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ELYXYB - celecoxib 120 mg/4.8mL Liquid, 1 bottle — NDC 69557-0333-02 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

ELYXYB - celecoxib 120 mg/4.8mL Liquid, 1 bottle — NDC 69557-333-02 (Billing 69557-0333-02)

by SCILEX PHARMACEUTICALS INC. · 1 BOTTLE in 1 CARTON / 4.8 mL in 1 BOTTLE

This is a package of 1 bottle of ELYXYB - celecoxib 120 mg/4.8mL Liquid from SCILEX PHARMACEUTICALS INC., marketed since Nov 2023 and currently FDA-listed.

NDC 69557-0333-02
🏷️ FDA NDC (as labeled) 69557-333-02 billing pads the product segment with a zero
This package
Contains1 bottle Pack sizes2 compare ↓
Also priced by: Part D plans $30.25/unit — full pricing hub ↓
Product page 69557-0333-01 Also comes in: 6 bottles 69557-333-01
Rx only Brand On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed Jul 24, 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

⚠️
Other active recalls for Celecoxib (different manufacturers) — 2 · tap to view
These affect other manufacturers’ products for the same ingredient — not necessarily the exact NDC on this page.
Class II · May 13, 2025 — Presence of Foreign Tablets/Capsules: manufacturer recalled because one tadalafil 5mg tablet was found in 500 count bottle of Celecoxib 200 mg capsules (AvKARE) · FDA recall D-0460-2025
Class II · May 9, 2025 — Presence of Foreign Tablets/Capsules; customer complaint found one Tadalafil 5mg tablet inside a sealed 500-count bottle of Celecoxib 200mg capsule (Alembic Pharmaceuticals Limited) · FDA recall D-0459-2025
Each entry is an official FDA enforcement report — look up any recall number in the FDA recall database ↗

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 69557-333-02
Product NDC 69557-333
11-digit billing NDC 69557033302
NCPDP billing unit ML — per mL (volume)
RxCUI 2373454, 2373460
UNII JCX84Q7J1L
Application # NDA212157
SPL Set ID c8a5de07-9f27-4a54-a885-8089f0307bd7
Established class (EPC) Nonsteroidal Anti-inflammatory Drug
Mechanism of action Cyclooxygenase Inhibitors
Chemical class Anti-Inflammatory Agents, Non-Steroidal
DEA schedule Non-controlled
Marketing category NDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2023-11-27
Route ORAL
Dosage form LIQUID
Substance CELECOXIB

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

GPI-14 67604030002020
GCN Seq No 081009
GCN 48006
HICL code 018979
Ingredient (HICL) Celecoxib
HIC1 code H
Therapeutic class — broad (HIC1) Nervous System (Except Autonomic)
HIC2 code H3
Therapeutic class — intermediate (HIC2) Analgesics
HIC3 code H3F
Therapeutic class — specific (HIC3) Antimigraine Preparations
AHFS code 28:08.04.08
AHFS class Cyclooxygenase-2 (Cox-2) Inhibitors
FDB label name ELYXYB 120 MG/4.8 ML SOLUTION
FDB brand name Elyxyb
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 081009
  • GCN: 48006
  • GPI-14 (Medi-Span): 67604030002020
  • HICL (First Databank): 018979
  • AHFS class code: 28:08.04.08
  • RxCUI (RxNorm): 2373454
Why two NDCs? The FDA registers this code as 69557-333-02 — 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 → 69557-0333-02. 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.

RxNorm drug class

This medicine belongs to the Nonsteroidal Anti-inflammatory Drug class.

Pharmacologic class Nonsteroidal Anti-inflammatory Drug
Drug family (ATC) Other antineoplastic agents, Coxibs, Dihydropyridine derivatives
How it works Cyclooxygenase Inhibitors
Where does this data come from?
Therapeutic classes from RxNorm RxClass (U.S. National Library of Medicine) — Established Pharmacologic Class (FDA), ATC drug family (WHO) and mechanism of action, matched by this product’s RxCUI.

Clinical

Label name ELYXYB 120 MG/4.8 ML SOLUTION Ingredient Celecoxib
📖 What it is MedlinePlus · NLM

Celecoxib is used to relieve pain, tenderness, swelling and stiffness caused by osteoarthritis (arthritis caused by a breakdown of the lining of the joints), rheumatoid arthritis (arthritis caused by swelling of the lining of the joints), and ankylosing spondylitis (arthritis that mainly affects the spine). Celecoxib is also used to treat juvenile rheumatoid arthritis (a type of arthritis that affects children) in children 2 years of age and older. Celecoxib is also used to treat painful menstrual periods and to relieve other types of short-term pain including pain caused by injuries, surgery...

Read the full MedlinePlus article ↗
📗 Our plain-language guide HelloPharmacist
  • It depends on the product. Celebrex and generic capsules are used for several types of arthritis, acute pain and painful periods. Vyscoxa liquid is for certain arthritis types. ELY...
  • For capsules, usual doses can be taken with or without food, but higher doses are taken with food. Vyscoxa suspension must be taken on an empty stomach, at least 2 hours before or...
  • The most common ones are stomach upset, indigestion, diarrhea, gas, swelling, dizziness, cold-like symptoms and rash. Call your doctor if they bother you or don't go away.
  • Get emergency help for chest pain, shortness of breath, weakness on one side, slurred speech, black or bloody stools, vomiting blood, or swelling of the face or throat. Stop it and...
📖 Read our full Celecoxib guide →
1
Nutrient depletion considerations

Celecoxib may be associated with lower levels of 1 nutrient — worth a chat with your pharmacist, not a cause for alarm.

🧪 Full Celecoxib nutrient depletion report →
An association is not a deficiency. Educational only — don't start or stop anything without professional guidance.
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 mLPer 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 · Q2 2026 $30.25 $145.22 / 4.8 ml
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 Per unit Per pack Marketing startMarketing endStatus
69557-0333-01 69557-333-01 Main listing 6 BOTTLE in 1 CARTON / 4.8 mL in 1 BOTTLE $30.54 / mL $879.50 2023-11-27 — Active
69557-0333-02 You're viewing this 1 BOTTLE in 1 CARTON / 4.8 mL in 1 BOTTLE Sample — — 2023-11-27 — Active

This pack shows little to no recent Medicaid volume — a different pack size carries most fills. See all packs ↓

Pack size FAQ

What quantity is in this package?
This package contains 1 bottle — 1 bottle in 1 carton / 4.8 ml in 1 bottle.
How does this package differ from NDC 69557-0333-01?
Both are ELYXYB - celecoxib 120 mg/4.8mL Liquid — the drug itself is identical. This page's package is the 1 bottle one, while NDC 69557-0333-01 is the 6 bottles package.
What NDC number is used to bill for this package of ELYXYB - celecoxib 120 mg/4.8mL Liquid?
Use the 11-digit billing form listed in the identifiers section of this page. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

Prices are the latest CMS NADAC pharmacy acquisition cost per NDC; per-pack figures are per-unit × pack quantity, shown only when the pack is denominated in the same measure NADAC prices.

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
ELYXYB - celecoxib 120 mg/4.8mLthis 69557-0333-02 SCILEX 1 bottle — — 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

🏛️
2020
First FDA approval
May 2020
📍
2026
Currently FDA-listed
6 years listed
🛡️
2036
Latest patent/protection listed
not a guaranteed launch date
🔒No FDA-approved generic found

We did not find an FDA-approved generic match for this exact strength, form and route. Patent/protection dates below may affect future generic timing.

🛡️ Latest patent/protection date listed: FDA patent/protection data lists protections through May 2036. This may affect when a full generic version becomes widely available, but it is not a guaranteed launch date.
📅 FDA approved May 5, 2020 RLD RS ⏳ ~9.6 yr to latest listed protection

Why the date isn’t exact: Generic timing can change because patents may be challenged, settled, licensed, added, removed, or worked around with a narrower label — and FDA approval does not always mean a pharmacy can get the generic today.

Patents & exclusivity — FDA Orange Book
US 10722456 — method of use (U-2718)
US 10799517 — method of use (U-2718)
US 9949990 — method of use (U-2718)
US 9795620 — method of use (U-2718)
US 9572819 — method of use (U-2718)
US 10376527 — method of use (U-2718)
2020 2022 2024 2026 2028 2030 2032 2034 2036
Today
LOE
Substance patent Formulation patent Method-of-use patent Exclusivity Pediatric +6mo
🏛️FDA exclusivity
FDA-granted marketing protection. It’s separate from patents and may be shorter than patent protection.
🧪Product / substance patents
Patents covering the active ingredient, product, formulation, or related drug features.
🎯Method-of-use patents
Patents covering specific approved uses. These can sometimes be carved out with a “skinny label,” but not always.
🛈 What do these terms mean?
Patent
Legal protection listed in the Orange Book that may delay generic approval or launch. Issued by the U.S. Patent & Trademark Office.
Substance patent
Covers the active drug molecule itself — the hardest to design around. A generic generally can’t launch until it expires.
Formulation (product) patent
Covers a specific formulation or dosage form. A generic can sometimes work around it with a different formulation.
Method-of-use patent
A patent covering one specific approved use of the drug — not necessarily the whole molecule. A generic can sometimes launch with a “skinny label” that carves out the protected use and keeps the others.
Skinny label
A generic label that omits a still-patented use when the FDA allows it — letting a generic reach the market for the unprotected uses.
Exclusivity
FDA-granted marketing protection, separate from patents — e.g. 5-yr new chemical entity, 7-yr orphan drug, or a +6-month pediatric extension.
Paragraph IV
A generic applicant’s formal challenge to a listed patent. It can potentially lead to earlier generic entry, but often involves litigation or a settlement.
RLD / RS
Reference Listed Drug — the brand product the FDA uses as the reference for generic applications. Reference Standard — the product the FDA expects generics to compare against in bioequivalence testing.
TE / AB rating
FDA therapeutic-equivalence rating. An AB rating generally means the FDA considers a generic therapeutically equivalent to — and substitutable for — the brand.
LOE (loss of exclusivity)
The latest patent or exclusivity currently listed — the loss-of-exclusivity / latest-listed-protection date shown on this page. Paragraph-IV challenges and settlements can move the real date earlier; FDA approval and a manufacturer’s decision to market can move it later.

