| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | ELLIOTTS B SOLUTION | CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM SULFATE; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE; SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE | INJECTABLE;INTRATHECAL | 0.2MG/ML;0.8MG/ML;0.3MG/ML;0.3MG/ML;1.9MG/ML;7.3MG/ML;0.2MG/ML | Yes | Yes |
| 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 |
Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report.
| 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 |
openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
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.
openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
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.
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 55792-007 | Elliotts B | sodium cation, sodium bicarbonate, anhydrous dextrose, magnesium sulfate, potassium chloride, calcium chloride, sodium phosphate | Lukare Medical, LLC | NDA | Current |
| 67871-007 | Elliotts B | sodium cation, sodium bicarbonate, anhydrous dextrose, magnesium sulfate, potassium chloride, calcium chloride, sodium phosphate | QOL Medical, LLC | NDA | Current |