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Celecoxib 200 mg 200 mg Capsule, 60-count

by Proficient Rx LP · 60 CAPSULE in 1 BOTTLE (63187-633-60)

NDC 63187-0633-60

🏷️ FDA NDC (as labeled) 63187-633-60 billing pads the product segment with a zero

This package

Contains60-count Pack sizes3 compare ↓

Also comes in: 30 capsules 63187-0633-30 90 capsules 63187-0633-90

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 Dr. Brian Staiger, PharmD

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) 63187-633-60

Product NDC 63187-633

11-digit billing NDC 63187063360

NCPDP billing unit EA — each (per item)

RxCUI 205323

UNII JCX84Q7J1L

Application # ANDA204519

SPL Set ID feee6a01-63f9-42c3-8bd8-ca713a08b36d

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 2015-11-24

Route ORAL

Dosage form CAPSULE

Substance CELECOXIB

GPI-14 66100525000130

GPI class Celecoxib

GCN Seq No 041286

GCN 42002

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 200 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 63187-633-60 — 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 → 63187-0633-60. 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 holderALEMBIC PHARMACEUTICALS LTD

FDA applicationANDA204519 (ANDA)

Labeler code63187

First marketedNov 2015

Product typeHuman Prescription Drug

Portfolio1,723 products on file

🔎 All NDCs from Proficient Rx LP

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 200 MG CAPSULE Ingredient Celecoxib

📖 What it is MedlinePlus · NLM

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

Read the full MedlinePlus article ↗

📗 Our plain-language guide HelloPharmacist

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 →

Patient education

📘 MedlinePlus patient leaflet ↗

Supplement & herbal interactions

Some supplements/herbs that may interact with Celecoxib — tap one for details:

Activated CharcoalMajor Coffee CharcoalModerate European MandrakeModerate GlucomannanModerate Guar GumModerate Gum ArabicModerate Slippery ElmModerate TragacanthModerate

🌿 Every supplement checked against Celecoxib (117 interactions) — ranked by severity →

Nutrient depletion considerations

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

FOLIC ACID Insufficient Evidence

🧪 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

ImprintA;136

Size19 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 M28OL1HH48
Croscarmellose sodium is a plant-based substance derived from cellulose. It acts as a disintegrant, helping tablets and capsules break down quickly in the digestive system so the medicine can be absorbed.
UNII 1K09F3G675
Ferric oxide red is an inorganic iron compound used as a colorant in medicines. It gives tablets, capsules, or other dosage forms a red or reddish tint for identification and appearance.
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 U725QWY32X
Povidone K30 is a synthetic polymer made from petroleum. It acts as a binder to hold tablet ingredients together and as a disintegrant to help the tablet break apart in the stomach so the medicine can be absorbed.
UNII 6DC9Q167V3
Propylene glycol is a clear liquid derived from petroleum or vegetable sources. It acts as a solvent, humectant, and preservative in medicines, helping dissolve active ingredients and maintain product stability.
UNII 46N107B71O
Shellac is a natural resin secreted by the lac beetle. It's used as a coating on tablets and capsules to control how quickly the medicine dissolves and to improve appearance and stability.
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.
UNII 15FIX9V2JP
Titanium dioxide is a bright white mineral powder commonly used as a colorant and opacifying agent. It makes pills and tablets white or lighter in color and helps make coatings non-transparent.

10 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 system	Per each	Per package
Retail pharmacies payNADAC · weekly	Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo	No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · quarterly	No Part D plan price is available for this NDC in our data.

ℹ️

No price is published for this exact package yet. CMS surveys NADAC per package size, so a different pack of the same drug often has one.

Try another pack size: 30 capsules 90 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

Product	Labeler	Pack	NADAC/unit	TE	Status	Price 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 mgthis 63187-0633-60	Proficient	60 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 mg 80425-0281-01	Advanced	30 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

🏛️

2015

On the market since

Nov 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 (matched by generic name) — the program that covers self-administered drugs. 25 manufacturers.

⚠️ Drug-level data: CMS publishes Part D spending by drug, not by NDC — these figures combine every manufacturer, strength and package size sold under the name Celecoxib. CMS lists 4 products for this generic; we show the highest-spend one. That’s a different level of aggregation than the Medicaid card above, which is specific to this exact 11-digit NDC (pack size included), so the two aren’t directly comparable.

