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Celecoxib 100 mg Capsule, 60-count — NDC 63187-0643-60 package photo

Celecoxib 100 mg Capsule, 60-count

by Proficient Rx LP · 60 CAPSULE in 1 BOTTLE (63187-643-60)
NDC 63187-0643-60
🏷️ FDA NDC (as labeled) 63187-643-60 billing pads the product segment with a zero
This package
Contains60-count Pack sizes3 compare ↓
Also priced by: Part D plans $0.2958/unit — full pricing hub ↓
Also comes in: 30 capsules 63187-0643-30 90 capsules 63187-0643-90
Rx only Generic On market Non-controlled
🗂️ Data synced 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

FDA NDC (as labeled) 63187-643-60
Product NDC 63187-643
11-digit billing NDC 63187064360
NCPDP billing unit EA — each (per item)
RxCUI 205322
UNII JCX84Q7J1L
UPC 0363187643607
Application # ANDA200562
SPL Set ID c529b321-38ed-434f-b76e-06902cdd40dc
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 ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2015-03-12
Route ORAL
Dosage form CAPSULE
Substance CELECOXIB
GPI-14 66100525000120
GPI class Celecoxib
GCN Seq No 041285
GCN 42001
HICL code 018979
Ingredient (HICL) Celecoxib
HIC1 code S
Therapeutic class — broad (HIC1) Locomotor System
HIC2 code S2
Therapeutic class — intermediate (HIC2) Drugs Acting Principally On Joints
HIC3 code S2L
Therapeutic class — specific (HIC3) Nsaids,Cyclooxygenase-2(Cox-2) Selective Inhibitor
AHFS code 28:08.04.08
AHFS class Cyclooxygenase-2 (Cox-2) Inhibitors
FDB label name CELECOXIB 100 MG CAPSULE
FDB brand name Celecoxib
Legend status F — Federal legend — prescription drug or device
TE code (Orange Book) AB · RLD · RS
Why two NDCs? The FDA registers this code as 63187-643-60 — 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 → 63187-0643-60. 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.

🏭 Manufacturer & labeler

LabelerProficient Rx LP
Application holderWATSON LABORATORIES INC
FDA applicationANDA200562 (ANDA)
Labeler code63187
First marketedMar 2015
Product typeHuman Prescription Drug
Portfolio1,723 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.

🩺 Clinical

Label name CELECOXIB 100 MG CAPSULE Ingredient Celecoxib
📗 Our plain-language guide HelloPharmacist
  • Celecoxib is used for several different conditions depending on the form you have. The capsules treat arthritis pain (osteoarthritis, rheumatoid arthritis, ankylosing spondylitis),...
  • What conditions is celecoxib actually used for?
  • It depends on which form you have. Regular celecoxib capsules at lower doses can be taken with or without food. At higher doses, taking them with food actually helps your body abso...
  • Should I take celecoxib with food or on an empty stomach?
📖 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.

💊 What it looks like

Color White / Blue
ShapeCapsule
ImprintWPI;100
Size14 mm
ScoringNot scored
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 68401960MK
    Crospovidone is a synthetic polymer made from polyvinylpyrrolidone. It acts as a disintegrant, helping tablets break apart quickly in the stomach so the medicine dissolves and absorbs into the body.
  • UNII 2G86QN327L
    Gelatin is a protein derived from animal collagen, commonly used in medicines as a gelling agent and capsule material. It helps create soft or hard capsule shells that hold and release medication, and can also thicken liquid formulations.
  • UNII EWQ57Q8I5X
    Lactose monohydrate is a natural sugar derived from milk. It serves as a filler and binder in tablets and capsules, helping create the proper size, texture, and consistency of the medicine.
  • UNII 70097M6I30
    Magnesium stearate is a salt made from magnesium and stearic acid, a fatty substance. It's used in tablets and capsules as a lubricant and glidant to help ingredients flow smoothly during manufacturing and prevent sticking.
  • UNII FZ989GH94E
    Povidone is a synthetic polymer made from a plastic-like material. It acts as a binder to hold tablet ingredients together and as a disintegrant to help the tablet break apart in your stomach so the medicine can be absorbed.
  • UNII 368GB5141J
    A detergent and foaming agent derived from coconut or palm oil. In medications, it helps break down and mix oil and water-based ingredients, aids in tablet disintegration, and improves how the drug dissolves and spreads in the mouth or digestive system.

6 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.

💲 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 · Q2 2026 $0.2958 $17.75 / 60 capsules
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.

