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Elliotts B sodium cation, sodium bicarbonate, anhydrous dextrose, magnesium sulfate, potassium chloride, calcium chloride, sodium phosphate 73 mg/10mL; 19 mg/10mL; 8 mg/10mL; 3 mg/10mL; 3 mg/10mL; 2 mg/10mL; 2 mg/10mL Injection — NDC 55792-007-10 (Billing 55792-0007-10)

by Lukare Medical, LLC · 10 AMPULE in 1 BOX / 10 mL in 1 AMPULE

This is a package of Elliotts B sodium cation, sodium bicarbonate, anhydrous dextrose, magnesium sulfate, potassium chloride, calcium chloride, sodium phosphate 73 mg/10mL; 19 mg/10mL; 8 mg/10mL; 3 mg/10mL; 3 mg/10mL; 2 mg/10mL; 2 mg/10mL Injection from Lukare Medical, LLC, marketed since Jun 2013 and currently FDA-listed. It is this product's only package size.

NDC 55792-0007-10
🏷️ FDA NDC (as labeled) 55792-007-10 billing pads the product segment with a zero
Rx only Brand On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 8, 2026 · this listing last changed Oct 8, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

This page is curated, coded, and maintained by

Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

NDC database record

One package, one record: these facts belong to NDC 55792-007-10 alone.

Record
FDA NDC Directory package listing · Human prescription drug
Code segments
55792 labeler · 007 product · 10 package
Package marketed since
Jun 4, 2013
Sample package
No — commercial package
Listing certified through
Dec 31, 2026
Barcode (UPC)
0355792007103
FDA record last changed
Oct 8, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 55792-007-10
Product NDC 55792-007
11-digit billing NDC 55792000710
NCPDP billing unit ML — per mL (volume)
UNII 451W47IQ8X, 8MDF5V39QO, 5SL0G7R0OK, DE08037SAB, 660YQ98I10, M4I0D6VV5M +1 more
UPC 0355792007103
Application # NDA020577
SPL Set ID 08036dbd-55b3-47b9-9890-000f253544f3
Established class (EPC) Blood Coagulation Factor; Calculi Dissolution Agent; Cations; Increased Large Intestinal Motility [
Mechanism of action Alkalinizing Activity
Physiologic effect Increased Coagulation Factor Activity; Increased Large Intestinal Motility
Chemical class Calcium; Divalent
DEA schedule Non-controlled
Marketing category NDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2013-06-04
Route INTRATHECAL
Dosage form INJECTION
Substance SODIUM CHLORIDE; SODIUM BICARBONATE; ANHYDROUS DEXTROSE; MAGNESIUM SULFATE, UNSPECIFIED FORM; POTASSIUM CHLORIDE; CALCIUM CHLORIDE; SODIUM PHOSPHATE

Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification

GPI-14 79993001002000
GPI class Elliotts B
GCN Seq No 054654
GCN 22653
HICL code 026355
Ingredient (HICL) Chemo Therapy Diluent No.1/Pf
HIC1 code C
Therapeutic class — broad (HIC1) Electrolyte Balance/Metabolism/Nutrition
HIC2 code C5
Therapeutic class — intermediate (HIC2) Carbohydrates And/Or Proteins
HIC3 code C5O
Therapeutic class — specific (HIC3) Diluent Solutions
AHFS code 96:00.00.00
AHFS class Pharmaceutical Aids
FDB label name ELLIOTTS B SOLUTION AMPULE
FDB brand name Elliotts B
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 054654
  • GCN: 22653
  • GPI-14 (Medi-Span): 79993001002000
  • HICL (First Databank): 026355
  • AHFS class code: 96:00.00.00
Why two NDCs? The FDA registers this code as 55792-007-10 — a 5-3-2 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the product segment → 55792-0007-10. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

Clinical

Label name ELLIOTTS B SOLUTION AMPULE Ingredient Chemo Therapy Diluent No.1/Pf

Supplement & herbal interactions

🌿 Drug–supplement interaction checker →
Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

Pricing

A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.

Price systemPer eachPer package
Retail pharmacies payNADAC · weekly Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · quarterly No Part D plan price is available for this NDC in our data.
ℹ️
No price is published for this exact package yet. CMS surveys NADAC per package size, so a different pack of the same drug often has one.
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
55792-0007-10 You're viewing this Main listing 10 AMPULE in 1 BOX / 10 mL in 1 AMPULE 2013-06-04 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Elliotts B 73 mg/10mL; 19 mg/10mL; 8 mg/10mL; 3 mg/10mL; 3 mg/10mL; 2 mg/10mL; 2 mg/10mLthis 55792-0007-10 Lukare 10 ampules — — FDA listed —
About this product: this is the brand-name version. We did not find an FDA-approved generic match for this exact strength, form and route.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

Availability & generic status

🏛️
2013
On the market since
Jun 2013
📍
2026
Currently FDA-listed
13 years listed
🔒
·
No generic listed yet
brand only
ℹ️No FDA-approved generic found

We did not find an FDA-approved generic match for this exact strength, form and route.

Where does this data come from?
Patents and exclusivity from the FDA Orange Book (small-molecule drugs), refreshed from public FDA data. Generic launch timing is an estimate, not a guarantee.

