Application 019308
- Type
- NDA
- Sponsor
- BAXTER HLTHCARE
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | POTASSIUM CHLORIDE 5MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE | INJECTABLE;INJECTION | 5GM/100ML;150MG/100ML;900MG/100ML | No | No |
| 002 | POTASSIUM CHLORIDE 10MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE | INJECTABLE;INJECTION | 5GM/100ML;150MG/100ML;900MG/100ML | No | No |
| 003 | POTASSIUM CHLORIDE 20MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE | INJECTABLE;INJECTION | 5GM/100ML;300MG/100ML;900MG/100ML | No | No |
| 004 | POTASSIUM CHLORIDE 10MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE | INJECTABLE;INJECTION | 5GM/100ML;75MG/100ML;900MG/100ML | No | No |
| 005 | POTASSIUM CHLORIDE 20MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE | INJECTABLE;INJECTION | 5GM/100ML;150MG/100ML;900MG/100ML | No | No |
| 006 | POTASSIUM CHLORIDE 30MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE | INJECTABLE;INJECTION | 5GM/100ML;224MG/100ML;900MG/100ML | No | No |
| 007 | POTASSIUM CHLORIDE 40MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE | INJECTABLE;INJECTION | 5GM/100ML;300MG/100ML;900MG/100ML | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N019308-001 | POTASSIUM CHLORIDE 5MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE | 5GM/100ML;150MG/100ML;900MG/100ML | INJECTABLE / INJECTION | 1985-04-05 | ||
| N019308-002 | POTASSIUM CHLORIDE 10MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE | 5GM/100ML;150MG/100ML;900MG/100ML | INJECTABLE / INJECTION | 1985-04-05 | ||
| N019308-003 | POTASSIUM CHLORIDE 20MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE | 5GM/100ML;300MG/100ML;900MG/100ML | INJECTABLE / INJECTION | 1985-04-05 | ||
| N019308-004 | POTASSIUM CHLORIDE 10MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE | 5GM/100ML;75MG/100ML;900MG/100ML | INJECTABLE / INJECTION | 1985-04-05 | ||
| N019308-005 | POTASSIUM CHLORIDE 20MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE | 5GM/100ML;150MG/100ML;900MG/100ML | INJECTABLE / INJECTION | AP | 1985-04-05 | |
| N019308-006 | POTASSIUM CHLORIDE 30MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE | 5GM/100ML;224MG/100ML;900MG/100ML | INJECTABLE / INJECTION | 1985-04-05 | ||
| N019308-007 | POTASSIUM CHLORIDE 40MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE | 5GM/100ML;300MG/100ML;900MG/100ML | INJECTABLE / INJECTION | AP | 1985-04-05 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| N019308-005 | AP |
| N019308-007 | AP |
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 | N019308-001 | POTASSIUM CHLORIDE 5MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | 5GM/100ML;150MG/100ML;900MG/100ML | INJECTABLE / INJECTION | 1985-04-05 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | N019308-002 | POTASSIUM CHLORIDE 10MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | 5GM/100ML;150MG/100ML;900MG/100ML | INJECTABLE / INJECTION | 1985-04-05 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | N019308-003 | POTASSIUM CHLORIDE 20MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | 5GM/100ML;300MG/100ML;900MG/100ML | INJECTABLE / INJECTION | 1985-04-05 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | N019308-004 | POTASSIUM CHLORIDE 10MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | 5GM/100ML;75MG/100ML;900MG/100ML | INJECTABLE / INJECTION | 1985-04-05 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | N019308-005 | POTASSIUM CHLORIDE 20MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | 5GM/100ML;150MG/100ML;900MG/100ML | INJECTABLE / INJECTION | AP | 1985-04-05 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N019308-006 | POTASSIUM CHLORIDE 30MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | 5GM/100ML;224MG/100ML;900MG/100ML | INJECTABLE / INJECTION | 1985-04-05 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | N019308-007 | POTASSIUM CHLORIDE 40MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | 5GM/100ML;300MG/100ML;900MG/100ML | INJECTABLE / INJECTION | AP | 1985-04-05 | 84e616aacf4f… | |