🔁 Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Celecoxib 100 mg 00591-3983-01 Actavis 100 capsules $0.062 AB Availability likely —
Celecoxib 100 mg 00904-7550-61 Major 100 capsules $0.062 AB Availability likely —
Celecoxib 100 mg 11788-0113-01 AiPing 100 capsules $0.062 AB Availability likely —
Celecoxib 100 mg 16714-0732-01 NorthStar 100 capsules $0.062 AB Availability likely —
Celecoxib 100 mg 23155-0964-01 Avet 100 capsules $0.062 AB Availability likely —
Celecoxib 100 mg 27808-0296-01 Cranbury 100 capsules $0.062 AB Availability likely —
celecoxib 100 mg 33342-0156-11 Macleods 100 capsules $0.062 AB Availability likely —
Celecoxib 100 mg 42571-0143-01 Micro 100 capsules $0.062 AB Availability likely —
Celecoxib 100 mg 42806-0721-01 EPIC 100 capsules $0.062 AB Availability likely —
Celecoxib 100 mg 50228-0157-01 ScieGen 100 capsules $0.062 AB Availability likely —
Celecoxib 100 mg 50268-0168-15 AvPAK 50 capsules $0.062 AB Availability likely —
Celecoxib 100 mg 60505-3848-01 Apotex 100 capsules $0.062 AB Availability likely —
Celecoxib 100 mg 60687-0436-01 American 100 capsules $0.062 AB Availability likely —
Celecoxib 100 mg 62135-0021-60 Chartwell 60 capsules $0.062 AB Availability likely —
Celecoxib 100 mg 65862-0908-01 Aurobindo 100 capsules $0.062 AB Availability likely —
celecoxib 100 mg 68180-0396-01 Lupin 100 capsules $0.062 AB Availability likely —
Celecoxib 100 mg 69367-0301-01 Westminster 100 capsules $0.062 AB Availability likely —
Celecoxib 100 mg 75834-0237-01 NIVAGEN 100 capsules $0.062 AB Availability likely —
Celecoxib 100 mg 82009-0068-05 Quallent 500 capsules $0.062 AB Availability likely —
Celecoxib 100 mg 83301-0011-01 Mullan 100 capsules $0.062 AB Availability likely —
celecoxib 100 mg 13668-0441-01 Torrent 100 capsules $0.090 AB FDA listed —
Celebrex 100 mg 58151-0083-01 Viatris 100 capsules $9.542 AB Availability likely —
Celecoxib 100 mg 00615-8572-39 NCS 30 capsules — AB FDA listed —
Celecoxib 100 mg 29300-0158-01 Unichem 100 capsules — — FDA listed —
Celecoxib 100 mg 46708-0268-10 Alembic 100 capsules — AB FDA listed —
Celecoxib 100 mg 50090-6380-00 A-S 30 capsules — AB FDA listed —
Celecoxib 100 mg 51655-0059-52 Northwind 30 capsules — AB FDA listed —
Celecoxib 100 mg 51655-0436-25 Northwind 60 capsules — AB FDA listed —
celecoxib 100 mg 55700-0613-30 Quality 30 capsules — AB FDA listed —
Celecoxib 100 mg 57582-0212-01 Tianjin 100 capsules — AB FDA listed —
Celecoxib 100 mg 60290-0017-01 Umedica 100 capsules — AB FDA listed —
Celecoxib 100 mg 60760-0649-60 ST. 60 capsules — AB FDA listed —
Celecoxib 100 mg 60760-0995-15 St. 15 capsules — AB FDA listed —
Celecoxib 100 mg 62332-0141-08 Alembic 80 capsules — AB FDA listed —
Celecoxib 100 mg 63187-0301-30 Proficient 30 capsules — AB FDA listed —
Celecoxib 100 mgthis 63187-0643-60 Proficient 60 capsules — AB FDA listed —
Celecoxib 100 mg 68788-4095-03 Preferred 30 capsules — AB FDA listed —
celecoxib 100 mg 68788-7286-03 Preferred 30 capsules — AB FDA listed —
Celecoxib 100 mg 68788-8206-03 Preferred 30 capsules — AB FDA listed —
Celecoxib 100 mg 69097-0422-02 Cipla 30 capsules — AB FDA listed —
Celecoxib 100 mg 69117-0021-01 Yiling 60 capsules — AB FDA listed —
Celecoxib 100 mg 70247-0007-10 Qingdao 100 capsules — AB FDA listed —
Celecoxib 100 mg 70518-3424-00 REMEDYREPACK 30 capsules — AB Discontinued —
Celecoxib 100 mg 70518-3826-00 REMEDYREPACK 90 capsules — AB FDA listed —
Celecoxib 100 mg 70518-4009-00 REMEDYREPACK 100 capsules — AB FDA listed —
Celecoxib 100 mg 70518-4508-00 REMEDYREPACK 60 capsules — AB FDA listed —
Celecoxib 100 mg 71205-0020-30 Proficient 30 capsules — AB FDA listed —
celecoxib 100 mg 71205-0439-30 Proficient 30 capsules — AB FDA listed —
Celecoxib 100 mg 71209-0055-03 Cadila 60 capsules — AB FDA listed —
Celecoxib 100 mg 71335-0292-01 Bryant 30 capsules — AB FDA listed —
celecoxib 100 mg 71335-0936-01 Bryant 30 capsules — AB FDA listed —
Celecoxib 100 mg 71335-1804-01 Bryant 30 capsules — AB FDA listed —
Celecoxib 100 mg 71335-2019-01 Bryant 30 capsules — AB FDA listed —
Celecoxib 100 mg 71335-2222-01 Bryant 30 capsules — AB FDA listed —
Celecoxib 100 mg 72162-2254-05 Bryant 500 capsules — AB FDA listed —
Celecoxib 100 mg 72189-0123-30 Direct 30 capsules — AB FDA listed —
Celecoxib 100 mg 72189-0662-60 Direct_Rx 60 capsules — AB FDA listed —
Celecoxib 100 mg 72241-0023-03 Modavar 60 capsules — AB FDA listed —
celecoxib 100 mg 76420-0243-01 Asclemed 1 capsule — AB FDA listed —
Celecoxib 100 mg 76420-0727-01 Asclemed 1 capsule — AB FDA listed —
Celecoxib 100 mg 76420-0843-00 Asclemed 1000 capsules — AB FDA listed —
Celecoxib 100 mg 77771-0157-01 Radha 100 capsules — AB FDA listed —
Celecoxib 100 mg 80425-0142-01 Advanced 30 capsules — AB FDA listed —
Celecoxib 100 mg 80425-0167-01 Advanced 30 capsules — AB FDA listed —
Celecoxib 100 mg 80425-0321-01 Advanced 30 capsules — AB FDA listed —
Celecoxib 100 mg 80425-0323-01 Advanced 30 capsules — AB FDA listed —
Celecoxib 100 mg 82804-0151-60 Proficient 60 capsules — AB FDA listed —
Celecoxib 100 mg 85509-1237-01 PHOENIX 120 capsules — AB FDA listed —
celecoxib 100 mg 85534-0014-00 HAWAII 30 capsules — AB FDA listed —
Celecoxib 100 mg 85534-0067-00 HAWAII 30 capsules — AB FDA listed —
Celecoxib 100 mg 55154-0160-00 Cardinal 10 capsules — AB FDA listed —
Celecoxib 100 mg 50090-8031-00 A-S 30 capsules — AB FDA listed —
Celecoxib 100 mg 72189-0685-72 Direct_Rx 120 capsules — AB FDA listed —
Celecoxib 100 mg 50090-8036-00 A-S 30 capsules — AB FDA listed —
Celecoxib 100 mg 60760-0942-60 St. 60 capsules — AB FDA listed —
About this product: this is a generic version of the medicine. FDA equivalence ratings are shown when available, and other versions are listed above, least expensive first.
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

🏛️
2015
On the market since
Mar 2015
📍
2026
Currently FDA-listed
11 years listed
🔓
·
Generic on the market
this product is a generic
✅This is a generic drug

This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.

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.

