Active ingredient
Celecoxib
237 finished FDA listings contain Celecoxib as their only active ingredient.
FDA NDC Directory
- Ingredient names as written by FDA
- CELECOXIB
- Dosage forms
- Capsule, Liquid, Suspension
- Routes
- Oral
- Manufacturers / labelers
- 68
- Strengths listed
- 10 mg/ml · 100 mg/1 · 120 mg/4.8ml · 200 mg/1 · 400 mg/1 · 50 mg/1
- Brand names in FDA listings
- Celebrex, Celecoxib 200 Mg, Elyxyb - Celecoxib, Vyscoxa
RxNorm (National Library of Medicine)
Ingredient concept RxCUI 140587
Drugs@FDA applications
Linked only where the FDA listing’s application number matches Drugs@FDA exactly. A listing in the NDC Directory does not by itself mean FDA approval.
| Application | Sponsor | Original approval | Listings |
|---|---|---|---|
| NDA 020998 | UPJOHN | 1998-12-31 | 4 |
| ANDA 202240 | LUPIN | 2014-10-29 | 5 |
| ANDA 200562 | WATSON LABS INC | 2015-02-11 | 8 |
| ANDA 204197 | APOTEX | 2015-06-02 | 6 |
| ANDA 204519 | ALEMBIC | 2015-08-21 | 17 |
| ANDA 207446 | CIPLA | 2015-09-23 | 19 |
| ANDA 207677 | TORRENT | 2015-12-23 | 4 |
| ANDA 206827 | AUROBINDO PHARMA | 2016-02-01 | 7 |
| ANDA 204590 | MACLEODS PHARMS | 2016-03-16 | 28 |
| ANDA 210071 | CSPC OUYI | 2018-01-23 | 30 |
| ANDA 204776 | MICRO LABS | 2018-04-30 | 15 |
| ANDA 208856 | QINGDAO BAHEAL PHARM | 2019-08-07 | 9 |
| ANDA 208701 | CADILA PHARMS LTD | 2019-11-14 | 10 |
| ANDA 210628 | PHARMAZONE | 2019-11-27 | 13 |
| ANDA 207872 | TIANJIN TIANYAO | 2020-02-25 | 8 |
| ANDA 211412 | YILING | 2020-03-06 | 11 |
| NDA 212157 | SCILEX PHARMS | 2020-05-05 | 1 |
| ANDA 205129 | SCIEGEN PHARMS | 2020-12-03 | 36 |
| ANDA 213301 | UNICHEM | 2021-01-12 | 4 |
| ANDA 213127 | STRIDES PHARMA | 2025-04-29 | 1 |
| NDA 211759 | CARWIN PHARM ASSOC | 2025-07-29 | 1 |
Official labeling on DailyMed
- CELECOXIB CAPSULE [MAJOR PHARMACEUTICALS] · version 2 · 2026-09-11
- CELECOXIB CAPSULE [MULLAN PHARMACEUTICAL INC.] · version 4 · 2026-09-02
- CELECOXIB CAPSULE [REMEDYREPACK INC.] · version 7 · 2026-08-31
- CELECOXIB CAPSULE [DIRECTRX] · version 3 · 2026-08-31
- CELECOXIB CAPSULE [ST. MARY'S MEDICAL PARK PHARMACY] · version 1 · 2026-08-28
- CELECOXIB CAPSULE [A-S MEDICATION SOLUTIONS] · version 1 · 2026-08-26
- CELECOXIB CAPSULE [REMEDYREPACK INC.] · version 9 · 2026-08-19
- CELECOXIB CAPSULE [ALEMBIC PHARMACEUTICALS INC.] · version 15 · 2026-08-17
- CELECOXIB CAPSULE [REMEDYREPACK INC.] · version 1 · 2026-08-17
- CELECOXIB CAPSULE [A-S MEDICATION SOLUTIONS] · version 1 · 2026-08-10
- CELECOXIB CAPSULE [PD-RX PHARMACEUTICALS, INC.] · version 7 · 2026-08-05
- CELECOXIB CAPSULE [REMEDYREPACK INC.] · version 8 · 2026-07-23
Showing the 12 most recent of 133 labels.
Sources: FDA NDC Directory (2026-09-29), RxNorm, Drugs@FDA, DailyMed. Each source’s facts are shown separately as published.