Elliotts B

Manufacturer
QOL Medical, LLC
Effective date
2012-08-22
Label type
HUMAN PRESCRIPTION DRUG LABEL
Version
6
Source
legacy-cache
Hydrated at
2026-08-02 01:44:52

Label at a glance#

ProductElliotts B
Active ingredientsodium chloride, sodium bicarbonate, anhydrous dextrose, magnesium sulfate, potassium chloride, calcium chloride, sodium phosphate
Label structure13 sections

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.

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 prepara...

Label contents#

Full prescribing information#

DESCRIPTION

DESCRIPTION SECTION

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, USP73 mg
Sodium Bicarbonate, USP19 mg
Dextrose, USP8 mg
Magnesium Sulfate • 7H2O, USP3 mg
Potassium Chloride, USP3 mg
Calcium Chloride • 2H2O, USP2 mg
Sodium Phosphate, dibasic • 7H2O, USP2 mg
Water for Injection, USPqs 10 mL

Concentration of Electrolytes:
Sodium149 mEq/literBicarbonate22.6 mEq/liter
Potassium4.0 mEq/literChloride132 mEq/liter
Calcium2.7 mEq/literSulfate2.4 mEq/liter
Magnesium2.4 mEq/literPhosphate1.5 mEq/liter


The formulae and molecular weights of the ingredients are:


INGREDIENTMOLECULAR
FORMULA
MOLECULAR
WEIGHT
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

CLINICAL PHARMACOLOGY SECTION

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+
mEq/L

K+
mEq/L

Ca++
mEq/L

Mg++
mEq/L

HCO3 -
mEq/L

Cl-
mEq/L

pH

Phosphorus
mg/dL

Glucose
mg/dL

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

4.0

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

INDICATIONS & USAGE SECTION

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

CONTRAINDICATIONS SECTION

None known.

WARNINGS

WARNINGS SECTION

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

PRECAUTIONS SECTION

General

GENERAL PRECAUTIONS SECTION

Particular attention should be taken to assure the maintenance of sterile technique throughout the procedure. (See DOSAGE AND ADMINISTRATION.)

Carcinogenesis, Mutagenesis, Impairment of Fertility

CARCINOGENESIS & MUTAGENESIS & IMPAIRMENT OF FERTILITY SECTION

No standard mutagenicity or carcinogenicity studies have been conducted with Elliotts B Solution.

Usage in Pregnancy

PREGNANCY SECTION

Pregnancy Category C


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 SECTION

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

DRUG ABUSE AND DEPENDENCE SECTION

There is no potential for drug abuse or drug dependence.

OVERDOSAGE

OVERDOSAGE SECTION

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

DOSAGE & ADMINISTRATION SECTION

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

SPL UNCLASSIFIED SECTION

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

HOW SUPPLIED SECTION

NDCSIZE
67871-007-10
10 mL ampule
Elliotts B Solution is available in single-use clear glass ampules, packaged 10 ampules per box.

Store at controlled room temperature, 20º-25ºC (68º-77ºF) [See USP].

Preservative Free.  Discard unused portion.  Use only if solution is clear and ampule is intact.

Distributed by:
QOL Medical, LLC
Vero Beach, FL 32963
1-866-528-4750
www.elliottsbsolution.com

REFERENCES:

REFERENCES SECTION

1. Cradock JC, et al. Evaluation of some pharmaceutical aspects of intrathecal methotrexate sodium, cytara­bine and hydrocortisone sodium succinate.  American Journal of Hospital Pharmacy (1978); 35:402.

Rev. 12/11
Part No. 210

PACKAGING

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Ampule labeling:

Ampule LabelingAmpule Labeling

Box labeling:

Box LabelingBox Labeling

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
67871-007-102019-11-27C16284748780-19855d018-dd0c-cd31-e053-dbdaa90ab51aELLIOTTS B ® SOLUTION (buffered intrathecal electrolyte/dextrose injection) Rx Only