Period

Total Part D spend

$38.36M

Claims incl. refills

1.6M

Beneficiaries

1.1M

Spend / beneficiary

$34.12

Spend / claim

$23.40

Trend by period

💵 About the dollar figures: spending is what Part D plans paid before confidential manufacturer rebates, so the program’s real net cost is lower. A blank patient count means fewer than 11 people — CMS hides counts that small to protect privacy. Source: CMS Medicare Quarterly Part D Spending by Drug (data.cms.gov), updated quarterly.

📦 Packaging — all sizes for this product

Package NDC	Description	Marketing start	Status
63187-0633-30	30 CAPSULE in 1 BOTTLE (63187-633-30)	2015-11-24	Active
63187-0633-60 You're viewing this	60 CAPSULE in 1 BOTTLE (63187-633-60)	2015-11-24	Active
63187-0633-90	90 CAPSULE in 1 BOTTLE (63187-633-90)	2015-11-24	Active

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

Pack size FAQ

What quantity is in NDC 63187-0633-60?

NDC 63187-0633-60 is a 60-count package — 60 capsule in 1 bottle.

What is the difference between NDC 63187-0633-60 and NDC 63187-0633-30?

Both are Celecoxib 200 mg 200 mg Capsule — the drug itself is identical. NDC 63187-0633-60 is the 60-count package, while NDC 63187-0633-30 is the 30 capsules package.

What NDC number is used to bill for this package of Celecoxib 200 mg 200 mg Capsule?

Bill NDC 63187-0633-60 — the 11-digit billing format is 63187063360. 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 63187-633-60, 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: 63187-0633-60, written without dashes as 63187063360. 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 63187-0633-60, the first segment (63187) is the labeler code FDA assigned to Proficient Rx LP; the middle segment (0633) 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?

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📄 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 🤰 Pregnancy 🧒 Pediatric Use 🧓 Geriatric Use 🆘 Overdosage 🧬 Clinical Pharmacology 🧬 Mechanism of Action 📦 How Supplied / Storage and Handling 📋 Description 💬 Information for Patients 💬 Medication Guide

🚨 Boxed Warning ~1 min read ▾

WARNING: CARDIOVASCULAR AND GASTROINTESTINAL RISKS WARNING: CARDIOVASCULAR AND GASTROINTESTINAL RISKS Cardiovascular Risk • Celecoxib 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) WARNING: CARDIOVASCULAR AND GASTROINTESTINAL RISKS See full prescribing information for complete boxed warning CardiovascularRisk • Celecoxib 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 208 words ▾

1. INDICATIONS AND USAGE Carefully consider the potential benefits and risks of celecoxib and other treatment options before deciding to use celecoxib. 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)R • heumatoid 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 inCelecoxib 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 to 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 to 8° C/ 35 to 45° F).

2.4Ankylosing Spondylitis For the management of the signs and symptoms of AS, the recommended dose of celecoxib 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 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 26 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 129 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 andPrecautions (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 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 celecoxibimmediately if abnormal liver enzymes persist or worsen (5.5, 17.4). • New onset or worsening of hypertension.

Blood pressure should be monitored closely duringtreatment with celecoxib (5.2, 7.4, 17.2). • Fluid retention and edema. Celecoxib should be used with caution in patients with fluid retentionor heart failure (5.3, 17.6). • Renal papillary necrosis and other renal injury with long term use. Use celecoxib with caution inthe 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 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 evenwithout known prior sulfa allergy. Discontinue celecoxib at first appearance of rash or skin reactions (5.8, 17.5).

5.1Cardiovascular Thrombotic Events Chronic use of celecoxib 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 to 8.5) for celecoxib 400 mg twice daily and 2.8 (95% CI 1.1 to 7.2) with celecoxib 200 mg twice daily compared to placebo. Cumulative rates for this composite endpoint over 3 years were 3% (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 to 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 response to these therapies when taking NSAIDs. NSAIDs, including celecoxib, should be used with caution in patients with hypertensi…

🤒 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 Sydon Labs, LLC at 1 866-487-4695 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 N=4, 146 Placebo N=1, 864 NAP N=1, 366 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% 4.2% 7.7% 5.3% 12.2% 3.6% 6% 9% 9.3% 10.9% 4.1% 3.4% 9% 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% 2.6% 1% 2.6% 0.9% 3.5% 3.2% Central, Peripheral Nervous system Dizziness Headache 2% 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% 5% 8.1% 1.1% 1.3% 4.3% 6.7% 1.7% 2.4% 4% 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 100 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 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 (100 to 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 hypertension, angina pectoris, coronary artery disorder, myocardial infarction General: Allergy aggravated, allergic…

🔄 Drug Interactions ~3 min read ▾

7 DRUG INTERACTIONS General: Celecoxib metabolism is predominantly mediated via cytochrome P450 (CYP) 2C9 in the liver. Co-administration 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. 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 antagonists (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 to 5 mg doses of warfarin. In these subjects, celecoxib did not alter the anticoagulant effect of warfarin as determined by prothrombin time.

