Multiple Electrolytes pH 5.5
- Product NDC
- 65219-387
- 11-digit product format
- 652190387
- Labeler code
- 65219
- Product ID
- 65219-387_847f9b87-ebe4-4ff7-89b7-bcee26ef1f49
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- sodium chloride, sodium gluconate, sodium acetate, potassium chloride and magnesium chloride
- Dosage form
- INJECTION, SOLUTION
- Route
- INTRAVENOUS
- Labeler
- Fresenius Kabi USA, LLC
- Application
- ANDA215370
- Marketing category
- ANDA
- Marketing start
- 2021-07-01
- Substance
- MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM ACETATE; SODIUM CHLORIDE; SODIUM GLUCONATE
- Active strength
- 30; 37; 368; 526; 502 mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL
- Pharmacologic classes
- Calculi Dissolution Agent [EPC], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Magnesium Ion Exchange Activity [MoA], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Potassium Compounds [CS], Potassium Salt [EPC], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]
- 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 |
|---|---|---|---|---|---|---|---|
| A215370-001 | MULTIPLE ELECTROLYTES INJECTION TYPE 1 USP PH 5.5 | MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM ACETATE; SODIUM CHLORIDE; SODIUM GLUCONATE | 30MG/100ML;37MG/100ML;368MG/100ML;526MG/100ML;502MG/100ML | INJECTABLE / INJECTION | 2022-06-29 |
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 | A215370-001 | MULTIPLE ELECTROLYTES INJECTION TYPE 1 USP PH 5.5 | 30MG/100ML;37MG/100ML;368MG/100ML;526MG/100ML;502MG/100ML | INJECTABLE / INJECTION | 2022-06-29 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A215370-001 | MULTIPLE ELECTROLYTES INJECTION TYPE 1 USP PH 5.5 | 30MG/100ML;37MG/100ML;368MG/100ML;526MG/100ML;502MG/100ML | INJECTABLE / INJECTION | 2022-06-29 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A215370-001 | MULTIPLE ELECTROLYTES INJECTION TYPE 1 USP PH 5.5 | 30MG/100ML;37MG/100ML;368MG/100ML;526MG/100ML;502MG/100ML | INJECTABLE / INJECTION | 2022-06-29 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A215370-001 | MULTIPLE ELECTROLYTES INJECTION TYPE 1 USP PH 5.5 | 30MG/100ML;37MG/100ML;368MG/100ML;526MG/100ML;502MG/100ML | INJECTABLE / INJECTION | AP | 2022-06-29 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A215370-001 | MULTIPLE ELECTROLYTES INJECTION TYPE 1 USP PH 5.5 | 30MG/100ML;37MG/100ML;368MG/100ML;526MG/100ML;502MG/100ML | INJECTABLE / INJECTION | AP | 2022-06-29 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A215370-001 | MULTIPLE ELECTROLYTES INJECTION TYPE 1 USP PH 5.5 | 30MG/100ML;37MG/100ML;368MG/100ML;526MG/100ML;502MG/100ML | INJECTABLE / INJECTION | AP | 2022-06-29 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A215370-001 | MULTIPLE ELECTROLYTES INJECTION TYPE 1 USP PH 5.5 | 30MG/100ML;37MG/100ML;368MG/100ML;526MG/100ML;502MG/100ML | INJECTABLE / INJECTION | AP | 2022-06-29 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A215370-001 | MULTIPLE ELECTROLYTES INJECTION TYPE 1 USP PH 5.5 | 30MG/100ML;37MG/100ML;368MG/100ML;526MG/100ML;502MG/100ML | INJECTABLE / INJECTION | AP | 2022-06-29 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A215370-001 | MULTIPLE ELECTROLYTES INJECTION TYPE 1 USP PH 5.5 | 30MG/100ML;37MG/100ML;368MG/100ML;526MG/100ML;502MG/100ML | INJECTABLE / INJECTION | AP | 2022-06-29 