Built from the FDA Orange Book. The bars above are scaled to each protection’s expiry; the red LOE marker is the last one to lapse.

Listed patents (6)
PatentTypeUse codeExpires
US 10722456 ↗ Method of use U-2718 May 27, 2036
US 10799517 ↗ Method of use U-2718 May 27, 2036
US 9949990 ↗ Method of use U-2718 May 27, 2036
US 9795620 ↗ Method of use U-2718 May 27, 2036
US 9572819 ↗ Method of use U-2718 May 27, 2036
US 10376527 ↗ Method of use U-2718 May 27, 2036
Common questions
Is there a generic version of ELYXYB 120 MG/4.8 ML SOLUTION?
No FDA-approved generic equivalent is currently listed in the FDA Orange Book for ELYXYB 120 MG/4.8 ML SOLUTION. Based on the patents and exclusivity currently listed, the Orange Book estimate is that full-label generic entry may be delayed until May 2036 — an estimate, not a guaranteed launch date.
The FDA approved a generic — why can’t I get it at my pharmacy yet?
FDA approval and pharmacy availability are two different things. The FDA can approve a generic years before it actually reaches pharmacies, because the brand company may still hold patents or have a settlement that delays the launch. A manufacturer also has to choose to make and sell it, and have supply ready. So a drug can be “FDA-approved generic exists” and still be brand-only at the counter today.
Why do different websites show different generic release dates?
Generic availability is not based on one single date. Some sources use the first exclusivity expiration, some use the last product patent, and others use the latest method-of-use patent. Patent challenges, settlements, licenses, and label carve-outs can also change the real-world launch date. This page shows the underlying Orange Book dates so you can see why estimates may differ.
What does “FDA listed” mean?
It means the product appears in the FDA’s official NDC directory. That’s a good sign a product exists and is intended for the U.S. market, but on its own it does not confirm a pharmacy can fill it today. Where we have recent retail pricing data (NADAC) for a product, we label it “Availability likely” instead.
What does a patent or protection date mean here?
It’s the latest date currently listed in the FDA Orange Book for a patent or exclusivity on the brand product. It can affect when a full generic version becomes widely available — but it is not a guaranteed generic launch date. Generics sometimes arrive earlier (through a settlement or patent challenge) or later (a manufacturer still has to make and sell one).
What does “current Orange Book estimate” mean?
It means we are using the latest patent and exclusivity dates currently listed in the FDA Orange Book. It is not a guaranteed launch date.
Can a generic come out before the last patent expires?
Sometimes. A generic company may challenge a patent, settle with the brand manufacturer, receive a license, or obtain approval with a narrower label that avoids a patented use. In other cases, the last listed protection may delay full-label generic competition.
Can a generic come out after the listed dates?
Yes. Even after patents or exclusivity expire, a generic still needs FDA approval and a manufacturer must choose to market it. Supply, litigation, business decisions, or regulatory issues can delay actual availability.
What is the difference between patents and exclusivity?
Patents are legal protections usually issued by the U.S. Patent and Trademark Office. FDA exclusivity is marketing protection granted by the FDA. They are separate, and either one can affect generic timing.
Why are there multiple patent dates?
One drug can have several patents covering different things: the active ingredient, a formulation, a manufacturing process, or a specific approved use. That is why a page may show several expiration dates instead of one simple generic date.
Built from FDA Orange Book patent and exclusivity data. Dates are refreshed from public FDA data when available; the marker is max(latest patent expiry, latest exclusivity expiry). Paragraph-IV settlements and first-filer 180-day exclusivity can shift the real date; a method-of-use patent may allow an earlier skinny-label generic for non-protected indications. Generic launch timing is an estimate, not a guarantee.
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.

What it looks like

FlavorBanana
One label can cover several strengths, so colors may be combined — always confirm a loose pill against the dispensed prescription label or a pharmacist.
Where does this data come from?
Physical description (imprint, shape, color, scoring, coating) from this product’s FDA Structured Product Labeling (SPL), mirrored from DailyMed / openFDA.

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.

💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.

  • UNII 23OV73Q5G9
    Acesulfame potassium is an artificial sweetener that tastes about 200 times sweeter than sugar. It's added to medicines to improve taste without adding calories or affecting blood sugar.
  • UNII 3K9958V90M
    A liquid solvent derived from fermentation or chemical synthesis. In medicines, alcohol dissolves active ingredients, helps preserve the product, and improves how the body absorbs certain drugs.
  • UNII 3VRD35U26C
    A natural extract from licorice root, ammonium glycyrrhizate is used as a flavoring agent and sweetener in medicines. It may also help soothe irritated tissues in the mouth or throat.
  • UNII 4AJZ4765R9
    A flavoring agent derived from bananas that gives medicine a banana taste. It's added to make oral medications more palatable, especially for children.
  • UNII PDC6A3C0OX
    Glycerin is a clear, thick liquid derived from plant oils or fats. It acts as a humectant to retain moisture, a sweetener, and a solvent in medications.
  • UNII TM2TZD4G4A
    A plant-derived oily substance used as an emulsifier and solubilizer in medicines. It helps blend water and oil-based ingredients together and improves how the body absorbs certain active drugs.
  • UNII H5ZC52369M
    A synthetic ingredient made from plant-based lauric acid and polyethylene glycol. It acts as a solubilizer and emulsifier to help dissolve and blend oil and water components in the medicine.
  • UNII BZ1R15MTK7
    Levomenthol is the left-handed form of menthol, a natural cooling compound from mint plants. It's used in medicines as a flavoring agent and to provide a cooling sensation on the skin or mucous membranes.
  • UNII C9H2L21V7U
    A fat derived from coconut or palm oil containing shorter fatty acid chains. It serves as a solvent and carrier to help dissolve or suspend active ingredients, improving absorption and stability in liquid formulations.
  • UNII V95R5KMY2B
    Peppermint is a flavoring agent derived from the peppermint plant. It's added to medicines to improve taste and mask bitter or unpleasant flavors, making them easier to take.
  • UNII 6D4M1DAL6O
    Polyoxyl 35 castor oil is a synthetic compound made by chemically treating castor oil. It works as a solubilizer and emulsifier to help dissolve and evenly mix oily and water-based ingredients in medicines.
  • UNII 7YC686GQ8F
    A synthetic oily substance made from castor oil. It works as a solubilizer and emulsifier to help mix oily and water-based ingredients together in the medicine.
  • UNII 8D4SNN7V92
    Propyl gallate is a synthetic antioxidant derived from gallic acid. It prevents oils and fats in the medicine from oxidizing and spoiling, helping the product stay stable and effective during storage.
  • UNII 96K6UQ3ZD4
    Sucralose is a synthetic sweetener made from sugar. It's added to medicines to improve taste without adding calories, helping make bitter or unpleasant-tasting drugs easier to take.

14 inactive ingredients listed in the exact product block matched to this NDC.

Where does this data come from?
Data sourced from official FDA Structured Product Labeling (SPL) via DailyMed — ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.

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

LabelerSCILEX PHARMACEUTICALS INC.
Application holderSCILEX PHARMACEUTICALS INC
FDA applicationNDA212157 (NDA)
Labeler code69557
First marketedNov 2023
Product typeHuman Prescription Drug
Portfolio3 products on file
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. Very long sections are excerpted here and marked; the full text is on DailyMed (linked in the sources below). Jump with a chip, search within the label, or expand everything.
🚨 Boxed Warning 🎯 Indications and Usage ⏱️ Dosage and Administration 💊 Dosage Forms and Strengths ⛔ Contraindications ⚠️ Warnings and Cautions 🤒 Adverse Reactions 🔄 Drug Interactions 👥 Use in Specific Populations 🤰 Pregnancy 🧒 Pediatric Use 🧓 Geriatric Use 🆘 Overdosage 🧬 Clinical Pharmacology 🧬 Mechanism of Action 📦 How Supplied / Storage and Handling 📦 Storage and Handling 📋 Description 💬 Information for Patients 💬 Medication Guide 🧬 Pharmacokinetics 🧬 Pharmacodynamics 🔬 Clinical Studies 🧪 Nonclinical Toxicology 📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 📖 Instructions for Use 📄 Recent Major Changes 📄 Package Label / Principal Display Panel
🚨 Boxed Warning ~1 min read ▾

WARNING: RISK OF SERIOUS CARDIOVASCULAR AND GASTROINTESTINAL EVENTS WARNING: RISK OF SERIOUS CARDIOVASCULAR and GASTROINTESTINAL EVENTS See full prescribing information for complete boxed warning. Nonsteroidal anti-inflammatory drugs (NSAIDs) cause an increased risk of serious cardiovascular thrombotic events, including myocardial infarction and stroke, which can be fatal. This risk may occur early in the treatment and may increase with duration of use.

