Isolyte S
- Product NDC
- 0264-7703
- 11-digit product format
- 002647703
- Labeler code
- 0264
- Product ID
- 0264-7703_e9350a07-ea60-46e4-9ed5-81cc371f9696
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- SODIUM CHLORIDE, SODIUM GLUCONATE, SODIUM ACETATE, POTASSIUM CHLORIDE, and MAGNESIUM CHLORIDE
- Dosage form
- INJECTION, SOLUTION
- Route
- INTRAVENOUS
- Labeler
- B. Braun Medical Inc.
- Application
- NDA019711
- Marketing category
- NDA
- Marketing start
- 1989-09-29
- Substance
- MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM ACETATE; SODIUM CHLORIDE; SODIUM GLUCONATE
- Active strength
- .03; .037; .37; .53; .5 g/100mL; g/100mL; g/100mL; g/100mL; g/100mL
- Pharmacologic classes
- Calculi Dissolution Agent [EPC], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], 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 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 Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Osmotic Laxative [EPC], 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 |
|---|---|---|---|---|---|---|---|
| N019711-001 | ISOLYTE S IN PLASTIC CONTAINER | MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM ACETATE; SODIUM CHLORIDE; SODIUM GLUCONATE | 30MG/100ML;37MG/100ML;370MG/100ML;530MG/100ML;500MG/100ML | INJECTABLE / INJECTION | 1989-09-29 |
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-08-18 06:07:40 | 2026-07 | N019711-001 | ISOLYTE S IN PLASTIC CONTAINER | 30MG/100ML;37MG/100ML;370MG/100ML;530MG/100ML;500MG/100ML | INJECTABLE / INJECTION | 1989-09-29 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | N019711-001 | ISOLYTE S IN PLASTIC CONTAINER | 30MG/100ML;37MG/100ML;370MG/100ML;530MG/100ML;500MG/100ML | INJECTABLE / INJECTION | 1989-09-29 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N019711-001 | ISOLYTE S IN PLASTIC CONTAINER | 30MG/100ML;37MG/100ML;370MG/100ML;530MG/100ML;500MG/100ML | INJECTABLE / INJECTION | 1989-09-29 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | N019711-001 | ISOLYTE S IN PLASTIC CONTAINER | 30MG/100ML;37MG/100ML;370MG/100ML;530MG/100ML;500MG/100ML | INJECTABLE / INJECTION | 1989-09-29 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N019711-001 | ISOLYTE S IN PLASTIC CONTAINER | 30MG/100ML;37MG/100ML;370MG/100ML;530MG/100ML;500MG/100ML | INJECTABLE / INJECTION | 1989-09-29 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N019711-001 | ISOLYTE S IN PLASTIC CONTAINER | 30MG/100ML;37MG/100ML;370MG/100ML;530MG/100ML;500MG/100ML | INJECTABLE / INJECTION | 1989-09-29 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N019711-001 | ISOLYTE S IN PLASTIC CONTAINER | 30MG/100ML;37MG/100ML;370MG/100ML;530MG/100ML;500MG/100ML | INJECTABLE / INJECTION | 1989-09-29 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N019711-001 | ISOLYTE S IN PLASTIC CONTAINER | 30MG/100ML;37MG/100ML;370MG/100ML;530MG/100ML;500MG/100ML | INJECTABLE / INJECTION | 1989-09-29 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N019711-001 | ISOLYTE S IN PLASTIC CONTAINER | 30MG/100ML;37MG/100ML;370MG/100ML;530MG/100ML;500MG/100ML | INJECTABLE / INJECTION | 1989-09-29 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N019711-001 | ISOLYTE S IN PLASTIC CONTAINER | 30MG/100ML;37MG/100ML;370MG/100ML;530MG/100ML;500MG/100ML | INJECTABLE / INJECTION | 1989-09-29 