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A215370-001 | MULTIPLE ELECTROLYTES INJECTION TYPE 1 USP PH 5.5 | 30MG/100ML;37MG/100ML;368MG/100ML;526MG/100ML;502MG/100ML | INJECTABLE / INJECTION | AP | 2022-06-29 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A215370-001 | MULTIPLE ELECTROLYTES INJECTION TYPE 1 USP PH 5.5 | 30MG/100ML;37MG/100ML;368MG/100ML;526MG/100ML;502MG/100ML | INJECTABLE / INJECTION | AP | 2022-06-29 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A215370-001 | MULTIPLE ELECTROLYTES INJECTION TYPE 1 USP PH 5.5 | 30MG/100ML;37MG/100ML;368MG/100ML;526MG/100ML;502MG/100ML | INJECTABLE / INJECTION | AP | 2022-06-29 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A215370-001 | MULTIPLE ELECTROLYTES INJECTION TYPE 1 USP PH 5.5 | 30MG/100ML;37MG/100ML;368MG/100ML;526MG/100ML;502MG/100ML | INJECTABLE / INJECTION | AP | 2022-06-29 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | A215370-001 | MULTIPLE ELECTROLYTES INJECTION TYPE 1 USP PH 5.5 | 30MG/100ML;37MG/100ML;368MG/100ML;526MG/100ML;502MG/100ML | INJECTABLE / INJECTION | AP | 2022-06-29 | 8072bd15b7f6… | |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A215370-001 | MULTIPLE ELECTROLYTES INJECTION TYPE 1 USP PH 5.5 | 30MG/100ML;37MG/100ML;368MG/100ML;526MG/100ML;502MG/100ML | INJECTABLE / INJECTION | AP | 2022-06-29 | 6a51e52b5d6a… | |
| 2024-02-18 07:12 UTC | 2024-02 | A215370-001 | MULTIPLE ELECTROLYTES INJECTION TYPE 1 USP PH 5.5 | 30MG/100ML;37MG/100ML;368MG/100ML;526MG/100ML;502MG/100ML | INJECTABLE / INJECTION | AP | 2022-06-29 | 1c564ffb4f44… | |
| 2023-12-20 04:57 UTC | 2023-12 | A215370-001 | MULTIPLE ELECTROLYTES INJECTION TYPE 1 USP PH 5.5 | 30MG/100ML;37MG/100ML;368MG/100ML;526MG/100ML;502MG/100ML | INJECTABLE / INJECTION | AP | 2022-06-29 | ea1830bbd6c7… | |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A215370-001 | MULTIPLE ELECTROLYTES INJECTION TYPE 1 USP PH 5.5 | 30MG/100ML;37MG/100ML;368MG/100ML;526MG/100ML;502MG/100ML | INJECTABLE / INJECTION | AP | 2022-06-29 | a72a2bbeb626… | |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A215370-001 | MULTIPLE ELECTROLYTES INJECTION TYPE 1 USP PH 5.5 | 30MG/100ML;37MG/100ML;368MG/100ML;526MG/100ML;502MG/100ML | INJECTABLE / INJECTION | AP | 2022-06-29 | 9b2671bbb829… | |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A215370-001 | MULTIPLE ELECTROLYTES INJECTION TYPE 1 USP PH 5.5 | 30MG/100ML;37MG/100ML;368MG/100ML;526MG/100ML;502MG/100ML | INJECTABLE / INJECTION | AP | 2022-06-29 | a67488948f0b… | |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A215370-001 | MULTIPLE ELECTROLYTES INJECTION TYPE 1 USP PH 5.5 | 30MG/100ML;37MG/100ML;368MG/100ML;526MG/100ML;502MG/100ML | INJECTABLE / INJECTION | AP | 2022-06-29 | 3f0d92c62455… | |
| 2023-05-13 08:27 UTC | 2023-05 | A215370-001 | MULTIPLE ELECTROLYTES INJECTION TYPE 1 USP PH 5.5 | 30MG/100ML;37MG/100ML;368MG/100ML;526MG/100ML;502MG/100ML | INJECTABLE / INJECTION | AP | 2022-06-29 | 053a50430f4f… | |
| 2023-01-26 05:58 UTC | 2023-01 | A215370-001 | MULTIPLE ELECTROLYTES INJECTION TYPE 1 USP PH 5.5 | 30MG/100ML;37MG/100ML;368MG/100ML;526MG/100ML;502MG/100ML | INJECTABLE / INJECTION | 2022-06-29 | 3bdfa0b2c4d7… | ||
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A215370-001 | MULTIPLE ELECTROLYTES INJECTION TYPE 1 USP PH 5.5 | 30MG/100ML;37MG/100ML;368MG/100ML;526MG/100ML;502MG/100ML | INJECTABLE / INJECTION | AP | 2022-06-29 | 3a93d1ddd44b… | |