( 5.1 ) ELYXYB is contraindicated in the setting of coronary artery bypass graft (CABG) surgery. ( 4 , 5.1 ) NSAIDs cause an increased risk of serious gastrointestinal (GI) adverse events including bleeding, ulceration, and perforation of the stomach or intestines, which can be fatal. These events can occur at any time during use and without warning symptoms.

Elderly patients and patients with a prior history of peptic ulcer disease and/or GI bleeding are at greater risk for serious GI events. ( 5.2 ) Cardiovascular Thrombotic Events Nonsteroidal anti-inflammatory drugs (NSAIDs) cause an increased risk of serious cardiovascular thrombotic events, including myocardial infarction and stroke, which can be fatal. This risk may occur early in the treatment and may increase with duration of use [see Warnings and Precautions ( 5.1 )].

ELYXYB is contraindicated in the setting of coronary artery bypass graft (CABG) surgery [see Contraindications ( 4 ) and Warnings and Precautions ( 5.1 )]. Gastrointestinal Bleeding, Ulceration, and Perforation NSAIDs cause an increased risk of serious gastrointestinal (GI) adverse events including bleeding, ulceration, and perforation of the stomach or intestines, which can be fatal. These events can occur at any time during use and without warning symptoms.

Elderly patients and patients with a prior history of peptic ulcer disease and/or GI bleeding are at greater risk for serious (GI) events [see Warnings and Precautions ( 5.2 )].

🎯 Indications and Usage 70 words ▾

1 INDICATIONS AND USAGE ELYXYB is indicated for the acute treatment of migraine with or without aura in adults. Limitations of Use ELYXYB is not indicated for the preventive treatment of migraine. ELYXYB is a nonsteroidal anti-inflammatory drug indicated for the acute treatment of migraine with or without aura in adults ( 1 ) Limitations of Use ELYXYB is not indicated for the preventive treatment of migraine. ( 1 )

⏱️ Dosage and Administration ~1 min read ▾

2 DOSAGE AND ADMINISTRATION The recommended dose of ELYXYB is 120 mg taken orally, with or without food ( 2.1 ) The maximum dosage in a 24-hour period is 120 mg ( 2.1 ) Use ELYXYB for the fewest number of days per month, as needed ( 2.1 ) Hepatic Impairment: The recommended and maximum dose is 60 mg (2.4 mL) in patients with moderate hepatic impairment (Child-Pugh Class B) ( 2.2 , 8.6 , 12.3 ) Poor Metabolizers of CYP2C9 Substrates: The recommended and maximum dose is 60 mg (2.4 mL) in patients who are known or suspected to be CYP2C9 poor metabolizers ( 2.3 , 8.8 , 12.5 )

2.1Recommended Dosage The recommended dose of ELYXYB is 120 mg taken orally, with or without food [see Clinical Pharmacology ( 12.3 ) ] . The maximum dosage in a 24-hour period is 120 mg. The safety and effectiveness of a second dose in a 24-hour period have not been established. Use ELYXYB for the fewest number of days per month, as needed.

2.2Dosage Modification in Patients with Hepatic Impairment The recommended and maximum dose in patients with moderate hepatic impairment (Child- Pugh Class B) is 60 mg (2.4 mL) [see Use in Specific Populations ( 8.6 ) and Clinical Pharmacology ( 12.3 )]. A calibrated measuring device is recommended to measure and deliver the prescribed dose accurately. A household teaspoon or tablespoon is not an adequate measuring device.

Use of ELYXYB in patients with severe hepatic impairment is not recommended.

2.3Dosage Modification in CYP2C9 Poor Metabolizers The recommended and maximum dose in patients who are known or suspected to be CYP2C9 poor metabolizers is 60 mg (2.4 mL) [see Use in Specific Populations ( 8.8 ) and Clinical Pharmacology ( 12.5 )]. A calibrated measuring device is recommended to measure and deliver the prescribed dose accurately. A household teaspoon or tablespoon is not an adequate measuring device.

💊 Dosage Forms and Strengths 27 words ▾

3 DOSAGE FORMS AND STRENGTHS Dosage form: Clear colorless oral solution Strength: 120 mg/4.8 mL (25 mg/mL) Oral solution, 120 mg/4.8 mL (25 mg/mL) ( 3 )

⛔ Contraindications 145 words ▾

4 CONTRAINDICATIONS ELYXYB is contraindicated in the following patients: Known hypersensitivity (e.g., anaphylactic reactions and serious skin reactions) to celecoxib, any components of the drug product [see Warnings and Precautions ( 5.7 , 5.9 )]. History of asthma, urticaria, or other allergic-type reactions after taking aspirin or other NSAIDs. Severe, sometimes fatal, anaphylactic reactions to NSAIDs have been reported in such patients [see Warnings and Precautions ( 5.7 , 5.8 )].

In the setting of coronary artery bypass graft (CABG) surgery [see Warnings and Precautions ( 5.1 )]. In patients who have demonstrated allergic-type reactions to sulfonamides [see Warnings and Precautions ( 5.7 )]. Known hypersensitivity to celecoxib, any components of the drug product, or sulfonamides ( 4 ) History of asthma, urticaria, or other allergic-type reactions after taking aspirin or other NSAIDs ( 4 ) In the setting of CABG surgery ( 4 )

⚠️ Warnings and Cautions ~3 min read ▾

5 WARNINGS AND PRECAUTIONS Hepatotoxicity : Inform patients of warning signs and symptoms of hepatotoxicity. Discontinue if abnormal liver tests persist or worsen or if clinical signs and symptoms of liver disease develop ( 5.3 ) Hypertension : Patients taking some antihypertensive medications may have impaired response to these therapies when taking NSAIDs. Monitor blood pressure ( 5.4 , 7 ) Heart Failure and Edema : Avoid use of ELYXYB in patients with severe heart failure unless benefits are expected to outweigh risk of worsening heart failure ( 5.5 ) Renal Toxicity : Monitor renal function in patients with renal or hepatic impairment, heart failure, dehydration, or hypovolemia.

Avoid use of ELYXYB in patients with severe renal impairment unless benefits are expected to outweigh risk of worsening renal function ( 5.6 ) Anaphylactic Reactions : Seek emergency help if an anaphylactic reaction occurs ( 5.7 ) Exacerbation of Asthma Related to Aspirin Sensitivity : ELYXYB is contraindicated in patients with aspirin-sensitive asthma. Monitor patients with preexisting asthma (without aspirin sensitivity) ( 5.8 ) Serious Skin Reactions : Discontinue ELYXYB at first appearance of skin rash or other signs of hypersensitivity ( 5.9 ) Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS) : Discontinue and evaluate clinically ( 5.10 ) Medication Overuse Headache : Detoxification may be necessary ( 5.11 ) Fetal Toxicity : Limit use of NSAIDs, including ELYXYB, between about 20 to 30 weeks in pregnancy due to the risk of oligohydramnios/fetal renal dysfunction.

Avoid use of NSAIDs in women at about 30 weeks gestation and later in pregnancy due to the risks of oligohydramnios/fetal renal dysfunction and premature closure of the fetal ductus arteriosus ( 5.12 , 8.1 ) Hematologic Toxicity : Monitor hemoglobin or hematocrit in patients with any signs or symptoms of anemia ( 5.13 , 7 )

5.1Cardiovascular Thrombotic Events Clinical trials of several cyclooxygenase (COX-2) selective and nonselective NSAIDs of up to three years duration have shown an increased risk of serious cardiovascular (CV) thrombotic events, including myocardial infarction (MI) and stroke, which can be fatal. Based on available data, it is unclear that the risk for CV thrombotic events is similar for all NSAIDs. The relative increase in serious CV thrombotic events over baseline conferred by NSAID use appears to be similar in those with and without known CV disease or risk factors for CV disease.

However, patients with known CV disease or risk factors had a higher absolute incidence of excess serious CV thrombotic events, due to their increased baseline rate. Some observational studies found that this increased risk of serious CV thrombotic events began as early as the first weeks of treatment. The increase in CV thrombotic risk has been observed most consistently at higher doses.

In a trial with celecoxib capsules, there was about a threefold increased risk of the composite endpoint of cardiovascular death, MI, or stroke for the celecoxib 400 mg twice daily and celecoxib 200 mg twice daily treatment arms compared to placebo. The increases in both celecoxib dose groups versus placebo-treated patients were mainly due to an increased incidence of myocardial infarction. To minimize the potential risk for an adverse CV event in NSAID-treated patients, use ELYXYB for the fewest number of days per month as needed, based on individual treatment goals.

Physicians and patients should remain alert for the development of such events, throughout the entire treatment course, even in the absence of previous CV symptoms. Patients should be informed about the symptoms of serious CV events and the steps to take if they occur. There is no consistent evidence that concurrent use of aspirin mitigates the increased risk of serious CV thrombotic events associated with NSAID use.

The concurrent use of aspirin and an NSAID, such as ELYXYB, increases the risk of serious gastrointestinal (GI… [Excerpted — this section continues on DailyMed.]