However, in postmarketing 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 with drawn.

7.3Aspirin Celecoxib 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 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)] .

7.8 Concomitant NSAID Use The concomi…

👥 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 0to 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 to 24 at 200 mg twice daily) throughout organogenesis. There are no studies in pregnant women. Celecoxib 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 to 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 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 AUC 0to 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 to 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 Administrati…

🤰 Pregnancy ~1 min read ▾

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

🧒 Pediatric Use ~1 min read ▾

Alternative therapies for treatment of JRA should be considered in pediatric patients identified to be CYP2C9 poor metabolizers [see Poor Metabolizers of CYP2C9 substrates (8.8)].

🧓 Geriatric Use 123 words ▾

8.5Geriatric Use Of the total number of patients who received celecoxib in pre-approval clinical trials, more than 3,300 were 65 to 74 years of age, while approximately 1,300 additional patients were 75 years and over. No substantial differences in effectiveness were observed between these subjects and younger subjects. In clinical studies comparing renal function as measured by the GFR, BUN and creatinine, and platelet function as measured by bleeding time and platelet aggregation, the results were not different between elderly and young volunteers.

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

🆘 Overdosage 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 hr V ss /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 to 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 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, 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 t 1/2 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, α 1 -acid glycoprotein. The apparent volume of distribution at steady state (Vss/F) is 1 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 metabolites, a pr…

🧬 Mechanism of Action 69 words ▾

📦 How Supplied / Storage and Handling 76 words ▾

16. HOW SUPPLIED/STORAGE AND HANDLING Celecoxib capsules 200 mg are opaque white/opaque white hard gelatin capsules size “1” having imprinting “136” on body with golden yellow ink and “A” on cap with golden yellow ink filled with white to off-white colored granular powder NDC 63187-633-30 bottle of 30 capsules NDC 63187-633-60 bottle of 60 capsules NDC 63187-633-90 bottle of 90 capsules Storage: Store at 20°-25°C (68°-77°F) excursions permitted to 15°-30°C (59°-86°F) [see USP Controlled Room Temperature].

📋 Description 149 words ▾

11. DESCRIPTION Celecoxib is chemically designated as 4-[5-(4-methylphenyl)-3-(trifluoromethyl)-1H-pyrazol1-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: croscarmellose sodium, lactose monohydrate, magnesium stearate, povidone, sodium lauryl sulfate, titanium dioxide and gelatin.

Details of non-volatile components of the imprinting ink are given below. 50 mg capsule contains shellac, propylene glycol and red iron oxide. 100 mg capsule contains shellac, propylene glycol and FD & C Blue No. # 2 aluminum lake.

200 mg capsule contains shellac, propylene glycol and yellow iron oxide. 400 mg capsule contains shellac, propylene glycol, titanium dioxide, yellow iron oxide and FD & C Blue No. # 2 aluminum lake. 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.

17.2Cardiovascular Effects Patients should be informed that celecoxib 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 can lead to the onset of new hypertension or worsening of preexisting hypertension, and that celecoxib 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 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 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 [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 should be avoided because it may cause premature closure of the ductus arteriosus [see Warnings and Precautions (5.9), Use in Specific Po…

💬 Medication Guide ~3 min read ▾

Medication Guide 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. • 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 • stroke • high blood pressure • heart failure from body swelling (fluid retention) • kidney problems including kidney failure • bleeding and ulcers in the stomach and intestine • low red blood cells (anemia) • life-threatening skin reactions • life-threatening allergic reactions • liver problems including liver failure • asthma attacks in people who have asthma • stomach pain • constipation • diarrhea • gas • heartburn • nausea • vomiting • dizziness Get emergency help right away if you have any of the following symptoms: • shortness of breath or trouble breathing • chest pain • weakness in one part or side of your body • slurred speech • swelling of the face or throat Stop your NSAID medicine and call your healthcare provider right away if you have 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 • itching • your skin or eyes look yellow • skin rash or blisters with fever • stomach pain • flu-like symptoms • unusual weight gain • 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 (overthecounter).

Talk to your…

Glossary — plain-language definitions of medical terms used in this label:

anticoagulant: A medicine that slows down blood clotting; often called a blood thinner.

contraindicated: Should not be used in that situation, because the risk is considered too high.

in vitro: In a laboratory dish or test tube rather than in a living person or animal; results may not carry over to people.

in vivo: In a living person or animal rather than in a laboratory dish.

abdominal pain: Pain, cramping, or discomfort felt anywhere in the belly area.

