Indications and uses
Elliotts B Solution is indicated as a diluent for the intrathecal administration of methotrexate sodium and cytarabine for the prevention or treatment of meningeal leukemia or lymphocytic lymphoma.
Elliotts B
- Manufacturer
- Lukare Medical, LLC | Neopharm Labs Inc. | Nelson Laboratories, LLC | LabAnalysis s.r.l. | SGS Canada Inc
- Effective date
- 2024-10-16
- Label type
- HUMAN PRESCRIPTION DRUG LABEL
- Version
- 6
- Source
- full-release
- Hydrated at
- 2026-05-31 21:14:43
Label at a glance#
ProductElliotts B
Active ingredientsodium chloride, sodium bicarbonate, anhydrous dextrose, MAGNESIUM SULFATE, UNSPECIFIED FORM, potassium chloride, calcium chloride, sodium phosphate
Label structure13 sections
Dosage and administration
See product labeling for methotrexate sodium and cytarabine. Elliotts B Solution is intended for intrathecal administration only. Elliotts B Solution does not contain antibacterial preservatives and introduction of contaminated solutions into the cerebrospinal fluid may have extremely serious consequences. Therefore, administration of intrathecal solutions should be accomplished as soon as possible after preparati...
Contacts and useful links#
Websitewww.elliottsbsolution.com
www.elliottsbsolution.com
www.elliottsbsolution.comLabel contents#
Full prescribing information#
DESCRIPTION
Elliotts B® Solution is a sterile, nonpyrogenic, isotonic solution containing no bacteriostatic preservatives. Elliotts B Solution is a diluent for intrathecal administration of methotrexate sodium and cytarabine.
Each 10 mL of Elliotts B Solution contains:
Sodium Chloride, USP | 73 mg |
Sodium Bicarbonate, USP | 19 mg |
Dextrose, USP | 8 mg |
Magnesium Sulfate • 7H2O, USP | 3 mg |
Potassium Chloride, USP | 3 mg |
Calcium Chloride • 2H2O, USP | 2 mg |
Sodium Phosphate, dibasic • 7H2O, USP | 2 mg |
Water for Injection, USP | qs 10 mL |
Concentration of Electrolytes:
Sodium | 149 mEq/liter | Bicarbonate | 22.6 mEq/liter |
Potassium | 4 mEq/liter | Chloride | 132 mEq/liter |
Calcium | 2.7 mEq/liter | Sulfate | 2.4 mEq/liter |
Magnesium | 2.4 mEq/liter | Phosphate | 1.5 mEq/liter |
The formulae and molecular weights of the ingredients are:
INGREDIENT | MOLECULAR | MOLECULAR |
Sodium Chloride | NaCl | 58.44 |
Sodium Bicarbonate | NaHCO3 | 84.01 |
Dextrose | C6H12O6 | 180.16 |
Magnesium Sulfate • 7H2O | Mg2SO4 • 7H2O | 246.48 |
Potassium Chloride | KCl | 74.55 |
Calcium Chloride • 2H2O | CaCl2 • 2H2O | 147.01 |
Sodium Phosphate, dibasic • 7H2O | Na2HPO4 • 7H2O | 268.07 |
The pH of Elliotts B Solution is 6.0-7.5, and the osmolarity is 288 mOsmol per liter (calculated).
CLINICAL PHARMACOLOGY
Elliotts B Solution provides a buffered salt solution for use as a diluent for the intrathecal administration of methotrexate sodium and cytarabine. It has been demonstrated that Elliotts B Solution is comparable to cerebrospinal fluid in pH, electrolyte composition, glucose content, and osmolarity:
Comparison of Electrolyte Composition, pH and Nonelectrolytic Constituents of Elliotts B Solution and CSF
Solution | Na+
| K+
| Ca++
| Mg++
| HCO3
-
| Cl-
| pH | Phosphorus | Glucose |
Cerebrospinal Fluid | 117-137 | 2.3-4.6 | 2.2 | 2.2 | 22.9 | 113-127 | 7.31 | 1.2-2.1 | 45-80 |
Elliotts B Solution | 149 | 4 | 2.7 | 2.4 | 22.6 | 132 | 6.0-7.5 | 2.3 | 80 |
The approximate buffer capacity of Elliotts B Solution is 1.1 X 10-2 equivalents when the challenge solution is 0.01 N HCl and 7.8 X 10-3 equivalents when the challenge solution is 0.01 N NaOH.1
Compatibility studies with methotrexate sodium and cytarabine indicate these drugs are physically compatible with Elliotts B Solution.