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

Medicare Part D (outpatient prescription) spending for Celecoxib — 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. 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

Age at onset

Neonate63
Infant15
Child143
Adolescent146
Adult9,514
Elderly5,530

Reporter sex

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

Serious outcomes

Hospitalization40,400
Life-threatening7,448
Reports over time (by year) — tap or hover for the count & year
2020 2022 2024 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.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
63187-0643-30 30 CAPSULE in 1 BOTTLE (63187-643-30) 2018-12-01 Active
63187-0643-60 You're viewing this 60 CAPSULE in 1 BOTTLE (63187-643-60) 2018-12-01 Active
63187-0643-90 90 CAPSULE in 1 BOTTLE (63187-643-90) 2018-12-01 Active

You're viewing one of 3 pack sizes for this product.

Pack size FAQ

What quantity is in NDC 63187-0643-60?
NDC 63187-0643-60 is a 60-count package — 60 capsule in 1 bottle.
What is the difference between NDC 63187-0643-60 and NDC 63187-0643-30?
Both are Celecoxib 100 mg Capsule — the drug itself is identical. NDC 63187-0643-60 is the 60-count package, while NDC 63187-0643-30 is the 30 capsules package.
What NDC number is used to bill for this package of Celecoxib 100 mg Capsule?
Bill NDC 63187-0643-60 — the 11-digit billing format is 63187064360. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

🧭 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 FDA registers it as 63187-643-60, which is what is printed on the packaging and shown on DailyMed. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero: 63187-0643-60, written without dashes as 63187064360. The Identity section at the top of this page lists every form of this code.
What do the three segments of this NDC mean?
In 63187-0643-60, the first segment (63187) is the labeler code FDA assigned to Proficient Rx LP; the middle segment (0643) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (60) identifies this exact package size and type. Together they name one specific package of one specific product.
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 Proficient Rx LP. 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 2 other package presentations of this same product, including 30 capsules (63187-0643-30), 90 capsules (63187-0643-90). 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?
Proficient Rx LP 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.

📄 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.
🚨 Boxed Warning 🎯 Indications and Usage ⏱️ Dosage and Administration 💊 Dosage Forms and Strengths ⛔ Contraindications ⚠️ Warnings and Cautions 🤒 Adverse Reactions 🔄 Drug Interactions 👥 Use in Specific Populations 🆘 Overdosage 🧬 Clinical Pharmacology 📦 How Supplied / Storage and Handling 📋 Description 💬 Information for Patients 💬 Medication Guide
🚨 Boxed Warning ~1 min read ▾

WARNING: CARDIOVASCULAR AND GASTROINTESTINAL RISKS Cardiovascular Risk • Celecoxib capsules may cause an increased risk of serious cardiovascular thrombotic events, myocardial infarction, and stroke, which can be fatal. All nonsteroidal anti-inflammatory drugs (NSAIDs) may have a similar risk. This risk may increase with duration of use.

Patients with cardiovascular disease or risk factors for cardiovascular disease may be at greater risk. ( 5.1 , 14.6 ) • Celecoxib is contraindicated for the treatment of perioperative pain in the setting of coronary artery bypass graft (CABG) surgery. ( 4 , 5.1 ) Gastrointestinal Risk • NSAIDs, including celecoxib, cause an increased risk of serious gastrointestinal 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 are at greater risk for serious gastrointestinal events. ( 5.4 ) WARNING: CARDIOVASCULAR AND GASTROINTESTINAL RISKS See full prescribing information for complete boxed warning Cardiovascular Risk • Celecoxib capsules may cause an increased risk of serious cardiovascular thrombotic events, myocardial infarction, and stroke, which can be fatal.

All NSAIDs may have a similar risk. This risk may increase with duration of use. Patients with cardiovascular disease or risk factors for cardiovascular disease may be at greater risk.

( 5.1 , 14.6 ) • Celecoxib is contraindicated for the treatment of peri-operative pain in the setting of coronary artery bypass graft (CABG) surgery. ( 4, 5.1 ) Gastrointestinal Risk • NSAIDs, including celecoxib, cause an increased risk of serious gastrointestinal 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 are at greater risk for serious gastrointestinal (GI) events. ( 5.4 )

🎯 Indications and Usage ~1 min read ▾

1. INDICATIONS AND USAGE Carefully consider the potential benefits and risks of celecoxib capsules and other treatment options before deciding to use celecoxib capsules. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals [see Warnings and Precautions (5) ] Celecoxib is a nonsteroidal anti-inflammatory drug indicated for: • Osteoarthritis (OA) ( 1.1 ) • Rheumatoid Arthritis (RA) ( 1.2 ) • Juvenile Rheumatoid Arthritis (JRA) in patients 2 years and older ( 1.3 ) • Ankylosing Spondylitis (AS) ( 1.4 ) • Acute Pain (AP) ( 1.5 ) • Primary Dysmenorrhea (PD) ( 1.6 )

1.1Osteoarthritis (OA) Celecoxib is indicated for relief of the signs and symptoms of OA [see Clinical Studies (14.1) ]

1.2Rheumatoid Arthritis (RA) Celecoxib is indicated for relief of the signs and symptoms of RA [see Clinical Studies (14.2) ]

1.3Juvenile Rheumatoid Arthritis (JRA) Celecoxib is indicated for relief of the signs and symptoms of JRA in patients 2 years and older [see Clinical Studies (14.3) ]

1.4Ankylosing Spondylitis (AS) Celecoxib is indicated for the relief of signs and symptoms of AS [see Clinical Studies (14.4) ]

1.5Acute Pain (AP) Celecoxib is indicated for the management of AP in adults [see Clinical Studies (14.5) ]

1.6Primary Dysmenorrhea (PD) Celecoxib is indicated for the treatment of PD [see Clinical Studies (14.5) ]

⏱️ Dosage and Administration ~3 min read ▾

2. DOSAGE AND ADMINISTRATION Use lowest effective dose for the shortest duration consistent with treatment goals for the individual patient. These doses can be given without regard to timing of meals.

Use lowest effective dose for the shortest duration consistent with treatment goals for the individual patient. ( 1 , 5.1 , 5.4 ) • OA: 200 mg once daily or 100 mg twice daily ( 2.1 , 14.1 ) • RA: 100 to 200 mg twice daily ( 2.2 , 14.2 ) • JRA: 50 mg twice daily in patients 10-25 kg. 100 mg twice daily in patients more than 25 kg ( 2.3 , 14.3 ) • AS: 200 mg once daily single dose or 100 mg twice daily.

