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Celecoxib 200 mg Capsule, 180-count — NDC 80425-0281-04 package photo

Celecoxib 200 mg Capsule, 180-count

by Advanced Rx Pharmacy of Tennessee, LLC · 180 CAPSULE in 1 BOTTLE (80425-0281-4)
NDC 80425-0281-04
🏷️ FDA NDC (as labeled) 80425-0281-4 billing pads the package segment with a zero
This package
Contains180-count Pack sizes4 compare ↓
Also priced by: Part D plans $0.2958/unit — full pricing hub ↓
Also comes in: 30 capsules 80425-0281-01 60 capsules 80425-0281-02 90 capsules 80425-0281-03
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) 80425-0281-4
Product NDC 80425-0281
11-digit billing NDC 80425028104
NCPDP billing unit EA — each (per item)
RxCUI 205323
UNII JCX84Q7J1L
Application # ANDA210628
SPL Set ID f60394f5-fd69-929b-e053-2995a90a5793
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 2023-03-03
Route ORAL
Dosage form CAPSULE
Substance CELECOXIB
TE code (Orange Book) AB · RLD · RS
Why two NDCs? The FDA registers this code as 80425-0281-4 — a 5-4-1 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 package segment → 80425-0281-04. 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

LabelerAdvanced Rx Pharmacy of Tennessee, LLC
Application holderUMEDICA LABORATORIES PRIVATE LTD
FDA applicationANDA210628 (ANDA)
Labeler code80425
First marketedMar 2023
Product typeHuman Prescription Drug
Portfolio254 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

📖 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
  • 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
ShapeCapsule
ImprintCEL;200mg
Size18 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.

A current SPL was checked, but it does not contain a structured or narrative inactive-ingredient list for this product. This does not mean the product has no inactive ingredients.
Where does this data come from?
Source: official FDA Structured Product Labeling (SPL) via DailyMed and the openFDA label index. Structured IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.

