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Celecoxib 100 mg Capsule, 60-count — NDC 63187-301-60 (Billing 63187-0301-60)

by Proficient Rx LP · 60 CAPSULE in 1 BOTTLE

This is a package of 60 capsules of Celecoxib 100 mg Capsule from Proficient Rx LP, marketed since Sep 2015 and currently FDA-listed.

NDC 63187-0301-60
🏷️ FDA NDC (as labeled) 63187-301-60 billing pads the product segment with a zero
This package
Contains60-count Pack sizes3 compare ↓
Also priced by: Part D plans $0.2958/unit — full pricing hub ↓
Product page 63187-0301-30 Also comes in: 30 capsules 63187-301-30 90 capsules 63187-301-90
Rx only Generic On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

This page is curated, coded, and maintained by

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

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

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 63187-301-60
Product NDC 63187-301
11-digit billing NDC 63187030160
NCPDP billing unit EA — each (per item)
RxCUI 205322
UNII JCX84Q7J1L
Application # ANDA207446
SPL Set ID c91e5933-1798-4096-9f08-fb1200e154e1
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 2015-09-23
Route ORAL
Dosage form CAPSULE
Substance CELECOXIB
TE code (Orange Book) AB · RLD · RS

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

GPI-14 66100525000120
GPI class Celecoxib
GCN Seq No 041285
GCN 42001
HICL code 018979
Ingredient (HICL) Celecoxib
HIC1 code S
Therapeutic class — broad (HIC1) Locomotor System
HIC2 code S2
Therapeutic class — intermediate (HIC2) Drugs Acting Principally On Joints
HIC3 code S2L
Therapeutic class — specific (HIC3) Nsaids,Cyclooxygenase-2(Cox-2) Selective Inhibitor
AHFS code 28:08.04.08
AHFS class Cyclooxygenase-2 (Cox-2) Inhibitors
FDB label name CELECOXIB 100 MG CAPSULE
FDB brand name Celecoxib
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 041285
  • GCN: 42001
  • GPI-14 (Medi-Span): 66100525000120
  • HICL (First Databank): 018979
  • AHFS class code: 28:08.04.08
  • RxCUI (RxNorm): 205322
Why two NDCs? The FDA registers this code as 63187-301-60 — 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 → 63187-0301-60. 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.

Clinical

Label name CELECOXIB 100 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
  • It depends on the product. Celebrex and generic capsules are used for several types of arthritis, acute pain and painful periods. Vyscoxa liquid is for certain arthritis types. ELY...
  • For capsules, usual doses can be taken with or without food, but higher doses are taken with food. Vyscoxa suspension must be taken on an empty stomach, at least 2 hours before or...
  • The most common ones are stomach upset, indigestion, diarrhea, gas, swelling, dizziness, cold-like symptoms and rash. Call your doctor if they bother you or don't go away.
  • Get emergency help for chest pain, shortness of breath, weakness on one side, slurred speech, black or bloody stools, vomiting blood, or swelling of the face or throat. Stop it and...
📖 Read our full Celecoxib guide →
1
Nutrient depletion considerations

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

🧪 Full Celecoxib nutrient depletion report →
An association is not a deficiency. Educational only — don't start or stop anything without professional guidance.
Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

Pricing

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

Price systemPer eachPer package
Retail pharmacies payNADAC · weekly Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · Q2 2026 $0.2958 $17.75 / 60 capsules
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
63187-0301-30 63187-301-30 Main listing 30 CAPSULE in 1 BOTTLE 2016-05-02 — Active
63187-0301-60 You're viewing this 60 CAPSULE in 1 BOTTLE 2016-05-02 — Active
63187-0301-90 63187-301-90 90 CAPSULE in 1 BOTTLE 2016-05-02 — Active

