Potassium Chloride in Dextrose and Sodium Chloride
- Product NDC
- 65219-151
- 11-digit product format
- 652190151
- Labeler code
- 65219
- Product ID
- 65219-151_6320e059-cc2f-48b8-8ef5-c0080c35eaca
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- DEXTROSE MONOHYDRATE, SODIUM CHLORIDE, and POTASSIUM CHLORIDE
- Dosage form
- INJECTION, SOLUTION
- Route
- INTRAVENOUS
- Labeler
- Fresenius Kabi USA, LLC
- Application
- ANDA212348
- Marketing category
- ANDA
- Marketing start
- 2022-09-02
- Substance
- DEXTROSE MONOHYDRATE; SODIUM CHLORIDE; POTASSIUM CHLORIDE
- Active strength
- 50; 2.25; 1.49 g/1000mL; g/1000mL; g/1000mL
- Pharmacologic classes
- Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], 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 |
|---|---|---|---|---|---|---|---|
| A212348-001 | POTASSIUM CHLORIDE 10MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.225% IN PLASTIC CONTAINER | DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE | 5GM/100ML;149MG/100ML;225MG/100ML | INJECTABLE / INJECTION | AP | 2021-07-30 | |
| A212348-002 | POTASSIUM CHLORIDE 20MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.225% IN PLASTIC CONTAINER | DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE | 5GM/100ML;149MG/100ML;225MG/100ML | INJECTABLE / INJECTION | AP | 2021-07-30 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A212348-001 | AP |
| A212348-002 | 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 | A212348-001 | POTASSIUM CHLORIDE 10MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.225% IN PLASTIC CONTAINER | 5GM/100ML;149MG/100ML;225MG/100ML | INJECTABLE / INJECTION | AP | 2021-07-30 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A212348-002 | POTASSIUM CHLORIDE 20MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.225% IN PLASTIC CONTAINER | 5GM/100ML;149MG/100ML;225MG/100ML | INJECTABLE / INJECTION | AP | 2021-07-30 | 84e616aacf4f… | |
| 2026-08-18 06:07:40 | 2026-07 | A212348-001 | POTASSIUM CHLORIDE 10MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.225% IN PLASTIC CONTAINER | 5GM/100ML;149MG/100ML;225MG/100ML | INJECTABLE / INJECTION | AP | 2021-07-30 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A212348-002 | POTASSIUM CHLORIDE 20MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.225% IN PLASTIC CONTAINER | 5GM/100ML;149MG/100ML;225MG/100ML | INJECTABLE / INJECTION | AP | 2021-07-30 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | A212348-001 | POTASSIUM CHLORIDE 10MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.225% IN PLASTIC CONTAINER | 5GM/100ML;149MG/100ML;225MG/100ML | INJECTABLE / INJECTION | AP | 2021-07-30 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A212348-002 | POTASSIUM CHLORIDE 20MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.225% IN PLASTIC CONTAINER | 5GM/100ML;149MG/100ML;225MG/100ML | INJECTABLE / INJECTION | AP | 2021-07-30 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A212348-001 | POTASSIUM CHLORIDE 10MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.225% IN PLASTIC CONTAINER | 5GM/100ML;149MG/100ML;225MG/100ML | INJECTABLE / INJECTION | AP | 2021-07-30 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A212348-002 | POTASSIUM CHLORIDE 20MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.225% IN PLASTIC CONTAINER | 5GM/100ML;149MG/100ML;225MG/100ML | INJECTABLE / INJECTION | AP | 2021-07-30 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A212348-001 | POTASSIUM CHLORIDE 10MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.225% IN PLASTIC CONTAINER | 5GM/100ML;149MG/100ML;225MG/100ML | INJECTABLE / INJECTION | AP | 2021-07-30 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A212348-002 | POTASSIUM CHLORIDE 20MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.225% IN PLASTIC CONTAINER | 5GM/100ML;149MG/100ML;225MG/100ML | INJECTABLE / INJECTION | AP | 2021-07-30 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A212348-001 | POTASSIUM CHLORIDE 10MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.225% IN PLASTIC CONTAINER | 5GM/100ML;149MG/100ML;225MG/100ML | INJECTABLE / INJECTION | AP | 2021-07-30 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A212348-002 | POTASSIUM CHLORIDE 20MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.225% IN PLASTIC CONTAINER | 5GM/100ML;149MG/100ML;225MG/100ML | INJECTABLE / INJECTION | AP | 2021-07-30 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A212348-001 | POTASSIUM