Quick answers
- What is Celecoxib used for?
- The FDA-approved label (Celebrex, Viatris Specialty LLC, November 22, 2024) says: “CELEBREX is indicated CELEBREX is a nonsteroidal anti-inflammatory drug indicated for: • Osteoarthritis (OA) • Rheumatoid Arthritis (RA) • Juvenile Rheumatoid Arthritis (JRA) in patients 2 years and older • Ankylosing Spondylitis (AS) • Acute Pain (AP) • Primary Dysmenorrhea (PD) 1.1 Osteoarthritis (OA) For the management of the signs and symptoms of OA […]. …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Celecoxib have a boxed warning?
- Yes. The FDA label for Celebrex has a boxed warning (“WARNING: RISK OF SERIOUS CARDIOVASCULAR AND GASTROINTESTINAL EVENTS”), the FDA’s strongest warning. Read it on the full label and ask your pharmacist.
- Is there a shortage of Celecoxib?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Celecoxib been recalled?
- FDA enforcement reports list 2 recalls of products of this medicine; the newest started May 13, 2025 (Class II). A recall usually concerns specific lots, not every product.
- Who makes Celecoxib?
- 61 companies list prescription products of Celecoxib in the FDA NDC Directory, including Bryant Ranch Prepack, Proficient Rx LP and A-S Medication Solutions.
What Celecoxib is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
CELEBREX is indicated CELEBREX is a nonsteroidal anti-inflammatory drug indicated for: • Osteoarthritis (OA) • Rheumatoid Arthritis (RA) • Juvenile Rheumatoid Arthritis (JRA) in patients 2 years and older • Ankylosing Spondylitis (AS) • Acute Pain (AP) • Primary Dysmenorrhea (PD) 1.1 Osteoarthritis (OA) For the management of the signs and symptoms of OA […]. …
— FDA label: Celebrex, Viatris Specialty LLC, effective November 22, 2024. Read the full label on DailyMed →
The FDA has 128 labels for products of this medicine (different makers and forms); uses can differ between them. Check the label that comes with your own medicine.
This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
Conditions named on the label
These condition names appear word for word in the label’s “Indications and Usage” text (matched with a reviewed table). Each page lists hospitals whose own websites name the condition.
Related medical specialties
Boxed warning
A boxed warning (“black box”) is the FDA’s strongest warning on a drug label, for serious or life-threatening risks.
This label has a boxed warning. Its heading: WARNING: RISK OF SERIOUS CARDIOVASCULAR AND GASTROINTESTINAL EVENTS
. Read it on the full label →
126 of 128 FDA labels for this medicine have a boxed warning.
Forms and how it is given
| Dosage forms | Capsule · Suspension · Liquid |
|---|---|
| Route | Oral |
| Prescription products | 237 in the FDA NDC Directory |
| Brand names | Celebrex, Vyscoxa, Elyxyb - Celecoxib |
What pharmacies pay (NADAC)
The National Average Drug Acquisition Cost (NADAC) is the average price U.S. retail pharmacies paid to buy one unit of a medicine (one tablet, one mL or one gram), from a monthly survey of pharmacy invoices by the Centers for Medicare & Medicaid Services (CMS). State Medicaid programs use it to pay pharmacies.
This is not the price you pay. What you pay depends on your insurance (copay or coinsurance), your pharmacy and any discounts, and pharmacies also charge for filling a prescription. Ask your pharmacist or your health plan what your price will be.
| Strength and form | Generic or brand | Pharmacies pay |
|---|---|---|
| celecoxib 100 mg capsule | Generic | $0.0615 per capsule |
| celecoxib 100 mg capsule | Brand: Celebrex | $9.53 per capsule |
| celecoxib 120 mg/4.8 mL liquid | Brand: ELYXYB - celecoxib | $30.50 per mL |
| celecoxib 200 mg capsule | Generic | $0.0749 per capsule |
| celecoxib 200 mg capsule | Brand: Celebrex | $15.65 per capsule |
| celecoxib 400 mg capsule | Generic | $0.2589 per capsule |
| celecoxib 400 mg capsule | Brand: Celebrex | $23.50 per capsule |
| celecoxib 50 mg capsule | Generic | $0.0812 per capsule |
NADAC list of November 4, 2026; these prices took effect on October 21, 2026. Shown only where a package’s NDC code matches the NADAC list exactly, and only for that exact strength and form: nothing is averaged across strengths. Strengths and forms not listed here have no NADAC price.
Source: NADAC (National Average Drug Acquisition Cost) 2026, data.medicaid.gov (CMS) →
Companies that list this medicine
Labelers in the FDA NDC Directory: the company named on the package (maker or distributor), with the number of prescription products.
