FDA.reportPublic FDA data

Elliotts B

Product NDC
55792-007
11-digit product format
557920007
Labeler code
55792
Product ID
55792-007_4a638cd1-6922-477a-aa17-a70865ae0bd8
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
sodium cation, sodium bicarbonate, anhydrous dextrose, magnesium sulfate, potassium chloride, calcium chloride, sodium phosphate
Dosage form
INJECTION
Route
INTRATHECAL
Labeler
Lukare Medical, LLC
Application
NDA020577
Marketing category
NDA
Marketing start
2013-06-04
Substance
ANHYDROUS DEXTROSE; CALCIUM CHLORIDE; MAGNESIUM SULFATE, UNSPECIFIED FORM; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE; SODIUM PHOSPHATE
Active strength
8; 2; 3; 3; 19; 73; 2 mg/10mL; mg/10mL; mg/10mL; mg/10mL; mg/10mL; mg/10mL; mg/10mL
Pharmacologic classes
Alkalinizing Activity [MoA], Blood Coagulation Factor [EPC], Calcium [CS], Calculi Dissolution Agent [EPC], Cations, Divalent [CS], Increased Coagulation Factor Activity [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 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], Phosphate Binder [EPC], Phosphate Chelating Activity [MoA], 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 table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N020577-001ELLIOTTS B SOLUTIONCALCIUM CHLORIDE; DEXTROSE; MAGNESIUM SULFATE; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE; SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE0.2MG/ML;0.8MG/ML;0.3MG/ML;0.3MG/ML;1.9MG/ML;7.3MG/ML;0.2MG/MLINJECTABLE / INTRATHECALRLD, RS1996-09-27

openFDA label cross-check#

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 table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Elliotts BSODIUM CATION, SODIUM BICARBONATE, ANHYDROUS DEXTROSE, MAGNESIUM SULFATE, POTASSIUM CHLORIDE, CALCIUM CHLORIDE, SODIUM PHOSPHATELukare Medical, LLC08036dbd-55b3-47b9-9890-000f253544f32024-10-16Warnings, Adverse reactionsExact identifier

Warnings cross-check#

openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.

warnings

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.

Adverse reactions cross-check#

openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.

adverse reactions

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.

Additional Listing Data#

Finished product
Yes
Brand name base
Elliotts B
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SODIUM CHLORIDE8 mg/10mL
SODIUM BICARBONATE2 mg/10mL
ANHYDROUS DEXTROSE3 mg/10mL
MAGNESIUM SULFATE, UNSPECIFIED FORM3 mg/10mL
POTASSIUM CHLORIDE19 mg/10mL
CALCIUM CHLORIDE73 mg/10mL
SODIUM PHOSPHATE2 mg/10mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii451W47IQ8X, 8MDF5V39QO, 5SL0G7R0OK, DE08037SAB, 660YQ98I10, M4I0D6VV5M, SE337SVY37

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
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DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55792-007-01Elliotts B10 mL in 1 AMPULEINJECTION106
55792-007-10Elliotts B10 in 1 BOXINJECTION106