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67871-007ELLIOTTS B (SODIUM CATION, SODIUM BICARBONATE, ANHYDROUS DEXTROSE, MAGNESIUM SULFATE, POTASSIUM CHLORIDE, CALCIUM CHLORIDE, SODIUM PHOSPHATE) INJECTION [QOL MEDICAL, LLC]6Legacy NDC20121023_b1e83fb1-7f51-41b7-a1eb-495414bbf1f2.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
67871-007-10ML - Milliliter67871-0079c97a8d2-a7da-498c-b0d9-91a997abd66712012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
anhydrous dextroseACTIVE INGREDIENT5SL0G7R0OK6
calcium chlorideACTIVE INGREDIENTM4I0D6VV5M6
magnesium sulfateACTIVE INGREDIENTDE08037SAB6
potassium chlorideACTIVE INGREDIENT660YQ98I106
sodium bicarbonateACTIVE INGREDIENT8MDF5V39QO6
sodium chlorideACTIVE INGREDIENT451W47IQ8X6
sodium phosphateACTIVE INGREDIENTSE337SVY376
anhydrous dextroseACTIVE MOIETY5SL0G7R0OK6
bicarbonate ionACTIVE MOIETYHN1ZRA3Q206
calcium cationACTIVE MOIETY2M83C4R6ZB6
chloride ionACTIVE MOIETYQ32ZN486986
magnesium cationACTIVE MOIETYT6V3LHY8386
phosphate ionACTIVE MOIETYNK08V8K8HR6
potassium cationACTIVE MOIETY295O53K1526
WaterINACTIVE INGREDIENT059QF0KO0R6

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 17 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
67871-00767871-007-01, 67871-007-10

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 8 matching rows.

Source Document#

Source XML

Orange Book application contexts#

All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.

Orange Book application contexts page 1 of 1 · 1 matching rows.

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

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

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.