- Bryant Ranch Prepack15 products
- Proficient Rx LP11 products
- A-S Medication Solutions11 products
- Asclemed USA, Inc.10 products
- Remedyrepack Inc.9 products
- Hawaii Repack, Inc.8 products
- Advanced Rx Pharmacy of Tennessee, LLC7 products
- St. Mary's Medical Park Pharmacy6 products
- Northwind Health Company, LLC6 products
- PD-Rx Pharmaceuticals, Inc.5 products
- Preferred Pharmaceuticals Inc.5 products
- AiPing Pharmaceutical, Inc.4 products
- Unichem Pharmaceuticals (USA), Inc.4 products
- Macleods Pharmaceuticals Limited4 products
- Yiling Pharmaceutical, Inc.4 products
- Modavar Pharmaceuticals LLC4 products
- Nivagen Pharmaceuticals, Inc.4 products
- Radha Pharmaceuticals, Inc.4 products
- Avet Pharmaceuticals Inc.4 products
- Micro Labs Limited4 products
- Epic Pharma, LLC4 products
- Alembic Pharmaceuticals Limited4 products
- Advanced Rx of Tennessee, LLC4 products
- NorthStar RxLLC4 products
- ScieGen Pharmaceuticals, Inc.4 products
- Viatris Specialty LLC4 products
- Qingdao BAHEAL Pharmaceutical Co., Ltd.4 products
- Cadila Pharmaceuticals Limited4 products
- Torrent Pharmaceuticals Limited4 products
- Umedica Laboratories USA Inc.4 products
- Aurobindo Pharma Limited4 products
- Cipla USA Inc.4 products
- Tianjin Tianyao Pharmaceuticals Co., Ltd.4 products
- Alembic Pharmaceuticals Inc.4 products
- Lupin Pharmaceuticals, Inc.4 products
- Direct_Rx3 products
- NuCare Pharmaceuticals, Inc.3 products
- Mullan Pharmaceutical Inc.3 products
- Chartwell RX, LLC3 products
- Cranbury Pharmaceuticals, LLC3 products
- Quallent Pharmaceuticals Health LLC2 products
- Phoenix RX LLC2 products
- Major Pharmaceuticals2 products
- Quality Care Products, LLC2 products
- Actavis Pharma, Inc.2 products
- Sportpharm LLC2 products
- AvPAK2 products
- NCS HealthCare of KY, LLC dba Vangard Labs2 products
- Westminster Pharmaceuticals, LLC2 products
- Apotex Corp.2 products
- American Health Packaging2 products
- Redpharm Drug2 products
- Medsource Pharmaceuticals1 product
- Cardinal Health 107, LLC1 product
- Aphena Pharma Solutions - Tennessee, LLC1 product
- DirectRx1 product
- Preferred Pharmaceutical, Inc.1 product
- RedPharm Drug, Inc.1 product
- Carwin Pharmaceutical Associates, LLC1 product
- Strides Pharma Science Limited1 product
- Scilex Pharmaceuticals Inc.1 product
FDA approval history
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
- ANDA: Abbreviated New Drug Application: how a generic version is approved.
| Application | Sponsor | Approved | Later changes approved |
|---|---|---|---|
| NDA020998 CELEBREX | Upjohn | December 31, 1998 | 30, latest November 21, 2024 2024: Labeling · 2021: Labeling · 2019: Labeling |
| NDA211759 VYSCOXA | Carwin Pharm Assoc | July 29, 2025 | — |
| NDA212157 ELYXYB | Scilex Pharms | May 5, 2020 | 2, latest November 21, 2024 2024: Labeling · 2021: Labeling |
Generic approvals (18)
- ANDA202240Lupin · October 29, 2014
- ANDA200562Watson Labs Inc · February 11, 2015
- ANDA204197Apotex · June 2, 2015
- ANDA204519Alembic · August 21, 2015
- ANDA207446Cipla · September 23, 2015
- ANDA207677Torrent · December 23, 2015
- ANDA206827Aurobindo Pharma · February 1, 2016
- ANDA204590Macleods Pharms · March 16, 2016
- ANDA210071Cspc Ouyi · January 23, 2018
- ANDA204776Micro Labs · April 30, 2018
- ANDA208856Qingdao Baheal Pharm · August 7, 2019
- ANDA208701Cadila Pharms Ltd · November 14, 2019
- ANDA210628Pharmazone · November 27, 2019
- ANDA207872Tianjin Tianyao · February 25, 2020
- ANDA211412Pharmobedient · March 6, 2020
- ANDA205129Sciegen Pharms · December 3, 2020
- ANDA213301Unichem · January 12, 2021
- ANDA213127Strides Pharma · April 29, 2025
Shortage status
The FDA drug shortage list does not show these products.
Recalls
From FDA enforcement reports, matched by the product’s NDC code. A recall usually covers specific lots only: check the lot number on your package and ask your pharmacist. Do not stop a medicine on your own.
-
May 13, 2025 · Class II · Ongoing · D-0460-2025
Presence of Foreign Tablets/Capsules: manufacturer recalled because one tadalafil 5mg tablet was found in 500 count bottle of Celecoxib 200 mg capsules
Celecoxib Capsules, 200 mg, 50 Capsules (5x10) Unit Dose per carton, Rx Only, Manufactured for: AvKARE, Pulaski, TN 38478. NDC 50268-169-15 — AvKARE
-
May 9, 2025 · Class II · Ongoing · D-0459-2025
Presence of Foreign Tablets/Capsules; customer complaint found one Tadalafil 5mg tablet inside a sealed 500-count bottle of Celecoxib 200mg capsule
Celecoxib Capsules, 200 mg, 500-count bottle, Rx only, Manufactured by: Alembic Pharmaceuticals Limited (Formulation Division), Panelav 389350, Gujarat, India, Manufactured for: Alembic Pharmaceuticals, Inc., Bedminster, — Alembic Pharmaceuticals Limited
What do the recall classes mean?
Class I: The most serious type: there is a reasonable chance that using the product will cause serious health problems or death.
Class II: Using the product may cause temporary or medically reversible health problems, or the chance of serious problems is remote.
Class III: Using the product is not likely to cause health problems (for example a labeling or packaging issue).
Official identifiers
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Celebrex, Viatris Specialty LLC, effective November 22, 2024; via openFDA, FDA data exported October 30, 2026, retrieved October 31, 2026
- NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
- Drug shortages (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
openFDA data is provided by the FDA as is; it may be incomplete. Always rely on the label that comes with your medicine. FDA Enforcement Report search →