Potassium Chloride
- Product NDC
- 0904-7548
- Requested package NDC
- 0904-7548-61
- 11-digit product format
- 009047548
- Labeler code
- 0904
- Product ID
- 0904-7548_5c2e888c-2f1e-4d5a-a456-20774ca83302
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Potassium Chloride
- Dosage form
- TABLET, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Major Pharmaceuticals
- Application
- ANDA076368
- Marketing category
- ANDA
- Marketing start
- 2026-02-04
- Substance
- POTASSIUM CHLORIDE
- Active strength
- 20 meq/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 |
|---|---|---|---|---|---|---|---|
| A076368-001 | POTASSIUM CHLORIDE | POTASSIUM CHLORIDE | 20MEQ | TABLET, EXTENDED RELEASE / ORAL | AB1 | 2004-08-18 | |
| A076368-002 | POTASSIUM CHLORIDE | POTASSIUM CHLORIDE | 10MEQ | TABLET, EXTENDED RELEASE / ORAL | AB1 | 2019-06-05 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A076368-001 | AB1 |
| A076368-002 | AB1 |
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-10-15 13:18:30 | 2026-09 | A076368-001 | POTASSIUM CHLORIDE | 20MEQ | TABLET, EXTENDED RELEASE / ORAL | AB1 | 2004-08-18 | c2088c7a36db… | |
| 2026-10-15 13:18:30 | 2026-09 | A076368-002 | POTASSIUM CHLORIDE | 10MEQ | TABLET, EXTENDED RELEASE / ORAL | AB1 | 2019-06-05 | c2088c7a36db… | |
| 2026-09-14 22:38:34 | 2026-08 | A076368-001 | POTASSIUM CHLORIDE | 20MEQ | TABLET, EXTENDED RELEASE / ORAL | AB1 | 2004-08-18 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A076368-002 | POTASSIUM CHLORIDE | 10MEQ | TABLET, EXTENDED RELEASE / ORAL | AB1 | 2019-06-05 | 84e616aacf4f… | |
| 2026-08-18 06:07:40 | 2026-07 | A076368-001 | POTASSIUM CHLORIDE | 20MEQ | TABLET, EXTENDED RELEASE / ORAL | AB1 | 2004-08-18 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A076368-002 | POTASSIUM CHLORIDE | 10MEQ | TABLET, EXTENDED RELEASE / ORAL | AB1 | 2019-06-05 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | A076368-001 | POTASSIUM CHLORIDE | 20MEQ | TABLET, EXTENDED RELEASE / ORAL | AB1 | 2004-08-18 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A076368-002 | POTASSIUM CHLORIDE | 10MEQ | TABLET, EXTENDED RELEASE / ORAL | AB1 | 2019-06-05 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A076368-001 | POTASSIUM CHLORIDE | 20MEQ | TABLET, EXTENDED RELEASE / ORAL | AB1 | 2004-08-18 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A076368-002 | POTASSIUM CHLORIDE | 10MEQ | TABLET, EXTENDED RELEASE / ORAL | AB1 | 2019-06-05 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A076368-001 | POTASSIUM CHLORIDE | 20MEQ | TABLET, EXTENDED RELEASE / ORAL | AB1 | 2004-08-18 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A076368-002 | POTASSIUM CHLORIDE | 10MEQ | TABLET, EXTENDED RELEASE / ORAL | AB1 | 2019-06-05 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A076368-001 | POTASSIUM CHLORIDE | 20MEQ | TABLET, EXTENDED RELEASE / ORAL | AB1 | 2004-08-18 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A076368-002 | POTASSIUM CHLORIDE | 10MEQ | TABLET, EXTENDED RELEASE / ORAL | AB1 | 2019-06-05 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A076368-001 | POTASSIUM CHLORIDE | 20MEQ | TABLET, EXTENDED RELEASE / ORAL | AB1 | 2004-08-18 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A076368-002 | POTASSIUM CHLORIDE | 10MEQ | TABLET, EXTENDED RELEASE / ORAL | AB1 | 2019-06-05 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A076368-001 | POTASSIUM CHLORIDE | 20MEQ | TABLET, EXTENDED RELEASE / ORAL | AB1 | 2004-08-18 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A076368-002 | POTASSIUM CHLORIDE | 10MEQ | TABLET, EXTENDED RELEASE / ORAL | AB1 | 2019-06-05 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A076368-001 | POTASSIUM CHLORIDE | 20MEQ | TABLET, EXTENDED RELEASE / ORAL | AB1 | 2004-08-18 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A076368-002 | POTASSIUM CHLORIDE | 10MEQ | TABLET, EXTENDED RELEASE / ORAL | AB1 | 2019-06-05 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A076368-001 | POTASSIUM CHLORIDE | 20MEQ | TABLET, EXTENDED RELEASE / ORAL | AB1 | 2004-08-18 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A076368-002 | POTASSIUM CHLORIDE | 10MEQ | TABLET, EXTENDED RELEASE / ORAL | AB1 | 2019-06-05 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A076368-001 | POTASSIUM CHLORIDE | 20MEQ | TABLET, EXTENDED RELEASE / ORAL | AB1 | 2004-08-18 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A076368-002 | POTASSIUM CHLORIDE | 10MEQ | TABLET, EXTENDED RELEASE / ORAL | AB1 | 2019-06-05 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A076368-001 | POTASSIUM CHLORIDE | 20MEQ | TABLET, EXTENDED RELEASE / ORAL | AB1 | 2004-08-18 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A076368-002 | POTASSIUM CHLORIDE | 10MEQ | TABLET, EXTENDED RELEASE / ORAL | AB1 | 2019-06-05 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A076368-001 | POTASSIUM CHLORIDE | 20MEQ | TABLET, EXTENDED RELEASE / ORAL | AB1 | 2004-08-18 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A076368-002 | POTASSIUM CHLORIDE | 10MEQ | TABLET, EXTENDED RELEASE / ORAL | AB1 | 2019-06-05 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A076368-001 | POTASSIUM CHLORIDE | 20MEQ | TABLET, EXTENDED RELEASE / ORAL | AB1 | 2004-08-18 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A076368-002 | POTASSIUM CHLORIDE | 10MEQ | TABLET, EXTENDED RELEASE / ORAL | AB1 | 2019-06-05 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A076368-001 | POTASSIUM CHLORIDE | 20MEQ | TABLET, EXTENDED RELEASE / ORAL | AB1 | 2004-08-18 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A076368-002 | POTASSIUM CHLORIDE | 10MEQ | TABLET, EXTENDED RELEASE / ORAL | AB1 | 2019-06-05 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | A076368-001 | POTASSIUM CHLORIDE | 20MEQ | TABLET, EXTENDED RELEASE / ORAL | AB1 | 2004-08-18 | 8072bd15b7f6… | |
| 2024-05-31 18:47 UTC | 2024-05 | A076368-002 | POTASSIUM CHLORIDE | 10MEQ | TABLET, EXTENDED RELEASE / ORAL | AB1 | 2019-06-05 | 8072bd15b7f6… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A076368-001 | POTASSIUM CHLORIDE | 20MEQ | TABLET, EXTENDED RELEASE / ORAL | AB1 | 2004-08-18 | 5c6f7cd8ea54… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A076368-002 | POTASSIUM CHLORIDE | 10MEQ | TABLET, EXTENDED RELEASE / ORAL | AB1 | 2019-06-05 | 5c6f7cd8ea54… | |
| 2022-04-08 23:34 UTC | 2022-04 | A076368-001 | POTASSIUM CHLORIDE | 20MEQ | TABLET, EXTENDED RELEASE / ORAL | AB1 | 2004-08-18 | 5d02ea3f76ae… | |
| 2022-04-08 23:34 UTC | 2022-04 | A076368-002 | POTASSIUM CHLORIDE | 10MEQ | TABLET, EXTENDED RELEASE / ORAL | AB1 | 2019-06-05 | 5d02ea3f76ae… | |
| 2022-04-04 05:41 UTC | 2022-04 | A076368-001 | POTASSIUM CHLORIDE | 20MEQ | TABLET, EXTENDED RELEASE / ORAL | AB1 | 2004-08-18 | 4b0b4de00fa7… | |
| 2022-04-04 05:41 UTC | 2022-04 | A076368-002 | POTASSIUM CHLORIDE | 10MEQ | TABLET, EXTENDED RELEASE / ORAL | AB1 | 2019-06-05 | 4b0b4de00fa7… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-10-15 13:18:30 | 2026-09 | A076368-001 | AB1 | 1 | c2088c7a36db… |
| 2026-10-15 13:18:30 | 2026-09 | A076368-002 | AB1 | 1 | c2088c7a36db… |
| 2026-09-14 22:38:34 | 2026-08 | A076368-001 | AB1 | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A076368-002 | AB1 | 1 | 84e616aacf4f… |