Inactive ingredient FAQ

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

💲 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 $53.24 / 180 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 200 mg 00591-3984-01 Actavis 100 capsules $0.076 — Availability likely —
Celecoxib 200 mg 00904-7551-61 Major 100 capsules $0.076 AB Availability likely —
Celecoxib 200 mg 11788-0114-01 AiPing 100 capsules $0.076 AB Availability likely —
Celecoxib 200 mg 16714-0733-01 NorthStar 100 capsules $0.076 AB Availability likely —
Celecoxib 200 mg 27808-0297-01 Cranbury 100 capsules $0.076 AB Availability likely —
celecoxib 200 mg 33342-0157-11 Macleods 100 capsules $0.076 AB Availability likely —
Celecoxib 200 mg 42571-0144-01 Micro 100 capsules $0.076 AB Availability likely —
Celecoxib 200 mg 42806-0722-01 EPIC 100 capsules $0.076 AB Availability likely —
Celecoxib 200 mg 50228-0158-01 ScieGen 100 capsules $0.076 AB Availability likely —
Celecoxib 200 mg 50268-0169-15 AvPAK 50 capsules $0.076 AB Availability likely —
Celecoxib 200 mg 60505-3849-01 Apotex 100 capsules $0.076 AB Availability likely —
Celecoxib 200 mg 60687-0447-01 American 100 capsules $0.076 AB Availability likely —
Celecoxib 200 mg 65862-0909-01 Aurobindo 100 capsules $0.076 AB Availability likely —
celecoxib 200 mg 68180-0399-01 Lupin 100 capsules $0.076 AB Availability likely —
Celecoxib 200 mg 69367-0302-01 Westminster 100 capsules $0.076 AB Availability likely —
Celecoxib 200 mg 75834-0238-01 NIVAGEN 100 capsules $0.076 AB Availability likely —
Celecoxib 200 mg 82009-0069-05 Quallent 500 capsules $0.076 AB Availability likely —
Celecoxib 200 mg 83301-0012-01 Mullan 100 capsules $0.076 AB Availability likely —
Celecoxib 200 mg 00904-6503-61 Major 100 capsules $0.081 AB Discontinued —
celecoxib 200 mg 13668-0442-01 Torrent 100 capsules $0.103 AB FDA listed —
Celebrex 200 mg 58151-0084-01 Viatris 100 capsules $15.650 AB Availability likely —
Celecoxib 200 mg 00615-8571-39 NCS 30 capsules — AB FDA listed —
Celecoxib 200 mg 23155-0965-01 Avet 100 capsules — AB FDA listed —
Celecoxib 200 mg 29300-0373-01 Unichem 100 capsules — — FDA listed —
Celecoxib 200 mg 43063-0669-10 PD-Rx 10 capsules — AB FDA listed —
Celecoxib 200 mg 43063-0825-10 PD-Rx 10 capsules — AB FDA listed —
celecoxib 200 mg 43063-0967-14 PD-Rx 14 capsules — AB FDA listed —
Celecoxib 200 mg 45865-0234-30 Medsource 30 capsules — AB FDA listed —
Celecoxib 200 mg 46708-0269-10 Alembic 100 capsules — AB FDA listed —
Celecoxib 200 mg 50090-4789-00 A-S 30 capsules — AB FDA listed —
celecoxib 200 mg 50090-5638-00 A-S 30 capsules — AB FDA listed —
Celecoxib 200 mg 50090-6577-00 A-S 30 capsules — AB FDA listed —
Celecoxib 200 mg 50090-6758-00 A-S 30 capsules — AB FDA listed —
Celecoxib 200 mg 50090-6759-00 A-S 90 capsules — AB FDA listed —
Celecoxib 200 mg 50090-7072-00 A-S 90 capsules — AB FDA listed —
Celecoxib 200 mg 51655-0060-25 Northwind 60 capsules — AB FDA listed —
celecoxib 200 mg 51655-0253-52 Northwind 30 capsules — AB FDA listed —
Celecoxib 200 mg 51655-0437-25 Northwind 60 capsules — AB FDA listed —
Celecoxib 200 mg 55154-7646-00 Cardinal 10 capsules — AB Discontinued —
Celecoxib 200 mg 57582-0213-01 Tianjin 100 capsules — AB FDA listed —
Celecoxib 200 mg 60290-0018-01 Umedica 100 capsules — AB FDA listed —
Celecoxib 200 mg 60760-0742-15 St 15 capsules — AB FDA listed —
Celecoxib 200 mg 60760-0996-30 ST. 30 capsules — AB FDA listed —
Celecoxib 200 mg 62135-0022-01 Chartwell 100 capsules — AB FDA listed —
Celecoxib 200 mg 62332-0142-08 Alembic 80 capsules — AB FDA listed —
Celecoxib 200 mg 63187-0562-15 Proficient 15 capsules — AB FDA listed —
Celecoxib 200 mg 63187-0633-30 Proficient 30 capsules — AB FDA listed —
celecoxib 200 mg 67296-1399-01 RedPharm 10 capsules — AB FDA listed —