| 2022-10-28 04:53 UTC | 2022-10 | A215370-001 | MULTIPLE ELECTROLYTES INJECTION TYPE 1 USP PH 5.5 | 30MG/100ML;37MG/100ML;368MG/100ML;526MG/100ML;502MG/100ML | INJECTABLE / INJECTION | AP | 2022-06-29 | f41ea6bd6efb… | |
| 2022-09-29 23:25 UTC | 2022-09 | A215370-001 | MULTIPLE ELECTROLYTES INJECTION TYPE 1 USP PH 5.5 | 30MG/100ML;37MG/100ML;368MG/100ML;526MG/100ML;502MG/100ML | INJECTABLE / INJECTION | AP | 2022-06-29 | e64feba35796… | |
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | A215370-001 | MULTIPLE ELECTROLYTES INJECTION TYPE 1 USP PH 5.5 | 30MG/100ML;37MG/100ML;368MG/100ML;526MG/100ML;502MG/100ML | INJECTABLE / INJECTION | AP | 2022-06-29 | cb3db0bc1861… | |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A215370-001 | MULTIPLE ELECTROLYTES INJECTION TYPE 1 USP PH 5.5 | 30MG/100ML;37MG/100ML;368MG/100ML;526MG/100ML;502MG/100ML | INJECTABLE / INJECTION | 2022-06-29 | a50c72e98297… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A215370-001 | AP | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A215370-001 | AP | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A215370-001 | AP | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A215370-001 | AP | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A215370-001 | AP | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A215370-001 | AP | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A215370-001 | AP | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A215370-001 | AP | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A215370-001 | AP | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A215370-001 | AP | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | A215370-001 | AP | 1 | 8072bd15b7f6… |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A215370-001 | AP | 1 | 6a51e52b5d6a… |
| 2024-02-18 07:12 UTC | 2024-02 | A215370-001 | AP | 1 | 1c564ffb4f44… |
| 2023-12-20 04:57 UTC | 2023-12 | A215370-001 | AP | 1 | ea1830bbd6c7… |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A215370-001 | AP | 1 | a72a2bbeb626… |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A215370-001 | AP | 1 | 9b2671bbb829… |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A215370-001 | AP | 1 | a67488948f0b… |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A215370-001 | AP | 1 | 3f0d92c62455… |
| 2023-05-13 08:27 UTC | 2023-05 | A215370-001 | AP | 1 | 053a50430f4f… |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A215370-001 | AP | 1 | 3a93d1ddd44b… |
| 2022-10-28 04:53 UTC | 2022-10 | A215370-001 | AP | 1 | f41ea6bd6efb… |
| 2022-09-29 23:25 UTC | 2022-09 | A215370-001 | AP | 1 | e64feba35796… |
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | A215370-001 | AP | 1 | cb3db0bc1861… |
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Multiple Electrolytes pH 5.5
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| SODIUM CHLORIDE | 30 mg/100mL |
| SODIUM GLUCONATE | 37 mg/100mL |
| SODIUM ACETATE | 368 mg/100mL |
| POTASSIUM CHLORIDE | 526 mg/100mL |
| MAGNESIUM CHLORIDE | 502 mg/100mL |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| 451W47IQ8X | Internal UNII lookup |
| R6Q3791S76 | Internal UNII lookup |
| 4550K0SC9B | Internal UNII lookup |
| 660YQ98I10 | Internal UNII lookup |