If no effect is observed after 6 weeks, a trial of 400 mg (single or divided doses) may be of benefit ( 2.4 , 14.4 ) • AP and PD: 400 mg initially, followed by 200 mg dose if needed on first day. On subsequent days, 200 mg twice daily as needed ( 2.5 , 14.5 ) Reduce daily dose by 50% in patients with moderate hepatic impairment (Child-Pugh Class B). Consider a dose reduction by 50% (or alternative management for JRA) in patients who are known or suspected to be CYP2C9 poor metabolizers, ( 2.6 , 8.4 , 8.8 , 12.3 ).

2.1Osteoarthritis For relief of the signs and symptoms of OA the recommended oral dose is 200 mg per day administered as a single dose or as 100 mg twice daily.

2.2Rheumatoid Arthritis For relief of the signs and symptoms of RA the recommended oral dose is 100 to 200 mg twice daily.

2.3Juvenile Rheumatoid Arthritis For the relief of the signs and symptoms of JRA the recommended oral dose for pediatric patients (age 2 years and older) is based on weight. For patients > 10 kg to < 25 kg the recommended dose is 50 mg twice daily. For patients >25 kg the recommended dose is 100 mg twice daily.

For patients who have difficulty swallowing capsules, the contents of a celecoxib capsule can be added to applesauce. The entire capsule contents are carefully emptied onto a level teaspoon of cool or room temperature applesauce and ingested immediately with water. The sprinkled capsule contents on applesauce are stable for up to 6 hours under refrigerated conditions (2-8° C/ 35-45° F).

2.4Ankylosing Spondylitis For the management of the signs and symptoms of AS, the recommended dose of celecoxib capsules is 200 mg daily in single (once per day) or divided (twice per day) doses. If no effect is observed after 6 weeks, a trial of 400 mg daily may be worthwhile. If no effect is observed after 6 weeks on 400 mg daily, a response is not likely and consideration should be given to alternate treatment options.

2.5Management of Acute Pain and Treatment of Primary Dysmenorrhea The recommended dose of celecoxib capsules is 400 mg initially, followed by an additional 200 mg dose if needed on the first day. On subsequent days, the recommended dose is 200 mg twice daily as needed.

2.6Special Populations Hepatic insufficiency: The daily recommended dose of celecoxib capsules in patients with moderate hepatic impairment (Child-Pugh Class B) should be reduced by 50%. The use of celecoxib in patients with severe hepatic impairment is not recommended [see Warnings and Precautions (5.5) , Use in Specific Populations (8.6) and Clinical Pharmacology (12.3) ]. Poor Metabolizers of CYP2C9 Substrates: Patients who are known or suspected to be poor CYP2C9 metabolizers based on genotype or previous history/experience with other CYP2C9 substrates (such as warfarin, phenytoin) should be administered celecoxib with caution.

Consider starting treatment at half the lowest recommended dose in poor metabolizers (i.e. CYP2C9*3/*3). Consider using alternative management in JRA patients who are poor metabolizers. [see Use in Specific populations (8.8) , and Clinical Pharmacology (12.5) ].

💊 Dosage Forms and Strengths 28 words ▾

3. DOSAGE FORMS AND STRENGTHS Capsules: 50 mg, 100 mg, 200 mg and 400 mg Capsules: 50 mg, 100 mg, 200 mg and 400 mg ( 3 )

⛔ Contraindications 138 words ▾

4. CONTRAINDICATIONS Celecoxib is contraindicated: In patients with known hypersensitivity to celecoxib, aspirin, or other NSAIDs. In patients who have demonstrated allergic-type reactions to sulfonamides.

In patients who have experienced asthma, urticaria, or allergic-type reactions after taking aspirin or other NSAIDs. Severe anaphylactoid reactions to NSAIDs, some of them fatal, have been reported in such patients [see Warnings and Precautions (5.7 , 5.13) ]. For the treatment of peri-operative pain in the setting of coronary artery bypass graft (CABG) surgery [see Warnings and Precautions (5.1) ]. • Known hypersensitivity to celecoxib or sulfonamides ( 4 ) • History of asthma, urticaria, or other allergic-type reactions after taking aspirin or other NSAIDs ( 4 , 5.7 , 5.8 , 5.13 ) • Use during the perioperative period in the setting of coronary artery bypass graft (CABG) surgery (4, 5.1)

⚠️ Warnings and Cautions ~3 min read ▾

5. WARNINGS AND PRECAUTIONS • Serious and potentially fatal cardiovascular (CV) thrombotic events, myocardial infarction, and stroke. Patients with known CV disease/risk factors may be at greater risk ( 5.1 , 14.6 , 17.2 ). • Serious gastrointestinal (GI) adverse events, which can be fatal.

The risk is greater in patients with a prior history of ulcer disease or GI bleeding, and in patients at high risk for GI events, especially the elderly. Celecoxib capsules should be used with caution in these patients ( 5.4 , 8.5 , 14.6 , 17.3 ). • Elevated liver enzymes and, rarely, severe hepatic reactions. Discontinue use of celecoxib capsules immediately if abnormal liver enzymes persist or worsen ( 5.5 , 17.4 ). • New onset or worsening of hypertension.

Blood pressure should be monitored closely during treatment with celecoxib capsules ( 5.2 , 7.4 , 17.2 ). • Fluid retention and edema. Celecoxib capsules should be used with caution in patients with fluid retention or heart failure ( 5.3 , 17.6 ). • Renal papillary necrosis and other renal injury with long term use. Use celecoxib capsules with caution in the elderly, those with impaired renal function, heart failure, liver dysfunction, and those taking diuretics, ACE-inhibitors, or angiotensin II antagonists ( 5.6 , 7.4 , 8.7 , 17.6 ). • Anaphylactoid reactions.

Do not use celecoxib capsules in patients with the aspirin triad ( 5.7 , 10 , 17.7 ). • Serious skin adverse events such as exfoliative dermatitis, Stevens-Johnson syndrome (SJS), and toxic epidermal necrolysis (TEN), which can be fatal and can occur without warning even without known prior sulfa allergy. Discontinue celecoxib capsules at first appearance of rash or skin reactions ( 5.8 , 17.5 ).