Celecoxib 200 mg 67296-1920-01 RedPharm 10 capsules — AB FDA listed —
Celecoxib 200 mg 67296-2236-06 Redpharm 60 capsules — AB FDA listed —
Celecoxib 200 mg 68071-2733-03 NuCare 30 capsules — AB FDA listed —
Celecoxib 200 mg 68071-3642-03 NuCare 30 capsules — AB FDA listed —
celecoxib 200 mg 68071-4392-03 NuCare 30 capsules — AB FDA listed —
celecoxib 200 mg 68788-7264-01 Preferred 100 capsules — AB FDA listed —
Celecoxib 200 mg 68788-8197-01 Preferred 100 capsules — AB FDA listed —
Celecoxib 200 mg 68788-8679-01 Preferred 100 capsules — AB FDA listed —
Celecoxib 200 mg 69097-0421-02 Cipla 30 capsules — AB FDA listed —
Celecoxib 200 mg 69117-0022-01 Yiling 60 capsules — AB FDA listed —
Celecoxib 200 mg 70247-0008-10 Qingdao 100 capsules — AB FDA listed —
Celecoxib 200 mg 70518-2233-00 REMEDYREPACK 30 capsules — AB FDA listed —
Celecoxib 200 mg 70518-3733-00 REMEDYREPACK 45 capsules — AB Discontinued —
Celecoxib 200 mg 70518-4175-00 REMEDYREPACK 14 capsules — AB FDA listed —
celecoxib 200 mg 71205-0027-14 Proficient 14 capsules — AB FDA listed —
Celecoxib 200 mg 71205-0055-30 Proficient 30 capsules — AB FDA listed —
Celecoxib 200 mg 71205-0664-30 Proficient 30 capsules — AB FDA listed —
Celecoxib 200 mg 71209-0056-03 Cadila 60 capsules — AB FDA listed —
celecoxib 200 mg 71335-0868-00 Bryant 15 capsules — AB FDA listed —
Celecoxib 200 mg 71335-1066-00 Bryant 15 capsules — AB FDA listed —
Celecoxib 200 mg 71335-2220-00 Bryant 15 capsules — AB FDA listed —
Celecoxib 200 mg 71335-2456-00 Bryant 15 capsules — AB FDA listed —
Celecoxib 200 mg 71610-0584-30 Aphena 30 capsules — AB FDA listed —
Celecoxib 200 mg 72162-2175-05 Bryant 500 capsules — AB FDA listed —
Celecoxib 200 mg 72162-2357-01 Bryant 100 capsules — AB FDA listed —
Celecoxib 200 mg 72162-2380-01 Bryant 100 capsules — AB FDA listed —
Celecoxib 200 mg 72162-2421-01 Bryant 100 capsules — AB FDA listed —
celecoxib 200 mg 72162-2489-01 Bryant 100 capsules — AB FDA listed —
Celecoxib 200 mg 72189-0360-10 DirectRx 10 capsules — AB FDA listed —
Celecoxib 200 mg 72241-0024-03 Modavar 60 capsules — AB FDA listed —
Celecoxib 200 mg 72789-0259-14 PD-Rx 14 capsules — AB FDA listed —
celecoxib 200 mg 76420-0009-01 Asclemed 1 capsule — AB FDA listed —
Celecoxib 200 mg 76420-0714-01 Asclemed 1 capsule — AB FDA listed —
Celecoxib 200 mg 76420-0844-00 Asclemed 1000 capsules — AB FDA listed —
Celecoxib 200 mg 77771-0158-01 Radha 100 capsules — AB FDA listed —
Celecoxib 200 mg 80425-0037-01 Advanced 30 capsules — AB FDA listed —
Celecoxib 200 mg 80425-0039-01 Advanced 30 capsules — AB FDA listed —
Celecoxib 200 mg 80425-0040-01 Advanced 30 capsules — AB FDA listed —
Celecoxib 200 mg 80425-0096-01 Advanced 30 capsules — AB FDA listed —
Celecoxib 200 mg 80425-0209-01 Advanced 30 capsules — AB FDA listed —
Celecoxib 200 mgthis 80425-0281-04 Advanced 180 capsules — AB FDA listed —
Celecoxib 200 mg 80425-0382-01 Advanced 30 capsules — AB FDA listed —
Celecoxib 200 mg 82804-0213-14 Proficient 14 capsules — AB FDA listed —
Celecoxib 200 mg 82868-0034-90 Northwind 90 capsules — AB FDA listed —
Celecoxib 200 mg 83008-0013-30 Quality 30 capsules — AB FDA listed —
Celecoxib 200 mg 85509-1158-01 PHOENIX 10 capsules — AB FDA listed —
Celecoxib 200 mg 85766-0009-00 Sportpharm 1000 capsules — AB FDA listed —
Celecoxib 200 mg 50090-5178-00 A-S 30 capsules — AB Discontinued —
celecoxib 200 mg 85534-0065-00 HAWAII 30 capsules — AB FDA listed —
Celecoxib 200 mg 85534-0015-00 HAWAII 30 capsules — AB FDA listed —
Celecoxib 200 mg 60760-0958-15 St. 15 capsules — AB FDA listed —
Celecoxib 200 mg 72789-0582-14 PD-Rx 14 capsules — AB FDA listed —
Celecoxib 200 mg 70518-4726-00 REMEDYREPACK 100 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