Absorption: How a medicine moves from where it is taken, such as the stomach or gut, into the bloodstream.

active-controlled: Describes a study that compares a new medicine against another medicine already known to work, instead of a dummy pill.

adverse reaction: An unwanted or harmful effect that a medicine causes in the body.

Adverse Reactions: Unwanted or harmful effects that people experienced while taking a medicine, listed on its official label.

anaphylactoid reaction: A severe reaction that looks like a serious allergic reaction but is not caused by the usual allergy antibodies.

anemia: A low level of red blood cells or the oxygen-carrying protein inside them, which can cause tiredness, weakness, and paleness.

angina pectoris: Chest pain or a squeezing feeling that happens when the heart muscle does not get enough blood and oxygen.

AUC: A measure of total drug exposure over time, showing how much medicine the blood is exposed to overall.

Bioavailability: The share of a dose that actually reaches the bloodstream and is able to have an effect.

Boxed Warning: The strongest safety warning the FDA can require, set inside a bold black border because the risk it describes can be very serious.

BUN: Blood urea nitrogen, a waste product measured in a blood test that helps show how well the kidneys are working.

Child-Pugh: A scoring system doctors use to grade how severe long-term liver disease is, often to help set the right medicine dose.

Clinical Pharmacology: The label section explaining how a medicine works in the body and how the body processes it.

Clinical Studies: The label section summarizing the research trials used to show that a medicine works and is acceptably safe.

constipation: Having bowel movements less often than usual, or passing stools that are hard, dry, and difficult to move.

Contraindications: A list of situations or health conditions in which a medicine should not be used because the chance of harm is too high.

CYP2C9: A liver enzyme that breaks down certain medicines, including some blood thinners and anti-inflammatory drugs.

CYP2D6: A liver enzyme that breaks down many medicines; people inherit different versions, so it works faster in some and slower in others.

cytochrome P450: A large family of enzymes, mostly in the liver, that break down many medicines so the body can remove them.

depression: A lasting low mood with loss of interest that affects everyday life.

dermatitis: Inflammation of the skin, causing redness, itching, and sometimes swelling or blisters.

diarrhea: Loose, watery bowel movements that happen more often than normal.

discontinuation rate: The share of people in a study who stopped taking a treatment before the study was finished.

disseminated intravascular coagulation: A serious condition where many small clots form throughout the body, using up the proteins needed to clot and causing bleeding.

Distribution: How a medicine spreads from the blood into the body's tissues and organs after it is absorbed.

Dosage and Administration: The label section explaining how much of a medicine to use and how to take or give it.

dose reduction: Lowering the amount of a medicine, often to ease side effects or fit a person's needs.

double-blind: A study in which neither the patients nor their doctors know who is getting the real medicine and who is getting the dummy.

Drug Interactions: The label section listing other medicines, foods, or substances that can change how a medicine works or raise the chance of side effects.

dyspepsia: Discomfort, fullness, or a burning feeling in the upper belly, commonly called indigestion.

dysphagia: Trouble or discomfort swallowing food, liquids, or pills.

edema: Swelling caused by extra fluid trapped in the body's tissues.

efficacy: How well a treatment works under the controlled conditions of a clinical study.

emesis: The medical word for vomiting, or bringing up the contents of the stomach through the mouth.

endpoint: A specific outcome, such as a symptom or lab value, that a study measures to judge whether a treatment works.

eructation: The medical word for burping, or releasing gas from the stomach up through the mouth.

esophagitis: Swelling and irritation of the lining of the food pipe, or esophagus.

exfoliative dermatitis: Widespread redness with heavy scaling or peeling of the skin over most of the body.

flatulence: Passing gas from the bowel; feeling bloated or gassy.

Full Prescribing Information: The complete, detailed label for a prescription medicine that follows the summary highlights.

gastritis: Swelling or irritation of the lining of the stomach.

gastrointestinal bleeding: Bleeding anywhere along the digestive tract, from the food pipe down to the bowel.

GFR: A measure (glomerular filtration rate) of how well the kidneys filter the blood; lower numbers mean weaker kidney function.

hazard ratio: A number comparing how quickly an event happens in one group versus another; above 1 means more often, below 1 means less often.

heart failure: A condition in which the heart cannot pump blood as well as it should, causing tiredness, breathlessness, and swelling.

hematemesis: Vomiting blood, which may look bright red or like dark coffee grounds.

hemodialysis: A treatment that uses a machine to filter waste and extra fluid from the blood when the kidneys cannot.

hepatic impairment: Reduced liver function, meaning the liver does not work as well as normal at processing substances, including medicines.

hepatotoxicity: Damage to the liver caused by a medicine or other substance.

