAL | AB3 | 2022-07-25 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A215725-002 | POTASSIUM CHLORIDE | 20MEQ | TABLET, EXTENDED RELEASE / ORAL | AB3 | 2022-07-25 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A215725-003 | POTASSIUM CHLORIDE | 15MEQ | TABLET, EXTENDED RELEASE / ORAL | RS | 2024-08-22 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A215725-001 | POTASSIUM CHLORIDE | 10MEQ | TABLET, EXTENDED RELEASE / ORAL | AB3 | 2022-07-25 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A215725-002 | POTASSIUM CHLORIDE | 20MEQ | TABLET, EXTENDED RELEASE / ORAL | AB3 | 2022-07-25 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A215725-003 | POTASSIUM CHLORIDE | 15MEQ | TABLET, EXTENDED RELEASE / ORAL | RS | 2024-08-22 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A215725-001 | POTASSIUM CHLORIDE | 10MEQ | TABLET, EXTENDED RELEASE / ORAL | AB3 | 2022-07-25 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A215725-002 | POTASSIUM CHLORIDE | 20MEQ | TABLET, EXTENDED RELEASE / ORAL | AB3 | 2022-07-25 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A215725-003 | POTASSIUM CHLORIDE | 15MEQ | TABLET, EXTENDED RELEASE / ORAL | RS | 2024-08-22 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A215725-001 | POTASSIUM CHLORIDE | 10MEQ | TABLET, EXTENDED RELEASE / ORAL | AB3 | 2022-07-25 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A215725-002 | POTASSIUM CHLORIDE | 20MEQ | TABLET, EXTENDED RELEASE / ORAL | AB3 | 2022-07-25 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A215725-003 | POTASSIUM CHLORIDE | 15MEQ | TABLET, EXTENDED RELEASE / ORAL | RS | 2024-08-22 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A215725-001 | POTASSIUM CHLORIDE | 10MEQ | TABLET, EXTENDED RELEASE / ORAL | AB3 | 2022-07-25 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A215725-002 | POTASSIUM CHLORIDE | 20MEQ | TABLET, EXTENDED RELEASE / ORAL | AB3 | 2022-07-25 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A215725-001 | POTASSIUM CHLORIDE | 10MEQ | TABLET, EXTENDED RELEASE / ORAL | AB3 | 2022-07-25 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A215725-002 | POTASSIUM CHLORIDE | 20MEQ | TABLET, EXTENDED RELEASE / ORAL | AB3 | 2022-07-25 | 301d65b070ca… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | A215725-001 | AB3 | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A215725-002 | AB3 | 1 | 84e616aacf4f… |
| 2026-08-18 06:07:40 | 2026-07 | A215725-001 | AB3 | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A215725-002 | AB3 | 1 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | A215725-001 | AB3 | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A215725-002 | AB3 | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A215725-001 | AB3 | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A215725-002 | AB3 | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A215725-001 | AB3 | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A215725-002 | AB3 | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A215725-001 | AB3 | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A215725-002 | AB3 | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A215725-001 | AB3 | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A215725-002 | AB3 | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A215725-001 | AB3 | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A215725-002 | AB3 | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A215725-001 | AB3 | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A215725-002 | AB3 | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A215725-001 | AB3 | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A215725-002 | AB3 | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A215725-001 | AB3 | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A215725-002 | AB3 | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A215725-001 | AB3 | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A215725-002 | AB3 | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A215725-001 | AB3 | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A215725-002 | AB3 | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A215725-001 | AB3 | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A215725-002 | AB3 | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A215725-001 | AB3 | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A215725-002 | AB3 | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | A215725-001 | AB3 | 1 | 8072bd15b7f6… |