INDICATIONS AND USAGE
Elliotts B Solution is indicated as a diluent for the intrathecal administration of methotrexate sodium and cytarabine for the prevention or treatment of meningeal leukemia or lymphocytic lymphoma.
CONTRAINDICATIONS
None known.
WARNINGS
Intrathecal administration of drugs such as methotrexate sodium and cytarabine should be performed by personnel skilled in the technique of lumbar puncture under the supervision of a physician who is experienced in the use of cancer chemotherapeutic agents. The labeling for methotrexate sodium and cytarabine should be consulted.
PRECAUTIONS
General
Particular attention should be taken to assure the maintenance of sterile technique throughout the procedure. (See DOSAGE AND ADMINISTRATION.)
Carcinogenesis, Mutagenesis, Impairment of Fertility
No standard mutagenicity or carcinogenicity studies have been conducted with Elliotts B Solution.
Usage in Pregnancy
All components of Elliotts B Solution are normal body constituents. Animal reproduction studies have not been conducted with Elliotts B Solution.
ADVERSE REACTIONS
Adverse reactions may occur with any given intrathecal injection due to the chemotherapy or the technique of intrathecal administration. (See product labeling for methotrexate sodium and cytarabine.)
Preservative-free methotrexate sodium and cytarabine should be used to minimize adverse reactions due to preservatives.
If an adverse reaction does occur, discontinue the administration, evaluate the patient, institute appropriate therapeutic countermeasures and, if possible, save the remainder of the unused solution(s) for examination.
DRUG ABUSE AND DEPENDENCE
There is no potential for drug abuse or drug dependence.
OVERDOSAGE
Elliotts B Solution is a diluent. In the event of a drug, fluid or solute overload following administration, evaluate the patient's condition, and institute appropriate corrective treatment. (See product labeling for methotrexate sodium and cytarabine.)
DOSAGE AND ADMINISTRATION
See product labeling for methotrexate sodium and cytarabine.
Elliotts B Solution is intended for intrathecal administration only. Elliotts B Solution does not contain antibacterial preservatives and introduction of contaminated solutions into the cerebrospinal fluid may have extremely serious consequences. Therefore, administration of intrathecal solutions should be accomplished as soon as possible after preparation.
A sterile filter-needle should be used to withdraw the contents of the ampule.
Intrathecal drug products should be inspected visually for particulate matter and discoloration prior to administration.
Preparation and Administration Precautions
Elliotts B Solution is a diluent for the cytotoxic anticancer agents, methotrexate sodium and cytarabine. Care should be exercised in the handling and preparation of infusion solutions with these products. (See product labeling for methotrexate sodium and cytarabine.)
HOW SUPPLIED
NDC | SIZE |
55792-007-10 | 10 mL ampule |
Elliotts B Solution is available in single-use clear glass ampules, packaged 10 ampules per box.
Store at controlled room temperature, 20ºC-25ºC (68ºF-77ºF) [See USP].
Preservative Free. Discard unused portion. Use only if solution is clear and ampule is intact.
Distributed by:
Lukare Medical, LLC
Ponte Vedra Beach, FL 32082
1-855-752-9317www.elliottsbsolution.com
REFERENCES:
1. Cradock JC, et al. Evaluation of some pharmaceutical aspects of intrathecal methotrexate sodium, cytara‑bine and hydrocortisone sodium succinate. American Journal of Hospital Pharmacy (1978); 35:402.