5.1Cardiovascular Thrombotic Events Chronic use of celecoxib capsules may cause an increased risk of serious adverse cardiovascular thrombotic events, myocardial infarction, and stroke, which can be fatal. In the APC (Adenoma Prevention with Celecoxib) trial, the hazard ratio for the composite endpoint of cardiovascular death, MI, or stroke was 3.4 (95% CI 1.4 – 8.5) for celecoxib capsules 400 mg twice daily and 2.8 (95% CI 1.1 – 7.2) with celecoxib capsules 200 mg twice daily compared to placebo. Cumulative rates for this composite endpoint over 3 years were 3.0% (20/671 subjects) and 2.5% (17/685 subjects), respectively, compared to 0.9% (6/679 subjects) with placebo treatment.

The increases in both celecoxib dose groups versus placebo-treated patients were mainly due to an increased incidence of myocardial infarction [see Clinical Studies (14.6) ]. All NSAIDs, both COX-2 selective and non-selective, may have a similar risk. Patients with known CV disease or risk factors for CV disease may be at greater risk.

To minimize the potential risk for an adverse CV event in patients treated with celecoxib, the lowest effective dose should be used for the shortest duration consistent with individual patient treatment goals. Physicians and patients should remain alert for the development of such events, even in the absence of previous CV symptoms. Patients should be informed about the signs and/or symptoms of serious CV toxicity 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 celecoxib does increase the risk of serious GI events [see Warnings and Precautions (5.4) ]. Two large, controlled, clinical trials of a different COX-2 selective NSAID for the treatment of pain in the first 10-14 days following CABG surgery found an increased incidence of myocardial infarction and stroke [see Contraindications (4) ].

5.2Hypertension As with all NSAIDs, celecoxib can lead to the onset of new hypertension or worsening of preexisting hypertension, either of which may contribute to the increased incidence of CV events. Patients taking thiazides or loop diuretics may have impaired respo…

🤒 Adverse Reactions ~3 min read ▾

6. ADVERSE REACTIONS Of the celecoxib-treated patients in the pre-marketing controlled clinical trials, approximately 4,250 were patients with OA, approximately 2,100 were patients with RA, and approximately 1,050 were patients with post-surgical pain. More than 8,500 patients received a total daily dose of celecoxib of 200 mg (100 mg twice daily or 200 mg once daily) or more, including more than 400 treated at 800 mg (400 mg twice daily).

Approximately 3,900 patients received celecoxib at these doses for 6 months or more; approximately 2,300 of these have received it for 1 year or more and 124 of these have received it for 2 years or more. 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 rates in the clinical trials of another drug and may not reflect the rates observed in practice. The adverse reaction information from clinical trials does, however, provide a basis for identifying the adverse events that appear to be related to drug use and for approximating rates.

Most common adverse reactions in arthritis trials (>2% and >placebo): abdominal pain, diarrhea, dyspepsia, flatulence, peripheral edema, accidental injury, dizziness, pharyngitis, rhinitis, sinusitis, upper respiratory tract infection, rash ( 6.1 ). To report SUSPECTED ADVERSE REACTIONS, contact Watson at 1-800-272-5525 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

6.1Pre-marketing Controlled Arthritis Trials Table 1 lists all adverse events, regardless of causality, occurring in ≥2% of patients receiving celecoxib from 12 controlled studies conducted in patients with OA or RA that included a placebo and/or a positive control group. Since these 12 trials were of different durations, and patients in the trials may not have been exposed for the same duration of time, these percentages do not capture cumulative rates of occurrence. Table 1: Adverse Events Occurring in >2% of Celecoxib Patients from Pre-marketing Controlled Arthritis Trials CBX Placebo NAP DCF IBU N=4146 N=1864 N=1366 N=387 N=345 CBX = Celecoxib 100 – 200 mg twice daily or 200 mg once daily; NAP = Naproxen 500 mg twice daily; DCF = Diclofenac 75 mg twice daily; IBU = Ibuprofen 800 mg three times daily.

Gastrointestinal Abdominal Pain 4.1% 2.8% 7.7% 9.0% 9.0% Diarrhea 5.6% 3.8% 5.3% 9.3% 5.8% Dyspepsia 8.8% 6.2% 12.2% 10.9% 12.8% Flatulence 2.2% 1.0% 3.6% 4.1% 3.5% Nausea 3.5% 4.2% 6.0% 3.4% 6.7% Abdominal Pain 4.1% 2.8% 7.7% 9.0% 9.0% Body as a whole Back Pain 2.8% 3.6% 2.2% 2.6% 0.9% Peripheral Edema 2.1% 1.1% 2.1% 1.0% 3.5% Injury-Accidental 2.9% 2.3% 3.0% 2.6% 3.2% Central, Peripheral Nervous system Dizziness 2.0% 1.7% 2.6% 1.3% 2.3% Headache 15.8% 20.2% 14.5% 15.5% 15.4% Psychiatric Dizziness 2.0% 1.7% 2.6% 1.3% 2.3% Headache 15.8% 20.2% 14.5% 15.5% 15.4% Insomnia 2.3% 2.3% 2.9% 1.3% 1.4% Respiratory Pharyngitis 2.3% 1.1% 1.7% 1.6% 2.6% Rhinitis 2.0% 1.3% 2.4% 2.3% 0.6% Sinusitis 5.0% 4.3% 4.0% 5.4% 5.8% Upper Respiratory Infection 8.1% 6.7% 9.9% 9.8% 9.9% Skin Rash 2.2% 2.1% 2.1% 1.3% 1.2% In placebo- or active-controlled clinical trials, the discontinuation rate due to adverse events was 7.1% for patients receiving celecoxib and 6.1% for patients receiving placebo.

Among the most common reasons for discontinuation due to adverse events in the celecoxib treatment groups were dyspepsia and abdominal pain (cited as reasons for discontinuation in 0.8% and 0.7% of celecoxib patients, respectively). Among patients receiving placebo, 0.6% discontinued due to dyspepsia and 0.6% withdrew due to abdominal pain. The following adverse reactions occurred in 0.1 - 1.9% of patients treated with celecoxib (100 - 200 mg twice daily or 200 mg once daily): Gastrointestinal: Constipation, diverticulitis, dysphagia, eructation, esophagitis, gastritis, gastroenteritis, gastroesophageal reflux, hemorrhoids, hiatal hernia, melena, dry mouth, stomatitis, tenesmus, vomiting Cardiovascular: Aggravated…

🔄 Drug Interactions ~3 min read ▾

7. DRUG INTERACTIONS General: Celecoxib metabolism is predominantly mediated via cytochrome P450 (CYP) 2C9 in the liver. Coadministration of celecoxib with drugs that are known to inhibit CYP2C9 should be done with caution.