CHLORIDE 10MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.225% IN PLASTIC CONTAINER | 5GM/100ML;149MG/100ML;225MG/100ML | INJECTABLE / INJECTION | AP | 2021-07-30 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A212348-002 | POTASSIUM CHLORIDE 20MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.225% IN PLASTIC CONTAINER | 5GM/100ML;149MG/100ML;225MG/100ML | INJECTABLE / INJECTION | AP | 2021-07-30 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A212348-001 | POTASSIUM CHLORIDE 10MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.225% IN PLASTIC CONTAINER | 5GM/100ML;149MG/100ML;225MG/100ML | INJECTABLE / INJECTION | AP | 2021-07-30 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A212348-002 | POTASSIUM CHLORIDE 20MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.225% IN PLASTIC CONTAINER | 5GM/100ML;149MG/100ML;225MG/100ML | INJECTABLE / INJECTION | AP | 2021-07-30 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A212348-001 | POTASSIUM CHLORIDE 10MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.225% IN PLASTIC CONTAINER | 5GM/100ML;149MG/100ML;225MG/100ML | INJECTABLE / INJECTION | AP | 2021-07-30 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A212348-002 | POTASSIUM CHLORIDE 20MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.225% IN PLASTIC CONTAINER | 5GM/100ML;149MG/100ML;225MG/100ML | INJECTABLE / INJECTION | AP | 2021-07-30 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A212348-001 | POTASSIUM CHLORIDE 10MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.225% IN PLASTIC CONTAINER | 5GM/100ML;149MG/100ML;225MG/100ML | INJECTABLE / INJECTION | AP | 2021-07-30 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A212348-002 | POTASSIUM CHLORIDE 20MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.225% IN PLASTIC CONTAINER | 5GM/100ML;149MG/100ML;225MG/100ML | INJECTABLE / INJECTION | AP | 2021-07-30 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A212348-001 | POTASSIUM CHLORIDE 10MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.225% IN PLASTIC CONTAINER | 5GM/100ML;149MG/100ML;225MG/100ML | INJECTABLE / INJECTION | AP | 2021-07-30 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A212348-002 | POTASSIUM CHLORIDE 20MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.225% IN PLASTIC CONTAINER | 5GM/100ML;149MG/100ML;225MG/100ML | INJECTABLE / INJECTION | AP | 2021-07-30 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A212348-001 | POTASSIUM CHLORIDE 10MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.225% IN PLASTIC CONTAINER | 5GM/100ML;149MG/100ML;225MG/100ML | INJECTABLE / INJECTION | AP | 2021-07-30 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A212348-002 | POTASSIUM CHLORIDE 20MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.225% IN PLASTIC CONTAINER | 5GM/100ML;149MG/100ML;225MG/100ML | INJECTABLE / INJECTION | AP | 2021-07-30 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A212348-001 | POTASSIUM CHLORIDE 10MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.225% IN PLASTIC CONTAINER | 5GM/100ML;149MG/100ML;225MG/100ML | INJECTABLE / INJECTION | AP | 2021-07-30 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A212348-002 | POTASSIUM CHLORIDE 20MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.225% IN PLASTIC CONTAINER | 5GM/100ML;149MG/100ML;225MG/100ML | INJECTABLE / INJECTION | AP | 2021-07-30 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A212348-001 | POTASSIUM CHLORIDE 10MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.225% IN PLASTIC CONTAINER | 5GM/100ML;149MG/100ML;225MG/100ML | INJECTABLE / INJECTION | AP | 2021-07-30 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A212348-002 | POTASSIUM CHLORIDE 20MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.225% IN PLASTIC CONTAINER | 5GM/100ML;149MG/100ML;225MG/100ML | INJECTABLE / INJECTION | AP | 2021-07-30 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A212348-001 | POTASSIUM CHLORIDE 10MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.225% IN PLASTIC CONTAINER | 5GM/100ML;149MG/100ML;225MG/100ML | INJECTABLE / INJECTION | AP | 2021-07-30 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A212348-002 | POTASSIUM CHLORIDE 20MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.225% IN PLASTIC CONTAINER | 5GM/100ML;149MG/100ML;225MG/100ML | INJECTABLE / INJECTION | AP | 2021-07-30 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | A212348-001 | POTASSIUM CHLORIDE 10MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.225% IN PLASTIC CONTAINER | 5GM/100ML;149MG/100ML;225MG/100ML | INJECTABLE / INJECTION | AP | 2021-07-30 | 8072bd15b7f6… | |