Product history page 1 of 2 · 43 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08N020577-001ELLIOTTS B SOLUTION0.2MG/ML;0.8MG/ML;0.3MG/ML;0.3MG/ML;1.9MG/ML;7.3MG/ML;0.2MG/MLINJECTABLE / INTRATHECALRLD, RS1996-09-2784e616aacf4f…
2026-08-18 06:07:402026-07N020577-001ELLIOTTS B SOLUTION0.2MG/ML;0.8MG/ML;0.3MG/ML;0.3MG/ML;1.9MG/ML;7.3MG/ML;0.2MG/MLINJECTABLE / INTRATHECALRLD, RS1996-09-27caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N020577-001ELLIOTTS B SOLUTION0.2MG/ML;0.8MG/ML;0.3MG/ML;0.3MG/ML;1.9MG/ML;7.3MG/ML;0.2MG/MLINJECTABLE / INTRATHECALRLD, RS1996-09-27011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020577-001ELLIOTTS B SOLUTION0.2MG/ML;0.8MG/ML;0.3MG/ML;0.3MG/ML;1.9MG/ML;7.3MG/ML;0.2MG/MLINJECTABLE / INTRATHECALRLD, RS1996-09-2731067a03dcf5…
2025-08-23 18:47 UTC2025-08N020577-001ELLIOTTS B SOLUTION0.2MG/ML;0.8MG/ML;0.3MG/ML;0.3MG/ML;1.9MG/ML;7.3MG/ML;0.2MG/MLINJECTABLE / INTRATHECALRLD, RS1996-09-276a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020577-001ELLIOTTS B SOLUTION0.2MG/ML;0.8MG/ML;0.3MG/ML;0.3MG/ML;1.9MG/ML;7.3MG/ML;0.2MG/MLINJECTABLE / INTRATHECALRLD, RS1996-09-27fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020577-001ELLIOTTS B SOLUTION0.2MG/ML;0.8MG/ML;0.3MG/ML;0.3MG/ML;1.9MG/ML;7.3MG/ML;0.2MG/MLINJECTABLE / INTRATHECALRLD, RS1996-09-27b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020577-001ELLIOTTS B SOLUTION0.2MG/ML;0.8MG/ML;0.3MG/ML;0.3MG/ML;1.9MG/ML;7.3MG/ML;0.2MG/MLINJECTABLE / INTRATHECALRLD, RS1996-09-2703ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N020577-001ELLIOTTS B SOLUTION0.2MG/ML;0.8MG/ML;0.3MG/ML;0.3MG/ML;1.9MG/ML;7.3MG/ML;0.2MG/MLINJECTABLE / INTRATHECALRLD, RS1996-09-272680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N020577-001ELLIOTTS B SOLUTION0.2MG/ML;0.8MG/ML;0.3MG/ML;0.3MG/ML;1.9MG/ML;7.3MG/ML;0.2MG/MLINJECTABLE / INTRATHECALRLD, RS1996-09-275bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N020577-001ELLIOTTS B SOLUTION0.2MG/ML;0.8MG/ML;0.3MG/ML;0.3MG/ML;1.9MG/ML;7.3MG/ML;0.2MG/MLINJECTABLE / INTRATHECALRLD, RS1996-09-27d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N020577-001ELLIOTTS B SOLUTION0.2MG/ML;0.8MG/ML;0.3MG/ML;0.3MG/ML;1.9MG/ML;7.3MG/ML;0.2MG/MLINJECTABLE / INTRATHECALRLD, RS1996-09-27d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N020577-001ELLIOTTS B SOLUTION0.2MG/ML;0.8MG/ML;0.3MG/ML;0.3MG/ML;1.9MG/ML;7.3MG/ML;0.2MG/MLINJECTABLE / INTRATHECALRLD, RS1996-09-2779d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N020577-001ELLIOTTS B SOLUTION0.2MG/ML;0.8MG/ML;0.3MG/ML;0.3MG/ML;1.9MG/ML;7.3MG/ML;0.2MG/MLINJECTABLE / INTRATHECALRLD, RS1996-09-27301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N020577-001ELLIOTTS B SOLUTION0.2MG/ML;0.8MG/ML;0.3MG/ML;0.3MG/ML;1.9MG/ML;7.3MG/ML;0.2MG/MLINJECTABLE / INTRATHECALRLD, RS1996-09-271e350fbaab3a…
2024-05-31 18:47 UTC2024-05N020577-001ELLIOTTS B SOLUTION0.2MG/ML;0.8MG/ML;0.3MG/ML;0.3MG/ML;1.9MG/ML;7.3MG/ML;0.2MG/MLINJECTABLE / INTRATHECALRLD, RS1996-09-278072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N020577-001ELLIOTTS B SOLUTION0.2MG/ML;0.8MG/ML;0.3MG/ML;0.3MG/ML;1.9MG/ML;7.3MG/ML;0.2MG/MLINJECTABLE / INTRATHECALRLD, RS1996-09-275c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N020577-001ELLIOTTS B SOLUTION0.2MG/ML;0.8MG/ML;0.3MG/ML;0.3MG/ML;1.9MG/ML;7.3MG/ML;0.2MG/MLINJECTABLE / INTRATHECALRLD, RS1996-09-275d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N020577-001ELLIOTTS B SOLUTION0.2MG/ML;0.8MG/ML;0.3MG/ML;0.3MG/ML;1.9MG/ML;7.3MG/ML;0.2MG/MLINJECTABLE / INTRATHECALRLD, RS1996-09-274b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N020577-001ELLIOTTS B SOLUTION0.2MG/ML;0.8MG/ML;0.3MG/ML;0.3MG/ML;1.9MG/ML;7.3MG/ML;0.2MG/MLINJECTABLE / INTRATHECALRLD, RS1996-09-2774a2ff9319b5…