🤒 Adverse Reactions ~2 min read ▾

6 ADVERSE REACTIONS The following adverse reactions are discussed in greater detail in other sections of the labeling: Cardiovascular Thrombotic Events [see Warnings and Precautions ( 5.1 )] GI Bleeding, Ulceration, and Perforation [see Warnings and Precautions ( 5.2 )] Hepatotoxicity [see Warnings and Precautions ( 5.3 )] Hypertension [see Warnings and Precautions ( 5.4 )] Heart Failure and Edema [see Warnings and Precautions ( 5.5 )] Renal Toxicity and Hyperkalemia [see Warnings and Precautions ( 5.6 )] Anaphylactic Reactions [see Warnings and Precautions ( 5.7 )] Exacerbation of Asthma Related to Aspirin Sensitivity [see Warnings and Precautions ( 5.8 )] Serious Skin Reactions [see Warnings and Precautions ( 5.9 )] Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS) [see Warnings and Precautions ( 5.10 )] Medication Overuse Headache [see Warnings and Precautions ( 5.11 )] Fetal Toxicity [see Warnings and Precautions ( 5.12 )] Hematologic Toxicity [see Warnings and Precautions ( 5.13 )] Most common adverse reaction (at least 3% and greater than placebo) is dysgeusia ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact SCILEX Pharmaceuticals Inc. at 1-866-SCILEX3 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch

6.1Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to the rates in the clinical trials of another drug and may not reflect the rates observed in practice. The safety of ELYXYB was evaluated in 815 patients who received at least one dose of ELYXYB in two, randomized, double-blind, placebo-controlled trials (Study 1 and 2) in adult patients with migraine [see Clinical Studies ( 14 )].

The most common (at least 2% of patients who received ELYXYB and greater than placebo) adverse reaction in Study 1 and Study 2 was dysgeusia, which occurred in 3% of patients who received ELYXYB compared to 1% of patients who received placebo.

6.2Postmarketing Experience The following adverse reactions have been identified during post-approval use of celecoxib. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Cardiovascular: Vasculitis, deep venous thrombosis General: Anaphylactic reaction, angioedema Liver and biliary: Liver necrosis, hepatitis, jaundice, hepatic failure Hemic and lymphatic: Agranulocytosis, aplastic anemia, pancytopenia, leucopenia Metabolic: Hypoglycemia, hyponatremia Nervous: Aseptic meningitis, ageusia, anosmia, fatal intracranial hemorrhage Renal: Interstitial nephritis Skin and Appendages : Erythema multiforme, exfoliative dermatitis, Stevens-Johnson Syndrome (SJS), toxic epidermal necrolysis (TEN), drug reaction with eosinophilia and systemic symptoms (DRESS), acute generalized exanthematous pustulosis (AGEP), and fixed drug eruption (FDE) [ see Warnings and Precautions ( 5.9 ) ].

🔄 Drug Interactions ~3 min read ▾

7 DRUG INTERACTIONS See Table 1 for clinically significant drug interactions with celecoxib. Table 1: Clinically Significant Drug Interactions with Celecoxib Drugs That Interfere with Hemostasis Clinical Impact Celecoxib and anticoagulants such as warfarin have a synergistic effect on bleeding. The concomitant use of celecoxib and anticoagulants have an increased risk of serious bleeding compared to the use of either drug alone.

Serotonin release by platelets plays an important role in hemostasis. Case-control and cohort epidemiological studies showed that concomitant use of drugs that interfere with serotonin reuptake and an NSAID may potentiate the risk of bleeding more than an NSAID alone. Intervention Monitor patients with concomitant use of ELYXYB with anticoagulants (e.g., warfarin), antiplatelet drugs (e.g., aspirin), SSRIs, and SNRIs for signs of bleeding [see Warnings and Precautions ( 5.13 )].

Aspirin Clinical Impact In a clinical study, the concomitant use of an NSAID and aspirin was associated with a significantly increased incidence of GI adverse reactions as compared to use of the NSAID alone [see Warnings and Precautions ( 5.2 )]. In two studies in healthy volunteers and in patients with established heart disease respectively, celecoxib (200 mg to 400 mg daily) has demonstrated a lack of interference with the cardioprotective antiplatelet effect of aspirin (100 mg to 325mg). Intervention Concomitant use of ELYXYB and analgesic doses of aspirin is not generally recommended because of the increased risk of bleeding [see Warnings and Precautions ( 5.13 )].

ELYXYB is not a substitute for low dose aspirin for cardiovascular protection. ACE Inhibitors, Angiotensin Receptor Blockers, and Beta-Blockers Clinical Impact NSAIDs may diminish the antihypertensive effect of ACE inhibiters, ARBs, or beta-blockers (including propranolol). In patients who are elderly, volume-depleted (including those on diuretic therapy), or have renal impairment, co-administration of an NSAID with ACE inhibitors or ARBs may result in deterioration of renal function, including possible acute renal failure.

These effects are usually reversible. Intervention During concomitant use of ELYXYB and ACE inhibitors, ARBs, or beta- blockers, monitor blood pressure to ensure that the desired blood pressure is obtained. During concomitant use of ELYXYB and ACE inhibitors or ARBs in patients who are elderly, volume-depleted, or have impaired renal function, monitor for signs of worsening renal function [see Warnings and Precautions ( 5.6 )].

When these drugs are administered concomitantly, patients should be adequately hydrated. Assess renal function at the beginning of the concomitant treatment and periodically thereafter. Diuretics Clinical Impact Clinical studies, as well as postmarketing observations, showed that NSAIDs reduced the natriuretic effect of loop diuretics (e.g., furosemide) and thiazide diuretics in some patients.

This effect has been attributed to the NSAID inhibition of renal prostaglandin synthesis. Intervention During concomitant use of ELYXYB with diuretics, observe patients for signs of worsening renal function, in addition to assuring diuretic efficacy including antihypertensive effects [see Warnings and Precautions ( 5.6 )]. Digoxin Clinical Impact The concomitant use of celecoxib with digoxin has been reported to increase the serum concentration and prolong the half-life of digoxin.

Intervention During concomitant use of ELYXYB and digoxin, monitor serum digoxin levels. Lithium Clinical Impact NSAIDs have produced elevations in plasma lithium levels and reductions in renal lithium clearance. The mean minimum lithium concentration increased 15%, and the renal clearance decreased by approximately 20%.

This effect has been attributed to NSAID inhibition of renal prostaglandin synthesis. Intervention During concomitant use of ELYXYB and lithium, monitor patients for signs of lithium toxicity. Methotrexate Clinical Impact Concomitant us… [Excerpted — this section continues on DailyMed.]

👥 Use in Specific Populations ~3 min read ▾

8 USE IN SPECIFIC POPULATIONS Infertility : NSAIDs are associated with reversible infertility. Consider withdrawal of ELYXYB in women who have difficulties conceiving ( 8.3 )

8.1Pregnancy Risk Summary Use of NSAIDs, including ELYXYB, can cause premature closure of the fetal ductus arteriosus and fetal renal dysfunction leading to oligohydramnios and, in some cases, neonatal renal impairment. Because of these risks, limit dose and duration of ELYXYB use between about 20 and 30 weeks of gestation, and avoid ELYXYB use at about 30 weeks of gestation and later in pregnancy ( see Clinical Considerations , Data ). Premature Closure of Fetal Ductus Arteriosus Use of NSAIDs, including ELYXYB, at about 30 weeks gestation or later in pregnancy increases the risk of premature closure of the fetal ductus arteriosus.

Oligohydramnios/Neonatal Renal Impairment Use of NSAIDs at about 20 weeks gestation or later in pregnancy has been associated with cases of fetal renal dysfunction leading to oligohydramnios, and in some cases, neonatal renal impairment. Data from observational studies regarding other potential embryofetal risks of NSAID use in women in the first or second trimesters of pregnancy are inconclusive. In animal reproduction studies, administration of celecoxib during pregnancy resulted in adverse effects on development, including increases in embryonic death and fetal malformations, at doses or maternal plasma drug exposures greater than those used clinically ( see Data ).

Based on animal data, prostaglandins have been shown to have an important role in endometrial vascular permeability, blastocyst implantation, and decidualization. In animal studies, administration of prostaglandin synthesis inhibitors such as celecoxib, resulted in increased pre- and post- implantation loss. Prostaglandins also have been shown to have an important role in fetal kidney development.

In published animal studies, prostaglandin synthesis inhibitors have been reported to impair kidney development when administered at clinically relevant doses. All pregnancies have a background risk of birth defects, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively.

The reported rate of major birth defects among deliveries to women with migraine ranged from 2.2% to 2.9% and the reported rate of miscarriage was 17%, which were similar to rates reported in women without migraine. Clinical Considerations Fetal/Neonatal Adverse Reactions Premature Closure of Fetal Ductus Arteriosus: Avoid use of NSAIDs in women at about 30 weeks gestation and later in pregnancy, because NSAIDs, including ELYXYB, can cause premature closure of the fetal ductus arteriosus (see Data ). Oligohydramnios/Neonatal Renal Impairment If an NSAID is necessary at about 20 weeks gestation or later in pregnancy, limit the use to the lowest effective dose and shortest duration possible.