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

Pack size FAQ

What quantity is in this package?
This is a 60-count package — 60 capsule in 1 bottle.
How does this package differ from NDC 63187-0301-30?
Both are Celecoxib 100 mg Capsule — the drug itself is identical. This page's package is the 60-count one, while NDC 63187-0301-30 is the 30 capsules package.
What NDC number is used to bill for this package of Celecoxib 100 mg Capsule?
Use the 11-digit billing form listed in the identifiers section of this page. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Celecoxib 100 mg 00591-3983-01 Actavis 100 capsules $0.061 AB Discontinued —
Celecoxib 100 mg 00904-7550-61 Major 100 capsules $0.061 AB Availability likely —
Celecoxib 100 mg 11788-0113-01 AiPing 100 capsules $0.061 AB Availability likely —
Celecoxib 100 mg 16714-0732-01 NorthStar 100 capsules $0.061 AB Availability likely —
Celecoxib 100 mg 23155-0964-01 Avet 100 capsules $0.061 AB Availability likely —
Celecoxib 100 mg 27808-0296-01 Cranbury 100 capsules $0.061 AB Availability likely —
celecoxib 100 mg 33342-0156-11 Macleods 100 capsules $0.061 AB Availability likely —
Celecoxib 100 mg 42571-0143-01 Micro 100 capsules $0.061 AB Availability likely —
Celecoxib 100 mg 50228-0157-01 ScieGen 100 capsules $0.061 AB Availability likely —
Celecoxib 100 mg 50268-0168-15 AvPAK 50 capsules $0.061 AB Availability likely —
Celecoxib 100 mg 60505-3848-01 Apotex 100 capsules $0.061 AB Availability likely —
Celecoxib 100 mg 60687-0436-01 American 100 capsules $0.061 AB Availability likely —
Celecoxib 100 mg 62135-0021-60 Chartwell 60 capsules $0.061 AB Availability likely —
Celecoxib 100 mg 65862-0908-01 Aurobindo 100 capsules $0.061 AB Availability likely —
celecoxib 100 mg 68180-0396-01 Lupin 100 capsules $0.061 AB Availability likely —
Celecoxib 100 mg 69367-0301-01 Westminster 100 capsules $0.061 AB Availability likely —
Celecoxib 100 mg 75834-0237-01 NIVAGEN 100 capsules $0.061 AB Availability likely —
Celecoxib 100 mg 82009-0068-05 Quallent 500 capsules $0.061 AB Availability likely —
Celecoxib 100 mg 83301-0011-01 Mullan 100 capsules $0.061 AB Availability likely —
Celecoxib 100 mg 42806-0721-01 EPIC 100 capsules $0.062 AB Availability likely —
celecoxib 100 mg 13668-0441-01 Torrent 100 capsules $0.090 AB FDA listed —
Celebrex 100 mg 58151-0083-01 Viatris 100 capsules $9.534 AB Availability likely —
Celecoxib 100 mg 00615-8572-39 NCS 30 capsules — AB FDA listed —
Celecoxib 100 mg 29300-0158-01 Unichem 100 capsules — — FDA listed —
Celecoxib 100 mg 46708-0268-10 Alembic 100 capsules — AB FDA listed —
Celecoxib 100 mg 50090-6380-00 A-S 30 capsules — AB FDA listed —
Celecoxib 100 mg 51655-0059-52 Northwind 30 capsules — AB FDA listed —
Celecoxib 100 mg 51655-0436-25 Northwind 60 capsules — AB FDA listed —
celecoxib 100 mg 55700-0613-30 Quality 30 capsules — AB FDA listed —
Celecoxib 100 mg 57582-0212-01 Tianjin 100 capsules — AB FDA listed —
Celecoxib 100 mg 60290-0017-01 Umedica 100 capsules — AB FDA listed —
Celecoxib 100 mg 60760-0649-60 ST. 60 capsules — AB FDA listed —
Celecoxib 100 mg 60760-0995-15 St. 15 capsules — AB FDA listed —
Celecoxib 100 mg 62332-0141-08 Alembic 80 capsules — AB FDA listed —
Celecoxib 100 mgthis 63187-0301-60 Proficient 60 capsules — AB FDA listed —
Celecoxib 100 mg 63187-0643-30 Proficient 30 capsules — AB FDA listed —
Celecoxib 100 mg 68788-4095-03 Preferred 30 capsules — AB FDA listed —
celecoxib 100 mg 68788-7286-03 Preferred 30 capsules — AB FDA listed —
Celecoxib 100 mg 68788-8206-03 Preferred 30 capsules — AB FDA listed —
Celecoxib 100 mg 69097-0422-02 Cipla 30 capsules — AB FDA listed —
Celecoxib 100 mg 69117-0021-01 Yiling 60 capsules — AB FDA listed —
Celecoxib 100 mg 70247-0007-10 Qingdao 100 capsules — AB FDA listed —
Celecoxib 100 mg 70518-3424-00 REMEDYREPACK 30 capsules — AB Discontinued —
Celecoxib 100 mg 70518-3826-00 REMEDYREPACK 90 capsules — AB FDA listed —
Celecoxib 100 mg 70518-4009-00 REMEDYREPACK 100 capsules — AB FDA listed —
Celecoxib 100 mg 70518-4508-00 REMEDYREPACK 60 capsules — AB FDA listed —
Celecoxib 100 mg 71205-0020-30 Proficient 30 capsules — AB FDA listed —
celecoxib 100 mg 71205-0439-30 Proficient 30 capsules — AB FDA listed —
Celecoxib 100 mg 71209-0055-03 Cadila 60 capsules — AB FDA listed —
Celecoxib 100 mg 71335-0292-01 Bryant 30 capsules — AB FDA listed —
celecoxib 100 mg 71335-0936-01 Bryant 30 capsules — AB FDA listed —
Celecoxib 100 mg 71335-1804-01 Bryant 30 capsules — AB FDA listed —
Celecoxib 100 mg 71335-2019-01 Bryant 30 capsules — AB FDA listed —
Celecoxib 100 mg 71335-2222-01 Bryant 30 capsules — AB FDA listed —
Celecoxib 100 mg 72162-2254-05 Bryant 500 capsules — AB FDA listed —
Celecoxib 100 mg 72189-0123-30 Direct 30 capsules — AB FDA listed —
Celecoxib 100 mg 72189-0662-60 Direct_Rx 60 capsules — AB FDA listed —
Celecoxib 100 mg 72241-0023-03 Modavar 60 capsules — AB FDA listed —
celecoxib 100 mg 76420-0243-01 Asclemed 1 capsule — AB FDA listed —
Celecoxib 100 mg 76420-0727-01 Asclemed 1 capsule — AB FDA listed —
Celecoxib 100 mg 76420-0843-00 Asclemed 1000 capsules — AB FDA listed —
Celecoxib 100 mg 77771-0157-01 Radha 100 capsules — AB FDA listed —
Celecoxib 100 mg 80425-0142-01 Advanced 30 capsules — AB FDA listed —
Celecoxib 100 mg 80425-0167-01 Advanced 30 capsules — AB FDA listed —
Celecoxib 100 mg 80425-0321-01 Advanced 30 capsules — AB FDA listed —
Celecoxib 100 mg 80425-0323-01 Advanced 30 capsules — AB FDA listed —
Celecoxib 100 mg 82804-0151-60 Proficient 60 capsules — AB FDA listed —
Celecoxib 100 mg 85509-1237-01 PHOENIX 120 capsules — AB FDA listed —
celecoxib 100 mg 85534-0014-00 HAWAII 30 capsules — AB FDA listed —
Celecoxib 100 mg 85534-0067-00 HAWAII 30 capsules — AB FDA listed —
Celecoxib 100 mg 55154-0160-00 Cardinal 10 capsules — AB FDA listed —
Celecoxib 100 mg 50090-8031-00 A-S 30 capsules — AB FDA listed —
Celecoxib 100 mg 72189-0685-72 Direct_Rx 120 capsules — AB FDA listed —
Celecoxib 100 mg 50090-8036-00 A-S 30 capsules — AB FDA listed —
Celecoxib 100 mg 60760-0942-60 St. 60 capsules — AB FDA listed —
About this product: this is a generic version of the medicine. FDA equivalence ratings are shown when available, and other versions are listed above, least expensive first.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

