Active ingredient
Nabumetone
64 finished FDA listings contain Nabumetone as their only active ingredient.
FDA NDC Directory
- Ingredient names as written by FDA
- NABUMETONE
- Dosage forms
- Tablet, Tablet, Film Coated
- Routes
- Oral
- Manufacturers / labelers
- 28
- Strengths listed
- 1000 mg/1 · 500 mg/1 · 750 mg/1
- Brand names in FDA listings
- Nabumetone 1000 Mg, Nabumetone 500 Mg, Nabumetone 750 Mg, Relafen Ds
RxNorm (National Library of Medicine)
Ingredient concept RxCUI 31448
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 |
|---|---|---|---|
| ANDA 075280 | CHARTWELL RX | 2002-02-25 | 2 |
| ANDA 078671 | INVAGEN PHARMS | 2008-03-07 | 8 |
| ANDA 078420 | SCIEGEN PHARMS | 2008-09-24 | 40 |
| ANDA 090445 | ANNORA PHARMA | 2011-01-12 | 2 |
| ANDA 091083 | WATSON LABS | 2011-06-13 | 6 |
| ANDA 203166 | LGM PHARMA | 2019-08-30 | 4 |
| ANDA 219118 | NOVITIUM PHARMA | 2025-01-07 | 2 |
Official labeling on DailyMed
- NABUMETONE TABLET [SPORTPHARM LLC] · version 1 · 2026-08-24
- NABUMETONE TABLET [PREFERRED PHARMACEUTICALS INC.] · version 6 · 2026-07-30
- NABUMETONE TABLET [PREFERRED PHARMACEUTICALS, INC.] · version 7 · 2026-07-30
- NABUMETONE TABLET, FILM COATED [ANI PHARMACEUTICALS, INC.] · version 3 · 2026-07-13
- NABUMETONE TABLET [ST. MARY'S MEDICAL PARK PHARMACY] · version 5 · 2026-06-29
- NABUMETONE TABLET [ST. MARY'S MEDICAL PARK PHARMACY] · version 5 · 2026-06-26
- NABUMETONE TABLET [REMEDYREPACK INC.] · version 4 · 2026-06-10
- NABUMETONE TABLET [NORTHWIND HEALTH COMPANY, LLC] · version 5 · 2026-03-03
- NABUMETONE TABLET [NORTHWIND HEALTH COMPANY, LLC] · version 5 · 2026-02-26
- NABUMETONE TABLET [REMEDYREPACK INC.] · version 4 · 2026-02-25
- NABUMETONE TABLET, FILM COATED [NORTHWIND HEALTH COMPANY, LLC] · version 4 · 2026-01-26
- NABUMETONE TABLET [REDPHARM DRUG] · version 3 · 2025-12-25
Showing the 12 most recent of 50 labels.
Sources: FDA NDC Directory (2026-09-29), RxNorm, Drugs@FDA, DailyMed. Each source’s facts are shown separately as published.