2022-03-09 01:35 UTC2022-03N020577-001ELLIOTTS B SOLUTION0.2MG/ML;0.8MG/ML;0.3MG/ML;0.3MG/ML;1.9MG/ML;7.3MG/ML;0.2MG/MLINJECTABLE / INTRATHECALRLD, RS1996-09-27bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N020577-001ELLIOTTS B SOLUTION0.2MG/ML;0.8MG/ML;0.3MG/ML;0.3MG/ML;1.9MG/ML;7.3MG/ML;0.2MG/MLINJECTABLE / INTRATHECALRLD, RS1996-09-27782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N020577-001ELLIOTTS B SOLUTION0.2MG/ML;0.8MG/ML;0.3MG/ML;0.3MG/ML;1.9MG/ML;7.3MG/ML;0.2MG/MLINJECTABLE / INTRATHECALRLD, RS1996-09-2787673890dc5c…
2021-03-12 10:30 UTC2021-03N020577-001ELLIOTTS B SOLUTION0.2MG/ML;0.8MG/ML;0.3MG/ML;0.3MG/ML;1.9MG/ML;7.3MG/ML;0.2MG/MLINJECTABLE / INTRATHECALRLD, RS1996-09-275aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N020577-001ELLIOTTS B SOLUTION0.2MG/ML;0.8MG/ML;0.3MG/ML;0.3MG/ML;1.9MG/ML;7.3MG/ML;0.2MG/MLINJECTABLE / INTRATHECALRLD, RS1996-09-278869cabd3fbd…
2020-11-12 02:37 UTC2020-11N020577-001ELLIOTTS B SOLUTION0.2MG/ML;0.8MG/ML;0.3MG/ML;0.3MG/ML;1.9MG/ML;7.3MG/ML;0.2MG/MLINJECTABLE / INTRATHECALRLD, RS1996-09-27c0c555d07b60…
2019-12-14 00:12 UTC2019-12N020577-001ELLIOTTS B SOLUTION0.2MG/ML;0.8MG/ML;0.3MG/ML;0.3MG/ML;1.9MG/ML;7.3MG/ML;0.2MG/MLINJECTABLE / INTRATHECALRLD, RS1996-09-273f01610625f2…
2019-09-15 20:21 UTC2019-09N020577-001ELLIOTTS B SOLUTION0.2MG/ML;0.8MG/ML;0.3MG/ML;0.3MG/ML;1.9MG/ML;7.3MG/ML;0.2MG/MLINJECTABLE / INTRATHECALRLD, RS1996-09-27b00525d2431f…
2019-07-19 19:46 UTC2019-07N020577-001ELLIOTTS B SOLUTION0.2MG/ML;0.8MG/ML;0.3MG/ML;0.3MG/ML;1.9MG/ML;7.3MG/ML;0.2MG/MLINJECTABLE / INTRATHECALRLD, RS1996-09-27ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N020577-001ELLIOTTS B SOLUTION0.2MG/ML;0.8MG/ML;0.3MG/ML;0.3MG/ML;1.9MG/ML;7.3MG/ML;0.2MG/MLINJECTABLE / INTRATHECALRLD, RS1996-09-276a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N020577-001ELLIOTTS B SOLUTION0.2MG/ML;0.8MG/ML;0.3MG/ML;0.3MG/ML;1.9MG/ML;7.3MG/ML;0.2MG/MLINJECTABLE / INTRATHECALRLD, RS1996-09-271c564ffb4f44…
2023-12-20 04:57 UTC2023-12N020577-001ELLIOTTS B SOLUTION0.2MG/ML;0.8MG/ML;0.3MG/ML;0.3MG/ML;1.9MG/ML;7.3MG/ML;0.2MG/MLINJECTABLE / INTRATHECALRLD, RS1996-09-27ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N020577-001ELLIOTTS B SOLUTION0.2MG/ML;0.8MG/ML;0.3MG/ML;0.3MG/ML;1.9MG/ML;7.3MG/ML;0.2MG/MLINJECTABLE / INTRATHECALRLD, RS1996-09-27a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N020577-001ELLIOTTS B SOLUTION0.2MG/ML;0.8MG/ML;0.3MG/ML;0.3MG/ML;1.9MG/ML;7.3MG/ML;0.2MG/MLINJECTABLE / INTRATHECALRLD, RS1996-09-279b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N020577-001ELLIOTTS B SOLUTION0.2MG/ML;0.8MG/ML;0.3MG/ML;0.3MG/ML;1.9MG/ML;7.3MG/ML;0.2MG/MLINJECTABLE / INTRATHECALRLD, RS1996-09-27a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N020577-001ELLIOTTS B SOLUTION0.2MG/ML;0.8MG/ML;0.3MG/ML;0.3MG/ML;1.9MG/ML;7.3MG/ML;0.2MG/MLINJECTABLE / INTRATHECALRLD, RS1996-09-273f0d92c62455…
2023-05-13 08:27 UTC2023-05N020577-001ELLIOTTS B SOLUTION0.2MG/ML;0.8MG/ML;0.3MG/ML;0.3MG/ML;1.9MG/ML;7.3MG/ML;0.2MG/MLINJECTABLE / INTRATHECALRLD, RS1996-09-27053a50430f4f…
2023-01-26 05:58 UTC2023-01N020577-001ELLIOTTS B SOLUTION0.2MG/ML;0.8MG/ML;0.3MG/ML;0.3MG/ML;1.9MG/ML;7.3MG/ML;0.2MG/MLINJECTABLE / INTRATHECALRLD, RS1996-09-273bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N020577-001ELLIOTTS B SOLUTION0.2MG/ML;0.8MG/ML;0.3MG/ML;0.3MG/ML;1.9MG/ML;7.3MG/ML;0.2MG/MLINJECTABLE / INTRATHECALRLD, RS1996-09-273a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N020577-001ELLIOTTS B SOLUTION0.2MG/ML;0.8MG/ML;0.3MG/ML;0.3MG/ML;1.9MG/ML;7.3MG/ML;0.2MG/MLINJECTABLE / INTRATHECALRLD, RS1996-09-27f41ea6bd6efb…

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.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
6b61a6f9-0cc7-47bf-a600-ae8bb89a9501b1e83fb1-7f51-41b7-a1eb-495414bbf1f22012-08-22Warnings, Adverse reactionsExact identifier
spl id: 6b61a6f9-0cc7-47bf-a600-ae8bb89a9501
spl set id: b1e83fb1-7f51-41b7-a1eb-495414bbf1f2

Reported adverse events (FAERS/openFDA)#

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