🏛️
2023
On the market since
Mar 2023
📍
2026
Currently FDA-listed
3 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
80425-0281-01 30 CAPSULE in 1 BOTTLE (80425-0281-1) 2023-03-03 Active
80425-0281-02 60 CAPSULE in 1 BOTTLE (80425-0281-2) 2023-03-03 Active
80425-0281-03 90 CAPSULE in 1 BOTTLE (80425-0281-3) 2023-03-03 Active
80425-0281-04 You're viewing this 180 CAPSULE in 1 BOTTLE (80425-0281-4) 2023-03-03 Active

You're viewing the largest of 4 pack sizes for this product.

Pack size FAQ

What quantity is in NDC 80425-0281-04?
NDC 80425-0281-04 is a 180-count package — 180 capsule in 1 bottle.
What is the difference between NDC 80425-0281-04 and NDC 80425-0281-01?
Both are Celecoxib 200 mg Capsule — the drug itself is identical. NDC 80425-0281-04 is the 180-count package, while NDC 80425-0281-01 is the 30 capsules package.
What NDC number is used to bill for this package of Celecoxib 200 mg Capsule?
Bill NDC 80425-0281-04 — the 11-digit billing format is 80425028104. 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) — Not published for this NDC The labeler did not submit a structured excipient list, or no SPL is available.
NADAC pharmacy acquisition price (CMS) — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey.
Orange Book / therapeutic-equivalence data ✓ 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 80425-0281-4, 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: 80425-0281-04, written without dashes as 80425028104. 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 80425-0281-04, the first segment (80425) is the labeler code FDA assigned to Advanced Rx Pharmacy of Tennessee, LLC; the middle segment (0281) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (04) 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 Advanced Rx Pharmacy of Tennessee, LLC. 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 3 other package presentations of this same product, including 30 capsules (80425-0281-01), 60 capsules (80425-0281-02), 90 capsules (80425-0281-03). 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?
Advanced Rx Pharmacy of Tennessee, LLC is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
Do I need a prescription for this product?
This NDC is listed with FDA as a prescription product, so it is dispensed under a prescriber's order. Your pharmacist can tell you whether any over-the-counter forms of the same medication exist.
This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.
Where does this data come from?
Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.

📄 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 💬 Medication Guide
🚨 Boxed Warning 152 words ▾

Boxed Warning WARNING: RISK OF SERIOUS CARDIOVASCULAR AND GASTROINTESTINALEVENTS 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)] . • Celecoxib capsules are 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 116 words ▾

1. Indications and Usage Celecoxib capsule are indicated

1.1Osteoarthritis For the management of the signs and symptoms of OA [ see CLINICAL STUDIES (14.1)].

1.2Rheumatoid Arthritis For the management of the signs and symptoms of RA [ see CLINICAL STUDIES (14.2)].

1.3Juvenile Rheumatoid Arthritis For the management of the signs and symptoms of JRA in patients 2 years and older [ see CLINICAL STUDIES (14.3)].

1.4Ankylosing Spondylitis For the management of the signs and symptoms of AS [ see CLINICAL STUDIES (14.4)].

1.5Acute Pain For the management of acute pain in adults [ see CLINICAL STUDIES (14.5)].

1.6Primary Dysmenorrhea For the management of primary dysmenorrhea [ see CLINICAL STUDIES (14.5)].

⏱️ Dosage and Administration ~2 min read ▾

2. Dosage and Administration

2.1General Dosing Instructions Carefully consider the potential benefits and risks of celecoxib capsules and other treatment options before deciding to use celecoxib capsules. Use the lowest effective dosage for the shortest duration consistent with individual patient treatment goals [ see WARNINGS AND PRECAUTIONS (5)]. These doses can be given without regard to timing of meals.

