Elliotts B

openFDA label record#

This page contains supplementary openFDA label data. For the canonical label presentation, use the corresponding DailyMed Structured Product Label.

Verified complete openFDA source JSON (canonical bytes are SHA-256 checked before publication)

Brand name: Elliotts B
Generic name: SODIUM CATION, SODIUM BICARBONATE, ANHYDROUS DEXTROSE, MAGNESIUM SULFATE, POTASSIUM CHLORIDE, CALCIUM CHLORIDE, SODIUM PHOSPHATE
Manufacturer: Lukare Medical, LLC
Product type: HUMAN PRESCRIPTION DRUG
SPL set ID: 08036dbd-55b3-47b9-9890-000f253544f3
SPL ID: 4a638cd1-6922-477a-aa17-a70865ae0bd8
Version: 6
Effective date: 2024-10-16
Source export date: 2026-09-28
Source partition: 2
Source file: https://download.open.fda.gov/drug/label/drug-label-0002-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-09-28/f7d2b6e3f8600cd856280ab55a9c6fa54a642647191d164f9d1110e89f3f4097/drug-label-0002-of-0014.json.zip
Source manifest SHA-256: cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run: 20260929T050834Z
Imported at: 2026-09-29 05:15:20

Harmonized routes table
Harmonized routes
INTRATHECAL

Harmonized identifier links#

Every typed identifier imported from the complete openFDA harmonization object is paginated here; values are not reduced to a first match.

Harmonized identifiers page 1 of 1 · 19 matching rows.

Type, Scope, Identifier table
Type	Scope	Identifier	Source field
application applno	NDA	020577	derived:openfda.application_number
application number		NDA020577	openfda.application_number
brand name		Elliotts B	openfda.brand_name
generic name		SODIUM CATION, SODIUM BICARBONATE, ANHYDROUS DEXTROSE, MAGNESIUM SULFATE, POTASSIUM CHLORIDE, CALCIUM CHLORIDE, SODIUM PHOSPHATE	openfda.generic_name
manufacturer name		Lukare Medical, LLC	openfda.manufacturer_name
ndc	package	55792-007-10	openfda.package_ndc
ndc	package	55792-007-01	openfda.package_ndc
ndc	product	55792-007	openfda.product_ndc
ndc11	package	55792000710	derived:openfda.package_ndc
ndc11	package	55792000701	derived:openfda.package_ndc
spl id		4a638cd1-6922-477a-aa17-a70865ae0bd8	id
spl set id		08036dbd-55b3-47b9-9890-000f253544f3	set_id
unii		451W47IQ8X	openfda.unii
unii		DE08037SAB	openfda.unii
unii		660YQ98I10	openfda.unii
unii		M4I0D6VV5M	openfda.unii
unii		SE337SVY37	openfda.unii
unii		8MDF5V39QO	openfda.unii
unii		5SL0G7R0OK	openfda.unii

Warnings cross-check#

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

Warnings sections page 1 of 1 · 1 matching rows.

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#

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Adverse reactions sections page 1 of 1 · 1 matching rows.

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.

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.