POTASSIUM CHLORIDE
- Product NDC
- 63629-1076
- 11-digit product format
- 636291076
- Labeler code
- 63629
- Product ID
- 63629-1076_97679451-0039-4663-ae3a-5b71fe9be517
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- POTASSIUM CHLORIDE
- Dosage form
- CAPSULE, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Bryant Ranch Prepack
- Application
- ANDA208864
- Marketing category
- ANDA
- Marketing start
- 2020-06-17
- Marketing end
- 0000-00-00
- Substance
- POTASSIUM CHLORIDE
- Active strength
- 600 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
- 2023-12-31
- Current FDA listing
- Historical FDA.report record
NDC auxiliary status#
These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.
| Dataset | Scope | Product NDC | Package NDC | Code | Status | Reporting period | Source date |
|---|---|---|---|---|---|---|---|
| excluded product | product | 63629-1076 | D | Discontinued by firm | 2026-08-10 | ||
| excluded package | package | 63629-1076 | 63629-1076-1 | D | Discontinued by firm | 2026-08-10 |
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… |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 63629-1076-1 | EA - Each | 63629-1076 | 93244122-0b75-4c31-b3ba-9c58d6ea5bd0 | 1 | 2020-09-14 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 63629-1076 | POTASSIUM CHLORIDE CAPSULE, EXTENDED RELEASE [BRYANT RANCH PREPACK] | 7 | Legacy NDC | 20240404_772cbb58-676c-4f9e-9ebe-0756b5c3eaab.zip |
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 |
| 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 |
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 63629-1076-1 | 63629107601 | 100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (63629-1076-1) | 2020-06-17 | 0000-00-00 | No | No | Current |