2.2Osteoarthritis For OA, the dosage is 200 mg per day administered as a single dose or as 100 mg twice daily.

2.3Rheumatoid Arthritis For RA, the dosage is 100 mg to 200 mg twice daily.

2.4Juvenile Rheumatoid Arthritis For JRA, the dosage 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 (2ºC to 8ºC / 35°F to 45°F).

2.5Ankylosing Spondylitis For AS, the dosage 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.

2.6Management of Acute Pain and Treatment of Primary Dysmenorrhea For management of Acute Pain and Treatment of Primary Dysmenorrhea, the dosage 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.

2.7Special Populations Hepatic Impairment In patients with moderate hepatic impairment (Child-Pugh Class B), reduce the dose by 50%. The use of celecoxib capsules in patients with severe hepatic impairment is not recommended [ see WARNINGS AND PRECAUTIONS (5.3), USE IN SPECIFIC POPULATIONS (8.6) and CLINICAL PHARMACOLOGY (12.3)]. Poor Metabolizers of CYP2C9 Substrates In adult 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), initiate treatment with half of the lowest recommended dose.

In patients with JRA who are known or suspected to be poor CYP2C9 metabolizers, consider using alternative treatments. [ SEE USE IN SPECIFIC POPULATIONS (8.8), and CLINICAL PHARMACOLOGY (12.5)].

💊 Dosage Forms and Strengths 95 words ▾

3. Dosage Forms and Strengths Celecoxib capsules: 50 mg white to white opaque hard gelatin capsules, imprinted with 'CEL' on cap & '50 mg' on body in black ink. 100 mg white to white opaque hard gelatin capsules, imprinted with 'CEL' on cap & '100 mg' on body in black ink.

200 mg white to white opaque hard gelatin capsules, imprinted with 'CEL' on cap & '200 mg' on body in black ink. 400 mg white to white opaque hard gelatin capsules, imprinted with 'CEL' on cap & '400 mg' on body in black ink.

⛔ Contraindications 95 words ▾

4. Contraindications Celecoxib capsules are 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 CABG surgery [see WARNINGS AND PRECAUTIONS (5.1)] . In patients who have demonstrated allergic-type reactions to sulfonamides [see WARNINGS AND PRECAUTIONS (5.7)] .

⚠️ Warnings and Cautions ~3 min read ▾

5. Warnings and Precautions

5.1Cardiovascular Thrombotic Events Clinical trials of several Cyclooxygenose-2 (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 the APC (Adenoma Prevention with Celecoxib) trial, there was about a threefold increased risk of the composite endpoint of cardiovascular death, MI, or stroke for celecoxib capsules 400 mg twice daily and celecoxib capsules 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 [ see CLINICAL STUDIES (14.7)]. A randomized controlled trial entitled the Prospective Randomized Evaluation of Celecoxib Integrated Safety vs.

Ibuprofen Or Naproxen (PRECISION) was conducted to assess the relative cardiovascular thrombotic risk of a COX-2 inhibitor, celecoxib, compared to the non-selective NSAIDs naproxen and ibuprofen. Celecoxib 100 mg twice daily was non-inferior to naproxen 375 to 500 mg twice daily and ibuprofen 600 to 800 mg three times daily for the composite endpoint of the Antiplatelet Trialists’ Collaboration (APTC), which consists of cardiovascular death (including hemorrhagic death), non-fatal myocardial infarction, and non-fatal stroke [ See CLINICAL STUDIES (14.6)].

To minimize the potential risk for an adverse CV event in NSAID-treated patients, use the lowest effective dose for the shortest duration possible. 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 celecoxib, increases the risk of serious gastrointestinal (GI) events [ see WARNINGS AND PRECAUTIONS (5.2)]. Status Post Coronary Artery Bypass Graft (CABG) Surgery Two large, controlled clinical trials of a COX-2 selective NSAID for the treatment of pain in the first 10 to 14 days following CABG surgery found an increased incidence of myocardial infarction and stroke.