Availability & generic status

🏛️
2015
On the market since
Sep 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.

Inactive Ingredients / Excipients

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

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

Inactive ingredient FAQ

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

Manufacturer & labeler

LabelerProficient Rx LP
Application holderCIPLA LTD
FDA applicationANDA207446 (ANDA)
Labeler code63187
First marketedSep 2015
Product typeHuman Prescription Drug
Portfolio1,729 products on file
The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Very long sections are excerpted here and marked; the full text is on DailyMed (linked in the sources below). Jump with a chip, search within the label, or expand everything.
🚨 Boxed Warning 🎯 Indications and Usage ⏱️ Dosage and Administration 💊 Dosage Forms and Strengths ⛔ Contraindications ⚠️ Warnings and Cautions 🤒 Adverse Reactions 🔄 Drug Interactions 👥 Use in Specific Populations 🤰 Pregnancy 🧒 Pediatric Use 🧓 Geriatric Use 🆘 Overdosage 🧬 Clinical Pharmacology 🧬 Mechanism of Action 📦 How Supplied / Storage and Handling 📋 Description 💬 Information for Patients 💬 Medication Guide 🍼 Nursing Mothers 🧬 Pharmacokinetics 🧬 Pharmacodynamics 🔬 Clinical Studies 🧪 Nonclinical Toxicology 📄 Package Label / Principal Display Panel
🚨 Boxed Warning ~1 min read ▾

WARNING: CARDIOVASCULAR AND GASTROINTESTINAL RISKS See full prescribing information for complete boxed warning 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 Cardiovascular Risk • Celecoxib may cause an increased risk of serious cardiovascular thrombotic events, myocardial infarction, and stroke, which can be fatal.

All non-steroidal anti-inflammatory drugs (NSAIDs) may have a similar risk. This risk may increase with duration of use. Patients with cardiovascular disease or risk factors for cardiovascular disease may be at greater risk.