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | N019711-001 | ISOLYTE S IN PLASTIC CONTAINER | 30MG/100ML;37MG/100ML;370MG/100ML;530MG/100ML;500MG/100ML | INJECTABLE / INJECTION | 1989-09-29 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N019711-001 | ISOLYTE S IN PLASTIC CONTAINER | 30MG/100ML;37MG/100ML;370MG/100ML;530MG/100ML;500MG/100ML | INJECTABLE / INJECTION | 1989-09-29 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N019711-001 | ISOLYTE S IN PLASTIC CONTAINER | 30MG/100ML;37MG/100ML;370MG/100ML;530MG/100ML;500MG/100ML | INJECTABLE / INJECTION | 1989-09-29 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N019711-001 | ISOLYTE S IN PLASTIC CONTAINER | 30MG/100ML;37MG/100ML;370MG/100ML;530MG/100ML;500MG/100ML | INJECTABLE / INJECTION | 1989-09-29 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | N019711-001 | ISOLYTE S IN PLASTIC CONTAINER | 30MG/100ML;37MG/100ML;370MG/100ML;530MG/100ML;500MG/100ML | INJECTABLE / INJECTION | 1989-09-29 | 8072bd15b7f6… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N019711-001 | ISOLYTE S IN PLASTIC CONTAINER | 30MG/100ML;37MG/100ML;370MG/100ML;530MG/100ML;500MG/100ML | INJECTABLE / INJECTION | 1989-09-29 | 5c6f7cd8ea54… | ||
| 2022-04-08 23:34 UTC | 2022-04 | N019711-001 | ISOLYTE S IN PLASTIC CONTAINER | 30MG/100ML;37MG/100ML;370MG/100ML;530MG/100ML;500MG/100ML | INJECTABLE / INJECTION | 1989-09-29 | 5d02ea3f76ae… | ||
| 2022-04-04 05:41 UTC | 2022-04 | N019711-001 | ISOLYTE S IN PLASTIC CONTAINER | 30MG/100ML;37MG/100ML;370MG/100ML;530MG/100ML;500MG/100ML | INJECTABLE / INJECTION | 1989-09-29 | 4b0b4de00fa7… | ||
| 2019-12-13 00:20 UTC | 2019-12 | N019711-001 | ISOLYTE S IN PLASTIC CONTAINER | 30MG/100ML;37MG/100ML;370MG/100ML;530MG/100ML;500MG/100ML | INJECTABLE / INJECTION | 1989-09-29 | 74a2ff9319b5… | ||
| 2022-03-09 01:35 UTC | 2022-03 | N019711-001 | ISOLYTE S IN PLASTIC CONTAINER | 30MG/100ML;37MG/100ML;370MG/100ML;530MG/100ML;500MG/100ML | INJECTABLE / INJECTION | 1989-09-29 | bb7c543d1eb4… | ||
| 2021-12-28 21:50 UTC | 2021-12 | N019711-001 | ISOLYTE S IN PLASTIC CONTAINER | 30MG/100ML;37MG/100ML;370MG/100ML;530MG/100ML;500MG/100ML | INJECTABLE / INJECTION | 1989-09-29 | 782e0a99824c… | ||
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | N019711-001 | ISOLYTE S IN PLASTIC CONTAINER | 30MG/100ML;37MG/100ML;370MG/100ML;530MG/100ML;500MG/100ML | INJECTABLE / INJECTION | 1989-09-29 | 87673890dc5c… | ||
| 2021-03-12 10:30 UTC | 2021-03 | N019711-001 | ISOLYTE S IN PLASTIC CONTAINER | 30MG/100ML;37MG/100ML;370MG/100ML;530MG/100ML;500MG/100ML | INJECTABLE / INJECTION | 1989-09-29 | 5aa47cf7b7d7… | ||
| 2020-12-22 03:56 UTC | 2020-12 | N019711-001 | ISOLYTE S IN PLASTIC CONTAINER | 30MG/100ML;37MG/100ML;370MG/100ML;530MG/100ML;500MG/100ML | INJECTABLE / INJECTION | 1989-09-29 | 8869cabd3fbd… | ||
| 2020-11-12 02:37 UTC | 2020-11 | N019711-001 | ISOLYTE S IN PLASTIC CONTAINER | 30MG/100ML;37MG/100ML;370MG/100ML;530MG/100ML;500MG/100ML | INJECTABLE / INJECTION | 1989-09-29 | c0c555d07b60… | ||
| 2019-12-14 00:12 UTC | 2019-12 | N019711-001 | ISOLYTE S IN PLASTIC CONTAINER | 30MG/100ML;37MG/100ML;370MG/100ML;530MG/100ML;500MG/100ML | INJECTABLE / INJECTION | 1989-09-29 | 3f01610625f2… | ||
| 2019-09-15 20:21 UTC | 2019-09 | N019711-001 | ISOLYTE S IN PLASTIC CONTAINER | 30MG/100ML;37MG/100ML;370MG/100ML;530MG/100ML;500MG/100ML | INJECTABLE / INJECTION | 1989-09-29 | b00525d2431f… | ||