NSAIDs are contraindicated in the setting of CABG [ see CONTRAINDICATIONS (4)]. Post-MI Patients Observational studies conducted in the Danish National Registry have demonstrated that patients treated with NSAIDs in the post-MI period were at increased risk of reinfarction, CV-related death, and all-cause mortality beginning in the first week of treatment. In this same cohort, the incidence of death in the first year post-MI was 20 per 100 person years in NSAID-treated patients compared to 12 per 100 person years in non-NSAID exposed patients.

Although the absolute rate of death declined somewhat after the first year post-MI, the increased relative risk of death in NSAID users persisted over at least the next four years of follow-up. Avoid the use of celecoxib capsules in patients with a recent MI unless the benefits are expected to outweigh the risk…

🤒 Adverse Reactions ~3 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)] Serious Skin Reactions [see WARNINGS AND PRECAUTIONS (5.9)] Hematologic Toxicity [see WARNINGS AND PRECAUTIONS (5.12)]

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 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. Of the celecoxib capsules -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 capsules 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 capsules 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. Pre-marketing Controlled Arthritis Trials Table 1 lists all adverse events, regardless of causality, occurring in ≥2% of patients receiving celecoxib capsules 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 Capsules Patients from Pre-marketing Controlled Arthritis Trials CBX N=4146 Placebo N=1864 NAP N=1366 DCF N=387 IBU N=345 Gastrointestinal Abdominal Pain Diarrhea Dyspepsia Flatulence Nausea 4.1% 5.6% 8.8% 2.2% 3.5% 2.8% 3.8% 6.2% 1.0% 4.2% 7.7% 5.3% 12.2% 3.6% 6.0% 9.0% 9.3% 10.9% 4.1% 3.4% 9.0% 5.8% 12.8% 3.5% 6.7% Body as a whole Back Pain Peripheral Edema Injury-Accidental 2.8% 2.1% 2.9% 3.6% 1.1% 2.3% 2.2% 2.1% 3.0% 2.6% 1.0% 2.6% 0.9% 3.5% 3.2% Central, Peripheral Nervous system Dizziness Headache 2.0% 15.8% 1.7% 20.2% 2.6% 14.5% 1.3% 15.5% 2.3% 15.4% Psychiatric Insomnia 2.3% 2.3% 2.9% 1.3% 1.4% Respiratory Pharyngitis Rhinitis Sinusitis Upper Respiratory Infection 2.3% 2.0% 5.0% 8.1% 1.1% 1.3% 4.3% 6.7% 1.7% 2.4% 4.0% 9.9% 1.6% 2.3% 5.4% 9.8% 2.6% 0.6% 5.8% 9.9% Skin Rash 2.2% 2.1% 2.1% 1.3% 1.2% CBX = Celecoxib capsules 100 mg to 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.

In placebo- or active-controlled clinical trials, the discontinuation rate due to adverse events was 7.1% for patients receiving celecoxib capsules 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% to 1.9% of patients treated with Celecoxib capsules (100 mg to 20…

🔄 Drug Interactions ~3 min read ▾

7. Drug Interactions See Table 3 for clinically significant drug interactions with celecoxib Table 3: 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 celecoxib capsules with anticoagulants (e.g., warfarin), antiplatelet agents (e.g., aspirin), (SSRIs), and (SNRIs) for signs of bleeding [ see WARNINGS AND PRECAUTIONS (5.12)].

Aspirin Clinical Impact: Controlled clinical studies showed that the concomitant use of NSAIDs and analgesic doses of aspirin does not produce any greater therapeutic effect than the use of NSAIDs alone. 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 osteoarthritis and established heart disease respectively, celecoxib (200 mg to 400 mg daily) has demonstrated a lack of interference with the cardioprotective antiplatelet effect of aspirin (100mg to 325 mg).