( 5.1 , 14.6 ) • Celecoxib is contraindicated for the treatment of 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 events. ( 5.4 )

🎯 Indications and Usage ~1 min read ▾

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

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

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

1.3Juvenile Rheumatoid Arthritis (JRA) Celecoxib Capsules 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 Capsules is indicated for the relief of signs and symptoms of AS [see Clinical Studies ( 14.4 )]

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

1.6Primary Dysmenorrhea (PD) Celecoxib Capsules 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. ( 1 , 5.1 , 5.4 ) • OA: 200 mg once daily or 100 mg twice daily ( 2.1 , 14.1 ) • RA: 100 to 200 mg twice daily ( 2.2 , 14.2 ) • JRA: 50 mg twice daily in patients 10-25 kg. 100 mg twice daily in patients more than 25 kg ( 2.3 , 14.3 ) • AS: 200 mg once daily single dose or 100 mg twice daily.

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

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.

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

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

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

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

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

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

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

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

💊 Dosage Forms and Strengths 28 words ▾

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

⛔ Contraindications 148 words ▾

4 CONTRAINDICATIONS • 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 ) Celecoxib Capsules is contraindicated: • In patients with known hypersensitivity to celecoxib, aspirin, or other NSAIDs. • In patients who have demonstrated allergic-type reactions to sulfonamides. • In patients who have experienced asthma, urticaria, or allergic-type reactions after taking aspirin or other NSAIDs.

Severe anaphylactoid reactions to NSAIDs, some of them fatal, have been reported in such patients [see Warnings and Precautions ( 5.7 , 5.13 )]. • For the treatment of peri-operative pain in the setting of coronary artery bypass graft (CABG) surgery [see Warnings and Precautions ( 5.1 )].

⚠️ Warnings and Cautions ~3 min read ▾

5 WARNINGS AND PRECAUTIONS • Serious and potentially fatal cardiovascular (CV) thrombotic events, myocardial infarction, and stroke. Patients with known CV disease/risk factors may be at greater risk ( 5.1 , 14.6 , 17.2 ). • Serious gastrointestinal (GI) adverse events, which can be fatal. The risk is greater in patients with a prior history of ulcer disease or GI bleeding, and in patients at high risk for GI events, especially the elderly.

Celecoxib Capsules should be used with caution in these patients ( 5.4 , 8.5 , 14.6 , 17.3 ). • Elevated liver enzymes and, rarely, severe hepatic reactions. Discontinue use of Celecoxib Capsules immediately if abnormal liver enzymes persist or worsen ( 5.5 , 17.4 ). • New onset or worsening of hypertension. Blood pressure should be monitored closely during treatment with Celecoxib Capsules ( 5.2 , 7.4 , 17.2 ). • Fluid retention and edema.

Celecoxib Capsules should be used with caution in patients with fluid retention or heart failure ( 5.3 , 17.6 ). • Renal papillary necrosis and other renal injury with long term use. Use Celecoxib Capsules with caution in the elderly, those with impaired renal function, heart failure, liver dysfunction, and those taking diuretics, ACE-inhibitors, or angiotensin II antagonists ( 5.6 , 7.4 , 8.7 , 17.6 ). • Anaphylactoid reactions. Do not use Celecoxib Capsules in patients with the aspirin triad ( 5.7 , 10 , 17.7 ). • Serious skin adverse events such as exfoliative dermatitis, Stevens-Johnson syndrome (SJS), and toxic epidermal necrolysis (TEN), which can be fatal and can occur without warning even without known prior sulfa allergy.

Discontinue Celecoxib Capsules at first appearance of rash or skin reactions ( 5.8 , 17.5 ).

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

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

To minimize the potential risk for an adverse CV event in patients treated with Celecoxib Capsules, 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 Capsules does increase the risk of serious GI events [see Warnings and Precautions ( 5.4 )]. Two large, controlled, clinical trials of a different COX-2 selective NSAID for the treatment of pain in the first 10-14 days following CABG surgery found an increased incidence of myocardial infarction and stroke [see Contraindications ( 4 )].

5.2Hypertension As with all NSAIDs, celecoxib can lead to the onset of new hypertension or worsening of preexisting hypertension, either of which may contribute to the increased incidence of CV events. Patients taking thiazides or loop diuretics may… [Excerpted — this section continues on DailyMed.]

🤒 Adverse Reactions ~3 min read ▾

6 ADVERSE REACTIONS 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 Cipla Ltd, at 1-866-604-3268 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch 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. 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.

6.1Pre-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 Patients from Pre-marketing Controlled Arthritis Trials Celecoxib = Celecoxib Capsules 100 - 200 mg twice daily or 200 mg once daily; NAP = Naproxen 500 mg twice daily; DCF = Diclofenac 75 mg twice daily; IBU = Ibuprofen 800 mg three times daily.