| 2019-07-19 19:46 UTC | 2019-07 | N019711-001 | ISOLYTE S IN PLASTIC CONTAINER | 30MG/100ML;37MG/100ML;370MG/100ML;530MG/100ML;500MG/100ML | INJECTABLE / INJECTION | 1989-09-29 | ea99ee380514… | ||
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | N019711-001 | ISOLYTE S IN PLASTIC CONTAINER | 30MG/100ML;37MG/100ML;370MG/100ML;530MG/100ML;500MG/100ML | INJECTABLE / INJECTION | 1989-09-29 | 6a51e52b5d6a… | ||
| 2024-02-18 07:12 UTC | 2024-02 | N019711-001 | ISOLYTE S IN PLASTIC CONTAINER | 30MG/100ML;37MG/100ML;370MG/100ML;530MG/100ML;500MG/100ML | INJECTABLE / INJECTION | 1989-09-29 | 1c564ffb4f44… | ||
| 2023-12-20 04:57 UTC | 2023-12 | N019711-001 | ISOLYTE S IN PLASTIC CONTAINER | 30MG/100ML;37MG/100ML;370MG/100ML;530MG/100ML;500MG/100ML | INJECTABLE / INJECTION | 1989-09-29 | ea1830bbd6c7… | ||
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | N019711-001 | ISOLYTE S IN PLASTIC CONTAINER | 30MG/100ML;37MG/100ML;370MG/100ML;530MG/100ML;500MG/100ML | INJECTABLE / INJECTION | 1989-09-29 | a72a2bbeb626… | ||
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | N019711-001 | ISOLYTE S IN PLASTIC CONTAINER | 30MG/100ML;37MG/100ML;370MG/100ML;530MG/100ML;500MG/100ML | INJECTABLE / INJECTION | 1989-09-29 | 9b2671bbb829… | ||
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | N019711-001 | ISOLYTE S IN PLASTIC CONTAINER | 30MG/100ML;37MG/100ML;370MG/100ML;530MG/100ML;500MG/100ML | INJECTABLE / INJECTION | 1989-09-29 | a67488948f0b… | ||
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | N019711-001 | ISOLYTE S IN PLASTIC CONTAINER | 30MG/100ML;37MG/100ML;370MG/100ML;530MG/100ML;500MG/100ML | INJECTABLE / INJECTION | 1989-09-29 | 3f0d92c62455… | ||
| 2023-05-13 08:27 UTC | 2023-05 | N019711-001 | ISOLYTE S IN PLASTIC CONTAINER | 30MG/100ML;37MG/100ML;370MG/100ML;530MG/100ML;500MG/100ML | INJECTABLE / INJECTION | 1989-09-29 | 053a50430f4f… | ||
| 2023-01-26 05:58 UTC | 2023-01 | N019711-001 | ISOLYTE S IN PLASTIC CONTAINER | 30MG/100ML;37MG/100ML;370MG/100ML;530MG/100ML;500MG/100ML | INJECTABLE / INJECTION | 1989-09-29 | 3bdfa0b2c4d7… | ||
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | N019711-001 | ISOLYTE S IN PLASTIC CONTAINER | 30MG/100ML;37MG/100ML;370MG/100ML;530MG/100ML;500MG/100ML | INJECTABLE / INJECTION | 1989-09-29 | 3a93d1ddd44b… | ||
| 2022-10-28 04:53 UTC | 2022-10 | N019711-001 | ISOLYTE S IN PLASTIC CONTAINER | 30MG/100ML;37MG/100ML;370MG/100ML;530MG/100ML;500MG/100ML | INJECTABLE / INJECTION | 1989-09-29 | f41ea6bd6efb… | ||
| 2022-09-29 23:25 UTC | 2022-09 | N019711-001 | ISOLYTE S IN PLASTIC CONTAINER | 30MG/100ML;37MG/100ML;370MG/100ML;530MG/100ML;500MG/100ML | INJECTABLE / INJECTION | 1989-09-29 | e64feba35796… |
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Isolyte S
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| SODIUM CHLORIDE | .03 g/100mL |
| SODIUM GLUCONATE | .037 g/100mL |
| SODIUM ACETATE | .37 g/100mL |
| POTASSIUM CHLORIDE | .53 g/100mL |
| MAGNESIUM CHLORIDE | .5 g/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#
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 7e8fe27f-ff82-48c1-9bf6-3c589c8e985d | Available on FDA.report |