| 2026-08-18 06:07:40 | 2026-07 | A076368-001 | AB1 | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A076368-002 | AB1 | 1 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | A076368-001 | AB1 | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A076368-002 | AB1 | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A076368-001 | AB1 | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A076368-002 | AB1 | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A076368-001 | AB1 | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A076368-002 | AB1 | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A076368-001 | AB1 | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A076368-002 | AB1 | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A076368-001 | AB1 | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A076368-002 | AB1 | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A076368-001 | AB1 | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A076368-002 | AB1 | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A076368-001 | AB1 | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A076368-002 | AB1 | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A076368-001 | AB1 | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A076368-002 | AB1 | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A076368-001 | AB1 | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A076368-002 | AB1 | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A076368-001 | AB1 | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A076368-002 | AB1 | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A076368-001 | AB1 | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A076368-002 | AB1 | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A076368-001 | AB1 | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A076368-002 | AB1 | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A076368-001 | AB1 | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A076368-002 | AB1 | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | A076368-001 | AB1 | 1 | 8072bd15b7f6… |
| 2024-05-31 18:47 UTC | 2024-05 | A076368-002 | AB1 | 1 | 8072bd15b7f6… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A076368-001 | AB1 | 1 | 5c6f7cd8ea54… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A076368-002 | AB1 | 1 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | A076368-001 | AB1 | 1 | 5d02ea3f76ae… |
| 2022-04-08 23:34 UTC | 2022-04 | A076368-002 | AB1 | 1 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | A076368-001 | AB1 | 1 | 4b0b4de00fa7… |
| 2022-04-04 05:41 UTC | 2022-04 | A076368-002 | AB1 | 1 | 4b0b4de00fa7… |
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 | 20 meq/1 |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| 660YQ98I10 | Internal UNII lookup |
Harmonized RxCUI identifiers#
| Identifier | FDA.report destination |
|---|---|
| 1801294 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 5c2e888c-2f1e-4d5a-a456-20774ca83302 | Available on FDA.report |
DailyMed Product Concepts#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 0904-7548-61 | Potassium Chloride | 1 in 1 BLISTER PACK | TABLET, EXTENDED RELEASE | 1 | 1 | |
| 0904-7548-61 | Potassium Chloride | 100 in 1 CARTON | TABLET, EXTENDED RELEASE | 100 | 1 |
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.
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1801294 | potassium chloride 20 MEQ Microencapsulated Extended Release Oral Tablet | PSN | 5c2e888c-2f1e-4d5a-a456-20774ca83302 | 1 |
| 1801294 | Microencapsulated potassium chloride 20 MEQ Extended Release Oral Tablet | SCD | 5c2e888c-2f1e-4d5a-a456-20774ca83302 | 1 |
| 1801294 | Microencapsulated K+ Chloride 20 MEQ Extended Release Oral Tablet | SY | 5c2e888c-2f1e-4d5a-a456-20774ca83302 | 1 |
| 1801294 | Microencapsulated Pot Chloride 20 MEQ Extended Release Oral Tablet | SY | 5c2e888c-2f1e-4d5a-a456-20774ca83302 | 1 |
| 1801294 | potassium chloride 1500 MG Microencapsulated Extended Release Oral Tablet | SY | 5c2e888c-2f1e-4d5a-a456-20774ca83302 | 1 |
| 1801294 | potassium chloride 20 MEQ Microencapsulated Extended Release Oral Tablet | SY | 5c2e888c-2f1e-4d5a-a456-20774ca83302 | 1 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 0904-7548-61 | 00904754861 | 100 BLISTER PACK in 1 CARTON (0904-7548-61) / 1 TABLET, EXTENDED RELEASE in 1 BLISTER PACK | 100 blister pack | 2026-02-04 | No | No | Current |