Significant interactions may occur when celecoxib is administered together with drugs that inhibit CYP2C9. In vitro studies indicate that celecoxib, although not a substrate, is an inhibitor of CYP2D6. Therefore, there is a potential for an in vivo drug interaction with drugs that are metabolized by CYP2D6. • Concomitant use of celecoxib and warfarin may result in increased risk of bleeding complications.

( 7.1 ) • Concomitant use of celecoxib increases lithium plasma levels. ( 7.2 ) • Concomitant use of celecoxib may reduce the antihypertensive effect of ACE Inhibitors and angiotensin II antaonists ( 7.4 ) • Use caution with drugs known to inhibit P450 2C9 or metabolized by 2D6 due to the potential for increased plasma levels ( 2.6 , 8.4 , 8.8 , 12.3 )

7.1Warfarin Anticoagulant activity should be monitored, particularly in the first few days, after initiating or changing celecoxib therapy in patients receiving warfarin or similar agents, since these patients are at an increased risk of bleeding complications. The effect of celecoxib on the anticoagulant effect of warfarin was studied in a group of healthy subjects receiving daily 2-5 mg doses of warfarin. In these subjects, celecoxib did not alter the anticoagulant effect of warfarin as determined by prothrombin time.

However, in post-marketing experience, serious bleeding events, some of which were fatal, have been reported, predominantly in the elderly, in association with increases in prothrombin time in patients receiving celecoxib concurrently with warfarin.

7.2Lithium In a study conducted in healthy subjects, mean steady-state lithium plasma levels increased approximately 17% in subjects receiving lithium 450 mg twice daily with celecoxib 200 mg twice daily as compared to subjects receiving lithium alone. Patients on lithium treatment should be closely monitored when celecoxib is introduced or withdrawn.

7.3Aspirin Celecoxib capsules can be used with low-dose aspirin. However, concomitant administration of aspirin with celecoxib increases the rate of GI ulceration or other complications, compared to use of celecoxib alone [see Warnings and Precautions (5.1 , 5.4) and Clinical Studies (14.6) ]. Because of its lack of platelet effects, Celecoxib is not a substitute for aspirin for cardiovascular prophylaxis [see Clinical Pharmacology (12.2) ].

7.4ACE-Inhibitors and Angiotensin II Antagonists Reports suggest that NSAIDs may diminish the antihypertensive effect of Angiotensin Converting Enzyme (ACE) inhibitors and angiotensin II antagonists. This interaction should be given consideration in patients taking celecoxib concomitantly with ACE-inhibitors and angiotensin II antagonists [see Clinical Pharmacology (12.2) ].

7.5Fluconazole Concomitant administration of fluconazole at 200 mg once daily resulted in a two-fold increase in celecoxib plasma concentration. This increase is due to the inhibition of celecoxib metabolism via P450 2C9 by fluconazole [see Clinical Pharmacology (12.3) ]. Celecoxib capsules should be introduced at the lowest recommended dose in patients receiving fluconazole.

7.6Furosemide Clinical studies, as well as post-marketing observations, have shown that NSAIDs can reduce the natriuretic effect of furosemide and thiazides in some patients. This response has been attributed to inhibition of renal prostaglandin synthesis.

7.7Methotrexate In an interaction study of rheumatoid arthritis patients taking methotrexate, celecoxib did not have an effect on the pharmacokinetics of methotrexate [see Clinical Pharmacology (12.3) ].

7.8Concomitant NSAID Use The concomitant use of celecoxib capsules with any dose of a non-aspirin NSAID should be avoided due to the potential for increased risk of adverse reactions.

👥 Use in Specific Populations ~3 min read ▾

8. USE IN SPECIFIC POPULATIONS Pregnancy Category C prior to 30 weeks gestation; Category D starting at 30 weeks gestation ( 5.9 , 8.1 , 17.8 )

8.1Pregnancy Pregnancy Category C. Pregnancy category D from 30 weeks of gestation onward. Teratogenic effects: Celecoxib at oral doses ≥150 mg/kg/day (approximately 2-fold human exposure at 200 mg twice daily as measured by AUC 0-24 ), caused an increased incidence of ventricular septal defects, a rare event, and fetal alterations, such as ribs fused, sternebrae fused and sternebrae misshapen when rabbits were treated throughout organogenesis.

A dose-dependent increase in diaphragmatic hernias was observed when rats were given celecoxib at oral doses ≥30 mg/kg/day (approximately 6-fold human exposure based on the AUC 0-24 at 200 mg twice daily) throughout organogenesis. There are no studies in pregnant women. Celecoxib capsules should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Nonteratogenic effects: Celecoxib produced pre-implantation and post-implantation losses and reduced embryo/fetal survival in rats at oral dosages ≥50 mg/kg/day (approximately 6-fold human exposure based on the AUC 0-24 at 200 mg twice daily). These changes are expected with inhibition of prostaglandin synthesis and are not the result of permanent alteration of female reproductive function, nor are they expected at clinical exposures. No studies have been conducted to evaluate the effect of celecoxib on the closure of the ductus arteriosus in humans.

Therefore, use of celecoxib capsules during the third trimester of pregnancy should be avoided.

8.2Labor and Delivery Celecoxib produced no evidence of delayed labor or parturition at oral doses up to 100 mg/kg in rats (approximately 7-fold human exposure as measured by the AUC0-24 at 200 mg BID). The effects of celecoxib on labor and delivery in pregnant women are unknown.

8.3Nursing Mothers Limited data from 3 published reports that included a total of 12 breastfeeding women showed low levels of celecoxib in breast milk. The calculated average daily infant dose was 10-40 mcg/kg/day, less than 1% of the weight-based therapeutic dose for a two-year old-child. A report of two breastfed infants 17 and 22 months of age did not show any adverse events.

Caution should be exercised when celecoxib is administered to a nursing woman.

8.4Pediatric Use Celecoxib is approved for relief of the signs and symptoms of Juvenile Rheumatoid Arthritis in patients 2 years and older. Safety and efficacy have not been studied beyond six months in children. The long-term cardiovascular toxicity in children exposed to celecoxib has not been evaluated and it is unknown if long-term risks may be similar to that seen in adults exposed to celecoxib or other COX-2 selective and non-selective NSAIDs [(see Boxed Warning , Warnings and Precautions (5.12) , and Clinical Studies (14.3) ].