| 02F3473H9O | Internal UNII lookup |
Harmonized RxCUI identifiers#
| Identifier | FDA.report destination |
|---|---|
| 801109 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| cf1f5f15-d31d-4a02-8f7e-b289d5ad4b5c | Available on FDA.report |
DailyMed Product Concepts#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 65219-387-00 | Multiple Electrolytes pH 5.5 | 500 mL in 1 BAG | INJECTION, SOLUTION | 500 | 1 | |
| 65219-387-02 | Multiple Electrolytes pH 5.5 | 1000 mL in 1 BAG | INJECTION, SOLUTION | 1000 | 1 | |
| 65219-387-05 | Multiple Electrolytes pH 5.5 | 20 in 1 CASE | INJECTION, SOLUTION | 20 | 1 | |
| 65219-387-10 | Multiple Electrolytes pH 5.5 | 10 in 1 CASE | INJECTION, SOLUTION | 10 | 1 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 65219-387-00 | ML - Milliliter | 65219-387 | 12e29a76-1798-401c-b35f-43634f8f2a41 | 1 | 2023-07-06 |
| 65219-387-02 | ML - Milliliter | 65219-387 | e6c525a1-b019-48c6-b8f1-c4a59b1169e2 | 1 | 2023-07-06 |
| 65219-387-05 | ML - Milliliter | 65219-387 | b9ec69bc-a1ab-4a8e-8f34-4caadffb2143 | 1 | 2023-07-06 |
| 65219-387-10 | ML - Milliliter | 65219-387 | 402d40f3-2502-44b8-8533-0ae6ac0ffaf5 | 1 | 2023-07-06 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 65219-387 | MULTIPLE ELECTROLYTES PH 5.5 (SODIUM CHLORIDE, SODIUM GLUCONATE, SODIUM ACETATE, POTASSIUM CHLORIDE AND MAGNESIUM CHLORIDE) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC] | 1 | Current NDC, Legacy NDC, 4 package rows | 20221118_cf1f5f15-d31d-4a02-8f7e-b289d5ad4b5c.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 |
|---|---|---|---|---|---|---|
| Multiple Electrolytes pH 5.5 | SODIUM CHLORIDE, SODIUM GLUCONATE, SODIUM ACETATE, POTASSIUM CHLORIDE AND MAGNESIUM CHLORIDE | Fresenius Kabi USA, LLC | cf1f5f15-d31d-4a02-8f7e-b289d5ad4b5c | 2022-11-10 | Warnings, Adverse reactions | 215370 ANDA215370 65219-387 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 801109 | magnesium chloride 0.00148 MEQ/mL / potassium chloride 0.00497 MEQ/mL / sodium acetate 0.027 MEQ/mL / sodium chloride 0.0899 MEQ/mL / sodium gluconate 5.02 MG/mL Injectable Solution | PSN | cf1f5f15-d31d-4a02-8f7e-b289d5ad4b5c | 1 |
| 801109 | magnesium chloride 0.00148 MEQ/ML / potassium chloride 0.00497 MEQ/ML / sodium acetate 0.027 MEQ/ML / sodium chloride 0.0899 MEQ/ML / sodium gluconate 5.02 MG/ML Injectable Solution | SCD | cf1f5f15-d31d-4a02-8f7e-b289d5ad4b5c | 1 |
| 801109 | Magnesium Chloride 0.00148 MEQ/ML / K+ Chloride 0.00497 MEQ/ML / Sodium Acetate 0.027 MEQ/ML / NaCl 0.0899 MEQ/ML / Sodium gluconate 5.02 MG/ML Injectable Solution | SY | cf1f5f15-d31d-4a02-8f7e-b289d5ad4b5c | 1 |
| 801109 | Magnesium Chloride 0.00148 MEQ/ML / Pot Chloride 0.00497 MEQ/ML / Sodium Acetate 0.027 MEQ/ML / NaCl 0.0899 MEQ/ML / Sodium gluconate 5.02 MG/ML Injectable Solution | SY | cf1f5f15-d31d-4a02-8f7e-b289d5ad4b5c | 1 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 65219-387-00 | 65219038700 | 500 mL in 1 BAG | 500 ml | Historical | ||||
| 65219-387-02 | 65219038702 | 1000 mL in 1 BAG | 1000 ml | Historical | ||||
| 65219-387-05 | 65219038705 | 20 BAG in 1 CASE (65219-387-05) / 500 mL in 1 BAG (65219-387-00) | 20 bag | 2022-10-21 | 0000-00-00 | No | No | Current |
| 65219-387-10 | 65219038710 | 10 BAG in 1 CASE (65219-387-10) / 1000 mL in 1 BAG (65219-387-02) | 10 bag | 2022-10-21 | 0000-00-00 | No | No | Current |