Rev. 05/2024
PACKAGING
Ampule labeling:
Box labeling:
DailyMed Pharmacologic Classes#
| Class | Version | Type | Effective |
|---|---|---|---|
| BICARBONATE ION Pharmacologic Class Indexing | 1 | Indexing - Pharmacologic Class | 20220121 |
| CALCIUM CATION Pharmacologic Class Indexing | 3 | Indexing - Pharmacologic Class | 20230427 |
| MAGNESIUM CATION Pharmacologic Class Indexing | 4 | Indexing - Pharmacologic Class | 20180813 |
| POTASSIUM CATION Pharmacologic Class Indexing | 3 | Indexing - Pharmacologic Class | 20180813 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 55792-007-01 | Elliotts B | 10 mL in 1 AMPULE | INJECTION | 10 | 6 | |
| 55792-007-10 | Elliotts B | 10 in 1 BOX | INJECTION | 10 | 6 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 55792-007 | ELLIOTTS B (SODIUM CATION, SODIUM BICARBONATE, ANHYDROUS DEXTROSE, MAGNESIUM SULFATE, POTASSIUM CHLORIDE, CALCIUM CHLORIDE, SODIUM PHOSPHATE) INJECTION [LUKARE MEDICAL, LLC] | 6 | Current NDC, Legacy NDC, 2 package rows | 20241018_08036dbd-55b3-47b9-9890-000f253544f3.zip |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 55792-007-01 | ML - Milliliter | 55792-007 | 45675f1d-bf1f-4d54-be81-4f0c1cc9b517 | 1 | 2019-08-06 |
| 55792-007-10 | ML - Milliliter | 55792-007 | bdcae154-55aa-42ee-9f20-636d670a1376 | 1 | 2013-08-02 |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| anhydrous dextrose | ACTIVE INGREDIENT | 5SL0G7R0OK | 1 | |
| calcium chloride | ACTIVE INGREDIENT | M4I0D6VV5M | 1 | |
| magnesium sulfate | ACTIVE INGREDIENT | DE08037SAB | 1 | |
| potassium chloride | ACTIVE INGREDIENT | 660YQ98I10 | 1 | |
| sodium bicarbonate | ACTIVE INGREDIENT | 8MDF5V39QO | 1 | |
| sodium chloride | ACTIVE INGREDIENT | 451W47IQ8X | 1 | |
| sodium phosphate | ACTIVE INGREDIENT | SE337SVY37 | 1 | |
| anhydrous dextrose | ACTIVE MOIETY | 5SL0G7R0OK | 1 | |
| bicarbonate ion | ACTIVE MOIETY | HN1ZRA3Q20 | 1 | |
| calcium cation | ACTIVE MOIETY | 2M83C4R6ZB | 1 | |
| chloride ion | ACTIVE MOIETY | Q32ZN48698 | 1 | |
| magnesium cation | ACTIVE MOIETY | T6V3LHY838 | 1 | |
| phosphate ion | ACTIVE MOIETY | NK08V8K8HR | 1 | |
| potassium cation | ACTIVE MOIETY | 295O53K152 | 1 | |
| Water | INACTIVE INGREDIENT | 059QF0KO0R | 1 |
Products#
Every source-derived product name is available through these pages.