If ELYXYB treatment extends beyond 48 hours, consider monitoring with ultrasound for oligohydramnios. If oligohydramnios occurs, discontinue ELYXYB and follow up according to clinical practice ( see Data ). Labor or Delivery There are no studies on the effects of celecoxib during labor or delivery.

In animal studies, NSAIDs, including celecoxib, inhibit prostaglandin synthesis, cause delayed parturition, and increase the incidence of stillbirth. Data Human Data Premature Closure of Fetal Ductus Arteriosus: Published literature reports that the use of NSAIDs at about 30 weeks of gestation and later in pregnancy may cause premature closure of the fetal ductus arteriosus. Oligohydramnios/Neonatal Renal Impairment: Published studies and postmarketing reports describe maternal NSAID use at about 20 weeks gestation or later in pregnancy associated with fetal renal dysfunction leading to oligohydramnios, and in some cases, neonatal renal impairment.

These adverse outcomes are… [Excerpted — this section continues on DailyMed.]

🤰 Pregnancy ~3 min read ▾

8.1Pregnancy Risk Summary Use of NSAIDs, including ELYXYB, can cause premature closure of the fetal ductus arteriosus and fetal renal dysfunction leading to oligohydramnios and, in some cases, neonatal renal impairment. Because of these risks, limit dose and duration of ELYXYB use between about 20 and 30 weeks of gestation, and avoid ELYXYB use at about 30 weeks of gestation and later in pregnancy ( see Clinical Considerations , Data ). Premature Closure of Fetal Ductus Arteriosus Use of NSAIDs, including ELYXYB, at about 30 weeks gestation or later in pregnancy increases the risk of premature closure of the fetal ductus arteriosus.

Oligohydramnios/Neonatal Renal Impairment Use of NSAIDs at about 20 weeks gestation or later in pregnancy has been associated with cases of fetal renal dysfunction leading to oligohydramnios, and in some cases, neonatal renal impairment. Data from observational studies regarding other potential embryofetal risks of NSAID use in women in the first or second trimesters of pregnancy are inconclusive. In animal reproduction studies, administration of celecoxib during pregnancy resulted in adverse effects on development, including increases in embryonic death and fetal malformations, at doses or maternal plasma drug exposures greater than those used clinically ( see Data ).

Based on animal data, prostaglandins have been shown to have an important role in endometrial vascular permeability, blastocyst implantation, and decidualization. In animal studies, administration of prostaglandin synthesis inhibitors such as celecoxib, resulted in increased pre- and post- implantation loss. Prostaglandins also have been shown to have an important role in fetal kidney development.

In published animal studies, prostaglandin synthesis inhibitors have been reported to impair kidney development when administered at clinically relevant doses. All pregnancies have a background risk of birth defects, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively.

The reported rate of major birth defects among deliveries to women with migraine ranged from 2.2% to 2.9% and the reported rate of miscarriage was 17%, which were similar to rates reported in women without migraine. Clinical Considerations Fetal/Neonatal Adverse Reactions Premature Closure of Fetal Ductus Arteriosus: Avoid use of NSAIDs in women at about 30 weeks gestation and later in pregnancy, because NSAIDs, including ELYXYB, can cause premature closure of the fetal ductus arteriosus (see Data ). Oligohydramnios/Neonatal Renal Impairment If an NSAID is necessary at about 20 weeks gestation or later in pregnancy, limit the use to the lowest effective dose and shortest duration possible.

If ELYXYB treatment extends beyond 48 hours, consider monitoring with ultrasound for oligohydramnios. If oligohydramnios occurs, discontinue ELYXYB and follow up according to clinical practice ( see Data ). Labor or Delivery There are no studies on the effects of celecoxib during labor or delivery.

In animal studies, NSAIDs, including celecoxib, inhibit prostaglandin synthesis, cause delayed parturition, and increase the incidence of stillbirth. Data Human Data Premature Closure of Fetal Ductus Arteriosus: Published literature reports that the use of NSAIDs at about 30 weeks of gestation and later in pregnancy may cause premature closure of the fetal ductus arteriosus. Oligohydramnios/Neonatal Renal Impairment: Published studies and postmarketing reports describe maternal NSAID use at about 20 weeks gestation or later in pregnancy associated with fetal renal dysfunction leading to oligohydramnios, and in some cases, neonatal renal impairment.

These adverse outcomes are seen, on average, after days to weeks of treatment, although oligohydramnios has been infrequently reported as soon as 48 hours after NSAID initiation. In many cases, but not… [Excerpted — this section continues on DailyMed.]

🧒 Pediatric Use 28 words ▾

8.4Pediatric Use Safety and effectiveness in pediatric patients have not been established. Disseminated intravascular coagulation has occurred in pediatric patients [see Warnings and Precautions ( 5.16 )].

🧓 Geriatric Use 208 words ▾

8.5Geriatric Use Elderly patients, compared to younger patients, are at greater risk for NSAID-associated serious cardiovascular, gastrointestinal, and/or renal adverse reactions. If the anticipated benefit for the elderly patient outweighs these potential risks, treat for the fewest number of days per month, as needed, and monitor patients for adverse effects [see Warnings and Precautions ( 5.1 , 5.2 , 5.3 , 5.6 , 5.15 )]. In the controlled clinical trials for migraine, approximately 70 patients were ≥ 65 years of age.

Of the total number of patients who received celecoxib (for indications other than migraine) in pre-approval clinical trials, more than 3,300 were 65-74 years of age, while approximately 1,300 additional patients were 75 years and over. No substantial differences in effectiveness were observed between these subjects and younger subjects. In clinical studies comparing renal function as measured by the GFR, BUN and creatinine, and platelet function as measured by bleeding time and platelet aggregation, the results were not different between elderly and young volunteers.

However, as with other NSAIDs, including those that selectively inhibit COX-2, there have been more spontaneous postmarketing reports of fatal GI events and acute renal failure in the elderly than in younger patients [see Warnings and Precautions ( 5.4 , 5.6 )].

🆘 Overdosage 189 words ▾

10 OVERDOSAGE Symptoms following acute NSAID overdosages have been typically limited to lethargy, drowsiness, nausea, vomiting, and epigastric pain, which have been generally reversible with supportive care. Gastrointestinal bleeding has occurred. Hypertension, acute renal failure, respiratory depression, and coma have occurred, but were rare [see Warnings and Precautions ( 5.1 , 5.2 , 5.4 , 5.6 )].

No overdoses of celecoxib were reported during clinical trials. No information is available regarding the removal of celecoxib by hemodialysis, but based on its high degree of plasma protein binding (>97%), dialysis is unlikely to be useful in overdose. Manage patients with symptomatic and supportive care following an NSAID overdosage.

There are no specific antidotes. Consider emesis and/or activated charcoal (60 to 100 grams in adults, 1 to 2 grams per kg of body weight in pediatric patients) and/or osmotic cathartic in symptomatic patients seen within four hours of ingestion or in patients with a large overdosage (5 to 10 times the recommended dosage). Forced diuresis, alkalinization of urine, hemodialysis, or hemoperfusion may not be useful due to high protein binding.

For additional information about overdosage treatment contact a poison control center.

🧬 Clinical Pharmacology ~3 min read ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action Celecoxib is a nonsteroidal anti-inflammatory drug with analgesic, anti-inflammatory, and antipyretic properties. The mechanism of action by which celecoxib exerts therapeutic effects in migraine patients is not fully understood but may involve inhibition of prostaglandin synthesis, primarily via inhibition of COX-2.

12.2Pharmacodynamics Platelets In clinical trials using normal volunteers, celecoxib at single doses up to 800 mg and multiple doses of 600 mg twice daily for up to 7 days duration (higher than recommended therapeutic doses) had no effect on reduction of platelet aggregation or increase in bleeding time. Because of its lack of platelet effects, celecoxib is not a substitute for aspirin for cardiovascular prophylaxis. It is not known if there are any effects of celecoxib on platelets that may contribute to the increased risk of serious cardiovascular thrombotic adverse events associated with the use of celecoxib.

Fluid Retention Inhibition of PGE2 synthesis may lead to sodium and water retention through increased reabsorption in the renal medullary thick ascending loop of Henle and perhaps other segments of the distal nephron. In the collecting ducts, PGE2 appears to inhibit water reabsorption by counteracting the action of antidiuretic hormone.

12.3Pharmacokinetics Celecoxib exhibits a dose-proportional increase in exposure after once daily oral administration of 120 to 240 mg doses (2 times the recommended dosage) of ELYXYB. Absorption Following administration of 120 mg of ELYXYB under fasting condition in 24 healthy subjects, the median time to peak plasma levels (i.e., T max ) of celecoxib was 1 hour (range 0.67 to 3.00). Food Effect When ELYXYB was taken with a high-fat meal, the median time to peak plasma levels (i.e., T max ) was delayed by 2 hours with an approximately 50% decrease in C max and no change in total absorption (i.e., AUC) compared to fasting conditions.

However, in Study 1 and Study 2, ELYXYB was administered without regard to food [see Dosage and Administration ( 2.1 ), Clinical Studies ( 14 )]. Distribution In healthy subjects, celecoxib is highly protein bound (~97%) within the clinical dose range. In vitro studies indicate that celecoxib binds primarily to albumin and, to a lesser extent, α1-acid glycoprotein.