| 2024-05-31 18:47 UTC | 2024-05 | A215725-002 | AB3 | 1 | 8072bd15b7f6… |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A215725-001 | AB3 | 1 | 6a51e52b5d6a… |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A215725-002 | AB3 | 1 | 6a51e52b5d6a… |
| 2024-02-18 07:12 UTC | 2024-02 | A215725-001 | AB3 | 1 | 1c564ffb4f44… |
| 2024-02-18 07:12 UTC | 2024-02 | A215725-002 | AB3 | 1 | 1c564ffb4f44… |
| 2023-12-20 04:57 UTC | 2023-12 | A215725-001 | AB3 | 1 | ea1830bbd6c7… |
| 2023-12-20 04:57 UTC | 2023-12 | A215725-002 | AB3 | 1 | ea1830bbd6c7… |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A215725-001 | AB3 | 1 | a72a2bbeb626… |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A215725-002 | AB3 | 1 | a72a2bbeb626… |
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#
| Identifier | FDA.report destination |
|---|---|
| 628953 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| eb6b608f-5e51-4bc9-8339-c5d5264cba98 | Available on FDA.report |
DailyMed Product Concepts#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 50090-7748-0 | Potassium chloride | 30 in 1 BOTTLE | TABLET, FILM COATED, EXTENDED RE | 30 | 1 | |
| 50090-7748-1 | Potassium chloride | 100 in 1 BOTTLE | TABLET, FILM COATED, EXTENDED RE | 100 | 1 | |
| 50090-7748-2 | Potassium chloride | 90 in 1 BOTTLE | TABLET, FILM COATED, EXTENDED RE | 90 | 1 | |
| 50090-7748-3 | Potassium chloride | 60 in 1 BOTTLE | TABLET, FILM COATED, EXTENDED RE | 60 | 1 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 50090-7748-0 | EA - Each | 50090-7748 | a70f1e9a-7aaf-4e20-89a4-ab26aebfd924 | 1 | 2025-12-16 |
| 50090-7748-1 | EA - Each | 50090-7748 | 7ce462bc-eeee-433f-8d5d-26219e5ccaec | 1 | 2025-12-16 |
| 50090-7748-2 | EA - Each | 50090-7748 | 22d32efa-9848-489a-b084-acfdd6c59e36 | 1 | 2025-12-16 |
| 50090-7748-3 | EA - Each | 50090-7748 | c41d8063-6425-42d1-80d0-4785f4a68f00 | 1 | 2025-12-16 |
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 | Aphena Pharma Solutions - Tennessee, LLC | 42773f05-7c2c-1790-e063-6294a90a78b3 | 2025-11-24 | Warnings, Adverse reactions | 215725 ANDA215725 |
| Potassium chloride | POTASSIUM CHLORIDE | Advagen Pharma Ltd | 8000e242-fe20-4d02-8f7d-97298857cf4c | 2025-11-19 | Warnings, Adverse reactions | 215725 ANDA215725 |
| Potassium chloride | POTASSIUM CHLORIDE | A-S Medication Solutions | 4a2173ba-556b-4ad7-be81-4da79b739490 | 2025-11-06 | Warnings, Adverse reactions | 215725 ANDA215725 |
| Potassium chloride | POTASSIUM CHLORIDE | A-S Medication Solutions | eb6b608f-5e51-4bc9-8339-c5d5264cba98 | 2025-11-05 | Warnings, Adverse reactions | 215725 ANDA215725 50090-7748-0 50090-7748 50090774800 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 628953 | potassium chloride 10 MEQ (750 MG) Extended Release Oral Tablet | PSN | eb6b608f-5e51-4bc9-8339-c5d5264cba98 | 1 |
| 628953 | potassium chloride 10 MEQ Extended Release Oral Tablet | SCD | eb6b608f-5e51-4bc9-8339-c5d5264cba98 | 1 |
| 628953 | K+ Chloride 10 MEQ Extended Release Oral Tablet | SY | eb6b608f-5e51-4bc9-8339-c5d5264cba98 | 1 |
| 628953 | Pot Chloride 10 MEQ Extended Release Oral Tablet | SY | eb6b608f-5e51-4bc9-8339-c5d5264cba98 | 1 |
| 628953 | potassium chloride 750 MG (potassium 10 mEq) Extended Release Oral Tablet | SY | eb6b608f-5e51-4bc9-8339-c5d5264cba98 | 1 |
| 628953 | potassium chloride 750 MG Extended Release Oral Tablet | SY | eb6b608f-5e51-4bc9-8339-c5d5264cba98 | 1 |
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|
| 50090-7748-0 | 50090774800 | 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (50090-7748-0) | 2025-11-03 | No | No | Current |