The use of celecoxib in patients 2 years to 17 years of age with pauciarticular, polyarticular course JRA or in patients with systemic onset JRA was studied in a 12-week, double-blind, active controlled, pharmacokinetic, safety and efficacy study, with a 12-week open-label extension. Celecoxib has not been studied in patients under the age of 2 years, in patients with body weight less than 10 kg (22 lbs), and in patients with active systemic features. Patients with systemic onset JRA (without active systemic features) appear to be at risk for the development of abnormal coagulation laboratory tests.

In some patients with systemic onset JRA, both celecoxib and naproxen were associated with mild prolongation of activated partial thromboplastin time (APTT) but not prothrombin time (PT). NSAIDs including celecoxib should be used only with caution in patients with systemic onset JRA, due to the risk of disseminated intravascular coagulation. Patients with systemic onset JRA should be monitored for the development of abnormal coagulation tests [see Dosage and Adm…

🆘 Overdosage 188 words ▾

10. OVERDOSAGE No overdoses of celecoxib were reported during clinical trials. Doses up to 2400 mg/day for up to 10 days in 12 patients did not result in serious toxicity.

Symptoms following acute NSAID overdoses are usually limited to lethargy, drowsiness, nausea, vomiting, and epigastric pain, which are generally reversible with supportive care. Gastrointestinal bleeding can occur. Hypertension, acute renal failure, respiratory depression and coma may occur, but are rare.

Anaphylactoid reactions have been reported with therapeutic ingestion of NSAIDs, and may occur following an overdose. Patients should be managed by symptomatic and supportive care following an NSAID overdose. There are no specific antidotes.

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. Emesis and/or activated charcoal (60 to 100 g in adults, 1 to 2 g/kg in children) and/or osmotic cathartic may be indicated in patients seen within 4 hours of ingestion with symptoms or following a large overdose. Forced diuresis, alkalinization of urine, hemodialysis, or hemoperfusion may not be useful due to high protein binding.

🧬 Clinical Pharmacology ~3 min read ▾

12. CLINICAL PHARMACOLOGY

12.1Mechanism of Action Celecoxib is a nonsteroidal anti-inflammatory drug that exhibits anti-inflammatory, analgesic, and antipyretic activities in animal models. The mechanism of action of celecoxib is believed to be due to inhibition of prostaglandin synthesis, primarily via inhibition of cyclooxygenase-2 (COX-2), and at therapeutic concentrations in humans, celecoxib does not inhibit the cyclooxygenase-1 (COX-1) isoenzyme. In animal colon tumor models, celecoxib reduced the incidence and multiplicity of tumors.

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 Absorption: Peak plasma levels of celecoxib occur approximately 3 hrs after an oral dose. Under fasting conditions, both peak plasma levels (C max ) and area under the curve (AUC) are roughly dose-proportional up to 200 mg BID; at higher doses there are less than proportional increases in C max and AUC [see Food Effects] . Absolute bioavailability studies have not been conducted.

With multiple dosing, steady-state conditions are reached on or before Day 5. The pharmacokinetic parameters of celecoxib in a group of healthy subjects are shown in Table 3. Table 3 Summary of Single Dose (200 mg) Disposition Kinetics of Celecoxib in Healthy Subjects 1 Mean (%CV) PK Parameter Values C max , ng/mL T max , hr Effective t 1/2 , hr V ss /F, L CL/F, L/hr 1 Subjects under fasting conditions (n=36, 19-52 yrs.) 705 (38) 2.8 (37) 11.2 (31) 429 (34) 27.7 (28) Food Effects: When celecoxib capsules were taken with a high fat meal, peak plasma levels were delayed for about 1 to 2 hours with an increase in total absorption (AUC) of 10% to 20%.

Under fasting conditions, at doses above 200 mg, there is less than a proportional increase in C max and AUC, which is thought to be due to the low solubility of the drug in aqueous media. Coadministration of celecoxib capsules with an aluminum- and magnesium-containing antacids resulted in a reduction in plasma celecoxib concentrations with a decrease of 37% in C max and 10% in AUC. Celecoxib capsules, at doses up to 200 mg twice daily, can be administered without regard to timing of meals.

Higher doses (400 mg twice daily) should be administered with food to improve absorption. In healthy adult volunteers, the overall systemic exposure (AUC) of celecoxib was equivalent when celecoxib was administered as intact capsule or capsule contents sprinkled on applesauce. There were no significant alterations in C max , T max or t1/2 after administration of capsule contents on applesauce [see Dosage and Administration (2) ].

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 at steady state (V ss /F) is approximately 400 L, suggesting extensive distribution into the tissues.

Celecoxib is not preferentially bound to red blood cells. Metabolism: Celecoxib metabolism is primarily mediated via CYP2C9. Three metabo…

📦 How Supplied / Storage and Handling 65 words ▾

16. HOW SUPPLIED/STORAGE AND HANDLING Celecoxib 100 mg capsules are opaque light blue cap printed "WPI" with black ink and opaque white colored body printed "100" with black ink containing white colored granular powder, supplied as: NDC Number Size 63187-643-30 bottle of 30 63187-643-60 bottle of 60 63187-643-90 bottle of 90 Storage: Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].

📋 Description 77 words ▾

11. DESCRIPTION Celecoxib is chemically designated as 4-[5-(4-methylphenyl)-3-(trifluoromethyl)-1H-pyrazol-1-yl] benzenesulfonamide and is a diaryl-substituted pyrazole. The empirical formula is C 17 H 14 F 3 N 3 O 2 S, and the molecular weight is 381.38; the chemical structure is as follows: Celecoxib oral capsules contain either 50 mg, 100 mg, 200 mg or 400 mg of celecoxib, together with inactive ingredients including: sodium lauryl sulfate, edible inks, gelatin, lactose monohydrate, crospovidone, povidone and magnesium stearate. celecxib structure

💬 Information for Patients ~3 min read ▾

17. PATIENT COUNSELING INFORMATION Patients should be informed of the following information before initiating therapy with celecoxib and periodically during the course of ongoing therapy.