Celecoxib (N=4146) Placebo (N=1864) NAP (N=1366) DCF (N=387) IBU (N=345) Gastrointestinal Abdominal Pain 4.1% 2.8% 7.7% 9.0% 9.0% Diarrhea 5.6% 3.8% 5.3% 9.3% 5.8% Dyspepsia 8.8% 6.2% 12.2% 10.9% 12.8% Flatulence 2.2% 1.0% 3.6% 4.1% 3.5% Nausea 3.5% 4.2% 6.0% 3.4% 6.7% Body as whole Back Pain 2.8% 3.6% 2.2% 2.6% 0.9% Peripheral Edema 2.1% 1.1% 2.1% 1.0% 3.5% Injury-Accidental 2.9% 2.3% 3.0% 2.6% 3.2% Central, Peripheral Nervous System Dizziness 2.0% 1.7% 2.6% 1.3% 2.3% Headache 15.8% 20.2% 14.5% 15.5% 15.4% Psychatric Insomnia 2.3% 2.3% 2.9% 1.3% 1.4% Respiratory Pharyngitis 2.3% 1.1% 1.7% 1.6% 2.6% Rhinitis 2.0% 1.3% 2.4% 2.3% 0.6% Sinusitis 5.0% 4.3% 4.0% 5.4% 5.8% Upper Respiratory Infection 8.1% 6.7% 9.9% 9.8% 9.9% Skin Rash 2.2% 2.1% 2.1% 1.3% 1.2% The following adverse reactions occurred in 0.1 - 1.9% of patients treated with Celecoxib Capsules (100 - 200 mg twice daily or 200 mg once daily): Gastrointestinal: Constipation, diverticulitis, dysphagia, eructation, esophagitis, gastritis, gastroenteritis, gastroesophageal reflux, hemorrhoids, hiatal hernia, melena, dry mouth, stomatitis, tenesmus, vomiting Cardiovascular: Aggravated hypertension, angina pectoris, coronary artery disorder, myocardial infarction Allergy General: aggravated, allergic reaction, chest pain, cyst NOS, edema generalized, face edema, fatigue, fever, hot flushes, influenza-like symptoms, pain, peripheral pain Central, peripheral nervous system: Leg cramps, hypertonia, hypoesthesia, migraine, paresthesia, vertigo Hearing and vestibular: Deafness, tinnitus Heart rate and rhythm: Palpitation, tachycardia Liver and biliary: Hepatic function abnormal, SGOT increased, SGPT increased Metabolic and nutritional: BUN i… [Excerpted — this section continues on DailyMed.]

🔄 Drug Interactions ~3 min read ▾

7 DRUG INTERACTIONS • 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 ) 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.

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

However, in 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 Capsules 200 mg twice daily as compared to subjects receiving lithium alone. Patients on lithium treatment should be closely monitored when Celecoxib Capsules is introduced or withdrawn.

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 )].

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

👥 Use in Specific Populations ~3 min read ▾

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

8.1Pregnancy Pregnancy Category C. Pregnancy category D from 30 weeks of gestation onward Teratogenic effects: Celecoxib at oral doses ≥150 mg/kg/day (approximately 2-fold human exposure at 200 mg twice daily as measured by AUC 0-24 ), caused an increased incidence of ventricular septal defects, a rare event, and fetal alterations, such as ribs fused, sternebrae fused and sternebrae misshapen when rabbits were treated throughout organogenesis. A dose-dependent increase in diaphragmatic hernias was observed when rats were given celecoxib at oral doses ≥30 mg/kg/day (approximately 6-fold human exposure based on the AUC 0-24 at 200 mg twice daily) throughout organogenesis.

There are no studies in pregnant women. Celecoxib should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Nonteratogenic effects: Celecoxib produced pre-implantation and post-implantation losses and reduced embryo/fetal survival in rats at oral dosages ≥50 mg/kg/day (approximately 6-fold human exposure based on the AUC 0-24 at 200 mg twice daily).

These changes are expected with inhibition of prostaglandin synthesis and are not the result of permanent alteration of female reproductive function, nor are they expected at clinical exposures. No studies have been conducted to evaluate the effect of celecoxib on the closure of the ductus arteriosus in humans. Therefore, use of celecoxib 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 0-24 at 200 mg BID). The effects of Celecoxib on labor and delivery in pregnant women are unknown.

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

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

8.4Pediatric Use Celecoxib Capsules 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 Capsules has not been evaluated and it is unknown if long-term risks may be similar to that seen in adults exposed to Celecoxib Capsules 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 Capsules 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 Capsules 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 Capsules 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 abnorma… [Excerpted — this section continues on DailyMed.]

🤰 Pregnancy ~1 min read ▾

5.9Pregnancy In late pregnancy, starting at 30 weeks gestation, celecoxib should be avoided because it may cause premature closure of the ductus arteriosus [see Use in Specific Populations ( 8.1 )].