Intervention: Concomitant use of celecoxib capsules and analgesic doses of aspirin is not generally recommended because of the increased risk of bleeding [ see WARNINGS AND PRECAUTIONS (5.12)]. Celecoxib capsules 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 inhibitors, 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 celecoxib capsules and ACE-inhibitors, ARBs, or beta-blockers, monitor blood pressure to ensure that the desired blood pressure is obtained.

During concomitant use of celecoxib capsules 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 post-marketing 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 celecoxib capsules 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 celecoxib capsules 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…

👥 Use in Specific Populations ~3 min read ▾

8. Use in Specific Populations

8.1Pregnancy Risk Summary Use of NSAIDs, including celecoxib capsules, 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 celecoxib capsules use between about 20 and 30 weeks of gestation and avoid celecoxib capsules 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 celecoxib capsules, 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, embryo-fetal deaths and an increase in diaphragmatic hernias were observed in rats administered celecoxib daily during the period of organogenesis at oral doses approximately 6 times the maximum recommended human dose (MRHD) of 200 mg twice daily.

In addition, structural abnormalities (e.g., septal defects, ribs fused, sternebrae fused and sternebrae misshapen) were observed in rabbits given daily oral doses of celecoxib during the period of organogenesis at approximately 2 times the MRHD ( 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 postimplantation 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. The estimated background risk of major birth defects and miscarriage for the indicated population is unknown.

All pregnancies have a background risk of birth defect, 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% to 4% and 15% to 20%, respectively. 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 celecoxib capsules, 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 celecoxib capsules treatment extends beyond 48 hours, consider monitoring with ultrasound for oligohydramnios. If oligohydramnios occurs, discontinue celecoxib capsules and follow up according to clinical practice ( see Data).

Labor or Delivery There are no studies on the effects of celecoxib capsules 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 The available data do not establish the presence or absence of developmental toxicity related to the use of celecoxib capsules.

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 postma…

🆘 Overdosage 206 words ▾

10. Overdosage Symptoms following acute NSAID over dosages 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 occured, but were rare [ see WARNINGS AND PRECAUTIONS (5.2, 5.4, 5.6)]. No overdoses of celecoxib capsules 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.

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 (1-800-222-1222).

🧬 Clinical Pharmacology ~3 min read ▾

12. Clinical Pharmacology

12.1Mechanism of Action Celecoxib has analgesic, anti-inflammatory, and antipyretic properties. The mechanism of action of celecoxib capsules is believed to be due to inhibition of prostaglandin synthesis, primarily via inhibition of COX-2. Celecoxib is a potent inhibitor of prostaglandin synthesis in vitro.

Celecoxib concentrations reached during therapy have produced in vivo effects. Prostaglandins sensitize afferent nerves and potentiate the action of bradykinin in inducing pain in animal models. Prostaglandins are mediators of inflammation.

Since celecoxib is an inhibitor of prostaglandin synthesis, its mode of action may be due to a decrease of prostaglandins in peripheral tissues.

12.2Pharmacodynamics Platelets In clinical trials using normal volunteers, celecoxib capsules 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 capsules are not a substitute for aspirin for cardiovascular prophylaxis. It is not known if there are any effects of celecoxib capsules on platelets that may contribute to the increased risk of serious cardiovascular thrombotic adverse events associated with the use of celecoxib capsules.

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 dose-proportional increase in exposure after oral administration up to 200 mg twice daily and less than proportional increase at higher doses. It has extensive distribution and high protein binding. It is primarily metabolized by CYP2C9 with a half-life of approximately 11 hours.

Absorption Peak plasma levels of celecoxib occur approximately 3 hours 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 twice daily; 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 4. Table 4 Summary of Single Dose (200 mg) Disposition Kinetics of Celecoxib in Healthy Subjects 1 Mean (% CV) PK Parameter Values Cmax,ng/mL Tmax,hr Effectivet 1/2,hr Vss/F,L CL/F,L/hr 705(38) 2.8(37) 11.2(31) 429(34) 27.7(28) 1 Subjects under fasting conditions (n=36, 19-52 yrs.) 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, Tmax or t 1/2 after administration of capsule contents on applesauce [ see DOSAGE AND ADMINISTRATION (2)].