How Supplied/Storage and Handling: The label section describing the forms and strengths a medicine comes in and how to store it properly.

hypersensitivity: An overreaction of the body's defense system to a substance, causing symptoms such as rash, swelling, or trouble breathing.

hypertension: Blood pressure that stays higher than normal, commonly called high blood pressure.

incidence: How often a new event, such as a side effect, happens in a group of people over a set period of time.

Indications and Usage: The label section stating which medical conditions the FDA has officially approved the medicine to treat, prevent, or manage.

inhibitor: A substance that blocks an enzyme or transporter, which can raise the levels of drugs it normally handles.

insomnia: Trouble falling asleep, staying asleep, or getting restful sleep.

jaundice: Yellowing of the skin and the whites of the eyes caused by too much bilirubin in the blood.

lethargy: A state of tiredness and sluggishness, often with slowed thinking or movement.

Mechanism of Action: How a medicine produces its effect in the body, described at the level of cells or body chemistry.

Medication Guide: An FDA-approved handout written for patients that explains important safety information about certain medicines in plain language.

melena: Black, sticky, tar-like stools caused by blood that has been digested higher up in the gut.

Metabolism: How the body chemically changes a medicine, usually in the liver, into other substances.

myocardial infarction: The medical term for a heart attack, when blood flow to part of the heart muscle is blocked.

NDC: A unique number that identifies a specific medicine, its maker, strength, and package size.

open-label: A study in which both the patients and their doctors know which treatment each person is receiving.

organogenesis: The early stage of pregnancy when the developing baby's organs are first forming.

Overdosage: The label section describing what can happen if too much of a medicine is taken and how it may be treated.

Patient Counseling Information: The label section telling health professionals what to explain to patients about using a medicine safely.

perforation: A hole that forms all the way through the wall of the stomach or intestine.

peripheral edema: Swelling, usually in the feet, ankles, or legs, caused by extra fluid building up in the tissues.

Pharmacokinetics: The study of how the body takes in a medicine, spreads it around, breaks it down, and removes it over time.

placebo: An inactive treatment with no real medicine in it, such as a sugar pill, used for comparison in a study.

plasma concentration: The amount of medicine measured in the liquid part of the blood at a given time.

pregnancy category: An older letter rating (A, B, C, D, or X) once used to describe a medicine's possible risk during pregnancy.

Prescribing Information: The official, detailed document approved by the FDA that tells health professionals how to use a prescription medicine.

prophylaxis: Treatment given to prevent an infection or illness before it starts, rather than to treat one that is already present.

protein binding: How much of a medicine sticks to proteins in the blood instead of moving freely through the body.

prothrombin time: A blood test that measures how many seconds it takes for blood to form a clot.

pruritus: Itching of the skin.

respiratory depression: Breathing that becomes too slow or too shallow to move enough air, so the body may not get enough oxygen.

steady state: The point where the amount of medicine going in equals the amount leaving, so blood levels stay fairly even.

Stevens-Johnson syndrome: A rare, serious reaction causing painful blistering and peeling of the skin and the moist linings of the mouth, eyes, and other areas.

stomatitis: Soreness, swelling, or sores on the lining inside the mouth.

substrate: A drug or other substance that a particular enzyme or transporter acts on.

teratogenic: Able to cause physical birth defects in a developing baby when a medicine is taken during pregnancy.

toxic epidermal necrolysis: A rare, life-threatening reaction in which large areas of the top layer of skin blister and peel away, like a severe burn.

trimester: One of the three roughly three-month stages that a pregnancy is divided into.

ulceration: The forming of an open sore on the skin or on a lining inside the body, such as the stomach.

upper respiratory tract infection: An infection of the nose, sinuses, or throat, such as the common cold.

urticaria: Raised, itchy welts on the skin, commonly called hives.

Use in Specific Populations: The label section describing how a medicine affects particular groups, such as pregnant people, children, or older adults.

volume of distribution: A calculated value showing how widely a medicine spreads into body tissues versus staying in the blood.

Warnings and Precautions: The label section describing serious risks to know about and safety steps to follow while using a medicine.

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

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For educational and professional reference only — not medical advice. Pricing reflects published NADAC and CMS ASP (free public data) and may differ from your acquisition cost; always verify before billing or dispensing.

Celecoxib 200 mg 200 mg Capsule, 60-count

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