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
55792-007-01ML - Milliliter55792-00745675f1d-bf1f-4d54-be81-4f0c1cc9b51712019-08-06
55792-007-10ML - Milliliter55792-007bdcae154-55aa-42ee-9f20-636d670a137612013-08-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
anhydrous dextroseACTIVE INGREDIENT5SL0G7R0OKELLIOTTS B (SODIUM CATION, SODIUM BICARBONATE, ANHYDROUS DEXTROSE, MAGNESIUM SULFATE, POTASSIUM CHLORIDE, CALCIUM CHLORIDE, SODIUM PHOSPHATE) INJECTION [LUKARE MEDICAL, LLC]1
calcium chlorideACTIVE INGREDIENTM4I0D6VV5MELLIOTTS B (SODIUM CATION, SODIUM BICARBONATE, ANHYDROUS DEXTROSE, MAGNESIUM SULFATE, POTASSIUM CHLORIDE, CALCIUM CHLORIDE, SODIUM PHOSPHATE) INJECTION [LUKARE MEDICAL, LLC]1
magnesium sulfateACTIVE INGREDIENTDE08037SABELLIOTTS B (SODIUM CATION, SODIUM BICARBONATE, ANHYDROUS DEXTROSE, MAGNESIUM SULFATE, POTASSIUM CHLORIDE, CALCIUM CHLORIDE, SODIUM PHOSPHATE) INJECTION [LUKARE MEDICAL, LLC]1
potassium chlorideACTIVE INGREDIENT660YQ98I10ELLIOTTS B (SODIUM CATION, SODIUM BICARBONATE, ANHYDROUS DEXTROSE, MAGNESIUM SULFATE, POTASSIUM CHLORIDE, CALCIUM CHLORIDE, SODIUM PHOSPHATE) INJECTION [LUKARE MEDICAL, LLC]1
sodium bicarbonateACTIVE INGREDIENT8MDF5V39QOELLIOTTS B (SODIUM CATION, SODIUM BICARBONATE, ANHYDROUS DEXTROSE, MAGNESIUM SULFATE, POTASSIUM CHLORIDE, CALCIUM CHLORIDE, SODIUM PHOSPHATE) INJECTION [LUKARE MEDICAL, LLC]1
sodium chlorideACTIVE INGREDIENT451W47IQ8XELLIOTTS B (SODIUM CATION, SODIUM BICARBONATE, ANHYDROUS DEXTROSE, MAGNESIUM SULFATE, POTASSIUM CHLORIDE, CALCIUM CHLORIDE, SODIUM PHOSPHATE) INJECTION [LUKARE MEDICAL, LLC]1
sodium phosphateACTIVE INGREDIENTSE337SVY37ELLIOTTS B (SODIUM CATION, SODIUM BICARBONATE, ANHYDROUS DEXTROSE, MAGNESIUM SULFATE, POTASSIUM CHLORIDE, CALCIUM CHLORIDE, SODIUM PHOSPHATE) INJECTION [LUKARE MEDICAL, LLC]1
anhydrous dextroseACTIVE MOIETY5SL0G7R0OKELLIOTTS B (SODIUM CATION, SODIUM BICARBONATE, ANHYDROUS DEXTROSE, MAGNESIUM SULFATE, POTASSIUM CHLORIDE, CALCIUM CHLORIDE, SODIUM PHOSPHATE) INJECTION [LUKARE MEDICAL, LLC]1
bicarbonate ionACTIVE MOIETYHN1ZRA3Q20ELLIOTTS B (SODIUM CATION, SODIUM BICARBONATE, ANHYDROUS DEXTROSE, MAGNESIUM SULFATE, POTASSIUM CHLORIDE, CALCIUM CHLORIDE, SODIUM PHOSPHATE) INJECTION [LUKARE MEDICAL, LLC]1
calcium cationACTIVE MOIETY2M83C4R6ZBELLIOTTS B (SODIUM CATION, SODIUM BICARBONATE, ANHYDROUS DEXTROSE, MAGNESIUM SULFATE, POTASSIUM CHLORIDE, CALCIUM CHLORIDE, SODIUM PHOSPHATE) INJECTION [LUKARE MEDICAL, LLC]1
chloride ionACTIVE MOIETYQ32ZN48698ELLIOTTS B (SODIUM CATION, SODIUM BICARBONATE, ANHYDROUS DEXTROSE, MAGNESIUM SULFATE, POTASSIUM CHLORIDE, CALCIUM CHLORIDE, SODIUM PHOSPHATE) INJECTION [LUKARE MEDICAL, LLC]1
magnesium cationACTIVE MOIETYT6V3LHY838ELLIOTTS B (SODIUM CATION, SODIUM BICARBONATE, ANHYDROUS DEXTROSE, MAGNESIUM SULFATE, POTASSIUM CHLORIDE, CALCIUM CHLORIDE, SODIUM PHOSPHATE) INJECTION [LUKARE MEDICAL, LLC]1
phosphate ionACTIVE MOIETYNK08V8K8HRELLIOTTS B (SODIUM CATION, SODIUM BICARBONATE, ANHYDROUS DEXTROSE, MAGNESIUM SULFATE, POTASSIUM CHLORIDE, CALCIUM CHLORIDE, SODIUM PHOSPHATE) INJECTION [LUKARE MEDICAL, LLC]1
potassium cationACTIVE MOIETY295O53K152ELLIOTTS B (SODIUM CATION, SODIUM BICARBONATE, ANHYDROUS DEXTROSE, MAGNESIUM SULFATE, POTASSIUM CHLORIDE, CALCIUM CHLORIDE, SODIUM PHOSPHATE) INJECTION [LUKARE MEDICAL, LLC]1
WaterINACTIVE INGREDIENT059QF0KO0RELLIOTTS B (SODIUM CATION, SODIUM BICARBONATE, ANHYDROUS DEXTROSE, MAGNESIUM SULFATE, POTASSIUM CHLORIDE, CALCIUM CHLORIDE, SODIUM PHOSPHATE) INJECTION [LUKARE MEDICAL, LLC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55792-007ELLIOTTS B (SODIUM CATION, SODIUM BICARBONATE, ANHYDROUS DEXTROSE, MAGNESIUM SULFATE, POTASSIUM CHLORIDE, CALCIUM CHLORIDE, SODIUM PHOSPHATE) INJECTION [LUKARE MEDICAL, LLC]6Current NDC, Legacy NDC, 2 package rows20241018_08036dbd-55b3-47b9-9890-000f253544f3.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55792-007-015579200070110 mL in 1 AMPULE10 mlHistorical
55792-007-105579200071010 AMPULE in 1 BOX (55792-007-10) / 10 mL in 1 AMPULE (55792-007-01) 10 ampule2013-06-040000-00-00NoNoCurrent