D…

📦 How Supplied / Storage and Handling 81 words ▾

16. How Supplied/Storage and Handling Celecoxib capsules 200 mg are white to white opaque hard gelatin capsules, imprinted with "CEL" on cap & "200 mg" on body in black ink supplied as: Bottles of 30 Capsules NDC: 80425-0281-01 Bottles of 60 Capsules NDC: 80425-0281-02 Bottles of 90 Capsules NDC: 80425-0281-03 Bottles of 180 Capsules NDC: 80425-0281-04 Storage 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].

📋 Description 150 words ▾

11. Description Celecoxib capsules are a nonsteroidal anti-inflammatory drug, available as capsules containing 50 mg, 100 mg, 200 mg and 400 mg celecoxib for oral administration. The chemical name is 4-[5-(4-methylphenyl)- 3-(trifluoromethyl)- 1H-pyrazol-1-yl] benzenesulfonamide and is a diaryl-substituted pyrazole.

The molecular weight is 381.38. Its molecular formula is C 17H 14F 3N 3O 2S, and it has the following chemical structure: Celecoxib is a white or almost white, crystalline powder with a pKa of 11.1 (sulfonamide moiety). Celecoxib is hydrophobic (log P is 3.5) and is practically insoluble in aqueous media at physiological pH range.

The inactive ingredients in celecoxib capsules include: lactose monohydrate, croscarmellose sodium, povidone, sodium lauryl sulphate and magnesium stearate. The content of empty hard gelatin capsules: titanium dioxide, gelatin, sodium lauryl sulphate. The content of edible ink: shellac, propylene glycol, black iron oxide, potassium hydroxide, dehydrated alcohol, isopropyl alcohol, butyl alcohol and strong ammonia solution.

Description

💬 Medication Guide ~3 min read ▾

Medguide Medication Guide for Nonsteroidal Anti-inflammatory Drugs (NSAIDs) What is the most important information I should know about medicines called Nonsteroidal Anti-inflammatory Drugs (NSAIDs)? NSAIDs 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 NSAIDs right before or after a heart surgery called a “coronary artery bypass graft (CABG)." Avoid taking NSAIDs 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”, “anticoagulants”, “SSRIs” or “SNRIs” increasing doses of NSAIDs o older age longer use of NSAIDs o poor health smoking o advanced liver disease drinking alcohol o bleeding problems · NSAIDs should only be used: exactly as prescribed at the lowest dose possible for your treatment for the shortest time needed What are NSAIDs?

NSAIDs 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 NSAIDs? Do not take NSAIDs: 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 NSAIDS, tell your healthcare provider about all of your medical conditions, including if you: have liver or kidney problems have high blood pressure have asthma are pregnant or plan to become pregnant. Taking NSAIDs 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 . Tell your healthcare provider about all of the medicines you take, including prescription or over-the-counter medicines, vitamins or herbal supplements.NSAIDs 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.

What are the possible side effects of NSAIDs? NSAIDs can cause serious side effects, including: See “What is the most important information I should know about medicines called Nonsteroidal Anti-inflammatory Drugs (NSAIDs)? new or worse high blood pressure heart failure liver problems including liver failure kidney problems including kidney failure low red blood cells (anemia) life-threatening skin reactions life-threatening allergic reactions Other side effects of NSAIDs include: stomach pain, constipation, diarrhea, gas, heartburn, nausea, vomiting, and dizziness.

Get emergency help right away if you get any of the following symptoms: • shortness of breath or trouble breathing • slurred speech • chest pain • swelling of the face or throat • weakness in one part or side of your body Stop taking your NSAID and call your healthcare provider right away if you get any of the following symptoms: • nausea • vomit blood • more tired or weaker than usual • there is blood in your bowel movement or it is black and sticky like tar • diarrhea • unusual weight gain • itching • skin rash or blisters with fever • your skin or eyes look yellow • swelling of the arms, legs, hands and feet • indigestion or stomach pain…

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