- Elliotts B
- sodium cation, sodium bicarbonate, anhydrous dextrose, magnesium sulfate, potassium chloride, calcium chloride, sodium phosphate
- sodium chloride
- sodium cation
- chloride ion
- sodium bicarbonate
- bicarbonate ion
- anhydrous dextrose
- MAGNESIUM SULFATE, UNSPECIFIED FORM
- MAGNESIUM CATION
- potassium chloride
- potassium cation
- calcium chloride
- calcium cation
- sodium phosphate
- phosphate ion
- Water
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 55792-007 | 55792-007-01, 55792-007-10 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| sodium chloride | 451W47IQ8X | ACTIB |
| sodium bicarbonate | 8MDF5V39QO | ACTIB |
| anhydrous dextrose | 5SL0G7R0OK | ACTIB |
| MAGNESIUM SULFATE, UNSPECIFIED FORM | DE08037SAB | ACTIB |
| potassium chloride | 660YQ98I10 | ACTIB |
| calcium chloride | M4I0D6VV5M | ACTIB |
| sodium phosphate | SE337SVY37 | ACTIB |
| Water | 059QF0KO0R | IACT |
Source Document#
Orange Book application contexts#
All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N020577-001 | ELLIOTTS B SOLUTION | CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM SULFATE; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE; SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE | 0.2MG/ML;0.8MG/ML;0.3MG/ML;0.3MG/ML;1.9MG/ML;7.3MG/ML;0.2MG/ML | INJECTABLE / INTRATHECAL | RLD, RS | 1996-09-27 |
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-10-15 13:18:30 | 2026-09 | N020577-001 | ELLIOTTS B SOLUTION | 0.2MG/ML;0.8MG/ML;0.3MG/ML;0.3MG/ML;1.9MG/ML;7.3MG/ML;0.2MG/ML | INJECTABLE / INTRATHECAL | RLD, RS | 1996-09-27 | c2088c7a36db… | |
| 2026-09-14 22:38:34 | 2026-08 | N020577-001 | ELLIOTTS B SOLUTION | 0.2MG/ML;0.8MG/ML;0.3MG/ML;0.3MG/ML;1.9MG/ML;7.3MG/ML;0.2MG/ML | INJECTABLE / INTRATHECAL | RLD, RS | 1996-09-27 | 84e616aacf4f… | |
| 2026-08-18 06:07:40 | 2026-07 | N020577-001 | ELLIOTTS B SOLUTION | 0.2MG/ML;0.8MG/ML;0.3MG/ML;0.3MG/ML;1.9MG/ML;7.3MG/ML;0.2MG/ML | INJECTABLE / INTRATHECAL | RLD, RS | 1996-09-27 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | N020577-001 | ELLIOTTS B SOLUTION | 0.2MG/ML;0.8MG/ML;0.3MG/ML;0.3MG/ML;1.9MG/ML;7.3MG/ML;0.2MG/ML | INJECTABLE / INTRATHECAL | RLD, RS | 1996-09-27 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N020577-001 | ELLIOTTS B SOLUTION | 0.2MG/ML;0.8MG/ML;0.3MG/ML;0.3MG/ML;1.9MG/ML;7.3MG/ML;0.2MG/ML | INJECTABLE / INTRATHECAL | RLD, RS | 1996-09-27 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | N020577-001 | ELLIOTTS B SOLUTION | 0.2MG/ML;0.8MG/ML;0.3MG/ML;0.3MG/ML;1.9MG/ML;7.3MG/ML;0.2MG/ML | INJECTABLE / INTRATHECAL | RLD, RS | 1996-09-27 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N020577-001 | ELLIOTTS B SOLUTION | 0.2MG/ML;0.8MG/ML;0.3MG/ML;0.3MG/ML;1.9MG/ML;7.3MG/ML;0.2MG/ML | INJECTABLE / INTRATHECAL | RLD, RS | 1996-09-27 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N020577-001 | ELLIOTTS B SOLUTION | 0.2MG/ML;0.8MG/ML;0.3MG/ML;0.3MG/ML;1.9MG/ML;7.3MG/ML;0.2MG/ML | INJECTABLE / INTRATHECAL | RLD, RS | 1996-09-27 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N020577-001 | ELLIOTTS B SOLUTION | 0.2MG/ML;0.8MG/ML;0.3MG/ML;0.3MG/ML;1.9MG/ML;7.3MG/ML;0.2MG/ML | INJECTABLE / INTRATHECAL | RLD, RS | 1996-09-27 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N020577-001 | ELLIOTTS B SOLUTION | 0.2MG/ML;0.8MG/ML;0.3MG/ML;0.3MG/ML;1.9MG/ML;7.3MG/ML;0.2MG/ML | INJECTABLE / INTRATHECAL | RLD, RS | 1996-09-27 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N020577-001 | ELLIOTTS B SOLUTION | 0.2MG/ML;0.8MG/ML;0.3MG/ML;0.3MG/ML;1.9MG/ML;7.3MG/ML;0.2MG/ML | INJECTABLE / INTRATHECAL | RLD, RS | 1996-09-27 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N020577-001 | ELLIOTTS B SOLUTION | 0.2MG/ML;0.8MG/ML;0.3MG/ML;0.3MG/ML;1.9MG/ML;7.3MG/ML;0.2MG/ML | INJECTABLE / INTRATHECAL | RLD, RS | 1996-09-27 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | N020577-001 | ELLIOTTS B SOLUTION | 0.2MG/ML;0.8MG/ML;0.3MG/ML;0.3MG/ML;1.9MG/ML;7.3MG/ML;0.2MG/ML | INJECTABLE / INTRATHECAL | RLD, RS | 1996-09-27 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N020577-001 | ELLIOTTS B SOLUTION | 0.2MG/ML;0.8MG/ML;0.3MG/ML;0.3MG/ML;1.9MG/ML;7.3MG/ML;0.2MG/ML | INJECTABLE / INTRATHECAL | RLD, RS | 1996-09-27 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N020577-001 | ELLIOTTS B SOLUTION | 0.2MG/ML;0.8MG/ML;0.3MG/ML;0.3MG/ML;1.9MG/ML;7.3MG/ML;0.2MG/ML | INJECTABLE / INTRATHECAL | RLD, RS | 1996-09-27 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N020577-001 | ELLIOTTS B SOLUTION | 0.2MG/ML;0.8MG/ML;0.3MG/ML;0.3MG/ML;1.9MG/ML;7.3MG/ML;0.2MG/ML | INJECTABLE / INTRATHECAL | RLD, RS | 1996-09-27 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | N020577-001 | ELLIOTTS B SOLUTION | 0.2MG/ML;0.8MG/ML;0.3MG/ML;0.3MG/ML;1.9MG/ML;7.3MG/ML;0.2MG/ML | INJECTABLE / INTRATHECAL | RLD, RS | 1996-09-27 | 8072bd15b7f6… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N020577-001 | ELLIOTTS B SOLUTION | 0.2MG/ML;0.8MG/ML;0.3MG/ML;0.3MG/ML;1.9MG/ML;7.3MG/ML;0.2MG/ML | INJECTABLE / INTRATHECAL | RLD, RS | 1996-09-27 | 5c6f7cd8ea54… | |