The apparent volume of distribution following single dose administration of ELYXYB at fasting state is (Vz/F) is approximately 288 L, suggesting extensive distribution into the tissues. Celecoxib is not preferentially bound to red blood cells. Elimination Metabolism Celecoxib metabolism is primarily mediated via CYP2C9.

Three metabolites, a primary alcohol, the corresponding carboxylic acid, and its glucuronide conjugate, have been identified in human plasma. These metabolites are inactive as COX-1 or COX-2 inhibitors. Excretion Celecoxib is eliminated predominantly by hepatic metabolism with little (<3%) unchanged drug recovered in the urine and feces.

Following a single oral dose of radiolabeled drug, approximately 57% of the dose was excreted in the feces and 27% was excreted into the urine. The primary metabolite in both urine and feces was the carboxylic acid metabolite (73% of dose) with low amounts of the glucuronide also appearing in the urine. The mean apparent elimination t½ of celecoxib from ELYXYB was approximately 6 hours independent of dosing condition and similar to that observed for Celebrex under fed conditions.

Specific Populations Geriatric At steady state, elderly subjects (over 65 years old) had a 40% higher C max and a 50% higher AUC compared to the younger subjects for celecoxib oral capsules. In elderly females, celecoxib C max and AUC are higher than those for elderly males, but these increases are predominantly due to lower body weight in elderly females. Dose adjustment in the elderly is not generally necessary.

Race Meta-analysis of pharmacokinetic studies conducted using celecoxib oral capsules has sugge… [Excerpted — this section continues on DailyMed.]

🧬 Mechanism of Action 45 words ▾

12.1Mechanism of Action Celecoxib is a nonsteroidal anti-inflammatory drug with analgesic, anti-inflammatory, and antipyretic properties. The mechanism of action by which celecoxib exerts therapeutic effects in migraine patients is not fully understood but may involve inhibition of prostaglandin synthesis, primarily via inhibition of COX-2.

📦 How Supplied / Storage and Handling 142 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING

16.1How Supplied ELYXYB (celecoxib) oral solution, 120 mg/4.8 mL (25 mg/mL) is a clear colorless oral solution supplied in a disposable glass bottle with a child resistant cap. Each carton (NDC 69557-333-01) contains six (6) glass bottles, a Full Prescribing Information, Medication Guide, and Instructions for Use.

16.2Storage and Handling Store at room temperature 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature]. Do not refrigerate or freeze. Unused portion should be discarded immediately after use.

16.1How Supplied ELYXYB (celecoxib) oral solution, 120 mg/4.8 mL (25 mg/mL) is a clear colorless oral solution supplied in a disposable glass bottle with a child resistant cap. Each carton (NDC 69557-333-01) contains six (6) glass bottles, a Full Prescribing Information, Medication Guide, and Instructions for Use.

📦 Storage and Handling 41 words ▾

16.2Storage and Handling Store at room temperature 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature]. Do not refrigerate or freeze. Unused portion should be discarded immediately after use.

📋 Description 137 words ▾

11 DESCRIPTION ELYXYB is an oral solution of celecoxib, a nonsteroidal anti-inflammatory drug. Each unit dose of ELYXYB contains 120 mg of celecoxib. Celecoxib is a white or almost white, crystalline or amorphous powder with a pKa of 11.

Celecoxib is hydrophobic (log P is 3.0) and practically insoluble in water. Celecoxib is chemically designated as p -[5- p -tolyl-3-(trifluoromethyl) pyrazol-1-yl] benzenesulfonamide. The empirical formula for celecoxib is C 17 H 14 F 3 N 3 O 2 S, and the molecular weight is 381.37.

It has the following chemical structure: The inactive ingredients in ELYXYB include: acesulfame potassium, banana flavor, bubble gum flavor, ethyl alcohol, glycerin, glyceryl monocaprylate, L-menthol, lauroyl polyoxyl-32 glycerides, medium chain triglycerides, monoammonium glycyrrhizinate, peppermint flavor, polyoxyl 35 castor oil, polyoxyl 40 hydrogenated castor oil, propyl gallate, purified water, and sucralose. Chemical Structure

💬 Information for Patients ~3 min read ▾

17 PATIENT COUNSELING INFORMATION Advise the patient to read the FDA-approved patient labeling ( Medication Guide and Instructions for Use ). Administration Information For patients who are prescribed the recommended dosage of 120 mg, instruct them to drink the entire amount of ELYXYB directly from the bottle. For patients who are prescribed the reduced dosage (i.e., patients with moderate hepatic impairment or CYP2C9 poor metabolizers), instruct them to use an oral dosing syringe to correctly measure the prescribed amount of medication.

Inform these patients that oral dosing syringes may be obtained from their pharmacy and that a household teaspoon is not an accurate measuring device. Instruct these patients to discard the unused portion of ELYXYB. Cardiovascular Thrombotic Events Advise patients to be alert for the symptoms of cardiovascular thrombotic events, including chest pain, shortness of breath, weakness, or slurring of speech, and to report any of these symptoms to their health care provider immediately [see Warnings and Precautions ( 5.1 )].

Gastrointestinal Bleeding, Ulceration, and Perforation Advise patients to report symptoms of ulcerations and bleeding, including epigastric pain, dyspepsia, melena, and hematemesis to their health care provider. In the setting of concomitant use of low-dose aspirin for cardiac prophylaxis, inform patients of the increased risk for and the signs and symptoms of GI bleeding [see Warnings and Precautions ( 5.2 )]. Hepatotoxicity Inform patients of the warning signs and symptoms of hepatotoxicity (e.g., nausea, fatigue, lethargy, pruritus, diarrhea jaundice, right upper quadrant tenderness, and “flu-like” symptoms).

If these occur, instruct patients to stop ELYXYB and seek immediate medical therapy [see Warnings and Precautions ( 5.3 ) and Use in Specific Populations ( 8.6 )]. Heart Failure and Edema Advise patients to be alert for the symptoms of congestive heart failure including shortness of breath, unexplained weight gain, or edema and to contact their healthcare provider if such symptoms occur [see Warnings and Precautions ( 5.5 )]. Anaphylactic Reactions Inform patients of the signs of an anaphylactic reaction (e.g., difficulty breathing, swelling of the face or throat).

Instruct patients to seek immediate emergency help if these occur [see Contraindications ( 4 ) and Warnings and Precautions ( 5.7 )]. Serious Skin Reactions, including DRESS Advise patients to stop taking ELYXYB immediately if they develop any type of rash or fever and to contact their healthcare provider as soon as possible [see Warnings and Precautions ( 5.9 , 5.10 )]. Medication Overuse Headache Inform patients that use of acute migraine drugs for 10 or more days per month, including ELYXYB, may lead to an exacerbation of headache and encourage patients to record headache frequency and drug use (e.g., by keeping a headache diary).

Instruct patients to contact their healthcare provider if the frequency of their migraines increases; withdrawal of ELYXYB may be necessary [see Warnings and Precautions ( 5.11 )]. Female Fertility Advise females of reproductive potential who desire pregnancy that NSAIDs, including ELYXYB, may be associated with a reversible delay in ovulation [see Use in Specific Populations ( 8.3 )]. Fetal Toxicity Inform pregnant women to avoid use of ELYXYB and other NSAIDs starting at 30 weeks gestation because of the risk of the premature closing of the fetal ductus arteriosus.

If treatment with ELYXYB is needed for a pregnant woman between about 20 to 30 weeks gestation, advise her that she may need to be monitored for oligohydramnios, if treatment continues for longer than 48 hours [see Warnings and Precautions ( 5.12 ) and Use in Specific Populations ( 8.1 )] . Avoid Concomitant Use of NSAIDs Inform patients that the concomitant use of ELYXYB with other NSAIDs or salicylates (e.g., diflunisal, salsalate) is not recommended due to the increased risk of gastrointestinal toxicity, and little… [Excerpted — this section continues on DailyMed.]

💬 Medication Guide ~3 min read ▾

Medication Guide ELYXYB (ee-lix'-ib)) (celecoxib) oral solution What is the most important information I should know about ELYXYB? ELYXYB contains celecoxib (a non-steroidal anti-inflammatory drug or NSAID). NSAIDs, including ELYXYB, can cause serious side effects, including: Increased risk of a heart attack or stroke that can lead to death.

This risk may happen early in treatment and may increase: with increasing doses of NSAIDs with longer use of NSAIDs Do not take ELYXYB right before or after a heart surgery called a “coronary artery bypass graft (CABG)." Avoid taking NSAIDs, including ELYXYB, after a recent heart attack, unless your healthcare provider tells you to. You may have an increased risk of another heart attack if you take NSAIDs after a recent heart attack. Increased risk of bleeding, ulcers, and tears (perforation) of the esophagus (tube leading from the mouth to the stomach), stomach and intestines: anytime during use without warning symptoms that may cause death The risk of getting an ulcer or bleeding increases with: past history of stomach ulcers, or stomach or intestinal bleeding with use of NSAIDs taking medicines called “corticosteroids”, “antiplatelet drugs”, “anticoagulants”, “SSRIs” or “SNRIs” increasing doses of NSAIDs longer use of NSAIDs smoking drinking alcohol older age poor health advanced liver disease bleeding problems ELYXYB should only be used: exactly as prescribed for the shortest time needed What is ELYXYB?

ELYXYB is a prescription medicine used for the acute treatment of migraine attacks with or without aura in adults. ELYXYB is not used as a preventive treatment of migraine. It is not known if ELYXYB is safe and effective in children.