8.1Pregnancy Pregnancy Category C. Pregnancy category D from 30 weeks of gestation onward Teratogenic effects: Celecoxib at oral doses ≥150 mg/kg/day (approximately 2-fold human exposure at 200 mg twice daily as measured by AUC 0-24 ), caused an increased incidence of ventricular septal defects, a rare event, and fetal alterations, such as ribs fused, sternebrae fused and sternebrae misshapen when rabbits were treated throughout organogenesis. A dose-dependent increase in diaphragmatic hernias was observed when rats were given celecoxib at oral doses ≥30 mg/kg/day (approximately 6-fold human exposure based on the AUC 0-24 at 200 mg twice daily) throughout organogenesis.

There are no studies in pregnant women. Celecoxib should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Nonteratogenic effects: Celecoxib produced pre-implantation and post-implantation losses and reduced embryo/fetal survival in rats at oral dosages ≥50 mg/kg/day (approximately 6-fold human exposure based on the AUC 0-24 at 200 mg twice daily).

These changes are expected with inhibition of prostaglandin synthesis and are not the result of permanent alteration of female reproductive function, nor are they expected at clinical exposures. No studies have been conducted to evaluate the effect of celecoxib on the closure of the ductus arteriosus in humans. Therefore, use of celecoxib during the third trimester of pregnancy should be avoided.

🧒 Pediatric Use ~1 min read ▾

8.4Pediatric Use Celecoxib Capsules 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 Capsules has not been evaluated and it is unknown if long-term risks may be similar to that seen in adults exposed to Celecoxib Capsules 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 Capsules 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 Capsules 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 Capsules 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 Administration ( 2.3 ), Warnings and Precautions ( 5 ,.

12 ), Adverse Reactions ( 6.3 ), Animal Toxicology ( 13.2 ), Clinical Studies ( 14.3 )]. 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 125 words ▾

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

However, as with other NSAIDs, including those that selectively inhibit COX-2, there have been more spontaneous 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 189 words ▾

10 OVERDOSAGE 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. 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 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 is 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 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 1 Subjects under fasting conditions (n=36, 19-52 yrs.) Mean (%CV) PK Parameter Values Cmax, ng/mL Tmax, hr Effective t1/2, hr Vss/F, L CL/F, L/hr 705 (38) 2.8 (37) 11.2 (31) 429 (34) 27.7 (28) Food Effects: When Celecoxib Capsules were taken with a high fat meal, peak plasma levels were delayed for about 1 to 2 hours with an increase in total absorption (AUC) of 10% to 20%.

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

Higher doses (400 mg twice daily) should be administered with food to improve absorption. In healthy adult volunteers, the overall systemic exposure (AUC) of celecoxib was equivalent when celecoxib was administered as intact capsule or capsule contents sprinkled on applesauce. There were no significant alterations in C max , T max or 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, a 1 -acid glycoprotein. The apparent volume of distribution at steady state (V ss /F) is approximately 400 L, suggesting extensive distribution into the tissues.

Celecoxib is not preferentially bound to red blood cells. Metabolism: Celecoxib metabolism is primarily mediated vi… [Excerpted — this section continues on DailyMed.]

🧬 Mechanism of Action 69 words ▾

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.

📦 How Supplied / Storage and Handling 74 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING Celecoxib Capsules are available in the following strengths and configurations: Celecoxib Capsules 100 mg: White to off white colored granules filled in size 2 hard gelatin white capsule, axially printed with ‘Cipla’ on cap & ‘422’ over ‘100 mg’ on body in blue ink. Bottle of 30 NDC 63187-301-30 Bottle of 60 NDC 63187-301-60 Bottle of 90 NDC 63187-301-90 Storage: Store at 25°C (77°F) [see USP Controlled Room Temperature]

📋 Description 79 words ▾

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

💬 Information for Patients ~3 min read ▾

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

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

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

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

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

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

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

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

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

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

17.8Effects During Pregnancy Patients should be informed that in late pregnancy Celecoxib Capsules should be avoided because it m… [Excerpted — this section continues on DailyMed.]

💬 Medication Guide ~3 min read ▾

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 increasing doses of NSAID medicines • 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: • increasing doses of NSAID medicines • 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 past 30 weeks of pregnancy. • if you are breastfeeding, talk to your doctor.