| 2022-04-08 23:34 UTC | 2022-04 | N020577-001 | ELLIOTTS B SOLUTION | 0.2MG/ML;0.8MG/ML;0.3MG/ML;0.3MG/ML;1.9MG/ML;7.3MG/ML;0.2MG/ML | INJECTABLE / INTRATHECAL | RLD, RS | 1996-09-27 | 5d02ea3f76ae… | |
| 2022-04-04 05:41 UTC | 2022-04 | N020577-001 | ELLIOTTS B SOLUTION | 0.2MG/ML;0.8MG/ML;0.3MG/ML;0.3MG/ML;1.9MG/ML;7.3MG/ML;0.2MG/ML | INJECTABLE / INTRATHECAL | RLD, RS | 1996-09-27 | 4b0b4de00fa7… | |
| 2019-12-13 00:20 UTC | 2019-12 | N020577-001 | ELLIOTTS B SOLUTION | 0.2MG/ML;0.8MG/ML;0.3MG/ML;0.3MG/ML;1.9MG/ML;7.3MG/ML;0.2MG/ML | INJECTABLE / INTRATHECAL | RLD, RS | 1996-09-27 | 74a2ff9319b5… | |
| 2022-03-09 01:35 UTC | 2022-03 | N020577-001 | ELLIOTTS B SOLUTION | 0.2MG/ML;0.8MG/ML;0.3MG/ML;0.3MG/ML;1.9MG/ML;7.3MG/ML;0.2MG/ML | INJECTABLE / INTRATHECAL | RLD, RS | 1996-09-27 | bb7c543d1eb4… | |
| 2021-12-28 21:50 UTC | 2021-12 | N020577-001 | ELLIOTTS B SOLUTION | 0.2MG/ML;0.8MG/ML;0.3MG/ML;0.3MG/ML;1.9MG/ML;7.3MG/ML;0.2MG/ML | INJECTABLE / INTRATHECAL | RLD, RS | 1996-09-27 | 782e0a99824c… | |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | N020577-001 | ELLIOTTS B SOLUTION | 0.2MG/ML;0.8MG/ML;0.3MG/ML;0.3MG/ML;1.9MG/ML;7.3MG/ML;0.2MG/ML | INJECTABLE / INTRATHECAL | RLD, RS | 1996-09-27 | 87673890dc5c… | |
| 2021-03-12 10:30 UTC | 2021-03 | N020577-001 | ELLIOTTS B SOLUTION | 0.2MG/ML;0.8MG/ML;0.3MG/ML;0.3MG/ML;1.9MG/ML;7.3MG/ML;0.2MG/ML | INJECTABLE / INTRATHECAL | RLD, RS | 1996-09-27 | 5aa47cf7b7d7… | |
| 2020-12-22 03:56 UTC | 2020-12 | N020577-001 | ELLIOTTS B SOLUTION | 0.2MG/ML;0.8MG/ML;0.3MG/ML;0.3MG/ML;1.9MG/ML;7.3MG/ML;0.2MG/ML | INJECTABLE / INTRATHECAL | RLD, RS | 1996-09-27 | 8869cabd3fbd… | |
| 2020-11-12 02:37 UTC | 2020-11 | N020577-001 | ELLIOTTS B SOLUTION | 0.2MG/ML;0.8MG/ML;0.3MG/ML;0.3MG/ML;1.9MG/ML;7.3MG/ML;0.2MG/ML | INJECTABLE / INTRATHECAL | RLD, RS | 1996-09-27 | c0c555d07b60… | |
| 2019-12-14 00:12 UTC | 2019-12 | N020577-001 | ELLIOTTS B SOLUTION | 0.2MG/ML;0.8MG/ML;0.3MG/ML;0.3MG/ML;1.9MG/ML;7.3MG/ML;0.2MG/ML | INJECTABLE / INTRATHECAL | RLD, RS | 1996-09-27 | 3f01610625f2… | |
| 2019-09-15 20:21 UTC | 2019-09 | N020577-001 | ELLIOTTS B SOLUTION | 0.2MG/ML;0.8MG/ML;0.3MG/ML;0.3MG/ML;1.9MG/ML;7.3MG/ML;0.2MG/ML | INJECTABLE / INTRATHECAL | RLD, RS | 1996-09-27 | b00525d2431f… | |
| 2019-07-19 19:46 UTC | 2019-07 | N020577-001 | ELLIOTTS B SOLUTION | 0.2MG/ML;0.8MG/ML;0.3MG/ML;0.3MG/ML;1.9MG/ML;7.3MG/ML;0.2MG/ML | INJECTABLE / INTRATHECAL | RLD, RS | 1996-09-27 | ea99ee380514… | |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | N020577-001 | ELLIOTTS B SOLUTION | 0.2MG/ML;0.8MG/ML;0.3MG/ML;0.3MG/ML;1.9MG/ML;7.3MG/ML;0.2MG/ML | INJECTABLE / INTRATHECAL | RLD, RS | 1996-09-27 | 6a51e52b5d6a… | |