| 2024-05-31 18:47 UTC | 2024-05 | A212348-002 | POTASSIUM CHLORIDE 20MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.225% IN PLASTIC CONTAINER | 5GM/100ML;149MG/100ML;225MG/100ML | INJECTABLE / INJECTION | AP | 2021-07-30 | 8072bd15b7f6… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A212348-001 | POTASSIUM CHLORIDE 10MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.225% IN PLASTIC CONTAINER | 5GM/100ML;149MG/100ML;225MG/100ML | INJECTABLE / INJECTION | 2021-07-30 | 5c6f7cd8ea54… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A212348-002 | POTASSIUM CHLORIDE 20MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.225% IN PLASTIC CONTAINER | 5GM/100ML;149MG/100ML;225MG/100ML | INJECTABLE / INJECTION | 2021-07-30 | 5c6f7cd8ea54… | ||
| 2022-04-08 23:34 UTC | 2022-04 | A212348-001 | POTASSIUM CHLORIDE 10MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.225% IN PLASTIC CONTAINER | 5GM/100ML;149MG/100ML;225MG/100ML | INJECTABLE / INJECTION | 2021-07-30 | 5d02ea3f76ae… | ||
| 2022-04-08 23:34 UTC | 2022-04 | A212348-002 | POTASSIUM CHLORIDE 20MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.225% IN PLASTIC CONTAINER | 5GM/100ML;149MG/100ML;225MG/100ML | INJECTABLE / INJECTION | 2021-07-30 | 5d02ea3f76ae… | ||
| 2022-04-04 05:41 UTC | 2022-04 | A212348-001 | POTASSIUM CHLORIDE 10MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.225% IN PLASTIC CONTAINER | 5GM/100ML;149MG/100ML;225MG/100ML | INJECTABLE / INJECTION | 2021-07-30 | 4b0b4de00fa7… | ||
| 2022-04-04 05:41 UTC | 2022-04 | A212348-002 | POTASSIUM CHLORIDE 20MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.225% IN PLASTIC CONTAINER | 5GM/100ML;149MG/100ML;225MG/100ML | INJECTABLE / INJECTION | 2021-07-30 | 4b0b4de00fa7… | ||
| 2022-03-09 01:35 UTC | 2022-03 | A212348-001 | POTASSIUM CHLORIDE 10MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.225% IN PLASTIC CONTAINER | 5GM/100ML;149MG/100ML;225MG/100ML | INJECTABLE / INJECTION | 2021-07-30 | bb7c543d1eb4… | ||
| 2022-03-09 01:35 UTC | 2022-03 | A212348-002 | POTASSIUM CHLORIDE 20MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.225% IN PLASTIC CONTAINER | 5GM/100ML;149MG/100ML;225MG/100ML | INJECTABLE / INJECTION | 2021-07-30 | bb7c543d1eb4… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | A212348-001 | AP | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A212348-002 | AP | 1 | 84e616aacf4f… |
| 2026-08-18 06:07:40 | 2026-07 | A212348-001 | AP | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A212348-002 | AP | 1 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | A212348-001 | AP | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A212348-002 | AP | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A212348-001 | AP | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A212348-002 | AP | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A212348-001 | AP | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A212348-002 | AP | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A212348-001 | AP | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A212348-002 | AP | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A212348-001 | AP | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A212348-002 | AP | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A212348-001 | AP | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A212348-002 | AP | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A212348-001 | AP | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A212348-002 | AP | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A212348-001 | AP | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A212348-002 | AP | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A212348-001 | AP | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A212348-002 | AP | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A212348-001 | AP | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A212348-002 | AP | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A212348-001 | AP | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A212348-002 | AP | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A212348-001 | AP | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A212348-002 | AP | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A212348-001 | AP | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A212348-002 | AP | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | A212348-001 | AP | 1 | 8072bd15b7f6… |