What are the possible side effects of Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)? Serious side effects include: Other side effects include: ● heart attack ● stomach pain ● heart attack ● constipation ● stroke ● diarrhea ● high blood pressure ● gas ● heart failure from body swelling (fluid retention) ● heartburn ● kidney problems including kidney failure ● nausea ● bleeding and ulcers in the stomach and intestine ● vomiting ● low red blood cells (anemia) ● dizziness ● life-threatening skin reactions ● life-threatening allergic reactions ● liver problems including liver failure ● asthma attacks in people who have asthma Get emergency help right away if you have any of the following symptoms: ● shortness of breath or trouble breathing ● slurred speech ● chest pain ● swelling of the face or throat ● weakness in one part or side of your body Stop your NSAID medicine and call your healthcare provider right away if you have any of the following symptoms: ● nausea ● more tired or weaker than usual ● vomit blood ● itching ● there is blood in your bowel movement or it is black and sticky like tar ● your skin or eyes look yellow ● unusual weight gain ● stomach pain ● skin rash or blisters with fever ● flu-like symptoms ● 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… [Excerpted — this section continues on DailyMed.]

🍼 Nursing Mothers 76 words ▾

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

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

🧬 Pharmacokinetics ~3 min read ▾

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 1 Subjects under fasting conditions (n=36, 19-52 yrs.) Mean (%CV) PK Parameter Values Cmax, ng/mL Tmax, hr Effective t1/2, hr Vss/F, L CL/F, L/hr 705 (38) 2.8 (37) 11.2 (31) 429 (34) 27.7 (28) Food Effects: When Celecoxib Capsules were taken with a high fat meal, peak plasma levels were delayed for about 1 to 2 hours with an increase in total absorption (AUC) of 10% to 20%.

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

Higher doses (400 mg twice daily) should be administered with food to improve absorption. In healthy adult volunteers, the overall systemic exposure (AUC) of celecoxib was equivalent when celecoxib was administered as intact capsule or capsule contents sprinkled on applesauce. There were no significant alterations in C max , T max or 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, a 1 -acid glycoprotein. The apparent volume of distribution at steady state (V ss /F) is approximately 400 L, suggesting extensive distribution into the tissues.

Celecoxib is not preferentially bound to red blood cells. Metabolism: Celecoxib metabolism is primarily mediated via CYP2C9. Three metabolites, a primary alcohol, the corresponding carboxylic acid and its glucuronide conjugate, have been identified in human plasma.

These metabolites are inactive as COX-1 or COX-2 inhibitors. Excretion: Celecoxib is eliminated predominantly by hepatic metabolism with little (<3%) unchanged drug recovered in the urine and feces. Following a single oral dose of radiolabeled drug, approximately 57% of the dose was excreted in the feces and 27% was excreted into the urine.

The primary metabolite in both urine and feces was the carboxylic acid metabolite (73% of dose) with low amounts of the glucuronide also appearing in the urine. It appears that the low solubility of the drug prolongs the absorption process making terminal half-life (t 1/2 ) determinations more variable. The effective half-life is approximately 11 hours under fasted conditions.

The apparent plasma clearance (CL/F) is about 500 mL/min. Geriatric: At steady state, elderly subjects (over 65 years old) had a 40% higher C max and a 50% higher AUC compared to the young subjects. In elderly females, celecoxib C max and AUC are higher than those for elderly males, but these increases are predominantly due to lower body weight in elderly females.

Dose adjustment in the elderly is not generally necessary. However, for patients of less than 50 kg in body weight, initiate therapy at the lowest recommended dose [see Dosage and Administration ( 2.6 ) and Use in Specific Populations ( 8.5 )]. Pediatric: The steady state pharmacokinetics of celecoxib a… [Excerpted — this section continues on DailyMed.]

🧬 Pharmacodynamics 152 words ▾

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 is 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.

🔬 Clinical Studies ~3 min read ▾

14 CLINICAL STUDIES

14.1Osteoarthritis Celecoxib has demonstrated significant reduction in joint pain compared to placebo. Celecoxib was evaluated for treatment of the signs and the symptoms of OA of the knee and hip in placebo- and active-controlled clinical trials of up to 12 weeks duration. In patients with OA, treatment with Celecoxib Capsules 100 mg twice daily or 200 mg once daily resulted in improvement in WOMAC (Western Ontario and McMaster Universities) osteoarthritis index, a composite of pain, stiffness, and functional measures in OA.

In three 12-week studies of pain accompanying OA flare, Celecoxib Capsules doses of 100 mg twice daily and 200 mg twice daily provided significant reduction of pain within 24-48 hours of initiation of dosing. At doses of 100 mg twice daily or 200 mg twice daily the effectiveness of celecoxib was shown to be similar to that of naproxen 500 mg twice daily. Doses of 200 mg twice daily provided no additional benefit above that seen with 100 mg twice daily.

A total daily dose of 200 mg has been shown to be equally effective whether administered as 100 mg twice daily or 200 mg once daily.