Inactive Ingredients / Excipients

Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.

Loading inactive ingredients from the official FDA label in the background. No external source is being called by this page request.
Where does this data come from?
Source: official FDA Structured Product Labeling (SPL) via DailyMed and the openFDA label index. Structured IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.

Inactive ingredient FAQ

Are inactive ingredients the same for every manufacturer?
No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.
Why might an inactive ingredient be missing?
Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.
Can inactive ingredients matter?
Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

Manufacturer & labeler

LabelerLukare Medical, LLC
Application holderLUKARE MEDICAL LLC
FDA applicationNDA020577 (NDA)
Labeler code55792
First marketedJun 2013
Product typeHuman Prescription Drug
The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage ⏱️ Dosage and Administration ⛔ Contraindications ⚠️ Warnings 🤒 Adverse Reactions 🤰 Pregnancy 🆘 Overdosage 🧬 Clinical Pharmacology 📦 How Supplied / Storage and Handling 📋 Description ⚠️ Precautions 🔒 Drug Abuse and Dependence 📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 📚 References 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 31 words ▾

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.

⏱️ Dosage and Administration 126 words ▾

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.)

⛔ Contraindications 3 words ▾

CONTRAINDICATIONS None known.

⚠️ Warnings 49 words ▾

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 72 words ▾

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.

🤰 Pregnancy 24 words ▾

Usage in Pregnancy All components of Elliotts B Solution are normal body constituents. Animal reproduction studies have not been conducted with Elliotts B Solution.

🆘 Overdosage 36 words ▾

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.)

🧬 Clinical Pharmacology 161 words ▾

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 + mEq/L K + mEq/L Ca ++ mEq/L Mg ++ mEq/L HCO 3 - 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 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

0.01N NaOH. 1 Compatibility studies with methotrexate sodium and cytarabine indicate these drugs are physically compatible with Elliotts B Solution.

📦 How Supplied / Storage and Handling 59 words ▾

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 1-855-752-9317 www.elliottsbsolution.com

📋 Description 214 words ▾

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 • 7H 2 O, USP 3 mg Potassium Chloride, USP 3 mg Calcium Chloride • 2H 2 O, USP 2 mg Sodium Phosphate, dibasic • 7H 2 O, 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 FORMULA MOLECULAR WEIGHT Sodium Chloride NaCl

58.44 Sodium Bicarbonate NaHCO 3

84.01Dextrose C 6 H 12 O 6 180.16 Magnesium Sulfate • 7H 2 O Mg 2 SO 4 • 7H 2 O 246.48 Potassium Chloride KCl

74.55Calcium Chloride • 2H 2 O CaCl 2 • 2H 2 O 147.01 Sodium Phosphate, dibasic • 7H 2 O Na 2 HPO 4 • 7H 2 O 268.07 The pH of Elliotts B Solution is 6.0-7.5, and the osmolarity is 288 mOsmol per liter (calculated).

⚠️ Precautions 64 words ▾

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.

🔒 Drug Abuse and Dependence 14 words ▾

DRUG ABUSE AND DEPENDENCE There is no potential for drug abuse or drug dependence.

📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 18 words ▾

Carcinogenesis, Mutagenesis, Impairment of Fertility No standard mutagenicity or carcinogenicity studies have been conducted with Elliotts B Solution.

📚 References 29 words ▾

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

📄 Package Label / Principal Display Panel 15 words ▾

PACKAGING Ampule labeling: Box labeling: Elliotts B Solution Ampule Label Elliotts B Solution Carton Label

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗

About this NDC listing & data coverage

Finished prescription product
What data is (and isn’t) available for this NDC — tap to expand
NDC identity (package / product / labeler codes) ✓ Available
Labeler ✓ Available
Product & package description ✓ Available
Marketing category & status ✓ Available
Active ingredient / dosage form / route ✓ Available
FDA label (SPL via DailyMed) ✓ Available
Package photos — Not published for this NDC No photo available yet for this listing.
Inactive ingredients (structured) — Not published for this NDC The labeler did not submit a structured excipient list, or no SPL is available.
NADAC pharmacy acquisition price (CMS) — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey.
Orange Book / therapeutic-equivalence data — Not published for this NDC Applies only to products approved under an NDA/ANDA; many listings are out of scope.
HCPCS J-code billing crosswalk — Not published for this NDC Most self-administered / retail products have no J-code — that is normal.
Medicaid utilization (CMS SDUD) — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold.
“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.

Questions about this listing

Why is there no price listed?
The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The form printed on the packaging and shown on DailyMed is the one the FDA registered. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero and the dashes are dropped. The Identity section at the top of this page lists each form of this code.
Is this package still being marketed?
Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by Lukare Medical, LLC. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Lukare Medical, LLC is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
Do I need a prescription for this product?
This NDC is listed with FDA as a prescription product, so it is dispensed under a prescriber's order. Your pharmacist can tell you whether any over-the-counter forms of the same medication exist.
This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.
Where does this data come from?
Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.
← 55789-2503-06 · Mineral 55794-0101-01 · FARMSON →
For educational and professional reference only — not medical advice. Pricing reflects published NADAC and CMS ASP (free public data) and may differ from your acquisition cost; always verify before billing or dispensing.