Who should not take ELYXYB? Do not take ELYXYB: if you are allergic to celecoxib or any of the ingredients in ELYXYB. See the end of this Medication Guide for a complete list of ingredients in ELYXYB.

If you are allergic to sulfonamides. if you have had an asthma attack, hives, or other allergic reaction with aspirin or any other NSAIDs. right before or after heart bypass surgery. Before taking ELYXYB, tell your healthcare provider about all of your medical conditions, including if you: have liver or kidney problems. have a history of stomach ulcer or bleeding in your stomach or intestines. have heart disease or risk factors that increase your chance of getting heart disease. have high blood pressure. have asthma. are pregnant or plan to become pregnant.

Taking NSAIDs, including ELYXYB, at about 20 weeks of pregnancy or later may harm your unborn baby. If you need to take NSAIDs for more than 2 days when you are between 20 and 30 weeks of pregnancy, your healthcare provider may need to monitor the amount of fluid in your womb around your baby. You should not take NSAIDs after about 30 weeks of pregnancy. are breastfeeding or plan to breast feed.

ELYXYB may pass into your breast milk. Talk with your healthcare provider about the best way to feed your baby if you take ELYXYB. Tell your healthcare provider about all of the medicines you take, including prescription or over- the-counter medicines, vitamins or herbal supplements.

NSAIDs, including ELYXYB, and some other medicines can interact with each other and cause serious side effects. Do not start taking any new medicine without talking to your healthcare provider first. How should I take ELYXYB?

See the detailed “ Instructions for Use ” on how to take ELYXYB solution. Take ELYXYB exactly as your healthcare provider tells you to take it. Take ELYXYB by mouth with or without food.

Do not take more than one dose in a 24-hour period. Use ELYXYB for the fewest number of days a month, as needed. What are the possible side effects of ELYXYB?

ELYXYB can cause serious side effects, including: See “ What is the most important information I should know about ELYXYB? liver problems including liver failure new or worse high blood pressure heart failure kidney problems including kidney failure life-threatening allergic… [Excerpted — this section continues on DailyMed.]

🧬 Pharmacokinetics ~3 min read ▾

12.3Pharmacokinetics Celecoxib exhibits a dose-proportional increase in exposure after once daily oral administration of 120 to 240 mg doses (2 times the recommended dosage) of ELYXYB. Absorption Following administration of 120 mg of ELYXYB under fasting condition in 24 healthy subjects, the median time to peak plasma levels (i.e., T max ) of celecoxib was 1 hour (range 0.67 to 3.00). Food Effect When ELYXYB was taken with a high-fat meal, the median time to peak plasma levels (i.e., T max ) was delayed by 2 hours with an approximately 50% decrease in C max and no change in total absorption (i.e., AUC) compared to fasting conditions.

However, in Study 1 and Study 2, ELYXYB was administered without regard to food [see Dosage and Administration ( 2.1 ), Clinical Studies ( 14 )]. Distribution In healthy subjects, celecoxib is highly protein bound (~97%) within the clinical dose range. In vitro studies indicate that celecoxib binds primarily to albumin and, to a lesser extent, α1-acid glycoprotein.

The apparent volume of distribution following single dose administration of ELYXYB at fasting state is (Vz/F) is approximately 288 L, suggesting extensive distribution into the tissues. Celecoxib is not preferentially bound to red blood cells. Elimination Metabolism Celecoxib metabolism is primarily mediated via CYP2C9.

Three metabolites, a primary alcohol, the corresponding carboxylic acid, and its glucuronide conjugate, have been identified in human plasma. These metabolites are inactive as COX-1 or COX-2 inhibitors. Excretion Celecoxib is eliminated predominantly by hepatic metabolism with little (<3%) unchanged drug recovered in the urine and feces.

Following a single oral dose of radiolabeled drug, approximately 57% of the dose was excreted in the feces and 27% was excreted into the urine. The primary metabolite in both urine and feces was the carboxylic acid metabolite (73% of dose) with low amounts of the glucuronide also appearing in the urine. The mean apparent elimination t½ of celecoxib from ELYXYB was approximately 6 hours independent of dosing condition and similar to that observed for Celebrex under fed conditions.

Specific Populations Geriatric At steady state, elderly subjects (over 65 years old) had a 40% higher C max and a 50% higher AUC compared to the younger subjects for celecoxib oral capsules. In elderly females, celecoxib C max and AUC are higher than those for elderly males, but these increases are predominantly due to lower body weight in elderly females. Dose adjustment in the elderly is not generally necessary.

Race Meta-analysis of pharmacokinetic studies conducted using celecoxib oral capsules has suggested an approximately 40% higher AUC of celecoxib in Blacks compared to Caucasians. The cause and clinical significance of this finding is unknown. Hepatic Impairment The effect of hepatic impairment on the pharmacokinetics of ELYXYB has not been evaluated.

A pharmacokinetic study in subjects with mild (Child-Pugh Class A) and moderate (Child-Pugh Class B) hepatic impairment conducted using celecoxib oral capsule has shown that steady-state celecoxib AUC is increased about 40% and 180%, respectively, above that seen in healthy control subjects [see Dosage and Administration ( 2.2 ) and Use in Specific Populations ( 8.6 )]. Patients with severe hepatic impairment (Child-Pugh Class C) have not been studied. Renal Impairment In a cross-study comparison done for celecoxib oral capsules, celecoxib AUC was approximately 40% lower in patients with chronic renal impairment (GFR 35-60 mL/min) than that seen in subjects with normal renal function.

No significant relationship was found between GFR and celecoxib clearance. Patients with severe renal impairment have not been studied [see Warnings and Precautions ( 5.6 ) and Use in Specific Populations ( 8.6 )]. Drug Interaction Studies In vitro studies indicate that celecoxib is not an inhibitor of cytochrome P450 2C9, 2C19, or 3A4.

In vivo studies have shown the followi… [Excerpted — this section continues on DailyMed.]

🧬 Pharmacodynamics 148 words ▾

12.2Pharmacodynamics Platelets In clinical trials using normal volunteers, celecoxib at single doses up to 800 mg and multiple doses of 600 mg twice daily for up to 7 days duration (higher than recommended therapeutic doses) had no effect on reduction of platelet aggregation or increase in bleeding time. Because of its lack of platelet effects, celecoxib is not a substitute for aspirin for cardiovascular prophylaxis. It is not known if there are any effects of celecoxib on platelets that may contribute to the increased risk of serious cardiovascular thrombotic adverse events associated with the use of celecoxib.

Fluid Retention Inhibition of PGE2 synthesis may lead to sodium and water retention through increased reabsorption in the renal medullary thick ascending loop of Henle and perhaps other segments of the distal nephron. In the collecting ducts, PGE2 appears to inhibit water reabsorption by counteracting the action of antidiuretic hormone.

🔬 Clinical Studies ~2 min read ▾

14 CLINICAL STUDIES

14.1Migraine The efficacy of ELYXYB for the acute treatment of migraine with or without aura was demonstrated in two randomized, double-blind, placebo-controlled clinical trials [Study 1 (NCT03009019) and Study 2 (NCT03006276)]. In Study 1, patients were randomized to receive ELYXYB 120 mg (n=316) or placebo (n=315); in Study 2, patients were also randomized to receive ELYXYB 120 mg (n=311) or placebo (n=311). In both studies, patients were instructed to treat a migraine with moderate to severe pain intensity.

Patients enrolled in the trials were predominantly female (86%) and White (74%), with a mean age of 40.6 years (range 18 to 75 years). The primary efficacy analyses were conducted in patients who treated a migraine with moderate to severe pain. The efficacy of ELYXYB was established by an effect on pain freedom at 2 hours post-dose and most bothersome symptom (MBS) freedom at 2 hours post-dose.

Pain freedom was defined as a reduction of moderate or severe headache pain to no pain, and MBS freedom was defined as the absence of the self-identified MBS (photophobia, phonophobia, or nausea). Among patients who selected a MBS, the most commonly selected MBS was photophobia (56%), followed by nausea (25%), and phonophobia (18%). In both studies, the percentage of patients achieving MBS freedom at 2 hours post-dose was significantly greater among patients receiving ELYXYB, compared to those receiving placebo.

In Study 2, the percentage of patients achieving headache pain freedom at 2 hours post-dose was significantly greater among patients receiving ELYXYB, compared to those receiving placebo ( see Table 2 ). Table 2: Migraine Efficacy Endpoints for Study 1 and Study 2 a Not statistically significant Study 1 Study 2 Placebo ELYXYB 120 mg Placebo ELYXYB 120 mg Pain Free at 2 hours N 273 284 271 279 % Responders 25.3 32.4 21.0

35.1Difference from placebo (%) 7 14 p-value 0.076 a <0.001 Most Bothersome Symptom Free at 2 hours N 234 245 237 236 % Responders 44.4 58.0 43.9

56.8Difference from placebo (%) 14 13 p-value 0.003 0.006

🧪 Nonclinical Toxicology ~1 min read ▾

13 NONCLINICAL TOXICOLOGY

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Carcinogenesis Celecoxib was not carcinogenic when administered orally for two years to rats at oral doses up to 200 mg/kg for males and 10 mg/kg for females (associated with plasma exposures (AUC) approximately 14 and 7 times, respectively, that in humans at the maximum recommended human dose (MRHD) of 120 mg/day) or in mice at oral doses up to 25 mg/kg for males and 50 mg/kg for females (associated with plasma AUCs approximately 4 times in humans at the MRHD).