14.2Rheumatoid Arthritis Celecoxib Capsules has demonstrated significant reduction in joint tenderness/pain and joint swelling compared to placebo. Celecoxib Capsules was evaluated for treatment of the signs and symptoms of RA in placebo- and active-controlled clinical trials of up to 24 weeks in duration. Celecoxib was shown to be superior to placebo in these studies, using the ACR20 Responder Index, a composite of clinical, laboratory, and functional measures in RA.

Celecoxib Capsules doses of 100 mg twice daily and 200 mg twice daily were similar in effectiveness and both were comparable to naproxen 500 mg twice daily. Although Celecoxib Capsules 100 mg twice daily and 200 mg twice daily provided similar overall effectiveness, some patients derived additional benefit from the 200 mg twice daily dose. Doses of 400 mg twice daily provided no additional benefit above that seen with 100-200 mg twice daily.

14.3Juvenile Rheumatoid Arthritis In a 12-week, randomized, double-blind active-controlled, parallel-group, multicenter, non-inferiority study, patients from 2 years to 17 years of age with pauciarticular, polyarticular course JRA or systemic onset JRA (with currently inactive systemic features), received one of the following treatments: celecoxib 3 mg/kg (to a maximum of 150 mg) twice daily; celecoxib 6 mg/kg (to a maximum of 300 mg) twice daily; or naproxen 7.5 mg/kg (to a maximum of 500 mg) twice daily. The response rates were based upon the JRA Definition of Improvement greater than or equal to 30% (JRA DOI 30) criterion, which is a composite of clinical, laboratory, and functional measures of JRA.

The JRA DOI 30 response rates at week 12 were 69%, 80% and 67% in the celecoxib 3 mg/kg BID, celecoxib 6 mg/kg BID, and naproxen 7.5 mg/kg BID treatment groups, respectively. The efficacy and safety of celecoxib for JRA have not been studied beyond six months. The long-term cardiovascular toxicity in children exposed to celecoxib has not been evaluated and it is unknown if the long-term risk 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 )].

14.4Ankylosing Spondylitis Celecoxib Capsules was evaluated in AS patients in two placebo- and active-controlled clinical trials of 6 and 12 weeks duration. Celecoxib Capsules at doses of 100 mg twice daily, 200 mg once daily and 400 mg once daily was shown to be statistically superior to placebo in these studies for all three co-primary efficacy measures assessing global pain intensity (Visual Analogue Scale), global disease activity (Visual Analogue Scale) and functional impairment (Bath Ankylosing Spondylitis Functional Index).

In the 12-week study, there was no difference in the extent of improvement between the 200 mg and 400 mg Celecoxib Capsules… [Excerpted — this section continues on DailyMed.]

🧪 Nonclinical Toxicology ~1 min read ▾

13 NONCLINICAL TOXICOLOGY

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Celecoxib was not carcinogenic in rats given oral doses up to 200 mg/kg for males and 10 mg/kg for females (approximately 2-to 4-fold the human exposure as measured by the AUC 0-24 at 200 mg twice daily) or in mice given oral doses up to 25 mg/kg for males and 50 mg/kg for females (approximately equal to human exposure as measured by the AUC 0-24 at 200 mg twice daily) for two years. Celecoxib was not mutagenic in an Ames test and a mutation assay in Chinese hamster ovary (CHO) cells, nor clastogenic in a chromosome aberration assay in CHO cells and an in vivo micronucleus test in rat bone marrow.

Celecoxib did not impair male and female fertility in rats at oral doses up to 600 mg/kg/day (approximately 11-fold human exposure at 200 mg twice daily based on the AUC 0-24 ).

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

The clinical significance of this observation is unknown.

📄 Package Label / Principal Display Panel 28 words ▾

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL 100 mg Bottle Label Rx only NDC 63187-301-60 Celecoxib Capsules 100 mg PHARMACIST: Dispense the accompanying Medication Guide to each patient 60 Capsules 63187-301-60

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

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.

About this NDC listing & data coverage

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

Questions about this listing

Why is there no price listed?
The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The form printed on the packaging and shown on DailyMed is the one the FDA registered. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero and the dashes are dropped. The Identity section at the top of this page lists each form of this code.
Is this package still being marketed?
Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by Proficient Rx LP. Listing status can change — the directory data on this page refreshes weekly.
Does this product come in other package sizes?
Yes — the FDA directory lists 2 other package presentations of this same product, including 30 capsules (63187-0301-30), 90 capsules (63187-0301-90). Each has its own NDC and its own page — see the package list near the top of this page.
Who lists this product with the FDA?
Proficient Rx LP is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
Do I need a prescription for this product?
This NDC is listed with FDA as a prescription product, so it is dispensed under a prescriber's order. Your pharmacist can tell you whether any over-the-counter forms of the same medication exist.
This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.
Where does this data come from?
Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.
← 63187-0300-05 · Proficient 63187-0302-30 · Proficient →
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.