| 2026-08-18 06:07:40 | 2026-07 | N019308-001 | POTASSIUM CHLORIDE 5MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | 5GM/100ML;150MG/100ML;900MG/100ML | INJECTABLE / INJECTION | 1985-04-05 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | N019308-002 | POTASSIUM CHLORIDE 10MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | 5GM/100ML;150MG/100ML;900MG/100ML | INJECTABLE / INJECTION | 1985-04-05 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | N019308-003 | POTASSIUM CHLORIDE 20MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | 5GM/100ML;300MG/100ML;900MG/100ML | INJECTABLE / INJECTION | 1985-04-05 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | N019308-004 | POTASSIUM CHLORIDE 10MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | 5GM/100ML;75MG/100ML;900MG/100ML | INJECTABLE / INJECTION | 1985-04-05 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | N019308-005 | POTASSIUM CHLORIDE 20MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | 5GM/100ML;150MG/100ML;900MG/100ML | INJECTABLE / INJECTION | AP | 1985-04-05 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N019308-006 | POTASSIUM CHLORIDE 30MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | 5GM/100ML;224MG/100ML;900MG/100ML | INJECTABLE / INJECTION | 1985-04-05 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | N019308-007 | POTASSIUM CHLORIDE 40MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | 5GM/100ML;300MG/100ML;900MG/100ML | INJECTABLE / INJECTION | AP | 1985-04-05 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | N019308-001 | POTASSIUM CHLORIDE 5MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | 5GM/100ML;150MG/100ML;900MG/100ML | INJECTABLE / INJECTION | 1985-04-05 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | N019308-002 | POTASSIUM CHLORIDE 10MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | 5GM/100ML;150MG/100ML;900MG/100ML | INJECTABLE / INJECTION | 1985-04-05 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | N019308-003 | POTASSIUM CHLORIDE 20MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | 5GM/100ML;300MG/100ML;900MG/100ML | INJECTABLE / INJECTION | 1985-04-05 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | N019308-004 | POTASSIUM CHLORIDE 10MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | 5GM/100ML;75MG/100ML;900MG/100ML | INJECTABLE / INJECTION | 1985-04-05 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | N019308-005 | POTASSIUM CHLORIDE 20MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | 5GM/100ML;150MG/100ML;900MG/100ML | INJECTABLE / INJECTION | AP | 1985-04-05 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N019308-006 | POTASSIUM CHLORIDE 30MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | 5GM/100ML;224MG/100ML;900MG/100ML | INJECTABLE / INJECTION | 1985-04-05 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | N019308-007 | POTASSIUM CHLORIDE 40MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | 5GM/100ML;300MG/100ML;900MG/100ML | INJECTABLE / INJECTION | AP | 1985-04-05 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N019308-001 | POTASSIUM CHLORIDE 5MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | 5GM/100ML;150MG/100ML;900MG/100ML | INJECTABLE / INJECTION | 1985-04-05 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N019308-002 | POTASSIUM CHLORIDE 10MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | 5GM/100ML;150MG/100ML;900MG/100ML | INJECTABLE / INJECTION | 1985-04-05 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N019308-003 | POTASSIUM CHLORIDE 20MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | 5GM/100ML;300MG/100ML;900MG/100ML | INJECTABLE / INJECTION | 1985-04-05 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N019308-004 | POTASSIUM CHLORIDE 10MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | 5GM/100ML;75MG/100ML;900MG/100ML | INJECTABLE / INJECTION | 1985-04-05 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N019308-005 | POTASSIUM CHLORIDE 20MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | 5GM/100ML;150MG/100ML;900MG/100ML | INJECTABLE / INJECTION | AP | 1985-04-05 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N019308-006 | POTASSIUM CHLORIDE 30MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | 5GM/100ML;224MG/100ML;900MG/100ML | INJECTABLE / INJECTION | 1985-04-05 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N019308-007 | POTASSIUM CHLORIDE 40MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | 5GM/100ML;300MG/100ML;900MG/100ML | INJECTABLE / INJECTION | AP | 1985-04-05 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | N019308-001 | POTASSIUM CHLORIDE 5MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | 5GM/100ML;150MG/100ML;900MG/100ML | INJECTABLE / INJECTION | 1985-04-05 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | N019308-002 | POTASSIUM CHLORIDE 10MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | 5GM/100ML;150MG/100ML;900MG/100ML | INJECTABLE / INJECTION | 1985-04-05 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | N019308-003 | POTASSIUM CHLORIDE 20MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | 5GM/100ML;300MG/100ML;900MG/100ML | INJECTABLE / INJECTION | 1985-04-05 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | N019308-004 | POTASSIUM CHLORIDE 10MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | 5GM/100ML;75MG/100ML;900MG/100ML | INJECTABLE / INJECTION | 1985-04-05 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | N019308-005 | POTASSIUM CHLORIDE 20MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | 5GM/100ML;150MG/100ML;900MG/100ML | INJECTABLE / INJECTION | AP | 1985-04-05 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N019308-006 | POTASSIUM CHLORIDE 30MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | 5GM/100ML;224MG/100ML;900MG/100ML | INJECTABLE / INJECTION | 1985-04-05 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | N019308-007 | POTASSIUM CHLORIDE 40MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | 5GM/100ML;300MG/100ML;900MG/100ML | INJECTABLE / INJECTION | AP | 1985-04-05 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N019308-001 | POTASSIUM CHLORIDE 5MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | 5GM/100ML;150MG/100ML;900MG/100ML | INJECTABLE / INJECTION | 1985-04-05 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N019308-002 | POTASSIUM CHLORIDE 10MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | 5GM/100ML;150MG/100ML;900MG/100ML | INJECTABLE / INJECTION | 1985-04-05 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N019308-003 | POTASSIUM CHLORIDE 20MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | 5GM/100ML;300MG/100ML;900MG/100ML | INJECTABLE / INJECTION | 1985-04-05 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N019308-004 | POTASSIUM CHLORIDE 10MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | 5GM/100ML;75MG/100ML;900MG/100ML | INJECTABLE / INJECTION | 1985-04-05 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N019308-005 | POTASSIUM CHLORIDE 20MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | 5GM/100ML;150MG/100ML;900MG/100ML | INJECTABLE / INJECTION | AP | 1985-04-05 | fd3edfee7708… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2022-03-09 01:35 UTC | 2022-03 | N019308-005 | AP | 1 | bb7c543d1eb4… |
| 2022-03-09 01:35 UTC | 2022-03 | N019308-007 | AP | 1 | bb7c543d1eb4… |
| 2021-12-28 21:50 UTC | 2021-12 | N019308-005 | AP | 1 | 782e0a99824c… |
| 2021-12-28 21:50 UTC | 2021-12 | N019308-007 | AP | 1 | 782e0a99824c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | N019308-005 | AP | 1 | 87673890dc5c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | N019308-007 | AP | 1 | 87673890dc5c… |
| 2021-03-12 10:30 UTC | 2021-03 | N019308-005 | AP | 1 | 5aa47cf7b7d7… |
| 2021-03-12 10:30 UTC | 2021-03 | N019308-007 | AP | 1 | 5aa47cf7b7d7… |
| 2020-12-22 03:56 UTC | 2020-12 | N019308-005 | AP | 1 | 8869cabd3fbd… |
| 2020-12-22 03:56 UTC | 2020-12 | N019308-007 | AP | 1 | 8869cabd3fbd… |
| 2020-11-12 02:37 UTC | 2020-11 | N019308-005 | AP | 1 | c0c555d07b60… |
| 2020-11-12 02:37 UTC | 2020-11 | N019308-007 | AP | 1 | c0c555d07b60… |