Mutagenesis Celecoxib was not mutagenic in an Ames test and a mutation assay in Chinese hamster ovary (CHO) cells, nor clastogenic in a chromosome aberration assay in CHO cells and an in vivo micronucleus test in rat bone marrow. Impairment of Fertility Administration of celecoxib to male and female rats prior to and during mating and continuing in females through implantation had no effect on fertility or male reproductive function at oral doses up to 600 mg/kg/day, which were associated with plasma AUCs approximately 40 times that in humans at the MRHD.

Increased implantation loss was observed at doses ≥50 mg/kg/day, which was associated with plasma AUC approximately 20 times that in humans at the MRHD.

13.2Animal Toxicology and/or Pharmacology An increase in the incidence of background findings of spermatocele with or without secondary changes such as epididymal hypospermia as well as minimal to slight dilation of the seminiferous tubules were seen in the juvenile rat. These reproductive findings while apparently treatment-related did not increase in incidence or severity with dose and may indicate an exacerbation of a spontaneous condition. Similar reproductive findings were not observed in studies of juvenile or adult dogs or in adult rats treated with celecoxib.

The clinical significance of this observation is unknown.

📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 202 words ▾

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Carcinogenesis Celecoxib was not carcinogenic when administered orally for two years to rats at oral doses up to 200 mg/kg for males and 10 mg/kg for females (associated with plasma exposures (AUC) approximately 14 and 7 times, respectively, that in humans at the maximum recommended human dose (MRHD) of 120 mg/day) or in mice at oral doses up to 25 mg/kg for males and 50 mg/kg for females (associated with plasma AUCs approximately 4 times in humans at the MRHD).

Mutagenesis Celecoxib was not mutagenic in an Ames test and a mutation assay in Chinese hamster ovary (CHO) cells, nor clastogenic in a chromosome aberration assay in CHO cells and an in vivo micronucleus test in rat bone marrow. Impairment of Fertility Administration of celecoxib to male and female rats prior to and during mating and continuing in females through implantation had no effect on fertility or male reproductive function at oral doses up to 600 mg/kg/day, which were associated with plasma AUCs approximately 40 times that in humans at the MRHD.

Increased implantation loss was observed at doses ≥50 mg/kg/day, which was associated with plasma AUC approximately 20 times that in humans at the MRHD.

📖 Instructions for Use ~2 min read ▾

Instructions For Use ELYXYB (ee-lix'-ib) (celecoxib) oral solution 25 mg/mL Read this Instructions for Use before you start taking ELYXYB and each time you get a refill. There may be new information. This leaflet does not take the place of talking to your healthcare provider about your medical condition or treatment.

Take ELYXYB exactly how your healthcare provider tells you to. If your healthcare provider has prescribed 120 mg of ELYXYB, take all of the medicine in the bottle as described below in Instructions-1 . If your healthcare provider has prescribed 60 mg of ELYXYB, take 2.4 mL of the medicine, as described in Instructions-2 .

You will need a dosing syringe from the pharmacy to give the right amount of medicine. Do not use a household teaspoon to measure ELYXYB. Instructions-1 (Full dose of 120 mg) Step 1 : When you need to take ELYXYB, push down the cap and turn it to the left (counterclockwise) to open it.

Step 2 : When taking 120 mg of ELYXYB, drink it directly from the bottle. Hold the bottle upside down for 10 seconds to make sure the full amount of medicine is taken. Step 3 : Close the bottle by turning the cap to the right (clockwise) right away after drinking the medicine.

Step 4 : Throw away (discard) the bottle. Step 5 : After you take ELYXYB, you may drink up to 8 ounces (240 mL) of water. Instructions-2 (50% reduced dose of 60 mg) Step 1 : When you need to take ELYXYB, push down the cap and turn it to the left (counterclockwise to open it.

Step 2 : Use an oral dosing syringe (3 mL or 5 mL) from your pharmacy to withdraw 2.4 mL of ELYXYB. Insert the syringe through ELYXYB bottle opening and draw up 2.4 mL of ELYXYB directly from the bottle into the syringe. This 2.4 mL will be your 60 mg dose.

Note: Do not use a household teaspoon to measure ELYXYB. Step 3 : Place the 2.4 mL of the ELYXYB that is in the dosing syringe in your mouth and swallow it right away. Step 4 : Close the bottle tightly by turning the cap to the right (clockwise) right away after taking the correct dose of ELYXYB.

Note: Do not store the bottle to reuse the remaining medicine. Step 5 : Throw away (discard) the bottle with the unused ELYXYB. Step 6 : After you take ELYXYB, you may drink up to 8 ounces (240 mL) of water.

These Instructions for Use have been approved by the U.S. Food and Drug Administration Revised: June 2023 For more information call SCILEX Pharmaceuticals Inc. at 1-866-SCILEX3. Manufactured by: Contract Pharmaceuticals Limited, Mississauga, Ontario, Canada Manufactured for: SCILEX Pharmaceuticals Inc., Palo Alto, CA 94303 Active Ingredient Made in India ELYXYB is a trademark of SCILEX Pharmaceuticals Inc. ©2023 SCILEX Pharmaceuticals Inc.

All rights reserved. ELY-00085 06/2023 SCILEX ® PHARMACEUTICALS Figure Figure Figure Figure Figure Figure Figure Figure Figure Figure

📄 Recent Major Changes 7 words ▾

Warnings and Precautions ( 5.9 ) 11/2024

📄 Package Label / Principal Display Panel 90 words ▾

Principal Display Panel – 4.8 mL Carton Label SCILEX ® PHARMACEUTICALS NDC 69557-333-01 Elyxyb ™ (celecoxib) Oral Solution 120 mg/4.8 mL (25 mg/mL) For Oral use only Rx Only Discard unused portion immediately after use. Do not store or reuse leftover Elyxyb oral solution. Warning: Keep out of reach of children.

Warning: Check the dose your healthcare provider has prescribed. Pharmacist: Dispense in this sealed carton, which contains six (6) unit dose glass bottles. Dispense the enclosed Medication Guide to each patient.

Principal Display Panel – 4.8 mL Carton Label

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

Medicaid utilization by pack size

Medicaid (SDUD) totals over the four most recent reported quarters for every package size of this drug — handy when a specific package (e.g. a starter/titration pack) carries little or no Medicaid volume on its own.
6 bottles69557-0333-01 1,505 Rx · $1,450,149
1 bottle this page69557-0333-02 No Medicaid data
Drug total (last 4 qtrs): 1,505 Rx · 49,038 units · $1,450,149 gross reimbursed
Tap a pack size to open its page. Source: CMS State Drug Utilization Data, last 4 quarters.

Medicare Part D spend CMS · PART D · 2026 (Q1)

Medicare Part D (outpatient prescription) spending for Celecoxib (matched by generic name) — the program that covers self-administered drugs. 25 manufacturers.
⚠️ Drug-level data: CMS publishes Part D spending by drug, not by NDC — these figures combine every manufacturer, strength and package size sold under the name Celecoxib. CMS lists 4 products for this generic; we show the highest-spend one. That’s a different level of aggregation than the Medicaid card above, which is specific to this exact 11-digit NDC (pack size included), so the two aren’t directly comparable.
Period
Total Part D spend
$38.36M
Claims incl. refills
1.6M
Beneficiaries
1.1M
Spend / beneficiary
$34.12
Spend / claim
$23.40
Trend by period
💵 About the dollar figures: spending is what Part D plans paid before confidential manufacturer rebates, so the program’s real net cost is lower. A blank patient count means fewer than 11 people — CMS hides counts that small to protect privacy. Source: CMS Medicare Quarterly Part D Spending by Drug (data.cms.gov), updated quarterly.

Reported adverse events (FAERS)

Read carefully: FAERS reports are voluntary and unverified. Counts are not incidence, do not establish causation, are subject to reporting bias, and cannot be used to compare one drug to another. Shown for signal context only. Reports for Celecoxib — the ingredient across all brands.

Top reported reactions

Pain12,605
Arthralgia11,261
Fatigue10,100
Nausea9,771
Drug Hypersensitivity7,939
Diarrhoea7,598
Headache7,510

Reporter sex

130,888 reports
Male · 29%
Female · 70%
Unknown · 0%

Serious outcomes

Death12,395
Disabling8,158
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 8,494 0
Most recent year is provisional (FAERS lags ~3 months).
Where does this data come from?
Adverse-event reports from the FDA Adverse Event Reporting System (FAERS) via openFDA. FAERS reports are voluntary and unverified — counts are not incidence and don’t establish causation.

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 ✓ Available
Inactive ingredients (structured) ✓ 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 ✓ Available
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 SCILEX PHARMACEUTICALS INC.. Listing status can change — the directory data on this page refreshes weekly.
Does this product come in other package sizes?
Yes — the FDA directory lists 1 other package presentation of this same product, including 6 bottles (69557-0333-01). Each has its own NDC and its own page — see the package list near the top of this page.
Who lists this product with the FDA?
SCILEX PHARMACEUTICALS INC. 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.
← 69557-0222-01 · Scilex 69561-0005-01 · Henan →
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.