| 2024-05-31 18:47 UTC | 2024-05 | A212348-002 | AP | 1 | 8072bd15b7f6… |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A212348-001 | AP | 1 | 6a51e52b5d6a… |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A212348-002 | AP | 1 | 6a51e52b5d6a… |
| 2024-02-18 07:12 UTC | 2024-02 | A212348-001 | AP | 1 | 1c564ffb4f44… |
| 2024-02-18 07:12 UTC | 2024-02 | A212348-002 | AP | 1 | 1c564ffb4f44… |
| 2023-12-20 04:57 UTC | 2023-12 | A212348-001 | AP | 1 | ea1830bbd6c7… |
| 2023-12-20 04:57 UTC | 2023-12 | A212348-002 | AP | 1 | ea1830bbd6c7… |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A212348-001 | AP | 1 | a72a2bbeb626… |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A212348-002 | AP | 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 in Dextrose and Sodium Chloride
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| DEXTROSE MONOHYDRATE | 50 g/1000mL |
| SODIUM CHLORIDE | 2.25 g/1000mL |
| POTASSIUM CHLORIDE | 1.49 g/1000mL |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| 451W47IQ8X | Internal UNII lookup |
| LX22YL083G | Internal UNII lookup |
| 660YQ98I10 | Internal UNII lookup |
Harmonized RxCUI identifiers#
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| f0cc6713-4d47-49be-8116-901c99002b6b | Available on FDA.report |
DailyMed Product Concepts#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 65219-151-00 | Potassium Chloride in Dextrose and Sodium Chloride | 500 mL in 1 BAG | INJECTION, SOLUTION | 500 | 5 | |
| 65219-151-75 | Potassium Chloride in Dextrose and Sodium Chloride | 20 in 1 CASE | INJECTION, SOLUTION | 20 | 5 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 65219-151-00 | ML - Milliliter | 65219-151 | 51399c2e-81f3-4cf5-9359-f068158fe921 | 1 | 2023-06-06 |
| 65219-151-75 | ML - Milliliter | 65219-151 | 3bf8a0cb-0bce-43fb-86b3-8687f1aaf436 | 1 | 2023-06-06 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 65219-151 | POTASSIUM CHLORIDE IN DEXTROSE AND SODIUM CHLORIDE (DEXTROSE MONOHYDRATE, SODIUM CHLORIDE, AND POTASSIUM CHLORIDE) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC] | 5 | Current NDC, Legacy NDC, 2 package rows | 20240625_f0cc6713-4d47-49be-8116-901c99002b6b.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 in Dextrose and Sodium Chloride | DEXTROSE MONOHYDRATE, SODIUM CHLORIDE, AND POTASSIUM CHLORIDE | Fresenius Kabi USA, LLC | f0cc6713-4d47-49be-8116-901c99002b6b | 2024-05-07 | Warnings, Adverse reactions | 212348 ANDA212348 65219-151 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1863975 | potassium chloride 10 MEQ / dextrose 5 % / sodium chloride 0.225 % in 500 ML Injection | PSN | f0cc6713-4d47-49be-8116-901c99002b6b | 5 |
| 1863973 | potassium chloride 20 MEQ / dextrose 5 % / sodium chloride 0.225 % in 1000 ML Injection | PSN | f0cc6713-4d47-49be-8116-901c99002b6b | 5 |
| 1863973 | 1000 ML glucose 50 MG/ML / potassium chloride 0.02 MEQ/ML / sodium chloride 2.25 MG/ML Injection | SCD | f0cc6713-4d47-49be-8116-901c99002b6b | 5 |
| 1863975 | 500 ML glucose 50 MG/ML / potassium chloride 0.02 MEQ/ML / sodium chloride 2.25 MG/ML Injection | SCD | f0cc6713-4d47-49be-8116-901c99002b6b | 5 |
| 1863973 | 1000 ML Glucose 50 MG/ML / K+ Chloride 0.02 MEQ/ML / NaCl 2.25 MG/ML Injection | SY | f0cc6713-4d47-49be-8116-901c99002b6b | 5 |
| 1863973 | 1000 ML Glucose 50 MG/ML / Pot Chloride 0.02 MEQ/ML / NaCl 2.25 MG/ML Injection | SY | f0cc6713-4d47-49be-8116-901c99002b6b | 5 |
| 1863975 | 500 ML Glucose 50 MG/ML / K+ Chloride 0.02 MEQ/ML / NaCl 2.25 MG/ML Injection | SY | f0cc6713-4d47-49be-8116-901c99002b6b | 5 |
| 1863975 | 500 ML Glucose 50 MG/ML / Pot Chloride 0.02 MEQ/ML / NaCl 2.25 MG/ML Injection | SY | f0cc6713-4d47-49be-8116-901c99002b6b | 5 |
| 1863975 | potassium chloride 10 MEQ / dextrose 5 % / sodium chloride 0.225 % per 500 ML Injection | SY | f0cc6713-4d47-49be-8116-901c99002b6b | 5 |
| 1863973 | potassium chloride 20 MEQ / dextrose 5 % / sodium chloride 0.225 % per 1000 ML Injection | SY | f0cc6713-4d47-49be-8116-901c99002b6b | 5 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 65219-151-00 | 65219015100 | 500 mL in 1 BAG | 500 ml | Historical | ||||
| 65219-151-75 | 65219015175 | 20 BAG in 1 CASE (65219-151-75) / 500 mL in 1 BAG (65219-151-00) | 20 bag | 2022-09-02 | 0000-00-00 | No | No | Current |