| 2019-12-14 00:12 UTC | 2019-12 | N019308-005 | AP | 1 | 3f01610625f2… |
| 2019-12-14 00:12 UTC | 2019-12 | N019308-007 | AP | 1 | 3f01610625f2… |
| 2019-09-15 20:21 UTC | 2019-09 | N019308-005 | AP | 1 | b00525d2431f… |
| 2019-09-15 20:21 UTC | 2019-09 | N019308-007 | AP | 1 | b00525d2431f… |
| 2019-07-19 19:46 UTC | 2019-07 | N019308-005 | AP | 1 | ea99ee380514… |
| 2019-07-19 19:46 UTC | 2019-07 | N019308-007 | AP | 1 | ea99ee380514… |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | N019308-005 | AP | 1 | 6a51e52b5d6a… |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | N019308-007 | AP | 1 | 6a51e52b5d6a… |
| 2024-02-18 07:12 UTC | 2024-02 | N019308-005 | AP | 1 | 1c564ffb4f44… |
| 2024-02-18 07:12 UTC | 2024-02 | N019308-007 | AP | 1 | 1c564ffb4f44… |
| 2023-12-20 04:57 UTC | 2023-12 | N019308-005 | AP | 1 | ea1830bbd6c7… |
| 2023-12-20 04:57 UTC | 2023-12 | N019308-007 | AP | 1 | ea1830bbd6c7… |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | N019308-005 | AP | 1 | a72a2bbeb626… |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | N019308-007 | AP | 1 | a72a2bbeb626… |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | N019308-005 | AP | 1 | 9b2671bbb829… |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | N019308-007 | AP | 1 | 9b2671bbb829… |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | N019308-005 | AP | 1 | a67488948f0b… |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | N019308-007 | AP | 1 | a67488948f0b… |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | N019308-005 | AP | 1 | 3f0d92c62455… |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | N019308-007 | AP | 1 | 3f0d92c62455… |
| 2023-05-13 08:27 UTC | 2023-05 | N019308-005 | AP | 1 | 053a50430f4f… |
| 2023-05-13 08:27 UTC | 2023-05 | N019308-007 | AP | 1 | 053a50430f4f… |
| 2023-01-26 05:58 UTC | 2023-01 | N019308-005 | AP | 1 | 3bdfa0b2c4d7… |
| 2023-01-26 05:58 UTC | 2023-01 | N019308-007 | AP | 1 | 3bdfa0b2c4d7… |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | N019308-005 | AP | 1 | 3a93d1ddd44b… |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | N019308-007 | AP | 1 | 3a93d1ddd44b… |
| 2022-10-28 04:53 UTC | 2022-10 | N019308-005 | AP | 1 | f41ea6bd6efb… |
| 2022-10-28 04:53 UTC | 2022-10 | N019308-007 | AP | 1 | f41ea6bd6efb… |
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 in Dextrose and Sodium Chloride | POTASSIUM CHLORIDE, DEXTROSE MONOHYDRATE AND SODIUM CHLORIDE | Baxter Healthcare Company | c553fed1-3de5-4826-8eff-633b5923bf0b | 2019-02-21 | Warnings, Adverse reactions | 019308 NDA019308 0338-0807 0338-0803 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0338-0803 | Potassium Chloride in Dextrose and Sodium Chloride | Potassium Chloride, Dextrose Monohydrate and Sodium Chloride | Baxter Healthcare Corporation | NDA | Current |
| 0338-0803 | Potassium Chloride in Dextrose and Sodium Chloride | Potassium Chloride, Dextrose Monohydrate and Sodium Chloride | Baxter Healthcare Corporation | NDA | Current |
| 0338-0803 | Potassium Chloride in Dextrose and Sodium Chloride | Potassium Chloride, Dextrose Monohydrate and Sodium Chloride | Baxter Healthcare Corporation | NDA | Current |
| 0338-0803 | Potassium Chloride in Dextrose and Sodium Chloride | Potassium Chloride, Dextrose Monohydrate and Sodium Chloride | Baxter Healthcare Corporation | NDA | Current |
| 0338-0807 | Potassium Chloride in Dextrose and Sodium Chloride | Potassium Chloride, Dextrose Monohydrate and Sodium Chloride | Baxter Healthcare Corporation | NDA | Current |
| 0338-0807 | Potassium Chloride in Dextrose and Sodium Chloride | Potassium Chloride, Dextrose Monohydrate and Sodium Chloride | Baxter Healthcare Corporation | NDA | Current |
| 0338-0807 | Potassium Chloride in Dextrose and Sodium Chloride | Potassium Chloride, Dextrose Monohydrate and Sodium Chloride | Baxter Healthcare Corporation | NDA | Current |
| 0338-0807 | Potassium Chloride in Dextrose and Sodium Chloride | Potassium Chloride, Dextrose Monohydrate and Sodium Chloride | Baxter Healthcare Corporation | NDA | Current |