| 2024-02-18 07:12 UTC | 2024-02 | N020577-001 | ELLIOTTS B SOLUTION | 0.2MG/ML;0.8MG/ML;0.3MG/ML;0.3MG/ML;1.9MG/ML;7.3MG/ML;0.2MG/ML | INJECTABLE / INTRATHECAL | RLD, RS | 1996-09-27 | 1c564ffb4f44… | |
| 2023-12-20 04:57 UTC | 2023-12 | N020577-001 | ELLIOTTS B SOLUTION | 0.2MG/ML;0.8MG/ML;0.3MG/ML;0.3MG/ML;1.9MG/ML;7.3MG/ML;0.2MG/ML | INJECTABLE / INTRATHECAL | RLD, RS | 1996-09-27 | ea1830bbd6c7… | |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | N020577-001 | ELLIOTTS B SOLUTION | 0.2MG/ML;0.8MG/ML;0.3MG/ML;0.3MG/ML;1.9MG/ML;7.3MG/ML;0.2MG/ML | INJECTABLE / INTRATHECAL | RLD, RS | 1996-09-27 | a72a2bbeb626… | |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | N020577-001 | ELLIOTTS B SOLUTION | 0.2MG/ML;0.8MG/ML;0.3MG/ML;0.3MG/ML;1.9MG/ML;7.3MG/ML;0.2MG/ML | INJECTABLE / INTRATHECAL | RLD, RS | 1996-09-27 | 9b2671bbb829… | |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | N020577-001 | ELLIOTTS B SOLUTION | 0.2MG/ML;0.8MG/ML;0.3MG/ML;0.3MG/ML;1.9MG/ML;7.3MG/ML;0.2MG/ML | INJECTABLE / INTRATHECAL | RLD, RS | 1996-09-27 | a67488948f0b… | |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | N020577-001 | ELLIOTTS B SOLUTION | 0.2MG/ML;0.8MG/ML;0.3MG/ML;0.3MG/ML;1.9MG/ML;7.3MG/ML;0.2MG/ML | INJECTABLE / INTRATHECAL | RLD, RS | 1996-09-27 | 3f0d92c62455… | |
| 2023-05-13 08:27 UTC | 2023-05 | N020577-001 | ELLIOTTS B SOLUTION | 0.2MG/ML;0.8MG/ML;0.3MG/ML;0.3MG/ML;1.9MG/ML;7.3MG/ML;0.2MG/ML | INJECTABLE / INTRATHECAL | RLD, RS | 1996-09-27 | 053a50430f4f… | |
| 2023-01-26 05:58 UTC | 2023-01 | N020577-001 | ELLIOTTS B SOLUTION | 0.2MG/ML;0.8MG/ML;0.3MG/ML;0.3MG/ML;1.9MG/ML;7.3MG/ML;0.2MG/ML | INJECTABLE / INTRATHECAL | RLD, RS | 1996-09-27 | 3bdfa0b2c4d7… | |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | N020577-001 | ELLIOTTS B SOLUTION | 0.2MG/ML;0.8MG/ML;0.3MG/ML;0.3MG/ML;1.9MG/ML;7.3MG/ML;0.2MG/ML | INJECTABLE / INTRATHECAL | RLD, RS | 1996-09-27 | 3a93d1ddd44b… |
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 |
|---|---|---|---|---|---|---|
| Elliotts B | SODIUM CATION, SODIUM BICARBONATE, ANHYDROUS DEXTROSE, MAGNESIUM SULFATE, POTASSIUM CHLORIDE, CALCIUM CHLORIDE, SODIUM PHOSPHATE | Lukare Medical, LLC | 08036dbd-55b3-47b9-9890-000f253544f3 | 2024-10-16 | Warnings, Adverse reactions | 55792-007-10 55792-007-01 55792-007 55792000710 55792000701 4a638cd1-6922-477a-aa17-a70865ae0bd8 08036dbd-55b3-47b9-9890-000f253544f3 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.