DailyMed Product Concepts#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 0264-7703-00 | Isolyte S | 12 in 1 CASE | INJECTION, SOLUTION | 12 | 6 | |
| 0264-7703-00 | Isolyte S | 1000 mL in 1 CONTAINER | INJECTION, SOLUTION | 1000 | 6 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 0264-7703-00 | ML - Milliliter | 0264-7703 | 7484b669-c027-4b87-bf08-6830f902b683 | 1 | 2012-07-24 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 0264-7703 | ISOLYTE S (SODIUM CHLORIDE, SODIUM GLUCONATE, SODIUM ACETATE, POTASSIUM CHLORIDE, AND MAGNESIUM CHLORIDE) INJECTION, SOLUTION [B. BRAUN MEDICAL INC.] | 6 | Current NDC, Legacy NDC, 2 package rows | 20200516_7e8fe27f-ff82-48c1-9bf6-3c589c8e985d.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 |
|---|---|---|---|---|---|---|
| Isolyte S | SODIUM CHLORIDE, SODIUM GLUCONATE, SODIUM ACETATE, POTASSIUM CHLORIDE, AND MAGNESIUM CHLORIDE | B. Braun Medical Inc. | 7e8fe27f-ff82-48c1-9bf6-3c589c8e985d | 2020-05-14 | Warnings, Adverse reactions | 019711 NDA019711 0264-7703 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 800928 | Isolyte S Injectable Solution | PSN | 7e8fe27f-ff82-48c1-9bf6-3c589c8e985d | 6 |
| 800928 | magnesium chloride 0.00148 MEQ/ML / monobasic potassium phosphate 0.0082 MG/ML / potassium chloride 0.00497 MEQ/ML / sodium acetate 0.0272 MEQ/ML / sodium chloride 0.0906 MEQ/ML / sodium gluconate 5 MG/ML / sodium phosphate, dibasic 0.12 MG/ML Injectable Solution [Isolyte S] | SBD | 7e8fe27f-ff82-48c1-9bf6-3c589c8e985d | 6 |
| 800925 | magnesium chloride 0.00148 MEQ/ML / monobasic potassium phosphate 0.0082 MG/ML / potassium chloride 0.00497 MEQ/ML / sodium acetate 0.0272 MEQ/ML / sodium chloride 0.0906 MEQ/ML / sodium gluconate 5 MG/ML / sodium phosphate, dibasic 0.12 MG/ML Injectable Solution | SCD | 7e8fe27f-ff82-48c1-9bf6-3c589c8e985d | 6 |
| 800928 | Isolyte S pH 7.4 (Multi-Electrolyte) Injectable Solution | SY | 7e8fe27f-ff82-48c1-9bf6-3c589c8e985d | 6 |
| 800925 | Magnesium Chloride 0.00148 MEQ/ML / Monobasic K+ phosphate 0.0082 MG/ML / K+ Chloride 0.00497 MEQ/ML / Sodium Acetate 0.0272 MEQ/ML / NaCl 0.0906 MEQ/ML / Sodium gluconate 5 MG/ML / Sodium Phosphate, Dibasic 0.12 MG/ML Injectable Solution | SY | 7e8fe27f-ff82-48c1-9bf6-3c589c8e985d | 6 |
| 800928 | Magnesium Chloride 0.00148 MEQ/ML / Monobasic K+ phosphate 0.0082 MG/ML / K+ Chloride 0.00497 MEQ/ML / Sodium Acetate 0.0272 MEQ/ML / NaCl 0.0906 MEQ/ML / Sodium gluconate 5 MG/ML / Sodium Phosphate, Dibasic 0.12 MG/ML Injectable Solution [Isolyte S] | SY | 7e8fe27f-ff82-48c1-9bf6-3c589c8e985d | 6 |
| 800925 | Magnesium Chloride 0.00148 MEQ/ML / Monobasic Pot phosphate 0.0082 MG/ML / Pot Chloride 0.00497 MEQ/ML / Sodium Acetate 0.0272 MEQ/ML / NaCl 0.0906 MEQ/ML / Sodium gluconate 5 MG/ML / Sodium Phosphate, Dibasic 0.12 MG/ML Injectable Solution | SY | 7e8fe27f-ff82-48c1-9bf6-3c589c8e985d | 6 |
| 800928 | Magnesium Chloride 0.00148 MEQ/ML / Monobasic Pot phosphate 0.0082 MG/ML / Pot Chloride 0.00497 MEQ/ML / Sodium Acetate 0.0272 MEQ/ML / NaCl 0.0906 MEQ/ML / Sodium gluconate 5 MG/ML / Sodium Phosphate, Dibasic 0.12 MG/ML Injectable Solution [Isolyte S] | SY | 7e8fe27f-ff82-48c1-9bf6-3c589c8e985d | 6 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 0264-7703-00 | 00264770300 | 12 CONTAINER in 1 CASE (0264-7703-00) / 1000 mL in 1 CONTAINER | 12 container | 1989-09-29 | 0000-00-00 | No | No | Current |