17.1Medication Guide Patients should be informed of the availability of a Medication Guide for NSAIDs that accompanies each prescription dispensed, and should be instructed to read the Medication Guide prior to using celecoxib capsules.

17.2Cardiovascular Effects Patients should be informed that celecoxib capsules may cause serious CV side effects such as MI or stroke, which may result in hospitalization and even death. Patients should be informed of the the signs and symptoms of chest pain, shortness of breath, weakness, slurring of speech, and to seek immediate medical advice if they observe any of these signs or symptoms. [see Warnings and Precautions (5.1) ]. Patients should be informed that celecoxib capsules can lead to the onset of new hypertension or worsening of preexisting hypertension, and that celecoxib capsules may impair the response of some antihypertensive agents.

Patients should be instructed on the proper follow up for monitoring of blood pressure. [see Warnings and Precautions (5.2) and Drug Interactions (7.4) ].

17.3Gastrointestinal Effects Patients should be informed that celecoxib capsules can cause gastrointestinal discomfort and more serious side effects, such as ulcers and bleeding, which may result in hospitalization and even death. Patients should be informed of the signs and symptoms of ulcerations and bleeding, and to seek immediate medical advice if they observe any signs or symptoms that are indicative of these disorders, including epigastric pain, dyspepsia, melena, and hematemesis. [see Warnings and Precautions (5.4) ].

17.4Hepatic Effects Patients should be informed of the warning signs and symptoms of hepatotoxicity (e.g., nausea, fatigue, lethargy, pruritus, jaundice, right upper quadrant tenderness, and “flu-like” symptoms). Patients should be instructed that they should stop therapy and seek immediate medical therapy if these signs and symptoms occur [see Warnings and Precautions (5.5) , Use in Specific Populations (8.6) ].

17.5Adverse Skin Reactions Patients should be informed that celecoxib is a sulfonamide and can cause serious skin side effects such as exfoliative dermatitis, SJS, and TEN, which may result in hospitalizations and even death. Although serious skin reactions may occur without warning, patients should be informed of the signs and symptoms of skin rash and blisters, fever, or other signs of hypersensitivity such as itching, and seek immediate medical advice when observing any indicative signs or symptoms. Patients should be advised to stop celecoxib capsules immediately if they develop any type of rash and contact their physician as soon as possible.

Patients with prior history of sulfa allergy should not take celecoxib capsules [see Warnings and Precautions (5.8) ].

17.6Weight Gain and Edema Long-term administration of NSAIDs including celecoxib has resulted in renal injury. Patients at greatest risk are those taking diuretics, ACE-inhibitors, angiotensin II antagonists, or with renal or liver dysfunction, heart failure, and the elderly [see Warnings and Precautions (5.3 , 5.6) , Use in Specific Populations (8) ]. Patients should be instructed to promptly report to their physicians signs or symptoms of unexplained weight gain or edema following treatment with celecoxib [see Warnings and Precautions (5.3) ].

17.7Anaphylactoid Reactions Patients should be informed of the signs and symptoms of an anaphylactoid reaction (e.g., difficulty breathing, swelling of the face or throat). Patients should be instructed to seek immediate emergency assistance if they develop any of these signs and symptoms [see Warnings and Precautions (5.7) ].

17.8Effects During Pregnancy Patients should be informed that in late pregnancy celecoxib capsules should be avoided because it may cause premature clos…

💬 Medication Guide ~3 min read ▾

MEDGUIDE Medication Guide for Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) (See the end of this Medication Guide for a list of prescription NSAID medicines.) What is the most important information I should know about medicines called Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)? NSAID medicines may increase the chance of a heart attack or stroke that can lead to death. This chance increases: with longer use of NSAID medicines in people who have heart disease NSAID medicines should never be used right before or after a heart surgery called a “coronary artery bypass graft (CABG)." NSAID medicines can cause ulcers and bleeding in the stomach and intestines at any time during treatment.

Ulcers and bleeding: can happen without warning symptoms may cause death The chance of a person getting an ulcer or bleeding increases with: taking medicines called “corticosteroids” and “anticoagulants” longer use smoking drinking alcohol older age having poor health NSAID medicines should only be used: exactly as prescribed at the lowest dose possible for your treatment for the shortest time needed What are Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)? NSAID medicines are used to treat pain and redness, swelling, and heat (inflammation) from medical conditions such as: different types of arthritis menstrual cramps and other types of short-term pain Who should not take a Non-Steroidal Anti-Inflammatory Drug (NSAID)?

Do not take an NSAID medicine: • if you had an asthma attack, hives, or other allergic reaction with aspirin or any other NSAID medicine for pain right before or after heart bypass surgery Tell your healthcare provider: about all of your medical conditions. about all of the medicines you take. NSAIDs and some other medicines can interact with each other and cause serious side effects. Keep a list of your medicines to show to your healthcare provider and pharmacist.

1. if you are pregnant. NSAID medicines should not be used by pregnant women late in their pregnancy. if you are breastfeeding. Talk to your doctor.

What are the possible side effects of Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)? Serious side effects include: Other side effects include: • heart attack • stomach pain • stroke • constipation • high blood pressure • diarrhea • heart failure from body swelling (fluid retention) • gas • kidney problems including kidney failure • heartburn • bleeding and ulcers in the stomach and intestine • nausea • low red blood cells (anemia) • vomiting • life-threatening skin reactions • dizziness • life-threatening allergic reactions • liver problems including liver failure • asthma attacks in people who have asthma Get emergency help right away if you have any of the following symptoms: • shortness of breath or trouble breathing • slurred speech • swelling of the face or throat • chest pain • weakness in one part or side of your body Stop your NSAID medicine and call your healthcare provider right away if you have any of the following symptoms: • nausea • there is blood in your bowel usual movement or it is black and sticky like tar • more tired or weaker than usual • itching • your skin or eyes look yellow • skin rash or blisters • mach pain • flu-like symptoms • unusual weight gain • vomit blood • swelling of the arms and legs, hands and feet These are not all the side effects with NSAID medicines.

Talk to your healthcare provider or pharmacist for more information about NSAID medicines. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Other information about Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) • Aspirin is an NSAID medicine but it does not increase the chance of a heart attack. Aspirin can cause bleeding in the brain, stomach, and intestines. Aspirin can also cause ulcers in the stomach and intestines. • Some of these NSAID medicines are sold in lower doses without a prescription (over – the –counter).

Talk to your healthcare provider before using over –the…

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